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EO12866_2050-Pharms_AG39_NPRM_2015.07.04

6560-50-P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 261, 262, 266, 268, and 273

[EPA-HQ-RCRA-2007-0932; FRL_ -9924-08-OSWER ]

RIN 2050-AG39

Management Standards for Hazardous Waste Pharmaceuticals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Some pharmaceuticals are regulated as hazardous waste under the Resource 

Conservation and Recovery Act (RCRA) when discarded. Healthcare facilities that generate 

hazardous waste pharmaceuticals as well as associated facilities have reported difficulties 

complying with the Subtitle C hazardous waste regulations for a number of reasons. First, 

healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable 

about the RCRA hazardous waste regulations, but are often involved in the implementation of 

the regulations. Second, a healthcare facility can have thousands of items in its formulary, 

making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some 

active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in 

small amounts. To facilitate compliance and to respond to these concerns, the U.S. 

Environmental Protection Agency (EPA or the Agency) is proposing to revise the regulations to 

improve the management and disposal of hazardous waste pharmaceuticals and tailor them to 

address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. 

The revisions are also intended to clarify the regulation of the reverse distribution mechanism 
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used by healthcare facilities for the management of unused and/or expired pharmaceuticals.

DATES: Comments must be received on or before [insert date 9060 days after publication in 

the Federal Register]. 

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-RCRA-2007-

0932, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 

instructions for submitting comments. Comments may not be edited once submitted, and may 

publish in the docket without changes by the EPA. Do not submit electronically any information 

you consider to be Confidential Business Information (CBI) or other information whose 

disclosure is restricted by statute. If you need to include CBI as part of your comment, please 

visit http://www.epa.gov/dockets/comments for instructions. Multimedia submissions (audio, 

video, etc.) must be accompanied by a written comment. The written comment is considered the 

official comment and should include discussion of all points you wish to make. For additional 

submission methods, the full EPA public comment policy, and general guidance on making 

effective comments, please visit http://www.epa.gov/dockets/comments.

FOR FURTHER INFORMATION CONTACT: Kristin Fitzgerald, Office of Resource 

Conservation and Recovery (5304P), Environmental Protection Agency, 1200 Pennsylvania 

Avenue NW., Washington, DC 20460; telephone number: 703-308-8286; email address:

fitzgerald.kristin@epa.gov or Mary Jackson, Office of Resource Conservation and Recovery 

(5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 

20460; telephone number: 703-308-8453; email address: jackson.mary@epa.gov.
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SUPPLEMENTARY INFORMATION: 

I. General Information

Does this Action Apply to Me?

This is a proposed rule. If finalized, this rule would apply to healthcare facilities, 

pharmaceutical reverse distributors, and owners or operators of treatment, storage, and disposal 

facilities engaged in the management of hazardous waste pharmaceuticals. The list of NAICS 

codes for the potentially affected entities, other than RCRA treatment, storage and disposal 

facilities (TSDFs,), are presented in Table 1 below. More detailed information on the potentially 

affected entities is presented in Section V.A and Section V.B.1 of this preamble. 

Table 1: NAICS Codes of Entities Potentially Affected by this Final Rule: Healthcare 

Facilities and Pharmaceutical Reverse Distributors

NAICS Codes Description of NAICS Code

44611 Pharmacies

54194 Veterinary Clinics

6211 Physicians’ Offices

6212 Dentists’ Offices

6213 Other Health Practitioners (e.g., chiropractors)

6214 Outpatient Care Centers

6219 Other Ambulatory Health Care Services

622 Hospitals

6231 Nursing Care Facilities (e.g., assisted living facilities, 

nursing homes, U.S. veterans domiciliary centers)

623311 Continuing Care Retirement Communities (e.g., assisted 

living facilities with on-site nursing facilities)

Subset of 92219 Medical Examiners and Coroners' Offices

Various NAICS Pharmaceutical Reverse Distributors

This table is not intended to be exhaustive, but rather provides a guide for readers 

regarding entities potentially impacted by this action. This table lists examples of the types of 

entities of which EPA is aware that could potentially be affected by this action. Other types of 

entities not listed could also be affected. To determine whether your entity, company, business, 
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organization, etc. is affected by this action, you should examine the applicability criteria in this 

rule. If you have questions regarding the applicability of this action to a particular entity, consult 

the person listed in the preceding “FOR FURTHER INFORMATION” section of this 

document.

Preamble Outline

I. Statutory Authority

II. List of Abbreviations and Acronyms

III. Summary of the Proposed Rule

IV. Background

A. What Is the History of Hazardous Waste Pharmaceutical Management Under RCRA?

B. What Are the Rationale and Goals for this Proposed Rule?

C. What Was the 2008 Pharmaceutical Universal Waste Proposal?

D. EPA’s Office of Inspector General Report

V. Detailed Discussion of the Proposed Rule 

A. What Terms Are Defined in this Proposed Rule?

B. What Is the Scope of this Proposed Rule?

C. What Are the Proposed Standards for Healthcare Facilities that Manage Noncreditable Hazardous Waste Pharmaceuticals?

D. How Does this Proposed Rule Address Healthcare Facilities that Accumulate

Potentially Creditable Hazardous Waste Pharmaceuticals Prior to Shipment to 

Pharmaceutical Reverse Distributors?

E. What Are the Proposed Novel Prohibitions, Exemptions and Other Unique 

Management Requirements for Hazardous Waste Pharmaceuticals?
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F. What are the Proposed Standards for Shipping Hazardous Waste Pharmaceuticals?

G. What Are the Proposed Standards for Pharmaceutical Reverse Distributors?

VI. Implementation and Enforcement

A. Healthcare Facilities 

B. Pharmaceutical Reverse Distributors

C. Healthcare Facilities and Pharmaceutical Reverse Distributors Managing Nonpharmaceutical Hazardous Waste in Accordance with 40 CFR Part 262 or Part 273

D. State EnforcementEnforcement Activities and Interpretations

VII. Request for Comment on EPA’s Efforts to Identify Additional Pharmaceuticals as 

Hazardous Wastes

VIII. Request for Comment on EPA’s Efforts to Amend the Acute Hazardous Waste Listing for 

Nicotine and Salts (Hazardous Waste No. P075)

A. Background

B. Basis for Original Listing

C. Rationale for EPA's Efforts to Amend the P075 Listing

D. Two Possible Approaches for Amending the P075 Listing

E. Request for Comments

IX. State Authorization

A. Applicability of Rules in Authorized States

B. Effect on State Authorization

C. Effect on State Authorization in States that Have Added Pharmaceuticals to the 

Universal Waste Program

X. Adding and Reserving Part 266, Subpart O
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XI. Statutory and Executive Order Reviews

A. Summary of the Regulatory Impact Analysis

B. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: 

Improving Regulation and Regulatory Review

C. Paperwork Reduction Act (PRA)

D. Regulatory Flexibility Small Business AnalysisAct

E. Unfunded Mandates Reform Act (UMRA)

F. Executive Order 13132: (Federalism)

G. Executive Order 13175: Consultation and Coordination with Indian Tribal 

Governments

H. Executive Order 13045: Protection of Children from Environmental Health Risks and 

Safety Risks

I. Executive Order 13211: Actions that Concerning Regulations that Significantly Affect 

Energy Supply, Distribution, or Use

J. National Technology Transfer and Advancement Act (NTTAA)

K. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations

I. Statutory Authority

These regulations are proposed under the authority of §§ 2002, 3001, 3002, and 3004 of 

the Solid Waste Disposal Act (SWDA) of 1970, as amended by the Resource Conservation and 

Recovery Act (RCRA) of 1976, as amended by the Hazardous and Solid Waste Amendments of 

1984 (HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924.
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II. List of Abbreviations and Acronyms

AARP American Association of Retired Persons

AEA Atomic Energy Act

API Active Pharmaceutical Ingredient

BDAT Best Demonstrated Available Technology

CERCLA Comprehensive Environmental Response, Compensation and Liability Act

CESQG Conditionally Exempt Small Quantity Generator

CFR Code of Federal Regulations

CSA Controlled Substances Act

CWA Clean Water Act

DEA Drug Enforcement Administration

DHHS Department of Health and Human Services

DOE Department of Energy

DOT Department of Transportation

EPA Environmental Protection Agency

EO Executive Order

FDA U.S. Food and Drug Administration

FR Federal Register

HIPAA Health Insurance Portability and Accountability Act

HSWA Hazardous and Solid Waste Amendments

LQG Large Quantity Generator

LQUWH Large Quantity Universal Waste Handler
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LTCF Long-term Care Facility

LTCP Long-term Care Pharmacy

MSWLF Municipal Solid Waste Landfill

NIOSH National Institute for Occupational Safety and Health

NPRM Notice of Proposed Rulemaking

NRC Nuclear Regulatory Commission

OIG Office of Inspector General

OMB Office of Management and Budget

ONDCP Office of National Drug Control Policy

OSHA U.S. Department of Labor’s Occupational Safety and Health Administration

OSWER Office of Solid Waste and Emergency Response

OSWI Other Solid Waste Incinerators

OTC Over-the-counter

POTW Publicly Owned Treatment Works

RCRA Resource Conservation and Recovery Act

RQ Reportable Quantity

SQG Small Quantity Generator

SQUWH Small Quantity Universal Waste Handler

SWDA Solid Waste Disposal Act

TC Toxicity Characteristic

TCLP Toxicity Characteristic Leaching Procedure

TSDF Treatment, Storage and Disposal Facility
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III. Summary of the Proposed Rule

EPA is proposing to add a subpart P under 40 CFR part 266. This new subpartPart 266 is 

entitled, "Standards for the Management of Specific Hazardous Wastes and Specific Types of 

Hazardous Waste Management Facilities." This new subpart P is a tailored, sector-specific 

regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and 

pharmaceutical reverse distributors. If finalized, healthcare facilities that are currently small 

quantity generators (SQGs) or large quantity generators (LQGs) and all pharmaceutical reverse 

distributors, regardless of their RCRA generator category, will be required to manage their 

hazardous waste pharmaceuticals under subpart P of 40 CFR part 266, instead of 40 CFR part 

262. That is, the proposed standards are not an optional alternative to managing hazardous waste 

pharmaceuticals under 40 CFR part 262; they are mandatory standards. 

Briefly, healthcare facilities will have different management standards for their noncreditable and creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste 

pharmaceuticals (i.e., those that are not expected to be eligible to receive manufacturer's credit) 

will be managed on-site similar to how they would have been under a previous proposal for 

managing these wastes: the 2008 Universal Waste proposal for pharmaceutical waste (73 FR 

73520; December 2, 2008). When shipped off-site, they must be transported as hazardous 

wastes, including the use of the hazardous waste manifest, and sent to a RCRA interim status or 

permitted facility. On the other hand, healthcare facilities will continue to be allowed to send 

potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors for 

processing manufacturers’ credit. In response to comments received on the Universal Waste 

proposal, EPA is proposing standards to ensure the safe and secure delivery of the creditable 

hazardous waste pharmaceuticals to pharmaceutical reverse distributors. 
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EPA is also proposing standards for the accumulation of the creditable hazardous waste 

pharmaceuticals at pharmaceutical reverse distributors. Like healthcare facilities, pharmaceutical 

reverse distributors will not be regulated under 40 CFR part 262 as hazardous waste generators, 

nor will they be regulated under 40 CFR parts 264, 265 and 270 as treatment, storage, and 

disposal facilities (TSDFs). Rather, the proposal establishes a new category of hazardous waste

entity, called pharmaceutical reverse distributors. The proposed standards for pharmaceutical 

reverse distributors are, in many respects, similar to the LQGs standards, with supplementary 

standards added to respond to commenters’ concerns. 

For both healthcare facilities and reverse distributors, EPA is proposing to prohibit 

facilities from disposing of hazardous waste pharmaceuticals down the toilet or drain (i.e, 

flushed or sewered). Further, EPA proposes that hazardous waste pharmaceuticals managed 

under subpart P will not be counted toward calculating the site’s generator category.

Additionally, EPA is proposing a conditional exemption for hazardous waste pharmaceuticals 

that are also DEA controlled substances. Finally, EPA is proposing management standards for 

hazardous waste pharmaceutical residues remaining in containers.

IV. Background

A. What is the History of Hazardous Waste Pharmaceutical Management Under RCRA?

1. What Is the Resource Conservation and Recovery Act?

The Resource Conservation and Recovery Act governs the management and disposal of 

hazardous wastes.1 Under Subtitle C of RCRA, EPA has established a comprehensive set of 

 

1 RCRA also governs the disposal of non-hazardous solid wastes; however, state and/or local environmental 

regulatory agencies predominantly administer the regulations pertaining to the management of non-hazardous 

wastes. 
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regulations for hazardous waste management, generation, transportation, treatment, storage, and 

disposal. EPA can authorize an individual state hazardous waste program to operate in lieu of the 

federal program provided the authorized state’s program is at least as stringent as, and consistent 

with, the federal program.

2 However, EPA maintains oversight of the authorized state’s 

hazardous waste program and the authority to take independent enforcement actions. RCRA 

regulates pharmaceutical wastes that meet a listing of hazardous waste or exhibit one or more 

characteristics of hazardous waste. Accordingly, hospitals, pharmacies, reverse distributors and 

other healthcare-related establishments that generate hazardous wastes, including hazardous 

waste pharmaceuticals, are required to manage and dispose of their hazardous wastes in 

accordance with applicable federal, state, and/or local environmental regulations. 

2. What Are the Current Standards for Generators of Hazardous Waste? 

Currently, there are no RCRA Subtitle C regulations that focus specifically on the 

management of hazardous wastes from hospitals, pharmacies, reverse distributors and other 

healthcare-related facilities. Rather, healthcare facilities are currently required to comply with 

the same RCRA hazardous waste regulations as many other industries that generate hazardous 

waste. While the RCRA Subtitle C program has requirements for all aspects of hazardous waste 

management, including those generating (referred to as “generators” by RCRA), transporting, 

storing, treating, and disposing of hazardous wastes, it is the generator requirements found under 

40 CFR part 262 that will typically be most pertinent to healthcare-related facilities. 

Under the federal RCRA regulations, the standards for hazardous waste generators are 

divided into three categories—LQGs, SQGs, and Conditionally Exempt Small Quantity 

 

2 For more information on RCRA State Authorization, see: http://www.epa.gov/osw/laws-regs/state/index.htm
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Generators (CESQGs) depending upon the total amount of hazardous waste a facility generates 

per calendar month. It is the facility’s generator category that determines the applicable RCRA 

hazardous waste management requirements with which the generator must comply.3

A generator that generates a “solid waste”

4

is required by § 262.11 to determine whether 

such waste meets the definition of RCRA hazardous waste.5If the waste meets the RCRA 

definition of a hazardous waste, then the generator must manage the waste in accordance with 

the regulations that apply to its hazardous waste generator category (see § 261.5 and 40 CFR part 

262 for the generator regulations). In particular: 

 Facilities qualify as LQGs if in a calendar month they generate 1,000 kg or more of 

hazardous waste or more than 1 kg of acute hazardous waste (i.e., P-listed waste), or 

more than 100 kg of any residue or contaminated soil, waste, or other debris resulting 

from the clean-up of a spill, into or on any land or water, of any acute hazardous wastes 

listed in §§261.31 or 261.33(e). Federal regulations for LQGs include, but are not limited 

to the following: obtaining an EPA Identification number; a 90-day limit for 

accumulating hazardous waste on-site (with relevant standards for the accumulation of 

hazardous waste) without having to obtain a RCRA permit or comply with the interim 

status standards, provided that they comply with the conditions for exemption set forth in 

§ 262.34(a) such as management and labeling standards specific to the type of 

 

3 For more information on hazardous waste generators, please see: 

http://www.epa.gov/waste/hazard/generation/index.htm

4 See 40 CFR 261.2 for the definition of solid waste.

5 The waste determination process includes determining if the waste is specifically excluded or exempted from the 

RCRA hazardous waste regulations. If not, then the entity must determine if the waste is listed by EPA under the F-, 

K-, P- or U-lists of hazardous wastes (§§ 261.31‒33). If the waste is not listed, then it must be determined if the 

waste exhibits a characteristic of a hazardous waste: ignitability, corrosivity, reactivity, or toxicity (§§ 261.21–24). 
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accumulation unit (e.g., container, tank); RCRA training of personnel; contingency 

planning; manifesting and recordkeeping and reporting (biennial report). 

 Facilities qualify as SQGs if in a calendar month they generate more than 100 kg but less 

than 1,000 kg of hazardous waste. SQGs are subject to fewer requirements than LQGs

and are given additional flexibility. For example, SQGs have a longer on-site 

accumulation time limit (180 or 270 days vs. 90 days for LQGs), with fewer standards for 

the accumulation of hazardous waste, without having to obtain a RCRA permit or comply 

with the interim status standards, provided that they comply with the conditions set forth 

in § 262.34(d) (which have fewer personnel training and contingency planning 

obligations than in the conditions for exemption for LQGs); and do not need to complete 

a biennial report (BR).

 Facilities qualify as CESQGs if in a calendar month they generate less than or equal to 

100 kg of hazardous waste, and less than or equal to 1 kg of acutely hazardous waste (i.e., 

P-listed), and less than or equal to 100 kg of any residue or contaminated soil, waste, or 

other debris resulting from the clean-up of a spill, into or on any land or water, of any 

acute hazardous wastes listed in §§261.31, or 261.33(e).6 CESQGs are subject to very 

few of the RCRA Subtitle C hazardous waste regulations, provided that they comply with 

the conditions set forth in § 261.5(f)(3) and (g)(3). 

Finally, under the household hazardous waste exemption in § 261.4(b)(1), hazardous 

wastes generated by households are not subject to the RCRA hazardous waste regulations. This 

 

6 EPA recommends that facilities that qualify as CESQGs under the federal regulations contact their state and/or 

local environmental regulatory agencies, as authorized states can be more stringent than the federal regulations. As a 

result, not all authorized states recognize the CESQG category or they may have more stringent regulatory 

requirements for CESQGs. 
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exemption from the Subtitle C requirements extends to any household wastes collected during 

community-oriented take-back programs or events, as long as these collected household 

hazardous wastes are managed separately from regulated hazardous wastes.7 However, while 

collected household hazardous wastes are not regulated under the federal standards, more 

stringent state standards may apply. 

3. Are Pharmaceuticals Considered Hazardous Wastes Under RCRA? 

A portion of the pharmaceuticals currently on the market meets RCRA’s definition of 

hazardous waste when discarded. As previously explained, it is the responsibility of the 

generator of a solid waste to determine if the waste is hazardous; this includes solid wastes that 

are pharmaceuticals. If the pharmaceutical waste meets RCRA’s definition of hazardous waste, 

then the generator must manage it in accordance with all applicable federal, state, and/or local 

environmental regulations. A pharmaceutical is considered a hazardous waste under RCRA in 

one of two ways. First, a discarded pharmaceutical can be a listed hazardous waste if it is a 

commercial chemical product8that is listed under RCRA’s P- or U-list, and the pharmaceutical 

has not been used for its intended purpose (§ 261.33 (e) and (f), respectively).9 A few examples 

of pharmaceuticals that are considered P-listed wastes when discarded are arsenic trioxide 

 

7 For clarification on household hazardous waste collection issues, please see the November 1, 1988 memo from 

Win Porter to the Regional Waste Management Division Directors (RCRA Online # 11377) at: 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/2FD51915214EF63C8525670F006BD

C88/$file/11377.pdf

8 Commercial chemical product refers to a chemical substance which is manufactured or formulated for commercial 

or manufacturing use which consists of the commercially pure grade of the chemical, any technical grades of the 

chemical that are produced or marketed and all formulations in which the chemical is the sole active ingredient (§ 

261.33(d)). 

9 The P- and U-lists deem as hazardous certain commercial chemical products when they are discarded or intended 

to be discarded. These listings consist of commercial chemical products having the generic names listed, offspecification species, container residues, and spill residues. Chemicals on the P-list are identified as acute hazardous 

wastes and are regulated at lower amounts than those on the U-list. 
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(P012), smoking cessation products with nicotine as the sole active ingredient (P075), and 

pharmaceuticals with greater than 0.3% warfarin (and salts) as the sole active ingredient, such as 

Coumadin (P001). Some examples of pharmaceuticals that are considered U-listed wastes are: 

cyclophosphamide (U058), mitomycin C (U010), streptozotocin (U206) and warfarin and salts 

(≤ 0.3%) as the sole active ingredient (U248). 

Second, if the discarded pharmaceutical is not on the P- or U- list, then the 

pharmaceutical may be a hazardous waste if it exhibits one or more of the hazardous waste 

characteristics. Under the federal requirements (§ 261.21‒24), a waste is a characteristic 

hazardous waste if it is ignitable (D001), corrosive (D002), reactive (D003) or toxic (D004–

D043).10 A number of pharmaceuticals are prepared in alcohol, which may cause the waste to be 

hazardous due to ignitability (D001), even if the active pharmaceutical ingredient itself is not 

considered hazardous waste. The Regulatory Impact Analysis for this proposed rule includes a 

list of pharmaceuticals that, to our knowledge, are hazardous waste when disposed, although this 

list should not be considered exhaustive (see the docket for this proposed rule EPA-HQ-RCRA2007-0932).

Since the hazardous waste rules were initially promulgated, EPA has issued several 

clarifications regarding the regulatory status of certain commercial chemical products on the Pand U-lists, and these clarifications have affected the regulatory status of some active 

pharmaceutical ingredients.11 For example, EPA recently clarified that phentermine 

 

10 The toxicity characteristic (TC) indicates that the waste is likely to leach concentrations of contaminants that may 

be harmful, and TC waste is identified using the Toxicity Characteristic Leaching Procedure (see § 261.24). 

Examples of TC constituents that may be present in pharmaceuticals include, but are not limited to: arsenic, barium, 

cadmium, selenium, silver, chloroform, lindane and m-cresol. 

11 In addition, in December 2008, the Agency proposed to regulate hazardous waste pharmaceuticals under the 

Universal Waste rule. However, based on the comments received, the Agency decided not to finalize that proposal 
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hydrochloride and other phentermine salts are not included within the scope of the P046 

(phentermine) listing.12 Similarly, EPA has also clarified that epinephrine salts are not included 

in the epinephrine listing (P042).13 In addition, medicinal nitroglycerin typically is not 

considered P081 since the medicinal form of this compound generally does not exhibit the 

characteristic of reactivity for which nitroglycerin was originally listed.14 Furthermore, in a 1998 

memo, EPA clarified that the U034 listing includes both anhydrous chloral and chloral hydrate.

15

And in a 2010 memo, EPA stated that unused nicotine patches, gums and lozenges are finished 

dosage forms of nicotine and therefore are regulated as P075 when discarded.16

Finally, EPA has developed a “Hazardous Waste Pharmaceuticals Wiki” as a platform to 

facilitate the sharing of expertise among the healthcare industry and other stakeholders in order 

to help make accurate hazardous waste determinations for waste pharmaceuticals and increase 

compliance with the hazardous waste regulations. The Hazardous Waste Pharmaceuticals Wiki 

will also help users find guidance documents, state-specific information, and manufacturers’ 

information. The Hazardous Waste Pharmaceuticals Wiki can be viewed at: 

http://hwpharms.wikispaces.com. EPA encourages healthcare stakeholders to use the Wiki to 

 

and to proceed with a sector-based approach. (See section IV.C. of the preamble for further discussion of the 

Universal Waste proposal.)

12Memo from Devlin to RCRA Division Directors, February 17, 2012 (RCRA Online # 14831)

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/A5C07D01188ECA59852579EA0067

CDB1/$file/14831.pdf

13 Memo December 1, 1994 (RCRA Online # 13718)

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/1C1DEB3648A62A868525670F006B

CCD2/$file/13718.pdf

14 Memo from Dellinger to Smith, March 18, 2003 (RCRA Online # 14654)

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7ACFEC572DE8897F85256D1600748

BCB/$file/14654.pdf

15 Memo from Brandes to Knauss, April 6, 1998 (RCRA Online #14175)

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7417D2556AD322FA852568E300468

198/$file/14175.pdf

16 Memo from Dellinger to Smith, August 23, 2010 (RCRA Online # 14817)

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/209444BADDA4ECDC852577ED006

24E8F/$file/14817.pdf
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share information regarding federal hazardous waste pharmaceuticals, as well as state-only 

hazardous waste pharmaceuticals.17

B. What Aare the Rationale and Goals for this Proposed Rule?

1. Sector-based Approach

The impetus behind this proposal is to address the various concerns raised by 

stakeholders regarding the difficulty in implementing the Subtitle C hazardous waste regulations

for the management of hazardous waste pharmaceuticals generated at healthcare facilities. EPA 

has met with various stakeholders to learn about compliance challenges, and it has received input 

from stakeholders through more formal mechanisms. For instance, when EPA solicited 

stakeholder input in response to Executive Order 13563 (Improving Regulation and Regulatory 

Review), retailers submitted comments detailing compliance challenges with hazardous waste 

pharmaceuticals in their stores.18 Further, EPA’s Office of Inspector General (OIG) published a 

report citing the need to clarify how hazardous waste pharmaceuticals are regulated (for more 

information on both of these reports, see the next section). These two reports and input from 

healthcare (and associated) facilities identified a number of ways in which a healthcare facility 

differs from a manufacturing facility when it comes to applying the RCRA Subtitle C program 

for generating and managing hazardous waste.

First, in the healthcare setting, many hazardous waste pharmaceuticals are generated 

unpredictably and in relatively small quantities by a number of different employees across the 

 

17 Anyone may view the Wiki. Those in the healthcare community who wish to contribute content or edit the Wiki 

can register by sending an email request to HWPharmsWiki@epa.gov. 

18 Executive Order 13563 was signed by President Obama on January 18, 2011 and published in the Federal Register 

on January 21, 2011 (76 FR 3821). In response to the Executive Order, EPA solicited comments on "Improving 

EPA Regulations," in a Federal Register notice published on February 23, 2011 (76 FR 9988). See docket number 

EPA-HQ-OA-2011-0160 for public comments related to waste.
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facility. This situation differs from a manufacturing facility where fewer employees in a few 

locations generate comparatively much larger volumes of a smaller range of hazardous wastes. 

Second, under the current hazardous waste regulatory scheme, healthcare workers, whose 

primary focus is to provide care for patients, are typically responsible for making hazardous 

waste determinations since they are at the point of generation (e.g., a patient’s bedside). Yet, 

healthcare workers, such as nurses and doctors, do not typically have the expertise to make 

hazardous waste determinations.

Third, a healthcare facility can have thousands of items in its formulary at any one time 

and these may vary over time. In addition, pharmaceutical wastes come in many different forms, 

such as pills, patches, lozenges, gums, creams, and liquids, and are delivered by a variety of 

devices, such as nebulizers, intravenous (IV) tubing, syringes, etc. The combination of having 

thousands of different pharmaceutical products and little expertise in hazardous waste 

regulations makes it difficult for healthcare workers to make appropriate hazardous waste 

determinations when pharmaceuticals are disposed. This situation differs from manufacturing, 

where fewer, more predictable waste streams are generated.

Fourth, several of the hazardous waste pharmaceuticals that are generated by healthcare 

facilities are P-listed acute hazardous wastes (see § 261.33(e)), which are regulated at much 

smaller amounts. If a facility generates more than 1 kg of acute hazardous waste per calendar 

month or accumulates that amount at any time, it is regulated as an LQG. In addition to the 

pharmaceuticals, residues within pharmaceutical containers that contained P-listed commercial 

chemical products must be managed as acute hazardous waste even if the pharmaceutical was 
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fully dispensed,19 unless the container is RCRA-empty (e.g., by triple-rinsing the container). 

Triple rinsing can be impractical with certain medical devices, such as syringes and paper cups, 

so healthcare facilities often end up managing these containers as hazardous waste, which can 

result in the facilities being subject to the most stringently regulated generator category (i.e., 

LQG).20

To facilitate compliance among healthcare facilities and to respond to these concerns, 

EPA is proposing a new set of sector-specific regulations to improve the management and 

disposal of hazardous waste pharmaceuticals at healthcare facilities. This proposed rule also

intends to clarify the regulatory status of a major practice used by healthcare facilities for 

management of unused and/or expired pharmaceuticals, known as reverse distribution (see 

Sections V.D.1 and V.G).

In addition to improving compliance and responding to stakeholder concerns, the Agency 

has two additional goals for this proposal. The first is to reduce the amount of pharmaceuticals 

that are disposed of “down the drain.” This is presently an allowable and common disposal 

practice among healthcare facilities (as long as the pharmaceutical waste is not ignitable (see the 

Clean Water Act regulations of 40 CFR 403.5(b)(1)) and provided certain conditions are met 

(see the Clean Water Act regulations of 40 CFR 403.12(p))). Studies have found that many 

healthcare facilities, particularly long term-care facilities, are using drain disposal as a routine 

 

19 P-listed hazardous waste residues in containers are themselves considered P-listed hazardous wastes (see § 

261.33(c)), unless the container is considered “RCRA empty” either by undergoing triple-rinsing with an 

appropriate solvent; or cleaning with a method that has been proven in scientific literature or tests conducted by the 

generator to achieve equivalent removal (see § 261.7(b)(3)).

20 On November 4, 2011, ORCR issued a memo to the Regional RCRA Division Directors highlighting three 

acceptable approaches, beyond triple-rinsing containers, that healthcare facilities can employ when managing Plisted container residues. Please see: Memo from Suzanne Rudzinski to RCRA Division Directors (RCRA Online # 

14827) 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/57B21F2FE33735128525795F00610F

0F/$file/14827.pdf
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disposal method for pharmaceutical wastes. ReducingAlthough pharmaceuticals are also entering 

the environment through excretion, reducing sewer disposal is one mechanism to help reduce the 

environmental loading of pharmaceuticals into our Nation’s waters. For more information about 

sewer disposal and pharmaceuticals in water, see Section V.E.1.

The second goal is to address the overlap between EPA’s RCRA hazardous waste 

regulations and the controlled substances regulations of the Drug Enforcement Administration

(DEA). Stakeholders have indicated that hazardous waste pharmaceuticals that are also 

controlled substances are stringently regulated and expensive to dispose of in accordance with 

both sets of requirements when sent for incineration. In addition, stakeholders have indicated that

those regulated hazardous waste pharmaceuticals that are also controlled substances are most 

likely to be sewer disposed to avoid the costs of compliant incineration. EPA plans to address 

this overlap in this proposed rule, as this is an unnecessary burden for healthcare facilities and 

revised requirements will help to reduce sewer disposal.

2. Executive Order 13563 for the Retrospective Review of Existing Regulations 

On January 18, 2011, President Obama issued Executive Order 13563, which directed all 

federal agencies to perform periodic retrospective reviews of existing regulations to determine 

whether any should be modified, streamlined, expanded, or repealed.21 EPA made its preliminary 

plan available for public review and comment during the spring of 2011 and released the final 

version of the plan in August 2011.22 During the public comment process, EPA received requests 

 

21 For a copy of Executive Order 13563, please see: http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-

1385.pdf

22 US EPA. Improving Our Regulations: Final Plan for Periodic Retrospective Reviews of Existing Regulations. 

http://www.epa.gov/regdarrt/retrospective/documents/eparetroreviewplan-aug2011.pdf
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to clarify and make more effective the hazardous waste regulations as they pertain to discarded 

retail products, including pharmaceutical wastes. In response to this specific issue, EPA agreed 

to review data and information currently in its possession as part of the development for a 

rulemaking to address pharmaceutical waste management issues.23 This Notice of Proposed 

Rulemaking provides notice that EPA has completed its review and has satisfied this part of its 

obligation for retail hazardous waste pharmaceutical management issues.

3. Retail Notice of Data Availability

EPA published a Notice of Data Availability (NODA) for the Retail Sector on February 

14, 2014 (79 FR 8926), in which the Agency requested, among other things, comment on a series 

of topics related to retail operations in order to better understand the issues retail 

stores/establishments face in complying with RCRA regulations. Many retail commenters 

mentioned that because nicotine is an acute hazardous waste (P075), they are considered LQGs 

when they discard more than 1 kg per month of unused nicotine-containing products (e.g., ecigarettes and smoking cessation products such as gums, patches and lozenges). Retailers discard 

these products mainly because they are either expired or they are returned by customers and the 

retailer does not restock them due to safety concerns. In comments to the NODA, retailers urged 

the EPA to provide them some regulatory relief with regard to nicotine-containing products. See 

Section VIII of this preamble for a discussion of EPA’s potential future efforts to amend the 

acute hazardous waste listing for nicotine and salts (P075).

 

23See page 45, item 2.2.17 of EPA’s “Improving Our Regulations: Final Plan for Periodic Retrospective Reviews of 

Existing Regulations” at http://www.epa.gov/regdarrt/retrospective/documents/eparetroreviewplan-aug2011.pdf
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C. What Was the 2008 Pharmaceutical Universal Waste Proposal?

1. The 2008 Proposal to Add Hazardous Waste Pharmaceuticals to the Federal Universal Waste 

Program

On December 2, 2008, EPA proposed to add hazardous waste pharmaceuticals to the 

existing federal universal waste program, which would have provided a streamlined approach to 

facilitate the proper management and disposal of hazardous waste pharmaceuticals generated at 

pharmacies, hospitals, reverse distributors, and other healthcare-related facilities. Specifically, 

under the universal waste program, handlers and transporters who generate or manage items 

designated as a universal waste24 are subject to the management standards under part 273, rather 

than the full RCRA subtitle C hazardous waste regulations. Universal waste handlers include 

universal waste generators and collection facilities. The regulations distinguish between “large 

quantity handlers of universal waste” (or those who handle more than 5,000 kilograms of total 

universal waste at any one time) and “small quantity handlers of universal waste” (or those who 

handle 5,000 kilograms or less of universal waste at any one time).25 The streamlined 

requirements for all types of universal waste include modified requirements for storage, labeling 

and marking, preparing the waste for shipment off-site, employee training, response to releases 

and notification. 

Transporters of universal waste are also subject to less stringent requirements than the 

full RCRA subtitle C hazardous waste transportation regulations. However, the primary 

difference between the universal waste transportation requirements and full RCRA subtitle C 

requirements is that no hazardous waste manifest is required for the transport of universal waste. 

 

24 The current federal universal wastes include hazardous waste batteries, certain hazardous waste pesticides, 

mercury-containing equipment, and hazardous waste lamps. 

25 The 5,000 kilogram accumulation criterion applies to the quantity of all universal wastes accumulated. 
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Destination facilities under the universal waste program are those facilities that treat, 

store, dispose of, or recycle universal wastes. Universal waste destination facilities are subject to 

all currently applicable requirements for hazardous waste treatment, storage, and disposal 

facilities (TSDFs), including the requirement to obtain a RCRA permit for such activities. (See 

73 FR 73520, December 2, 2008, for a more detailed discussion of the proposed universal waste 

program for pharmaceutical wastes.)

2. What Were the Public Comments to the 2008 Pharmaceutical Universal Waste Proposal?

EPA received approximately 100 public comments on the 2008 proposal to add 

hazardous waste pharmaceuticals to the universal waste program.26 Generally, public 

commenters supported the Agency’s desire to address the issue of hazardous waste 

pharmaceutical management. However, although there were several aspects of the proposal that 

were well supported (e.g., training requirements, accumulation times, and hazardous waste 

pharmaceuticals not being counted towards the generator category), public commenters 

expressed concern over the lack of notification and tracking requirements for small quantity 

handlers of universal waste and the reduced notification and tracking requirements for large 

quantity handlers. As a result, commenters, including state environmental regulatory agencies, 

expressed concern that they would not be informed of hazardous waste pharmaceutical 

generation, management, and transportation in their regulatory jurisdictions. Furthermore, public 

commenters expressed concern that because the universal waste program does not require a

hazardous waste manifest or another tracking mechanism, the hazardous waste pharmaceuticals 

 

26 See docket EPA-HQ-RCRA-2007-0932 at www.regulations.gov for public comments: 

http://www.regulations.gov/#!docketDetail;D=EPA-HQ-RCRA-2007-

0932;dct=FR%252BPR%252BN%252BO%252BSR
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could be vulnerable to diversion. Public commenters argued that hazardous waste 

pharmaceuticals are different from the other federal universal wastes (batteries, mercurycontaining equipment, lamps, and pesticides) in that the pharmaceuticals, as well as their 

containers, still retain considerable value upon disposal and can be easily diverted for illicit 

purposes. Therefore, tracking requirements beyond the requirements included in the current 

universal waste program were considered necessary by the majority of the public commenters. 

In addition to the public comments about the strengths and weaknesses of using the 

universal waste program to address the disposal of hazardous waste pharmaceuticals, EPA 

received other comments expressing concern with the proposal, including the following: the 

point of generation of hazardous waste pharmaceuticals as it pertains to reverse distribution; the 

management of containers that contain hazardous waste pharmaceutical residues; the variability 

in the land disposal restriction (LDR) treatment standards for hazardous waste pharmaceuticals; 

the overlap of EPA and DEA regulations for the management of hazardous waste 

pharmaceuticals that are also controlled substances; and the lack of activity to add 

pharmaceutical wastes to the hazardous waste listings. The Agency provides additional 

discussion on these specific comments within this preamble. 

3. Why is EPA Not Finalizing the 2008 Pharmaceutical Universal Waste Proposal?

Based on the adverse comments received on the 2008 Pharmaceutical Universal Waste 

proposal regarding the lack of notification and tracking requirements for small quantity universal 

waste handlers, the reduced notification and tracking requirements for large quantity universal 

waste handlers, as well as the other issues raised in public comments, the Agency has decided to 

not finalize the proposal to add hazardous waste pharmaceuticals to the Universal Waste 
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program. In fact, EPA has concluded that the universal waste program is not appropriate for 

managing hazardous waste pharmaceuticals because, among other things, we are unable to 

adequately address the notification and tracking concerns raised by the public comments within 

the Universal Waste program.

Under the Universal Waste regulations, there are eight factors to consider when 

determining whether it is appropriate to add a new hazardous waste or category of hazardous 

waste to the Universal Waste program (§ 273.81). A hazardous waste does not need to meet 

every factor in order to be added to the Universal Waste program. Rather, the Agency’s decision 

is “based on the weight of evidence showing that regulation under part 273 is appropriate for the 

waste or category of waste, will improve management practices for the waste or category of

waste, and will improve implementation of the hazardous waste program” (§ 273.80(c)).

The Agency has concluded based on the comments received that the weight of evidence 

does not show that regulation under the Universal Waste program is appropriate for hazardous 

waste pharmaceuticals. Specifically, we find the Universal Waste program to be lacking with 

regard to the factor in § 273.81(e), which states that the risk posed by the waste being considered 

for universal waste be relatively low compared to other hazardous wastes and that the 

management standards would be protective of human health and the environment during 

accumulation and transport. Although we continue to believe that potentially creditable 

pharmaceuticals en route to reverse distributors pose a low risk for leaks and other releases to the 

environment, commenters urged us to consider the unique risk posed by the accumulation and 

transport of hazardous waste pharmaceuticals: the risk of diversion. Although it is rare that a 

hazardous waste is so valuable that it is sought for abuse or sale on the black market, EPA 
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believes that the diversion of hazardous waste pharmaceuticals for illicit use is a risk to human 

health. 

The Universal Waste program does not include sufficient tracking requirements to 

address the potential for diversion. Under part 273, tracking is not required for shipments by 

small quantity handlers of universal waste; certain tracking of shipments is required only for 

large quantity handlers of universal waste and destination facilities. More importantly, these 

basic tracking requirements consist only of recordkeeping of shipments sent and received and no 

tracking is required to ensure delivery. Commenters noted that these tracking requirements are 

not sufficient given the high value of many of the unused pharmaceuticals en route to reverse 

distribution and the potential for diversion. 

Accordingly, the Agency is proposing to amend § 273.80 to state that hazardous waste 

pharmaceuticals may not be added as a category of hazardous waste for management under the 

Universal Waste program. See Section IX State Authorization of the preamble for a discussion 

on the effect on the two states that have adopted pharmaceuticals under the Universal Waste 

program (Michigan and Florida).

By proposing a new set of management standards outside the confines of the Universal 

Waste program, it allows us greater flexibility in addressing the tracking of such shipments, as 

well as additional pharmaceutical waste management issues raised by stakeholders, such as drain 

disposal, container residues, pharmaceutical reverse distribution, and the overlap with DEA 

regulation. This new action will address the original stakeholder concerns that resulted in the 

2008 Pharmaceutical Universal Waste proposal, as well as the comments received on that 

proposal.
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To reiterate, EPA is not adding hazardous waste pharmaceuticals to the federal Universal 

Waste program. Rather, we are proposing sector-specific regulations for the management of 

hazardous waste pharmaceuticals by healthcare facilities and pharmaceutical reverse distributors.

If finalized, these regulations will be codified in 40 CFR part 266, separate from both the 

generator regulations (40 CFR part 262) and the Universal Waste program (40 CFR part 273). 

This new proposed rulemaking will pertain to those waste pharmaceuticals that meet the current 

definition of a RCRA hazardous waste and are generated by healthcare-related facilities and 

managed by pharmaceutical reverse distributors, as defined by this proposal. Finally, as this 

current proposal is a direct result of the comments received on the December 2, 2008,

Pharmaceutical Universal Waste proposal, the Agency considers the 2008 Pharmaceutical 

Universal Waste proposal obsolete. Therefore, EPA is withdrawing the Universal Waste 

proposal for pharmaceutical waste, and does not seek comment on any provisions of the 2008 

Pharmaceutical Universal Waste proposal or the current Universal Waste program. The Agency 

will only be accepting comments from the public on the provisions of this new proposed 

rulemaking.

D. EPA’s Office of Inspector General Report 

On May 25, 2012, the EPA’s Office of Inspector General (OIG) issued the report, “EPA 

Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal” 

(Report No. 12-P-0508).27 The OIG reviewed EPA’s process for identifying and listing 

pharmaceuticals as hazardous wastes. Because of this review, the OIG provided the following 

 

27 For a copy of the report, please see: http://www.epa.gov/oig/reports/2012/20120525-12-P0508.pdfhttp://www.epa.gov/oig/reports/2012/20120525-12-P-0508.pdf or see the docket for this proposed rule: 

EPA-HQ-RCRA-2007-0932.
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recommendations to the Assistant Administrator for the Office of Solid Waste and Emergency 

Response (OSWER):

1.1) Identify and review existing pharmaceuticals to determine whether they 

qualify for regulation as hazardous waste.

2.2) Establish a process to review new pharmaceuticals to determine 

whether they qualify for regulation as hazardous waste. 

3.3) Develop a nationally consistent outreach and compliance assistance 

plan to help states address challenges that healthcare facilities, and others 

as needed, have in complying with RCRA regulations for managing HWPs 

[hazardous waste pharmaceuticals] (Report No. 12-P-0508).

As detailed in OSWER’s response to OIG, this proposal fulfills our obligation for addressing the 

third recommendation.28 EPA does not address the OIG’s first two recommendations as part of 

this proposed rulemaking; however, in Section VII of this preamble, we solicit comment on our 

ongoing efforts to identify additional pharmaceuticals as hazardous wastes.

V. Detailed Discussion of the Proposed Rule

EPA is proposing an entirely new set of regulations (40 CFR part 266, subpart P) for 

managing hazardous waste pharmaceuticals at both healthcare facilities and pharmaceutical 

reverse distributors. This section discusses in detail the major features of the proposal. The 

Agency also presents other options that it is considering or were considered in developing the 

proposed rule. EPA welcomes comments on all aspects of this proposed rule, and on options 

 

28 For a copy of OSWER’s full response to OIG, please see: http://www.epa.gov/oig/reports/2012/12-P0508_Agency%20Response.pdf

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under consideration. Throughout this section, EPA requests comments on specific options and on 

specific issues, but comments are welcome on all provisions of this proposal. 

A. What Terms Are Defined in this Proposed Rule?

All the definitions that appear in this proposal are for the purposes of 40 CFR part 266,

subpart P only. Therefore, the definitions are relevant only to healthcare facilities and 

pharmaceutical reverse distributors that are subject to these proposed standards. For the purposes 

of this regulation, the Agency is proposing and soliciting public comment on the following terms 

and their definitions presented below: “evaluated hazardous waste pharmaceutical,” “hazardous 

waste pharmaceutical,” “healthcare facility,” “household waste pharmaceutical,” “long-term care 

facility,” “non-creditable hazardous waste pharmaceutical,” “non-hazardous waste 

pharmaceutical,” “non-pharmaceutical hazardous waste,” “pharmaceutical,” “pharmaceutical 

reverse distributor,” and “potentially creditable hazardous waste pharmaceutical.” Although the 

proposed definitions appear in alphabetical order in the regulations, we have chosen to discuss 

the proposed definitions in a different order in the preamble.

1. What is the Proposed Definition of “Pharmaceutical”?

This proposed rule defines “pharmaceutical” as any chemical or biological product that is 

intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or 

injury of a human or other animal; or any chemical or biological product that is intended to affect 

the structure or function of the body of a human or other animal. This definition includes, but is 

not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act

(FD&C Act), prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining 
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in containers, personal protective equipment contaminated with residues of pharmaceuticals, and 

clean-up material from the spills of pharmaceuticals.

This proposed definition of “pharmaceutical” is intended to include all dose forms, 

including, but not limited to tablets, capsules, medicinal gums or lozenges, medicinal liquids, 

ointments and lotions, intravenous (IV) or other compounded solutions, chemotherapy 

pharmaceuticals, vaccines, allergenics, medicinal shampoos, antiseptics, and any delivery device, 

including medicinal dermal patches, with the primary purpose to deliver or dispense the 

pharmaceutical. As a rule of thumb, if an over-the-counter product is required by the FDA to 

include “Drug Facts” on the label, it would be considered a pharmaceutical for the purposes of 

this rule. EPA asks for comment to identify additional types or forms of pharmaceuticals that are 

not adequately captured by the definition above.

EPA previously proposed to define the term “pharmaceutical” in the December 2008 

Pharmaceutical Universal Waste proposal to mean “any chemical product, vaccine or allergenic 

(including any product with the primary purpose to dispense or deliver a chemical product, 

vaccine or allergenic), not containing a radioactive component, that is intended for use in the 

diagnosis, cure, mitigation, treatment or prevention of disease or injury in man or other animals; 

or any chemical product, vaccine, or allergenic (including any product with the primary purpose 

to dispense or deliver a chemical product, vaccine, or allergenic), not containing a radioactive 

component, that is intended to affect the structure or function of the body in man or other 

animals. This definition includes products such as transdermal patches, and oral delivery devices 

such as gums or lozenges. This definition does not include sharps or other infectious or 

biohazard waste, dental amalgams, medical devices not used for delivery or dispensing purposes, 
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equipment, contaminated personal protective equipment or contaminated cleaning materials.” 

This definition was adapted from FD&C Act’s definition for “drug” 21 U.S.C. 321(g).

Based on the comments received in response to the Pharmaceutical Universal Waste 

proposal, the Agency is continuing to rely primarily on the FD&C Act’s definition for “drug” for 

the definition of pharmaceutical in this proposal and has preserved most of the definition 

proposed in the previous proposal. However, EPA is proposing to expand on its previous 

proposed definition of pharmaceutical based on stakeholder input. In particular, stakeholders 

requested that the Agency take a broad view in delineating what items are included in the 

definition of pharmaceutical so that the proposed standards apply broadly. Stakeholders indicated 

a preference for managing more items under the new standards than trying to determine how to 

apply the existing RCRA framework to pharmaceutical related items. Thus, the proposed 

definition of pharmaceutical no longer excludes pharmaceuticals with a radioactive component 

and includes items not specifically recognized by the U.S. Food and Drug Administration (FDA) 

as drugs, such as dietary supplements and pharmaceutical residues in containers (including 

delivery devices), personal protective equipment contaminated with residues of pharmaceuticals, 

and clean-up material from spills of pharmaceuticals. 

EPA’s decision to include dietary supplements under this rulemaking’s proposed 

definition of hazardous waste pharmaceutical reflects our interest in promoting a management 

scheme for all types of pharmaceuticals, and is based upon our understanding that dietary 

supplements are commonly found in various healthcare settings because they are recommended 
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or prescribed by healthcare providers to patients.29 Further, retail pharmacies routinely sell 

vitamins and other medicinal minerals and supplements.

When EPA uses the term “dietary supplements” in our proposed definition of 

“pharmaceutical,” EPA is referencing the definition for dietary supplement used by the FD&C 

Act, as amended by the Dietary Supplement Health and Education Act of 1994 (21 U.S.C. 

321(ff)).30 EPA understands that the FDA does not recognize dietary ingredients or dietary

supplements under its definition of “drug,” but rather categorizes such items under the general 

umbrella of foods and therefore, does not review them before being marketed.

31, 32 For the 

purposes of this proposed rule, however, EPA recognizes that healthcare facilities may benefit 

from managing dietary supplements along with other drugs under the regulatory scheme being 

proposed, and thus, is including it in the proposed definition of pharmaceutical. Although dietary 

supplements would be considered pharmaceuticals under this proposed definition, only the 

dietary supplements that meet the definition of hazardous waste (e.g., exhibits the toxicity 

characteristic for metal content) would be regulated under part 266, subpart P as hazardous waste 

pharmaceuticals (see the definition of “hazardous waste pharmaceutical”). We seek public 

 

29 Including dietary supplements under the definition of pharmaceutical for this regulation does not supersede the 

requirements of the Dietary Supplement Health and Education Act of 1994, the Federal Food, Drug and Cosmetic 

Act, or FDA regulations.

30 The substance of the definition is: a product (other than tobacco) intended to supplement the diet that bears or 

contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other 

botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total 

dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in 

clause (A), (B), (C), (D), or (E); For the complete definition for dietary supplement, please see: 

http://www.gpo.gov/fdsys/pkg/USCODE-20102013-title21/pdf/USCODE-20102013-title21-chap9-subchapIIsec321.pdf

31 For more information regarding dietary supplements, please see: 

http://www.fda.gov/Food/DietarySupplements/default.htm

32 It is the responsibility of the manufacturers to ensure their dietary supplements are safe and that all claims on 

labels are true and accurate. Nevertheless, FDA has the authority to take action against any unsafe dietary 

supplements, as well as to take action against any products with false and misleading claims. 

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comment on the Agency’s decision to recognize dietary supplements as pharmaceuticals under 

this regulation. 

The Agency also is clarifying that its proposed definition includes any items containing 

pharmaceutical residuals, such as dispensing bottles, IV bags and tubing, vials, unit dose 

packages, and delivery devices, such as syringes and patches. In addition, EPA is proposing that 

items contaminated with or containing residual pharmaceuticals, such as personal protective 

equipment containing trace amounts of pharmaceuticals or related spill clean-up materials 

(including loose tablets accumulated during pharmacy floor sweepings) also meet this proposed 

definition of pharmaceutical. However, this proposed definitions does not include sharps (e.g., 

needles from IV bags or syringes). Used sharps, such as needles or syringes with needles, are not 

included under the proposed rule because sharps are considered medical wastes, presently 

regulated at the state and local level. In addition, sharps pose both an unreasonable physical 

danger and biohazard danger so have not been included in the definition of pharmaceutical under 

this proposed rule. OSHA’s Technical Manual incorporates a recommendation from the 

American Society of Hospital Pharmacists that “all syringes and needles used in the course of 

preparation be placed in "sharps" containers for disposal without being crushed, clipped or 

capped.”

33 Further, as discussed in Section V.E.3.c of this preamble, EPA is proposing to 

conditionally exclude the residues of hazardous waste pharmaceuticals remaining in fully 

dispensed syringes from RCRA regulation. However, EPA is concerned about the possibility that 

some syringes may be disposed of in sharps containers that may contain significant amounts of 

undispensed pharmaceutical. EPA seeks comment on the prevalence of this situation.

 

33 See Section VI, Chapter 2 of OSHA’s Technical Manual (paragraph V.C.1.b.) 

https://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

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The Agency solicits public comment on the proposed definition of “pharmaceutical” in 

its entirety, and particularly on EPA’s decision to incorporate dietary supplements and items 

containing pharmaceutical residuals as part of the definition of pharmaceutical.

2. What Is the Proposed Definition of a “Hazardous Waste Pharmaceutical”?

This proposed rule defines ‘‘hazardous waste pharmaceutical” as a pharmaceutical that is 

a solid waste, as defined in § 261.2, and is listed in part 261, subpart D, or exhibits one or more 

characteristics identified in part 261, subpart C. See Section IV.A.3. of this preamble for a 

discussion of pharmaceuticals that may be listed or characteristic hazardous wastes.34

The Agency is proposing to define the term “hazardous waste pharmaceutical” in order to 

clarify its intent that only pharmaceuticals (as defined in this proposal) that meet the definition of 

hazardous waste when disposed or discarded need to be managed under these proposed 

management standards. This means that any pharmaceutical waste that meets the definition of 

hazardous waste is a hazardous waste pharmaceutical for the purposes of this rule. For example, 

the prescription pharmaceutical warfarin (brand name Coumadin) is a listed hazardous waste and 

when discarded meets the definition of a hazardous waste pharmaceutical. EPA requests public 

comment on the proposed definition for “hazardous waste pharmaceutical.” The Agency also 

solicits information on whether any dietary supplements currently on the market meet or 

potentially could meet RCRA’s definition of a hazardous waste. 

 

34 For additional information about RCRA hazardous waste listings and characteristics, see: 

http://www.epa.gov/osw/hazard/wastetypes/index.htm
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3. What Is the Proposed Definition of a “Potentially Creditable Hazardous Waste 

Pharmaceutical”? 

In order to distinguish hazardous waste pharmaceuticals that are transported to RCRA 

treatment, storage and disposal facilities (TSDFs) from those hazardous waste pharmaceuticals

being returned by a healthcare facility to a pharmaceutical reverse distributor for a determination 

or verification of manufacturer’s credit, the Agency is proposing a definition for “potentially 

creditable hazardous waste pharmaceutical.” 

The proposed rule defines “potentially creditable hazardous waste pharmaceutical” to mean a 

hazardous waste pharmaceutical that has the potential to receive manufacturer’s credit and is

(11i) unused or un-administered; and

(2ii2) unexpired or less than one year past expiration date.

The term does not include “evaluated hazardous waste pharmaceuticals,” residues of 

pharmaceuticals remaining in containers, contaminated personal protective equipment, and

clean-up material from the spills of pharmaceuticals.

Whether a pharmaceutical is eligible for manufacturer’s credit is determined solely by the 

manufacturer’s return policy. Based on comments received for the 2008 Universal Waste 

proposed rule and through discussions with various stakeholders, the Agency understands that 

the return policies of manufacturers change regularly. As a result, pharmacies are not always 

aware if a particular pharmaceutical will be creditable at the time that it is pulled from the 

shelves. However, the Agency also understands that there are instances where it is well known 

that a pharmaceutical will not be creditable. Examples of these instances include the following: if 

the pharmaceutical has been removed from the original container and re-packaged for dispensing 

purposes; if an attempt was made to administer a pharmaceutical, but the patient refused to take 
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it; if the hazardous waste pharmaceutical was generated during patient care; if the pharmacy

receives a return of a dispensed pharmaceutical for which they had already received 

compensation by a third-party payer; or if the pharmaceutical is more than one year past its 

expiration date. In these instances, as well as others, the healthcare facility knows that it will not 

receive manufacturer’s credit. It is the Agency’s intent for the proposed definition of potentially 

creditable hazardous waste pharmaceuticals to allow the return of hazardous waste 

pharmaceuticals to reverse distributors for the determination of credit. It is not the Agency’s 

intent, however, for reverse distributors to serve in the capacity as TSDFs when it is well known 

that the manufacturer will not give credit for those hazardous waste pharmaceuticals. 

Also, based on communication with stakeholders and the public comments received on 

the 2008 Universal Pharmaceutical Waste proposal, EPA understands that pharmaceutical 

manufacturers’ policies often allow for credit to be received on the return of ‘partials.’ Partials is 

a term used in the industry to refer to opened containers that have had some contents removed. 

Under the proposed definition, the Agency would consider partials to be potentially creditable 

hazardous waste pharmaceuticals. 

The Agency is soliciting comment on the proposed definition of “potentially creditable 

hazardous waste pharmaceutical” and whether the definition is broad enough to encompass the 

various types of hazardous waste pharmaceuticals that are shipped to reverse distributors for 

manufacturer’s credit, while also ensuring that non-creditable hazardous waste pharmaceuticals 

are not inappropriately shipped to reverse distributors solely for waste management purposes. 

Finally, the Agency is seeking comment on additional situations where it is well known that a 

returned pharmaceutical will or will not receive manufacturer’s credit. 
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4. What is the Proposed Definition of “Non-Creditable Hazardous Waste Pharmaceutical”?

As discussed abovepreviously, there are instances when it is well known that credit will 

not be received for certain hazardous waste pharmaceuticals. In order to distinguish hazardous 

waste pharmaceuticals that have the potential for credit from those that have no expectation of 

receiving credit, the Agency is proposing to define the term “non-creditable hazardous waste 

pharmaceutical.” The proposed definition of a “non-creditable hazardous waste pharmaceutical” 

is a hazardous waste pharmaceutical that is not expected to be eligible for manufacturer’s credit. 

Examples include, but are not limited to: if the pharmaceutical has been removed from the 

original container and re-packaged for dispensing purposes; if an attempt was made to administer 

a pharmaceutical, but the patient refused to take it; if the hazardous waste pharmaceutical was 

generated during patient care; if the pharmacy receives a return of a dispensed pharmaceutical 

for which they had already received compensation by a third-party payer; (e.g. health insurance 

company); or if the pharmaceutical is more than one year past its expiration date. EPA requests 

comment on the proposed definition and seeks additional examples of hazardous waste 

pharmaceuticals that have no expectation of receiving manufacturer’s credit. 

5. What is the Proposed Definition of “Evaluated Hazardous Waste Pharmaceutical”? 

After potentially creditable hazardous waste pharmaceuticals arrive at a pharmaceutical 

reverse distributor, they are evaluated to determine whether they are eligible for manufacturer’s 

credit, or whether they need to be transferred to another pharmaceutical reverse distributor for 

additional verification of manufacturer’s credit. Hazardous waste pharmaceuticals that need to be 

transferred to another pharmaceutical reverse distributor for additional verification of 

manufacturer’s credit will continue to be considered potentially creditable hazardous waste 
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pharmaceuticals. EPA is proposing that hazardous waste pharmaceuticals for which 

manufacturer’s credit has been issued (and no further verification of credit is required), as well as 

those that have been deemed non-creditable, be referred to as “evaluated hazardous waste 

pharmaceuticals.” EPA is proposing to define “evaluated hazardous waste pharmaceutical” as a 

hazardous waste pharmaceutical that was a potentially creditable hazardous waste 

pharmaceutical but has been evaluated by a pharmaceutical reverse distributor to establish 

whether it is eligible for manufacturer’s credit and will not be sent to another pharmaceutical 

reverse distributor for further evaluation or verification. It is important to define this term since 

the proposed management and shipping standards for potentially creditable hazardous waste 

pharmaceuticals differ from the proposed management and shipping standards for evaluated 

hazardous waste pharmaceuticals. For a discussion of the proposed management and shipping 

standards for potentially creditable hazardous waste pharmaceuticals, see Section V.F.2. For a 

discussion of the proposed management and shipping standards for evaluated hazardous waste 

pharmaceuticals, see Section V.F.1.b.

6. What is the Proposed Definition of “Household Waste Pharmaceutical”?

We are proposing to define the term “household waste pharmaceutical” as a solid waste, 

as defined in § 261.2, that also meets the definition of pharmaceutical, as defined in this 

proposed rule, but is not a hazardous waste because it is exempt from RCRA Subtitle C 

regulation by the household waste exclusion in § 261.4(b)(1). We are proposing this term to 

distinguish this type of waste pharmaceutical from the hazardous waste pharmaceuticals that are 

proposed to be regulated under this new subpart. This proposed rule does not apply to 

pharmaceutical waste that is exempt due to the household waste exclusion.
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7. What is the Proposed Definition of “Non-Hazardous Waste Pharmaceutical”?

We are proposing to define the term “non-hazardous waste pharmaceutical.” While 

hazardous waste pharmaceuticals are proposed to be regulated under this new subpart, nonhazardous waste pharmaceuticals will not be regulated under this new subpart, nor the RCRA 

subtitle C hazardous waste regulations. The Agency is proposing to include this definition since 

we believe it important to delineate what is and is not regulated under this new subpart. We 

propose to define the term “non-hazardous waste pharmaceutical” to mean a pharmaceutical that 

is a solid waste, as defined in § 261.2, but that is not a listed hazardous waste and does not 

exhibit any characteristics of hazardous waste (i.e., ignitable, corrosive, reactive, toxic).

8. What is the Proposed Definition of “Non-pharmaceutical Hazardous Waste”?

Like the previous definition, we are proposing a definition for non-pharmaceutical 

hazardous waste to help us delineate what is and what is not regulated under this new subpart. 

We are proposing to define the term “non-pharmaceutical hazardous waste” as a solid waste, as 

defined in § 261.2, that is either a listed hazardous waste or exhibits one or more characteristics 

of hazardous waste, but does not meet the definition of a pharmaceutical, as proposed under this 

new subpart. The management of non-pharmaceutical hazardous wastes is not regulated under 

this subpart; rather generators of non-pharmaceutical hazardous wastes, including healthcare 

facilities and reverse distributors, remain subject to the existing Subtitle C hazardous waste 

regulations for the management of those hazardous wastes. Examples of non-pharmaceutical 

hazardous wastes that healthcare facilities may generate include cleaning solutions, solvents, and 

laboratory wastes. Some hazardous wastes exist in pharmaceutical form and non-pharmaceutical 
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form. For example, warfarin, nicotine, and lindane were all originally listed as hazardous waste 

because they were pesticides, not medicines. If these products are not intended for human or 

animal use, they would be considered non-pharmaceutical hazardous wastes and remain subject 

to the existing RCRA hazardous waste regulations, not part 266, subpart P.

9. What is the Proposed Definition of a “Healthcare Facility”?

These proposed regulations differ from those in the Pharmaceutical Universal Waste 

proposal in that they apply based not only on the type of hazardous waste generated, but also on 

the sector generating the waste. Accordingly, EPA is proposing a definition for “healthcare 

facility” so that it is clear to whom these proposed regulations apply. This proposed definition is 

adapted from the definition of “health care” that the Department of Health and Human Services 

(DHHS) promulgated as a result of the Health Insurance Portability and Accountability Act of 

1996 (HIPAA) (45 CFR part 160.103).35 Thus, for the purposes of these proposed regulations, 

EPA is proposing that “healthcare facility” means any person that (1) provides preventative, 

diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, 

assessment or procedure with respect to the physical or mental condition, or functional status, of 

a human or animal or that affects the structure or function of the human or animal body; or (2) 

sells or dispenses over-the-counter or prescription pharmaceuticals. This definition includes, but 

is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, 

physicians' offices, optical and dental providers, chiropractors, long-term care facilities, 

ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, 

mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and 

 

3545 CFR part 160: http://aspe.hhs.gov/admnsimp/final/pvctxt01.htm
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hospitals. Thus, these proposed regulations will be applicable to any healthcare facility for 

human or animal which generates hazardous waste pharmaceuticals on its premises. 

EPA proposes to include coroners in the definition of a healthcare facility despite the fact 

that the services coroners provide occur after life. Coroners will often inventory, and then 

dispose of, any pharmaceuticals that may be found at the scene of a death. A common method of 

disposal is sewering. In order to reduce the sewer disposal practices of coroners, and to provide 

the same management options that are available to other healthcare facilities, EPA has decided to 

include “coroners” within the definition of healthcare facility, although the Agency solicits 

comment on including coroners within the definition of healthcare facility.36

Under the proposed definition, healthcare facilities include locations that sell 

pharmaceuticals over the internet, through the mail, or through other distribution mechanisms. A 

pharmacy does not necessarily have to have a “brick and mortar” or “store front” presence to be 

considered a healthcare facility for the purposes of this proposed rule. The proposed definition of 

a “healthcare facility” also applies to entities that engage in drug compounding. In general, 

compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of 

an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, 

mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual 

patient. The proposed definition of “healthcare facility” applies to state-licensed pharmacies, 

Federal facilities, and licensed physicians that compound drugs in accordance with section 503A 

of the FD&C Act, and to outsourcing facilities that compound drugs in accordance with section 

503B of the FD&C Act. The Agency is soliciting comment on the proposed definition of 

 

36 For more information on the disposal process, please see: Ruhoy, I.S. and Daughton, C.G. “Types and Quantities 

of Leftover Drugs Entering the Environment via Disposal to Sewage – Revealed by Coroner Records,” Sci. Total 

Environ., 2007, 388(1-3):137-148. http://www.epa.gov/nerlesd1/bios/daughton/SOTE2007.pdf.
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“healthcare facility,” including whether it is appropriate to consider these compounders as 

healthcare facilities within the scope of this proposed rule.

The proposed definition of “healthcare facility” does not apply to pharmaceutical 

manufacturers and their representatives, wholesalers, or any other entity that is involved in the 

manufacturing, processing or wholesale distribution of over-the-counter or prescription 

pharmaceuticals, unless they meet the definition of a “reverse distributor” as discussed below in 

this section and in Section V.G. The purpose for these sector-based regulations is to address the 

various issues that healthcare facilities and reverse distributors face when managing hazardous 

waste pharmaceuticals. As noted abovepreviously, the Agency does not anticipate that 

manufacturing facilities, which predictably generate a known range of hazardous wastes, face the 

same issues as healthcare facilities. 

These proposed regulations also do not apply to pharmacies that operate primarily as 

compounding pharmacies. A compounding pharmacy is a pharmacy that mixes or "compounds" 

chemical ingredients into a finished medication ready to use by an individual patient, based on a 

prescription ordered by a physician or other legally authorized prescriber. Compounding 

pharmacies have received new scrutiny from Congress and the Food and Drug Administration 

(FDA) since the fall of 2012, when a meningitis outbreak was traced to contaminated steroids 

from a compounding pharmacy in Massachusetts. As a result, in November 2013, new legislation 

was enacted specifically for compounding pharmacies: Title I of the Drug Quality and Security 

Act — the Compounding Quality Act. According to the Compounding Quality Act compounding 

“includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise 

altering of a drug or bulk drug substance to create a drug” (see Section 503B(d)(1)). The FDA is 

in the process of developing implementing regulations for the DQSA, including regulations for a 
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new category of compounding facilities known as “outsourcing facilities.” In light of the 

uncertainty about compounding pharmacies and outsourcing facilities, EPA does not believe it is 

appropriate to include them at this time under the proposed definition of healthcare facility. 

However, EPA is aware that retail pharmacies may conduct compounding in some instances and,

provided that it does not operate primarily as a compounding pharmacy or outsourcing facility, it 

would be included in the definition of healthcare facility. EPA seeks comment on whether it is 

appropriate to include compounding pharmacies or outsourcing facilities in the definition of 

healthcare facility. As events unfold with the FDA and based on comments, EPA will consider 

whether to include compounding pharmacies and outsourcing facilities in the final rule or leave 

the decision to a future rulemaking.

The Agency is soliciting comment on the proposed definition of “healthcare facility.” 

Specifically, the Agency is requesting comment on the clarity of the definition, including 

whether the phrase “operate primarily as compounding facility” is clear and whether or not the 

definition will inadvertently exclude any specific type of healthcare facility that generates 

hazardous waste pharmaceuticals.

10. What is the Proposed Definition of a “Long-Term Care Facility”?

The term “long-term care facility” does not have a standardized, industry definition. EPA 

is, therefore, proposing the following definition for “long-term care facility” (LTCF): a licensed 

entity that provides assistance with activities of daily living, including managing and 

administering pharmaceuticals to one or more individuals at the facility. This definition includes, 

but is not limited to, assisted living, hospices, nursing homes, skilled nursing facilities, and the 

assisted living and skilled nursing care portions of continuing care retirement communities. 
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These facilities are licensed care facilities that are more similar to hospitals than to standard 

residences. Not included within the scope of this definition are group homes, independent living 

communities, and the independent living portions of continuing care retirement communities.

The included facilities are licensed care facilities that are more similar to hospitals than to 

standard residences. Although group homes may be licensed care facilities, they are typically 

very small (under 10 beds). Independent living communities are not licensed care facilities, but 

rather are residences made up of individual units such as townhomes or apartments. Finally, 

private residences with visiting nurses are not considered long-term care facilities. EPA requests 

public comment on the proposed definition of long-term care facility, and the inclusion of 

assisted living facilities, skilled nursing facilities and other LTCFs that administer their 

residents’ pharmaceuticals as an integral part of their services within the definition of “healthcare 

facility.” 

The DEA's definition of "long term care facility" is “a nursing home, retirement care, 

mental care or other facility or institution which provides extended health care to resident 

patients” (21 CFR 1300.01). EPA’s definition is more descriptive, and includes a list – which is 

not exhaustive - of examples of long-term care facilities. We feel this a more flexible way to 

define the universe. Although the definitions differ, they are not necessarily incompatible.

11. What is the Proposed Definition of a “Pharmaceutical Reverse Distributor”?

As more fully discussed in Section V.G.1 of this preamble, pharmaceutical manufacturers 

often offer credit to healthcare facilities on the return of unused and/or expired 
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pharmaceuticals.37 Stakeholders have informed the Agency that manufacturers issue credit for a 

variety of reasons. For example, it is a marketing incentive tool that helps ensure against illicit 

diversion38 or improper disposal, and it allows manufacturers to collect data on the returned 

items, which then can be used to help plan for future pharmaceutical production. Reverse 

distributors are contracted by both pharmaceutical manufacturers and healthcare facilities to 

facilitate the crediting process. 

Some of the pharmaceuticals returned for credit will meet RCRA’s definition of a 

hazardous waste. Due to the fact that the vast majority of pharmaceuticals that are returned for 

manufacturer’s credit are disposed of once credit eligibility is determined, EPA is proposing new 

standards for shipment of potentially creditable hazardous waste pharmaceuticals (see Section 

V.F.2.) and the management of potentially creditable hazardous waste pharmaceuticals by 

reverse distributors (see Section V.G). Thus, EPA is proposing to define pharmaceutical reverse 

distributor to clearly delineate which types of facilities are subject to this proposed rule. In 

keeping with how the term is commonly used in the healthcare sector, EPA is proposing to 

define a “pharmaceutical reverse distributor” as any person that receives and accumulates 

potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or 

verifying manufacturer’s credit. Any person, including forward distributors and pharmaceutical 

manufacturers, that processes pharmaceuticals for the facilitation or verification of 

manufacturer’s credit is considered a pharmaceutical reverse distributor.

 

37 As noted in the definition of “potentially creditable hazardous waste pharmaceutical,” credit is provided for those 

pharmaceuticals that are less than one year past the expiration date. 

38 Through the return of pharmaceuticals by a pharmacy for manufacturer’s credit, manufacturers are able to 

maintain control of the pharmaceutical up to the point of its disposal, thereby, decreasing the risk of diversion of the 

pharmaceutical.
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The Agency also needs to clarify the difference between what is defined as a 

pharmaceutical reverse distributor for the purpose of these proposed regulations and how DEA 

regulations define “reverse distribute.” The recently amended DEA regulatory definition of

“reverse distribute” is to “acquire controlled substances from another registrant or law 

enforcement for the purposes of: (1) Return to the registered manufacturer or another registrant 

authorized by the manufacturer to accept returns on the manufacturer’s behalf; or (2) Destruction

(21 CFR part§ 1300.01).

39

Under DEA’s definition, a reverse distributor does not necessarily process 

pharmaceuticals for the purpose of determining manufacturer’s credit; rather, their main function 

under DEA’s definition is to destroy the controlled substances. Under EPA’s proposed 

definition, however, a pharmaceutical reverse distributor is defined more broadly as a facility 

that can accept potentially creditable pharmaceuticals for the purposes of determining 

manufacturer’s credit. These potentially creditable pharmaceuticals may or may not be identified 

as controlled substances by DEA.40 Therefore, a DEA-registered reverse distributor may or may 

not meet EPA’s definition of a pharmaceutical reverse distributor and vice versa. For example, a 

pharmaceutical reverse distributor that accepts controlled substances (that are also hazardous 

wastes) for the sole purpose of destruction (e.g., incineration) would be regulated as a DEAregistered reverse distributor and as a RCRA TSDF, and not as a pharmaceutical reverse 

distributor under the RCRA hazardous waste regulations. Conversely, a pharmaceutical reverse 

distributor that processes pharmaceuticals for manufacturer’s credit, but is not a DEA registrant 

 

39 On September 9, 21042014, DEA finalized new definitions for “reverse distribute” and “reverse distributor.” 

Please see 79 FR 53520. The term “reverse distributor” is defined as "a person registered with the Administration 

[DEA] as a

reverse distributor.."

40 In order for a reverse distributor to be able to accept controlled substances, the reverse distributor must be a DEA 

registrant. See 21 CFR part 1308 for a complete list of controlled substances.

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and therefore, cannot accept controlled substances, would meet the RCRA pharmaceutical 

reverse distributor definition, but not DEA’s reverse distributor definition. However, EPA has 

heard from stakeholders that many, if not all, entities that facilitate manufacturer’s credit are also 

DEA-registered reverse distributors. Therefore, such pharmaceutical reverse distributors would 

meet both EPA’s proposed definition of pharmaceutical reverse distributor, as well as the DEA’s 

definition of reverse distributor. Lastly, we would note that EPA’s definition for reverse 

distribution does not alter or supersede the requirements of the Controlled Substances Act and 

DEA regulations. 

In addition, the Department of Transportation’s Pipeline and Hazardous Materials Safety 

Administration (PHMSA) has defined the closely related term, “reverse logistics,” in a recent 

proposed rulemaking.41 The EPA has been coordinating with the PHMSA to ensure that our rules 

are compatible, even if the definitions differ. It is important to note that, when finalized, the 

PHMSA rule will not supersede EPA’s RCRA Subtitle C regulations for when something is 

considered a solid or hazardous waste or how a hazardous waste must be managed.

The Agency solicits public comment on its proposed definition of a “pharmaceutical 

reverse distributor.” Specifically, EPA asks for comment on whether the definition of 

“pharmaceutical reverse distributor” captures the universe of facilities acting as reverse 

distributors for pharmaceuticals. In addition, the Agency asks for comment regarding the 

intersection of DEA and EPA’s definitions.

B. What is the Scope of this Proposed Rule? 

 

41 79 FR 46748; August 11, 2014. The PHMSA’s proposed definition of reverse logistics “is the process of moving 

goods from their final destination for the purpose of capturing value, recall, replacement, proper disposal, or similar 

reason.”
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1. What Facilities are Subject to this Rulemaking?

a. Healthcare facilities. The Agency is proposing that healthcare facilities that are 

currently considered either SQGSQGs or LQGs will be required to manage all hazardous waste 

pharmaceuticals generated at their facilities in accordance with the standards proposed in this 

noticedocument. In other words, these management standards will apply to any healthcare 

facility that generates (or accumulates) more than 100 kg of hazardous waste per calendar month 

or more than 1 kg of acute hazardous waste per calendar month (e.g., P-listed hazardous waste) 

or more than 100 kg of any residue or contaminated soil, waste, or other debris resulting from 

the clean-up of a spill, into or on any land or water, of any acute hazardous wastes listed in §§ 

261.31, or 261.33(e) per calendar month. All healthcare facilities that meet these applicability 

criteria will be subject to the same set of standards for the management of their hazardous waste 

pharmaceuticals. That is, subpart P is not optional for healthcare facilities that generate above the 

CESQG monthly quantity limits (see Section V.B.1.c. of the preamble for a discussion of what 

regulations apply to CESQGs). EPA is proposing to make subpart P mandatory to promote 

national consistency, a goal championed by stakeholder comments as well as EPA. In addition, 

having one set of standards applicable to pharmaceutical waste will be less confusing to the 

regulated community, which should lead to better compliance. The stringency of the subpart P 

management standards for hazardous waste pharmaceuticals do not change if a healthcare facility 

generates more hazardous waste pharmaceuticals from one month to another. The generator 

categories – that is, LQG, SQG, and CESQG – under the part 262 RCRA requirements will only 

be relevant for the healthcare facilities’ non-pharmaceutical hazardous waste because nonpharmaceutical hazardous waste remain subject to the 40 CFR part 262 generator regulations

(see Section VI. Implementation and Enforcement for further discussion). 
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b. Long-term care facilities subject to this rule. Long-term care facilities are included 

within the proposed definition of healthcare facility. Further, EPA is proposing to change its 

policy regarding the management of hazardous waste and hazardous waste pharmaceuticals 

generated on the premises of long-term care facilities. Under current federal RCRA 

interpretation (see 73 FR 73525, December 2, 2008), hazardous wastes (including 

pharmaceuticals) generated on the premises of a long-term care facility can fall under two 

categories: (1) RCRA Subtitle C hazardous waste or (2) household hazardous waste that is 

exempt from RCRA Subtitle C regulation. As explained in the preamble to the proposal to add 

pharmaceuticals to the Universal Waste program, “the [long-term care] facility itself may 

generate hazardous wastes as a result of its central management of pharmaceuticals in its 

pharmacy or pharmacy-like area. These hazardous pharmaceutical wastes would be subject to the 

RCRA hazardous waste generator regulations since the pharmaceuticals are under the control of 

the facility, and thus, the resulting wastes are generated by that facility. However, patients and 

residents in long-term care facilities may generate hazardous wastes. Those pharmaceuticals that 

are under the control of the patient or resident of the long-term care facility, when discarded, 

would be subject to RCRA’s household hazardous waste exclusion (§261.4(b)(1)). Hazardous 

pharmaceutical wastes generated by the resident are excluded from regulation because they are 

considered to be derived from a household” (see December 2, 2008; 73 FR 73525).

The Agency is now providing notice that it intends to revise this interpretation. 

Specifically, hazardous waste (including pharmaceuticals) generated at long-term care facilities 

will no longer be considered exempt as household hazardous waste. It will be regulated as 

hazardous waste, subject to the appropriate RCRA Subtitle C management standards, including 

the standards being proposed. The Agency is revising its interpretation with regard to hazardous 
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wastes generated at long-term care facilities based on a reevaluation of how such facilities

operate. Specifically, in order for hazardous waste to qualify for the household hazardous waste 

exemption of § 261.4(b)(1), it must meet two criteria: (1) the hazardous waste must be generated 

by individuals on the premises of a household, and (2) the hazardous waste must be composed 

primarily of materials found in the wastes generated by consumers in their homes. 42 EPA now 

believes that hazardous waste generated at long-term care facilities, even when those 

pharmaceuticals are under the control of the patient or resident, does not meet either criterion for 

the household hazardous waste exemption. 

First, a long-term care facility is more akin to a hospital than it is a typical residence and 

EPA does not consider hospitals to be households. Long-term care facilities are licensed, 

residential care settings that offer their residents a wide range of services, many of which are 

centered on administering medications and providing healthcare by various professional 

healthcare providers, such as medical technicians, nurse’s aides, nurses, and doctors. Other 

services provided involve assistance in performing activities of daily living, such as bathing, and 

eating. A 2012 American Association of Retired Person (AARP) Public Policy Institute report 

indicates that there is an average of 24 beds per licensed residential care facilities (excluding 

nursing homes).43 Based on another report prepared as a collaborative project of the American 

Association of Homes and Services for the Aging (AAHSA), American Seniors Housing 

Association (ASHA), Assisted Living Federation of America (ALFA), National Center for 

 

42 See November 13, 1984; 49 FR 44978.

43 AARP Public Policy Institute, INSIGHT on the Issues 58, Assisted Living and Residential Care in the States in 

2010, April 2012. http://www.aarp.org/content/dam/aarp/research/public_policy_institute/ltc/2012/residential-careinsight-on-the-issues-july-2012-AARP-ppi-ltc.pdf or see the docket for this proposed rulemaking (EPA-HQ-RCRA2007-0932).
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Assisted Living (NCAL) and National Investment Center for the Seniors Housing and Care 

Industry (NIC), there is an average of 54 units (e.g., rooms) for all types of assisted 

living/dementia care properties.44 Unlike other multiple dwellings, approximately 81 percent of 

these facilities store medications in a central location and 89 percent administer medications to 

their residents.45 Given that long-term care facilities are licensed settings for the care of their 

residents and routinely provide healthcare services, we believe that long-term care facilities more 

closely resemble hospitals than typical residences.

Second, the hazardous wastes generated by long-term care facilities do not meet the 

second criteria for the waste to be considered household hazardous waste. This is primarily due 

to the quantity of pharmaceutical wastes that are often generated on the premises of long-term 

care facilities when compared to a typical residence. For example, the Colorado Department of 

Public Health and Environment estimates that a 100-bed nursing home might expect to generate 

approximately 120 to 336 pounds of pharmaceutical waste per year.46 In addition, long-term care 

facilities, such as assisted living facilities and nursing homes, generate a greater variety of 

hazardous waste pharmaceuticals and a greater quantity of hazardous waste than a typical 

household generates. The AARP Public Policy Institute report indicates that “residents take an 

average of seven or eight different prescriptions and two OTC [over-the-counter] medications 

daily.” This number is larger than what we would expect a typical household to generate. This 

distinction about volume of waste is analogous to the distinction that EPA has made in the past 

 

44 2009 Overview of Assisted Living; a collaborative research project of AAHSA, ASHA, ALFA, NCAL & NIC.

45 Ibid.

46 Net weight (without packaging) of types of pharmaceuticals wastes, including those that are RCRA hazardous, 

non-RCRA hazardous, DEA controlled, prescription and over-the-counter. Memo from Lillian Gonzalez, Colorado 

Department of Public Health and Environment to Kristin Fitzgerald, EPA; January 9, 2013, see the docket for this 

proposed rulemaking (EPA-HQ-RCRA-2007-0932).
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about contractor or do-it-yourself waste from households: waste from “routine residential 

maintenance” is exempt as household hazardous waste, while waste from “building construction, 

renovation, demolition” is not exempt. 47 Therefore, EPA is providing notice that if this rule is 

finalized, long-term care facilities may no longer use the household hazardous waste exemption. 

If this rule is finalized, long-term care facilities would need to manage their hazardous waste 

pharmaceuticals in accordance with the healthcare facility specific management standards in this 

proposal and their non-pharmaceutical hazardous wastes in accordance with the applicable 

RCRA hazardous waste generator requirements in § 261.5 (for CESQGs) or part 262 (for SQGS 

and LQGs). However, even though long-term care facilities will no longer be considered eligible 

to use the household hazardous waste exemption, our data show that only 28% of long-term care 

facilities generate hazardous waste pharmaceuticals, and of those, 85% are small enough to be 

considered CESQGs of hazardous waste (regulated under § 261.5) and therefore not subject to 

part 266, subpart P (except the sewer ban).

48 The Agency seeks comment on whether this 

proposed change to consider long-term care facilities to be healthcare facilities instead of 

households is appropriate. We also seeking comment on the extent to which long-term care 

facilities will pass the cost of compliance onto its customers. Until this rule is finalized, the 

current interpretation from the Universal Waste preamble will stand regarding hazardous waste 

from long-term care facilities.

c. Conditionally exempt small quantity generators (CESQGs). As discussed in the 

Background Section (Section IV.A.2), CESQGs are subject to a limited set of federal RCRA 

 

47Memo from Petruska to McNally, February 28, 1995; RCRA Online #11897 that discusses the distinction about 

what renovation waste is household hazardous waste and what is not. 

48 See the docket for this rulemaking for data about long-term care facilities which was developed using data in the 

economic analysis: EPA-HQ-RCRA-2007-0932.
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Subtitle C hazardous waste regulations, provided that they comply with the conditions set forth 

in § 261.5.49 This proposed rulemaking will preserve this current regulatory structure for the 

most part; therefore, healthcare facilities that generate hazardous waste pharmaceuticals and 

qualify as CESQGs, will maintain their conditional exemption under § 261.5 and will not be 

subject to most aspects of this proposal. However, as part of this rulemaking, EPA is proposing a 

ban on sewer disposal of hazardous waste pharmaceuticals by all healthcare facilities and reverse 

distributors. EPA is proposing that the sewer ban would apply to all healthcare facilities, 

including CESQG healthcare facilities. Please see Section V.E.1 of this preamble for a more 

detailed discussion on this proposed sewer prohibition. EPA asks for comment on whether the

proposed healthcare facility standards, in addition to the sewer ban, should apply to CESQG 

healthcare facilities.

EPA is proposing one additional change for CESQGs in order to allow them to continue 

to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse 

distributor. Currently, under § 261.5, CESQGs are limited in where they may send their 

hazardous waste for treatment and disposal (see § 261.5(f)(3)(i)-(vii) for acute hazardous waste 

and § 261.5(g)(3)(i)-(vii) for hazardous waste). However, in § 266.504(a) we are proposing to 

allow CESQGs to send their potentially creditable hazardous waste pharmaceuticals to a 

pharmaceutical reverse distributor. Without this change, CESQGs would be required to send all 

their hazardous waste pharmaceuticals, including those that are potentially creditable, to one of 

 

49 Not all authorized states recognize the CESQG category and may have more stringent regulatory requirements for 

CESQGs. Therefore, as noted previously, EPA recommends that facilities that qualify as CESQGs under the federal 

regulations contact their state and/or local environmental regulatory agencies to determine whether more stringent 

regulatory requirements apply to CESQGs in their state. 
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the types of facilities in § 261.5, which does not include a pharmaceutical reverse distributor.

Although we are proposing to make this change within part 266, subpart P, we request comment 

on whether stakeholders would prefer this change to be made within § 261.5 instead. CESQGs 

will still be required to send their non-pharmaceutical hazardous waste and their non-creditable 

hazardous waste pharmaceuticals to one of the types of facilities listed in § 261.5.

In addition, it has been suggested that EPA seek comment on providing a rebuttable 

presumption that LTCFs with fewer than 10-beds are assumed to be CESQGs and thus would not 

be required to count the amount of hazardous waste generated each month. Under this 

presumption, they would be subject to all the requirements for CESQGs as described elsewhere 

in this proposal, including the requirement not to sewer hazardous waste pharmaceuticals. 

Therefore, EPA asks for comment on this rebuttable presumption and specifically whether the 

10-bed cut off is appropriate or whether there are other criteria EPA should take into account. 

Further, EPA asks for commenters to submit data to support a 10-bed cut off to show that LTCFs 

with fewer than 10-beds are generally CESQGs. Alternatively, if comments wish to support a 

different cut-off for the rebuttable assumption, EPA also asks that the commenters submit 

information/data to support their suggested cut-off.

d. Pharmaceutical reverse distributors. EPA is proposing that pharmaceutical reverse 

distributors, including pharmaceutical manufacturers, which accumulate potentially creditable 

hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals are subject to 

this rule. Pharmaceutical reverse distributors are only subject to this proposed rule for the 

accumulation of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous 

waste pharmaceuticals; if a reverse distributor also treats and/or disposes of hazardous waste 
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pharmaceuticals, it is subject to the applicable RCRA Subtitle C TSDF regulations., including 

the requirement to have a permit or interim status. Stakeholders have indicated a strong 

preference for EPA to clarify how pharmaceutical reverse distributors are regulated under 

RCRA, as states have applied varied hazardous waste regulatory approaches to pharmaceutical 

reverse distributors. EPA is proposing specific standards in 40 CFR part 266, subpart P for 

pharmaceutical reverse distributors (as defined in this proposed rule) that incorporate various 

generator standards, as well as some TSDF standards. See Section V.G for more information.

2. To What Facilities Does this Rule Not Apply?

a. Pharmaceutical manufacturers. EPA does not intend for these proposed regulations to 

apply to hazardous waste pharmaceuticals that are generated by pharmaceutical manufacturers or 

wholesalers. Pharmaceutical manufacturers and wholesalers do not face the same challenges that 

healthcare facilities experience when managing hazardous waste pharmaceuticals and potentially 

creditable hazardous waste pharmaceuticals in accordance with the federal RCRA subtitle C 

requirements (for an explanation of the challenges healthcare facilities face, see discussion in 

section IV.B.1 of the preamble). These entities (i.e., manufacturers and wholesalers) generate 

hazardous waste pharmaceuticals that are more predictable and the staff have the necessary 

expertise to determine which pharmaceutical waste is hazardous waste. However, as mentioned 

previously, when any facility, including a pharmaceutical manufacturer, meets the definition 

found in this proposal for a “pharmaceutical reverse distributor,” it would be subject to the 

proposed regulations for pharmaceutical reverse distributors with respect to those operations.

b. Households. The Agency would like to emphasize that the regulatory requirements in 

this proposed rule do not apply to households or to household pharmaceutical collection and 

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take-back events and programs. (For information regarding collection programs, see Section 

V.E.2.) Pharmaceuticals that are unwanted by consumers (households) are not regulated as 

hazardous waste and are generally considered municipal solid wastes. While a small percentage 

of these household waste pharmaceuticals meet the definition of hazardous waste under RCRA, 

the federal RCRA hazardous waste regulations include an exclusion for all hazardous wastes 

generated by households (see the “household hazardous waste” exclusion at § 261.4(b)(1)). Thus 

household waste pharmaceuticals— like other household hazardous wastes— are not subject to 

the federal RCRA hazardous waste regulations. 

“EPA excluded household wastes because the legislative history of RCRA indicated an 

intent to exclude such wastes, though not because they necessarily pose no hazard.”50 Some 

household products, including pharmaceuticals, contain ignitable, corrosive, reactive, or toxic 

ingredients. As a result, for household hazardous waste collected at a take-back event or 

program, the Agency has historically recommended that communities operating the collection 

programs manage the collected household hazardous wastes as hazardous waste, even though it 

is not required by RCRA.

51 Furthermore, the Agency has recently recommended that collected

household waste pharmaceuticals be incinerated— preferably at a permitted hazardous waste 

incinerator, but when that is not feasible, at a large or small municipal waste combustor.52 The 

Agency believes that this practice is already common among collection programs since one goal 

of many collection programs is to divert pharmaceuticals from municipal landfills. Nevertheless, 

 

50 See 49 FR 44978; November 13, 1984

51 See memo November 1, 1988, from Porter to Regions (RCRA Online #11377). 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/2FD51915214EF63C8525670F006BD

C88/$file/11377.pdf

52 See memo September 26, 2012, Rudzinski to the Regional RCRA Division Directors (RCRA Online# 14833). 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/FCB11DD6F61D4B1685257AFE005E

B5CE/$file/14833.pdf
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the Agency is proposing to make this recommendation a requirement for collected household 

waste pharmaceuticals in §266.506.

53 The Agency seeks comment on changing this 

recommendation to a requirement for pharmaceutical collection programs.

The Agency recommends that, whenever possible, households utilize pharmaceutical 

collection and take-back events as the disposal option for their unwanted pharmaceuticals. For 

consumers without access to a pharmaceutical take-back event, FDA provides information on the 

disposal of unused pharmaceuticals and step-by-step guidance for disposing of pharmaceuticals

in the household trash. For more information on the safe disposal of household pharmaceuticals, 

please see: 

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Ensuring

SafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htmhttp://www.fda.gov/Drugs/Resour

cesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalo

fMedicines/ucm186187.htm.

3. Which Hazardous Wastes Are Addressed by this Proposed Rule?

a. Hazardous waste pharmaceuticals. If finalized, these regulations will only pertain to 

those pharmaceutical wastes that are RCRA hazardous wastes generated by healthcare facilities 

or managed by pharmaceutical reverse distributors. Under this rulemaking, EPA is not proposing 

to add additional pharmaceuticals to the hazardous waste listings or to expand the hazardous 

waste characteristics to include additional pharmaceuticals. See Section VII of the preamble,

 

53 Since pharmaceutical collection programs typically co-mingle DEA controlled substances with non-controlled 

substances, this requirement is included in a section of the regulations that pertains to controlled substances.
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Request for Comment on EPA’s Efforts to Identify Additional Pharmaceuticals as Hazardous 

Waste, for a discussion of possible future actions by EPA to regulate additional pharmaceuticals 

as hazardous waste.

b. How does this proposal affect hazardous waste pharmaceuticals that are also 

regulated by other federal or state regulations? The management, transportation, treatment, 

storage and disposal of hazardous waste pharmaceuticals are regulated under RCRA Subtitle C. 

However, hazardous waste pharmaceuticals may also be subject to a number of other statutes and 

implementing regulations administered by state or other federal agencies. Examples include 

pharmaceuticals that are subject to the Controlled Substances Act and DEA regulations; 

infectious pharmaceutical wastes that are subject to state and local medical waste regulations; 

and pharmaceuticals with a radioactive component that are subject to the Atomic Energy Act 

(AEA). These potentially overlapping requirements make the appropriate management of 

pharmaceutical wastes a complex matter. The following discusses the impact of this proposed 

rule on various dually regulated hazardous waste pharmaceuticals. 

i. Hazardous waste pharmaceuticals that are also controlled substances. Under current 

regulations, any healthcare facility generating or managing a RCRA hazardous waste 

pharmaceutical that is also a controlled substance listed in Schedule II-V

54 must comply with the 

RCRA hazardous waste requirements, as well as the requirements of the Controlled Substances 

Act and DEA regulations. Recently revised DEA regulations to implement the Secure and 

Responsible Drug Disposal Act of 2010 require that controlled substances be destroyed so that 

 

54 See 21 CFR 1308 for a complete list of controlled substances. 

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they are “non-retrievable.”55 In the past, flushing has been acceptable means of destroying DEA 

controlled substances. However, in the preamble to both the proposed and final rules, DEA has 

stated that flushing alone will not meet DEA’s new non-retrievable standard.

56 Stakeholders have 

told EPA that it is expensive and difficult to incinerate controlled substances that are also 

hazardous wastes under both DEA and EPA regulatory schemes. As a result, healthcare facilities 

with hazardous waste pharmaceuticals that are also controlled substances have often sewered onsite in order to avoid the expense of complying with dual regulation that would apply if they 

were incinerated. Due to difficulties associated with managing these hazardous waste

pharmaceuticals that are also controlled substances, the Agency is proposing to conditionally 

exempt from the proposed sector-specific RCRA regulatory requirements those pharmaceuticals 

that are both a RCRA hazardous waste and a DEA controlled substance as long as the healthcare 

facility meets certain conditions., provided the hazardous waste pharmaceuticals that are also 

DEA controlled substances are combusted at a permitted or interim status hazardous waste 

incinerator, or a permitted municipal solid waste incinerator . A more detailed discussion of this 

exemption is found in Section V.E.2 of this proposal, Conditional Exemption for Hazardous 

Waste Pharmaceuticals that are also Controlled Substances. 

ii. Hazardous waste pharmaceuticals that are also medical wastes. There are instances 

when a hazardous waste pharmaceutical will also exhibit a biological hazard. The healthcare 

industry often refers to pharmaceutical wastes that are both RCRA hazardous and a biological 

hazard as “dual wastes,” and such wastes must be managed in accordance with RCRA and state 

and/or local medical waste regulations. As a result, the healthcare facility must send these dual 

 

55 Final rule: September 9, 2014; 79 FR 53520.

56 Proposed rule: December 21, 2012; 77 FR 75784, see page 75803; and final rule: September 9, 2014; 79 FR 

53520, see page 53548).

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wastes to a hazardous waste treatment, storage and disposal facility that is also permitted to 

accept medical wastes. Some examples of dual wastes include un-administered syringes 

containing hazardous waste pharmaceuticals (e.g., physostigmine) or IV bags containing residues 

of a hazardous waste pharmaceutical that are attached to the tubing and needles used to 

administer the pharmaceutical. The RCRA hazardous waste pharmaceutical portion of these 

“dual” wastes are included within these proposed management standards so that healthcare 

facilities can obtain the benefits of this proposal, while ensuring the hazardous waste portion of 

the waste is managed appropriately and ultimately delivered to RCRA-permitted TSDFs. In 

addition, healthcare facilities must still manage the biological hazard in accordance with state 

and/or local medical waste requirements. EPA notes that autoclaving is not an acceptable method 

of treating hazardous wastes that are also medical waste. In addition, as discussed in Section 

V.E.3.c of this preamble, EPA is proposing to conditionally exclude the residues of hazardous 

waste pharmaceuticals remaining in fully dispensed syringes from RCRA regulation.

iii. Hazardous waste pharmaceuticals that contain a radioactive component. Hazardous 

waste pharmaceuticals that also contain a radioactive component subject to the Atomic Energy 

Act of 1954 (AEA) (i.e., “mixed waste”) are regulated by multiple agencies. The hazardous 

waste component is regulated under EPA or the authorized state RCRA programs, while either 

the Nuclear Regulatory Commission (NRC) or the Department of Energy (DOE) regulates the 

radioactive component of the waste under the AEA.

57 Healthcare facilities would be able to use 

this rule (if finalized) to comply with the hazardous waste component for hazardous waste 

pharmaceuticals. Although we do not believe that anything in this proposal is inconsistent with 

 

57 The NRC regulates radioactive wastes generated by commercial or non-DOE facilities, whereas DOE regulates 

radioactive wastes generated by DOE facilities. 

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the AEA, § 1006(a) of RCRA states that if the RCRA requirements are inconsistent with the 

AEA requirements, then the RCRA requirements do not apply. Therefore, if a healthcare facility 

that manages hazardous waste pharmaceuticals encounters specific RCRA requirements that are 

inconsistent with specific AEA requirements, only the AEA requirements would apply.

As is discussed in the Joint NRC/EPA Guidance on Testing Requirements for Mixed 

Radioactive and Hazardous Waste (62 FR 62079, 62085; November 20, 1997), an inconsistency 

occurs when compliance with one statute or set of regulations would necessarily cause noncompliance with the other statute or set of regulations. Relief from the regulatory inconsistency 

would be provided by the AEA requirement overriding the specific RCRA requirement. It is 

important to note, however, that the determination of an inconsistency would relieve the 

healthcare facility only from compliance with the specific RCRA requirement(s) that is deemed 

inconsistent with the AEA requirement(s); it would still be required to comply with all of the 

other hazardous waste pharmaceutical management standards.

4. Management of Wastes Generated at Healthcare Facilities That Are Not Included in the Scope 

of this Proposed Rule

Wastes that are not included in the scope of this proposed rule include non-hazardous 

wastes or non-pharmaceutical hazardous wastes. Pharmaceutical wastes that are not listed or 

characteristic hazardous wastes under RCRA Subtitle C may nonetheless pose some risks to 

public health and the environment. These wastes are discussed further below.

a. How should non-hazardous waste pharmaceutical be disposed? A large portion of the 

pharmaceutical wastes generated at healthcare facilities will not meet the definition of a RCRA 
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hazardous waste under RCRA Subtitle C. This proposal, therefore, does not require that

healthcare facilities manage these waste pharmaceuticals under the RCRA subtitle C hazardous 

waste regulations, including this proposed rule. However, a healthcare facility may choose to 

manage its solid and hazardous waste pharmaceuticals together (as hazardous waste 

pharmaceuticals) under these new proposed regulations. Because all healthcare facilities 

operating under this subpart are regulated in the same way regardless of quantity of 

pharmaceutical hazardous waste generated, managing non-hazardous waste pharmaceuticals as 

hazardous waste under this subpart would not affect the facility’s hazardous waste generator 

category. While not regulated by the federal RCRA hazardous waste requirements, nonhazardous waste pharmaceuticals are still considered solid wastes under the federal regulations 

and must be managed in accordance with applicable federal, state and/or local regulatory 

requirements.

If a healthcare facility decides to segregate its hazardous and non-hazardous 

pharmaceuticals, EPA recommends that healthcare facilities follow the best management 

practices (BMPs) outlined in the “Managing Pharmaceutical Waste: A 10-Step Blueprint for 

Healthcare Facilities in the United States” (Practice Greenhealth, Revised August 2008)58 for the 

management, treatment, storage and disposal of non-hazardous waste pharmaceuticals. The 

following summarizes the recommended BMPs found in the Blueprint for various categories of 

pharmaceutical wastes, including those wastes that possess hazardous waste-like qualities yet are 

not regulated as hazardous waste under RCRA Subtitle C. 

 

58 Published in 2006, the development of the original Blueprint was funded by the Office of Solid Waste and 

Emergency Response and managed by EPA Region 1. The 2008 revision of the Blueprint was funded by the 

Healthcare Environmental Resource Center. http://practicegreenhealth.org/sites/default/files/uploadfiles/pharmwasteblueprint.pdf
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i. Recommended BMPs for healthcare facilities managing non-hazardous waste 

pharmaceuticals possessing hazardous waste-like qualities. Currently, most pharmaceuticals are 

not regulated as RCRA hazardous wastes when discarded by healthcare facilities. These “nonRCRA-hazardous” pharmaceuticals can be divided into two categories: those that possess 

hazardous waste-like qualities and those that do not. As outlined in the Blueprint, there are 

pharmaceuticals that possess hazardous waste-like qualities, but for various reasons, are not 

regulated by the RCRA Subtitle C hazardous waste regulations. The Agency supports the 

Blueprint’s recommendation of hazardous waste incineration as the BMP for healthcare facilities 

and pharmaceutical reverse distributors discarding pharmaceuticals that may possess hazardous 

waste-like qualities, but are not regulated as RCRA hazardous waste. This recommendation 

would apply to pharmaceuticals with more than one active ingredient listed on the P- or U-lists,59

chemotherapeutic agents characterized as bulk wastes,

60

 pharmaceuticals which meet the 

NIOSH Hazardous Drug Criteria,61 pharmaceuticals listed in Appendix VI of the OSHA 

Technical Manual,62 pharmaceuticals with LD50s ≤ 50 mg/kg, pharmaceuticals that are 

carcinogenic or endocrine disrupting compounds, and vitamin/mineral preparations containing 

heavy metals. 

ii.. Recommended best management practices for other non-hazardous pharmaceutical 

wastes (i.e., those not possessing hazardous waste like-qualities). As far as other non-hazardous 

 

59 As noted in the comment after § 261.33(d), the phrase “commercial chemical product” includes formulations in 

which the P- or U-listed chemical is the sole active ingredient. Therefore, formulations with more than one active 

ingredient do not meet the specifications of the P- and U-listings even if one, two or all of the active ingredients are 

listed on the P- and/or U-lists. 

60 The descriptions “bulk” and “trace” when applied to chemotherapeutic wastes are industry terms and are not 

defined by the federal RCRA regulations.

61 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. 

http://www.cdc.gov/niosh/docs/2012-150/

62 OSHA Technical Manual, Section VI: Chapter 2, Appendix VI: 2-1.

http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

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waste pharmaceuticals (i.e., those not possessing hazardous waste-like qualities), disposing of 

non-hazardous waste pharmaceuticals at healthcare facilities via drain disposal is strongly 

discouraged and not recommended by EPA. Therefore, EPA endorses the Blueprint’s 

recommendation of municipal solid waste or medical waste incineration for any non-hazardous 

waste pharmaceuticals, even when they do not possess hazardous waste-like qualities. The 

potential risk remains for active pharmaceutical ingredients (APIs) to be released into the 

environment if municipal solid waste landfills or medical waste autoclaves are used for the 

purposes of pharmaceutical waste treatment and disposal. For example, autoclaves are designed 

to kill pathogens and do not achieve the temperatures required to destroy most APIs during the 

autoclaving process. As a result, there is the potential for wastewater containing APIs to be 

generated and discharged into the sewer. In addition, some limited studies have shown APIs 

present in landfill leachate collected in municipal solid waste landfill leachate systems.63,64

Typically, the collected landfill leachate is subsequently sent to wastewater treatment plants for 

treatment, but their treatment technologies are not designed to remove all APIs from the 

wastewater (See Section V.E.1 for more information regarding sewering and APIs). 

b. Non-pharmaceutical hazardous wastes. These proposed regulations will only pertain to 

hazardous waste pharmaceuticals. Therefore, other types of hazardous wastes generated at 

healthcare facilities that do not meet the definition of a hazardous waste pharmaceutical cannot 

be managed in accordance with these proposed regulations. For example, hazardous wastes 

 

63 Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio, M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and 

Barber, L. B. (2004), Pharmaceuticals and Other Organic Waste Water Contaminants Within a Leachate Plume 

Downgradient of a Municipal Landfill. Groundwater Monitoring & Remediation, 24: 119–126

64 Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., Zaugg, S.D., and Meyer, M.T. ( June 2009), WasteIndicator and Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water near Elkhart, Indiana, 2000–

2002. Bulletin of Environmental Contamination and Toxicology, V82.6 :635-659
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generated in hospital laboratories or during cleaning and maintenance of the facility are not 

considered hazardous waste pharmaceuticals and are not included within the scope of this 

proposal. The generation of non-pharmaceutical hazardous wastes is often more routine and does 

not trigger the same concerns that healthcare facilities experience when managing hazardous 

waste pharmaceuticals. 

After a healthcare facility determines it is subject to this proposed rule and manages its 

hazardous waste pharmaceuticals under part 266, subpart P, it is no longer required to count the 

hazardous waste pharmaceuticals that it generates towards its generator category. As a result, the 

healthcare facility may experience a change in RCRA generator category for its nonpharmaceutical hazardous waste. For example, a healthcare facility may shift from being an

LQG to a SQG or even CESQG by not counting its hazardous waste pharmaceuticals toward its 

generator category, especially when acute hazardous waste pharmaceuticals such as warfarin 

(brand name: Coumadin) no longer need to be counted. A shift in generator category, should it 

occur, would allow a healthcare facility to manage its non-pharmaceutical hazardous waste, such 

as hazardous waste from laboratories, according to the reduced generator requirements. It is 

important to note that only when a healthcare facility is managing its hazardous waste 

pharmaceuticals under the new proposed subpart does it have the benefit of not counting them 

towards its generator category (see Section VI. Implementation and Enforcement for further 

discussion). 

C. What are the Proposed Standards for Healthcare Facilities that Manage Non-creditable

Hazardous Waste Pharmaceuticals?
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This section discusses the proposed management standards for healthcare facilities 

(except CESQGs) that manage non-creditable hazardous waste pharmaceuticals, which include 

the following:

(1) notification requirements for healthcare facilities managing non-creditable hazardous waste 

pharmaceuticals;

(2) personnel training requirements for healthcare facilities managing non-creditable hazardous 

waste pharmaceuticals;

(3) making a hazardous waste determination for non-creditable hazardous waste 

pharmaceuticals;

(4) elimination of central accumulation area and satellite accumulation area requirements for 

healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(5) container standards for healthcare facilities managing non-creditable hazardous waste 

pharmaceuticals;

(6) labeling standards on containers for healthcare facilities managing non-creditable hazardous 

waste pharmaceuticals;

(7) accumulation time limits for healthcare facilities managing non-creditable hazardous waste 

pharmaceuticals;

(8) land disposal restrictions for non-creditable hazardous waste pharmaceuticals;

(9) procedures for shipping non-creditable hazardous waste pharmaceuticals off-site from 

healthcare facilities;

(10) procedures for managing rejected shipments of non-creditable hazardous waste 

pharmaceuticals from healthcare facilities;
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(11) reporting requirements for healthcare facilities managing non-creditable hazardous waste 

pharmaceuticals;

(12) recordkeeping requirements for healthcare facilities managing non-creditable hazardous 

waste pharmaceuticals;

(13) procedures for responses to releases by healthcare facilities managing non-creditable 

hazardous waste pharmaceuticals;

(14) special requirements for long-term care facilities managing non-creditable hazardous waste 

pharmaceuticals;

(15) conditions for healthcare facilities that accept hazardous waste pharmaceuticals from offsite CESQGs; and

(16) a prohibition of sewering hazardous waste pharmaceuticals for all healthcare facilities; (see 

section V.E.1. of the preamble, Sewer Disposal Prohibition).

The proposed management standards discussed in this section only apply to hazardous 

waste pharmaceuticals that are non-creditable hazardous waste pharmaceuticals (i.e., they are 

destined for a RCRA permitted or interim status TSDF). They do not apply to those hazardous 

waste pharmaceuticals that meet the definition of a “potentially creditable hazardous waste 

pharmaceutical.” Please refer to Section V.D for the proposed healthcare facility management 

standards for potentially creditable hazardous waste pharmaceuticals that are transported to 

reverse distributors for the processing of manufacturer’s credit. 

1. Notification Requirements for Healthcare Facilities Managing Non-creditable Hazardous 

Waste Pharmaceuticals
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In order to address commenters’ concerns from the 2008 Pharmaceutical Universal 

Waste proposal that regulatory agencies are unaware of hazardous waste pharmaceutical 

management activities, EPA is proposing to require that a healthcare facility that does not qualify 

as a CESQG to submit a one-time notification as a “healthcare facility” to the appropriate EPA 

Regional Administrator. Healthcare facilities subject to 40 CFR part 266, subpart P will have to 

submit notification even if the healthcare facility has previously obtained an EPA identification 

number. The required notification will enable EPA and state regulatory agencies to identify the 

universe of healthcare facilities managing hazardous waste pharmaceuticals subject to the 40 

CFR part 266, subpart P requirements. In addition, having this information allows EPA and state 

environmental regulatory agencies to track healthcare facilities for enforcement and inspection 

purposes, ensuring the hazardous waste pharmaceuticals are managed in accordance with the 

regulations. 

At any point a healthcare facility’s hazardous waste pharmaceutical generation may 

change due to waste minimization efforts or other reasons, causing the facility to legitimately 

decrease its total monthly hazardous waste generation enough to qualify as a CESQG. In this 

case, if the healthcare facility plans to withdraw from the 40 CFR part 266, subpart P 

requirements due to qualifying as a CESQG, it will be required to re-notify EPA of its choice to 

withdraw.

Alternatively, if a healthcare facility determines that it is a CESQG,65 but does not want 

to keep track of the amount of hazardous waste generated and whether it is above or below the 

 

65 A generator is a CESQG if it generates less than or equal to 100 kg of hazardous waste per calendar month, and 

less than or equal to1 kg of acute hazardous waste per calendar month and < 100 kg of any residue or contaminated 

soil, waste or other debris resulting from the clean-up of a spill, into or on any land or water, of any acute hazardous 

waste listed in §§ 261.31 or 261.33(e) per calendar month, provided it does not accumulate on-site at any time >1 kg 

of acute hazardous waste or >1000 kg of hazardous waste.
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CESQG threshold limit, it can choose to operate under this proposed rule. By choosing to 

operate under this proposed rule, the CESQG healthcare facility must comply with all of the 

requirements and must submit the one-time notification that it is operating under 40 CFR part 

266, subpart P. Healthcare facilities that are not CESQGs, however, are required to operate under 

40 CFR part 266, subpart P for the management of their hazardous waste pharmaceuticals.

The Agency is proposing that this notification occur via the RCRA Subtitle C Site 

Identification Form (EPA Form 8700-12; or Site Identification Form).66 EPA believes that 

notification via the Site Identification Form is the preferred approach for notification purposes 

for several reasons. First, both state environmental regulatory agencies and hazardous waste 

generators are familiar with the form, as it is the form currently used by hazardous waste 

generators to notify regulators of their RCRA Subtitle C activities. Second, as stated 

abovepreviously, the use of the Site Identification Form will allow for EPA and state regulatory 

agencies to monitor the healthcare facilities utilizing the new regulatory requirements. Lastly, 

public comments received on previous EPA actions (e.g., Academic Laboratories Rulemaking 

(73 FR 72912; December 1, 2008)) have indicated that notification via the Site Identification 

Form is the notification approach typically preferred by the regulated community. We are 

proposing that healthcare facilities can submit their notification as part of the Biennial Report, if 

the healthcare facility will be required to submit a Biennial Report due to its non-pharmaceutical 

hazardous waste. Otherwise, healthcare facilities are required to notify within 60 days of this 

new subpart becoming effective, or within 60 days of becoming subject to this new subpart.

 

66 For information on the current Site Identification Form, please see: 

http://www.epa.gov/wastes/inforesources/data/form8700/8700-12.pdf
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If this notification requirement is finalized, the Site Identification Form will be 

modified by EPA in a separate action.67 Specifically, the Agency intends to amend the Site 

Identification Form by adding a section to the form for a healthcare facility to indicate the type 

of entity it is (e.g., a hospital, a doctor’s office, a veterinary clinic, a pharmacy, an assisted living 

facility, etc.) and to indicate that it generates hazardous waste pharmaceuticals. The healthcare 

facility will no longer be required to identify on the Site Identification Form the specific types of 

hazardous waste pharmaceuticals it generates. The Agency also intends to add a checkbox to the 

section in order to allow a healthcare facility to indicate that its generator category is changing to 

a CESQG and it is no longer managing its hazardous waste pharmaceuticals according to 40 

CFR part 266, subpart P. 

The Agency does not anticipate that this proposed notification requirement will place 

any undue economic burden upon healthcare facilities or the environmental regulatory agencies 

that process these notifications (see the Regulatory Impact Analysis for the proposed rule in the 

rulemaking docket EPA-HQ-RCRA-2007-0932). In fact, under these proposed regulations, 

healthcare facilities would no longer need to count the hazardous waste pharmaceuticals

managed under 40 CFR part 266, subpart P towards a healthcare facility’s generator category. As 

a result, EPA anticipates that many healthcare facilities will change their generator category to

either a SQG or CESQG for their other, non-pharmaceutical hazardous wastes. So while the 

notification requirement ensures that the environmental regulatory agencies are informed of all 

hazardous waste pharmaceutical management activities subject to the 40 CFR part 266, subpart P 

requirements in their jurisdictions, the fact that some healthcare facilities will no longer qualify 

 

67 The Information Collection Request (ICR) for the Site Identification Form (87000-12) is updated every three 

years and must be approved by the Office of Management and Budget (OMB). These updates and OMB approvals 

are published in the Federal Register and are subject to public comment.
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as LQGs will reduce the number of healthcare facilities in the LQG universe. Because LQGs are

inspected more frequently than SQGs or CESQGs, EPA expects this could result in an overall 

decrease in burden for both the healthcare facilities and the environmental regulatory agencies. 

The Agency is soliciting comment on the notification requirement for healthcare 

facilities, the method of notification via the Site Identification Form, and whether this 

notification requirement will result in any undue burden to either healthcare facilities or state 

environmental regulatory agencies.

2. Personnel Training Requirements for Healthcare Facilities Managing Non-creditable 

Hazardous Waste Pharmaceuticals

Under the current RCRA Subtitle C regulations, an LQG healthcare facility must provide 

RCRA training to its healthcare workers involved in the generation and/or management of 

hazardous waste. Under § 262.34(a)(4), LQGs are required to comply with the personnel training 

requirements for interim status TSDFs (which are found in § 265.16). These personnel training 

requirements include either classroom instruction or on-the-job training in RCRA and state that 

the facility must maintain training documents and records for each trained staff person. On the 

other hand, under current regulation, healthcare facilities that are SQGs must meet a 

performance-based standard when training their healthcare workers. This entails ensuring “that 

all employees are thoroughly familiar with proper waste handling and emergency procedures 

relevant to their responsibilities during normal facility operations and emergencies” (§ 

262.34(d)(5)(iii)). For comparative purposes, healthcare facilities that are considered CESQGs 

do not have any personnel training requirements under the current federal regulations. Similarly, 

generators, including healthcare facilities, are not required to provide RCRA training to 
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personnel that only work in satellite accumulation areas regulated under § 262.34(c). However, 

healthcare personnel that are involved in the generation of pharmaceutical waste must be familiar 

enough with the pharmaceuticals with which they are working to know when they have 

generated a hazardous waste so that it will be managed in accordance with the RCRA 

regulations. 

EPA believes that the LQG RCRA training requirement is excessive for healthcare 

workers who sporadically generate hazardous waste pharmaceuticals at healthcare facilities, but 

believe it is necessary to have some familiarity with the dangers that hazardous waste 

pharmaceuticals can pose. Therefore, the Agency is proposing healthcare facility-specific 

personnel training requirements that are akin to the training requirements for SQGs and small 

quantity universal waste handlers. Specifically, healthcare facilities managing their hazardous 

waste pharmaceuticals in accordance with the proposed healthcare facility standards must inform 

all employees that handle or have responsibility for generating and/or managing hazardous waste 

pharmaceuticals of the proper handling and emergency procedures appropriate to their 

responsibilities during normal facility operations and emergencies. This training information can 

be disseminated through verbal communication or through distribution of pamphlets or other 

documentation. However, a healthcare facility that is an LQG due to its non-pharmaceutical 

hazardous wastes may choose to continue to use its existing training program as an LQG so as 

not to have different training programs and that would be acceptable, as well.

The Agency solicits comments on the personnel training requirements proposed in this 

notice document for healthcare facilities managing hazardous waste pharmaceuticals. 

Specifically, the Agency is seeking comment regarding the appropriateness of these personnel 
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training requirements and if these requirements will be sufficient for communicating key 

procedures to healthcare workers that generate and/or manage hazardous waste pharmaceuticals. 

EPA is seeking comment on whether documentation of training is necessary in order to 

verify compliance with the training requirement. Based on the comments received, we may 

include a requirement in the final rule for documenting and retaining records of healthcare 

personnel training. Finally, the Agency wants to reiterate that these proposed personnel training 

requirements only apply to staff generating and/or managing hazardous waste pharmaceuticals. 

The training requirements of 40 CFR part 262 will continue to apply to staff generating and/or 

managing other types of hazardous wastes at the healthcare facility. 

3. Making a Hazardous Waste Determination for Non-creditable Hazardous Waste 

Pharmaceuticals

Similar to the current RCRA Subtitle C generator requirements, healthcare facilities will 

still be required to make a hazardous waste determination on pharmaceutical wastes prior to 

managing them under the proposed cradle-to-grave standards. Therefore, when a healthcare 

facility generates a solid waste pharmaceutical, the healthcare facility must determine if the 

pharmaceutical waste is listed in 40 CFR part 261, subpart D and if it exhibits one or more of the 

four characteristics of hazardous waste identified in 40 CFR part 261, subpart C. However, 

unlike the existing generator requirements, the healthcare facility does not need to identify the 

specific waste codes applying to the pharmaceutical wastes. If the pharmaceutical waste is 

determined to be a hazardous waste, then the healthcare facility must manage the hazardous 

waste pharmaceuticals in accordance with these proposed requirements instead of 40 CFR part 

262. Pharmaceutical wastes not meeting the definition of a hazardous waste (i.e., non-hazardous 
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waste pharmaceuticals) must be managed in compliance with applicable federal, state and local 

regulations. 

EPA understands that healthcare facilities utilize various approaches when making 

hazardous waste determinations. For example, healthcare facilities may hire contractors to 

review their formularies and identify those pharmaceuticals that are hazardous wastes when 

discarded. These facilities may then identify hazardous waste pharmaceuticals at the pharmacy 

level, marking these pharmaceuticals with a special label so that healthcare personnel know how 

to properly dispose of the pharmaceutical when it becomes a waste. Other healthcare facilities 

may instruct personnel to dispose of all pharmaceutical wastes into one RCRA hazardous waste 

collection container. These facilities may then choose to manage all of the contents of the 

container as hazardous waste or they may choose to sort the hazardous waste portion from the 

non-hazardous waste pharmaceutical portion in the central accumulation area. Due to the various 

ways that healthcare facilities make the hazardous waste determination, the Agency is not 

proposing that a specific approach be utilized when making the determination, only that the 

facility performs the waste determination. However, healthcare facilities may choose to manage 

all of their pharmaceutical wastes as hazardous, and thus, if a healthcare facility chooses this 

approach, they would not need to make individual hazardous waste determinations, but would 

have made a generic decision that all of their waste pharmaceuticals are hazardous and manage 

them as hazardous waste pharmaceuticals in accordance with the proposed requirements in 40 

CFR part 266, subpart P. 

4. No Central Accumulation Area and Satellite Accumulation Area Requirements for Healthcare 

Facilities Managing Non-creditable Hazardous Waste Pharmaceuticals
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Hazardous waste pharmaceuticals are generated at numerous locations across a healthcare 

facility. Under the current RCRA Subtitle C requirements, each location at the healthcare facility 

with a RCRA hazardous waste receptacle for the disposal of hazardous waste pharmaceuticals is 

considered a satellite accumulation area and is subject to volume accumulation limits and other 

requirements.68 Of particular concern regarding the satellite accumulation requirements for 

healthcare facilities is the one quart accumulation limit for acute hazardous wastes (i.e., P-listed 

wastes). Under the December 2008 Pharmaceutical Universal Waste proposal, no accumulation 

areas, central or satellite, were proposed to be established for hazardous waste pharmaceuticals. 

This proposed approach was consistent with the current federal universal waste program, since 

facilities are not required to designate a special centralized area for the accumulation of universal 

wastes nor are they required to have satellite accumulation areas for universal wastes. 

Nevertheless, EPA understands that facilities that handle universal wastes will often accumulate 

their universal wastes within their 90- or 180-day hazardous waste accumulation areas.

For the reasons articulated in the Pharmaceutical Universal Waste proposal, the Agency 

has decided that a healthcare facility accumulating hazardous waste pharmaceuticals will not be 

subject to the satellite accumulation area regulations or the central accumulation area regulations 

(also sometimes called less than 90- or 180-day areas), but rather to the proposed accumulation 

time limits and container standards. 

A healthcare facility may choose to accumulate hazardous waste pharmaceuticals within 

its 90- or 180-day central accumulation area if it has one established for its other hazardous 

 

68 See § 262.34(c) for the satellite accumulation requirements. For additional information on satellite accumulation 

areas, please see the memorandum from Robert Springer to the EPA Regional RCRA Directors, “Frequently Asked 

Questions about Satellite Accumulation Areas” (RCRA Online #14703).) 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/0AC9E15424B2897D85257706006097

93/$file/14703.pdf
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wastes as long as it maintains compliance with the proposed accumulation time limit and 

container requirements of 40 CFR part 266, subpart P. The Agency notes that even if the 

hazardous waste pharmaceuticals are accumulated in a 90- or 180-day central accumulation area, 

these hazardous waste pharmaceuticals are not subject to the 90- or 180-day requirements. EPA 

solicits public comment on its decision to not require hazardous waste pharmaceutical-specific 

central and satellite accumulation area requirements. 

5. Container Standards for Healthcare Facilities Managing Non-creditable Hazardous Waste 

Pharmaceuticals

The container standards discussed in this section apply to those containers used by 

healthcare facilities to accumulate, store and transport non-creditable hazardous waste 

pharmaceuticals.69 First, we would note that due to the relatively small quantities of hazardous 

waste pharmaceuticals that are typically accumulated and stored at a healthcare facility, the 

Agency understands that other types of waste management units, such as tanks, are not used for 

the management of waste pharmaceuticals. Therefore, we are only proposing standards for 

containers. However, the Agency solicits comment as to whether other types of waste 

management units are also used by healthcare facilities to accumulate and store hazardous waste 

pharmaceuticals and whether EPA should establish technical standards for other types of waste 

management units. 

The Agency is proposing to require that healthcare facilities pack hazardous waste 

pharmaceuticals into containers that are structurally sound and that are compatible with the 

 

69 The container standards proposed do not apply to the various packaging, blister packs, bottles, vials, IV bags, etc., 

in which pharmaceuticals are stored prior to being dispensed or administered. 
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hazardous waste pharmaceuticals that will be contained within them. EPA intends this 

requirement to mean that containers used for holding hazardous waste pharmaceuticals must be 

in good condition, with no severe rusting, apparent structural defects, or deterioration. Containers 

also must not have any evidence of leakage, spillage or damage that could result in the release of 

waste under reasonably foreseeable circumstances. Furthermore, the Agency is proposing to 

require that incompatible wastes not be placed in the same container, unless the co-mingling of 

incompatible hazardous wastes is conducted in such a way that it does not have the potential to 

(1) generate extreme heat or pressure, fire or explosion, or violent reaction; (2) produce 

uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health; 

(3) produce uncontrollable flammable fumes or gases in sufficient quantities to pose a risk of fire 

or explosions; (4) damage the structural integrity of the facility or container containing the 

hazardous waste pharmaceuticals; or (5) through other like means threaten human health or 

environment. For example, the majority of a healthcare facility’s non-creditable hazardous waste 

pharmaceuticals are likely organic in nature, and thus, compatible with each other and can be 

accumulated together, especially since they will most likely be incinerated once they are 

transported to a TSDF. However, some non-creditable hazardous waste pharmaceuticals, such as 

metal bearing wastes not containing sufficient organics, are prohibited from being incinerated 

(e.g., P012, arsenic trioxide). The hazardous waste pharmaceuticals that cannot be incinerated

must be accumulated separately from organic wastes destined for incineration.

The Agency believes that these technical standards, like similar technical standards that 

EPA has promulgated in § 265.17 for interim status TSDFs, would ensure that hazardous waste 

pharmaceuticals are properly managed and would not be released into the environment, while at 
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the same time providing flexibility to the healthcare facility in selecting those containers that are 

most appropriate for their situation. 

In addition to the above proposed container standards , the Agency is also proposing that 

accumulation containers for hazardous waste pharmaceuticals be secured in a manner that 

prevents unauthorized access to the contents in order to prevent the pilfering of hazardous waste 

pharmaceuticals or inadvertent exposures to them. As we have noted previously, hazardous 

waste pharmaceuticals still retain considerable value and can easily be diverted for illicit 

purposes. To ensure this does not occur, we believe it is important to propose a requirement that 

would prevent the unauthorized access to the contents of these containers. EPA intends this 

requirement to be performance-based and does not intend to propose prescriptive regulatory 

requirements for this standard. The Agency believes that healthcare facilities can choose to 

utilize containers that have built-in mechanisms to prevent access to their contents or can choose 

to store containers in locked storage lockers, closets or rooms where the public does not have 

access to the containers or their contents. 

The Agency is seeking comment on the appropriateness of the proposed container 

management standards. In addition, the EPA is soliciting comment on the proposed requirement 

for ensuring that the hazardous waste pharmaceuticals contained in collection containers remain 

secure. 

6. Labeling Standards on Containers for Healthcare Facilities Managing Non-creditable 

Hazardous Waste Pharmaceuticals

During the period of accumulation and storage, the Agency is proposing that containers 

of hazardous waste pharmaceuticals be marked with the words “Hazardous Waste 
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Pharmaceuticals.” The Agency is not proposing to require that the hazardous waste numbers 

(often referred to as hazardous waste codes) of the container’s contents be listed on the label. 

The personnel at healthcare facilities that typically generate the hazardous waste pharmaceuticals 

will be healthcare workers (e.g., nurses). Healthcare workers are not usually intimately familiar 

with RCRA and its regulations and are primarily focused on patients and their health. In 

addition, while a healthcare facility may have an environmental compliance manager or 

environmental consultant that is knowledgeable about RCRA and its regulations and can make 

hazardous waste determinations, this individual cannot be present to assign a hazardous waste 

code and label the collection receptacle each time a pharmaceutical waste is generated. For these 

reasons, EPA does not believe it is necessary to require individual waste codes on the hazardous 

waste pharmaceutical collection container at the healthcare facility. The Agency is soliciting 

comment on the appropriateness of the proposed general labeling requirement. The Agency also 

requests comment on security concerns regarding having the word “pharmaceutical” marked on 

the containers. 

7. Accumulation Time Limits for Healthcare Facilities Managing Non-creditable Hazardous 

Waste Pharmaceuticals

Several hazardous waste pharmaceuticals are P-listed, acute hazardous wastes (e.g., 

nicotine, warfarin, etc.). Under current regulations, if a generator generates more than 1 kg of 

acute hazardous waste per calendar month or accumulates more than1 kg of acute hazardous 

waste at any time, the generator is regulated as an LQG. Due to this low generation/accumulation 

threshold associated with P-listed wastes, healthcare facilities are often LQGs. However, while 

healthcare facilities can generate enough P-listed waste to become LQGs, they often do not 
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generate sufficient amounts of hazardous waste pharmaceuticals within the allowed 

accumulation period of 90 days to make off-site shipments using a hazardous waste transporter 

cost-effective. 

Under the 2008 Pharmaceutical Universal Waste proposal, universal waste handlers 

would have had one year for accumulation of its hazardous waste pharmaceuticals in order to 

facilitate proper treatment and disposal. Commenters on the 2008 Universal Waste proposed rule 

indicated support for the one-year accumulation time limit. Thus, the Agency is proposing to 

allow healthcare facilities to accumulate hazardous waste pharmaceuticals for up to one year, 

without having interim status or a RCRA permit. As with Universal Waste, one year is an 

appropriate timeframe because it strikes a balance between allowing healthcare facilities enough 

time to accumulate amounts of hazardous waste pharmaceuticals to make it economically viable 

for transporting their hazardous waste pharmaceuticals off-site while ensuring that the hazardous 

wastes are not accumulated beyond the one year storage limit under the land disposal restrictions 

programs (see § 268.50).

70

Healthcare facilities will have various approaches to demonstrate the length of time that 

hazardous waste pharmaceuticals are accumulated on-site. For example, a healthcare facility can 

choose to mark the container label with the date that accumulation first began, maintain an 

inventory system that identifies dates when the hazardous waste pharmaceuticals were first 

accumulated, identify in the central accumulation area71 the earliest date that a hazardous waste 

pharmaceutical became a waste, or any other method that clearly demonstrates the length of time 

 

70 See the preamble to the Universal Waste final rule: May 11, 1995; 60 FR 25492 (page 25526).

71 While the proposed rules do not require healthcare facilities to comply with the central accumulation requirements 

under 262.34, a healthcare facility may have a central accumulation area for the other hazardous wastes that it 

generates. 
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that the hazardous waste pharmaceutical has been accumulated from the date it became a 

hazardous waste. The Agency assumes that any accumulation for up to one year is for the 

purpose of facilitating proper treatment and disposal. EPA proposes to require that any 

healthcare facility needing a longer accumulation time for any unforeseen circumstances beyond 

the control of the healthcare facility (e.g., a recall or litigation) request an extension from the 

appropriate EPA Regional Administrator. This request must be sent in writing (electronic or 

paper) explaining the need for the extension, the approximate amount of hazardous waste 

pharmaceuticals accumulated beyond the 90 daysone year, and the amount of extra time 

requested. An extension period will be granted at the discretion of the Regional Administrator 

on a case-by-case basis. 

Finally, the Agency reiterates that the one-year accumulation time limit only applies to a 

healthcare facility’s non-creditable hazardous waste pharmaceuticals and does not apply to any 

other types of hazardous waste generated on-site or to potentially creditable hazardous waste 

pharmaceuticals. EPA solicits comment on the proposed accumulation time limit of one year in 

order to allow healthcare facilities to generate enough non-creditable hazardous waste 

pharmaceuticals for cost-effective shipment, and solicits comment on the proposed mechanism to 

request a time extension. 

8. Land Disposal Restrictions for Non-creditable Hazardous Waste Pharmaceuticals

Similar to the current RCRA Subtitle C generator requirements, healthcare facilities must

comply with the land disposal restrictions (LDR) prior to land disposal of the hazardous waste 

pharmaceuticals they generate. Since healthcare facilities are generators, even though they are 

not subject to the 40 CFR part 262 requirements for the management of hazardous waste 
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pharmaceuticals, they must comply with the land disposal restrictions found at 40 CFR part 268.

The land disposal restrictions are in place to ensure that toxic constituents present in hazardous 

waste are properly treated to reduce their mobility or toxicity before hazardous waste is placed 

into or onto the land (i.e., land disposed). With limited exceptions, hazardous waste must be 

treated by a RCRA permitted or interim status TSDF. Again, EPA notes that autoclaving is not 

an acceptable method of treating hazardous waste.

In general, generators of hazardous waste assign the appropriate hazardous waste 

numbers codes to allow TSDFs to determine the specific treatment standard(s) for each 

prohibited waste. The Agency is proposing that healthcare facilities generating non-creditable 

hazardous waste pharmaceuticals do not have to assign hazardous waste codes to these wastes, 

but rather label them as “hazardous waste pharmaceuticals”. They do, however, need to be aware 

that while most of the hazardous waste pharmaceuticals are likely organic in nature and will be 

incinerated, some of their hazardous waste pharmaceuticals may not be suitable for incineration 

and therefore must be segregated from the organic wastes. The pharmaceutical hazardous wastes 

not suitable for incineration include characteristic metal wastes prohibited from being combusted 

because of the dilution prohibition of § 268.3(c), as well as the listed wastes U151 (mercury), 

U205 (selenium sulfide), and P012 (arsenic trioxide), unless they contain greater than 1% total 

organic carbon. HealthcareIn order to comply with the LDRs, healthcare facilities mustwill need 

to segregate these wastes from the organic pharmaceutical hazardous wastes so that they can be 

properly treated atby the TSDF. The Agency seeks comment on whether it is necessary to 

incorporate into the regulations a requirement to segregate these wastes and whether additional 

labeling requirements are necessary to identify the hazardous waste pharmaceuticals that are not 

suitable for incineration. 
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Tables 2 through 4 below list the hazardous waste pharmaceuticals with their hazardous 

waste codes and their LDR treatment standards.

Table 2: Waste Codes of Characteristic Hazardous Waste Pharmaceuticals

Waste 

Code 

Description Non-Wastewater

Treatment Standard

D001 Ignitable

Ignitable All D001, except 

high TOC D001 261.21(a)(1)

DEACT and UTS or

RORGS or

CMBST

Ignitable High TOC D001

based on 261.21(a)(1)

RORGS or

CMBST or

POLYM

D002 Corrosivity DEACT

and UTS

D004 * Arsenic 5.0 mg/L TCLP

and UTS

D005 * Barium 21 mg/L TCLP

and UTS

D006 * Cadmium 0.11 mg/L TCLP

and UTS

D007 * Chromium 0.60 mg/L TCLP

and UTS

D008 * Lead 0.75 mg/L TCLP

and UTS

D009* Mercury

Mercury ≥260 mg/kg total Hg

(high mercury organics) IMERC or RMERC

Mercury < 260 mg/kg total 

Hg & are not 

residues from RMERC

(low mercury)

0.025 mg/L TCLP

and UTS

D010 * Selenium 5.7 mg/L TCLP

and UTS

D011 * Silver 0.14 mg/L TCLP

and UTS

D013 Lindane

Lindane alpha-BHC 0.066 mg/kg

and UTS

Lindane beta-BHC 0.066 mg/kg

and UTS

Lindane delta-BHC 0.066 mg/kg

and UTS
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Waste 

Code 

Description Non-Wastewater

Treatment Standard

Lindane gamma-BHC 0.066 mg/kg

and UTS

D022 Chloroform 6.0 mg/kg

and UTS

D024 m-Cresol 5.6 mg/kg

and UTS

*Waste code may not be treated by combustion unless the waste meets one of the criteria in § 

268.3(c) (e.g., has >1% total organic carbon)

BOLD indicates that the waste is an organic waste with a concentration-based treatment standard

UTS = Universal Treatment Standards in § 268.48

Table 3: P-listed Hazardous Waste Pharmaceuticals

Waste 

Code 

Description Non-Wastewater 

Treatment Standard 

P001 Warfarin

(concentration > 0.3%)

CMBST 

P012 * Arsenic trioxide 5.0 mg/L TCLP

P042 Epinephrine CMBST 

P046 Phentermine CMBST 

P075 Nicotine CMBST 

P081 Nitroglycerin CMBST 

P188 Physostigmine salicylate 1.4 mg/kg

or CMBST

P204 Physostigmine 1.4 mg/kg

or CMBST

*Waste code may not be treated by combustion unless the waste meets one of the criteria in § 

268.3(c) (e.g., has >1% total organic carbon)

Table 4: U-listed Hazardous Waste Pharmaceuticals

Waste 

Code 

Description Non-Wastewater

Treatment Standard

U010 Mitomycin CMBST

U015 Azaserine CMBST

U034 Chloral hydrate CMBST

U035 Chlorambucil CMBST
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Waste 

Code 

Description Non-Wastewater

Treatment Standard

U044 Chloroform 6.0 mg/kg

U058 Cyclophosphamide CMBST

U059 Daunomycin CMBST

U075 Dichlorodifluoromethane 7.2 mg/kg

U089 Diethylstilbestrol CMBST

U121 Trichloromonofluoromethane 30 mg/kg

U122 Formaldehyde CMBST

U129 Lindane

Lindane alpha-BHC 0.066 mg/kg

Lindane beta-BHC 0.066 mg/kg

Lindane delta-BHC 0.066 mg/kg

Lindane gamma-BHC 0.066 mg/kg

U132 Hexachlorophene CMBST

U150 Melphalan CMBST

U151* Mercury

Mercury ≥260 mg/kg total Hg

(high mercury organics) IMERC or RMERC

Mercury < 260 mg/kg total 

Hg & are not 

residues from RMERC

(low mercury)

0.025 mg/L TCLP

and UTS

U182 Paraldehyde CMBST

U187 Phenacetin 16 mg/kg

U188 Phenol 6.2 mg/kg

U200 Reserpine CMBST

U201 Resorcinol CMBST

U205 * Selenium sulfide 5.7 mg/L TCLP

U206 Streptozotocin CMBST

U237 Uracil mustard CMBST

U248 Warfarin 

(Concentration ≤ 0.3%) CMBST

*Waste code may not be treated by combustion unless the waste meets one of the criteria in § 

268.3(c) (e.g., has >1% total organic carbon)

BOLD indicates that the waste is an organic waste with a concentration-based treatment standard

UTS = Universal Treatment Standards in § 268.48
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The organic hazardous waste pharmaceuticals (other than arsenic trioxide) may all be 

incinerated at RCRA permitted or interim status hazardous waste combustors. As noted in Tables 

2–4, most of the organic wastes have a specified treatment standard of combustion (CMBST). 

The remaining seven organics (lindane, chloroform, m-cresol, dichlorodifluoro methane, 

trichloromonofluoromethane, phenacetin and phenol) have numerical treatment standards, such 

that no particular treatment technology is specified or required in order to achieve the numerical 

treatment standards. While these wastes may be incinerated, the incinerator residue (ash) must be 

analyzed for these seven organic constituents to demonstrate compliance with the LDR treatment 

standards before that ash can be disposed.

As mentioned earlier, because this proposed rule does not require that healthcare facilities 

label their waste with the hazardous waste codes, the TSDF must always analyze the incinerator 

ash must always be analyzed for these seven constituents—lindane, chloroform, m-cresol, 

dichlorodifluoro methane, trichloromonofluoromethane, phenacetin, and phenol—according to 

their waste analysis plan, as they could possibly be present in any shipment of organic hazardous 

waste pharmaceuticals.

a. Alternative treatment standards considered. In their comments to the 2008 Universal 

Waste proposal, Environmental Technology Council (ETC) suggested revising the treatment 

standards for the organic hazardous waste pharmaceuticals that have numerical treatment 

standards to the specified treatment standard of combustion.72 Specifying combustion would 

relieve the TSDFs from demonstrating compliance with the numerical treatment standards. EPA 

explored the feasibility of making combustion an alternative treatment standard for the seven 

organic hazardous waste pharmaceuticals that currently have numeric treatment standards. In 

 

72 See comment number 0125 in the docket for this rulemaking. EPA-HQ-RCRA-2007-0932.
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fact, EPA notes that the numerical treatment standards were developed based on levels achieved 

through combustion. However, in order to allow maximum flexibility, EPA has indicated a 

preference for numerical treatment standards over specifying treatment standards whenever 

possible. Furthermore, it is not clear that pharmaceuticals would be the sole source of the seven 

organic constituents in question. Therefore, even if we proposed an alternative treatment 

standard of combustion for the seven organic pharmaceuticals, hazardous waste incinerators 

would still be required to test their ash for these constituents to demonstrate compliance with 

numeric treatment standards if they received the organics from another, non-pharmaceutical 

source. 

b. Incineration of mercury-containing hazardous waste pharmaceuticals. It is rare, but 

some pharmaceuticals contain mercury (e.g., thimerosal, a mercury-containing preservative). 

When discarded, a mercury-containing pharmaceutical would be a D009 hazardous waste if the 

leachate generated by the toxicity characteristic leaching procedure (TCLP), or if the 

pharmaceutical itself (when the waste contains < 0.5% filterable solids), contains ≥ 0.2 mg/L 

mercury (see § 261.24).73 As indicated in Table 2 above, a D009 hazardous waste with mercury 

content ≥ 260 mg/kg of total mercury and that also contains organics, must be treated by IMERC 

(incineration) or RMERC (mercury retorting). However, hazardous waste pharmaceuticals that 

are D009 are expected to have mercury content <260 mg/kg, in which case the treatment 

standards are numeric and treatment by RMERC or IMERC is not required. With numeric 

treatment standards, the generator has flexibility regarding which hazardous waste treatment 

method to use to meet the treatment standard. As explained abovepreviously, incineration of 

 

73 The Agency is not aware of any hazardous waste pharmaceuticals that would be considered U151 because 

mercury would have to be the sole active ingredient.
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mercury-bearing hazardous waste with >1% total organic carbon is not considered impermissible 

dilution (see § 268.3(c)) and therefore is an allowable form of treatment. 

Emissions from combustion units that burn hazardous waste74 are regulated under RCRA 

and the Clean Air Act (CAA). The implementing regulations under these statutory authorities 

include emission limits for new and existing combustion units for mercury, semi-volatile metals 

(cadmium and lead), low volatility metals (arsenic, beryllium, and chromium), particulate matter, 

chlorinated dioxins and furans, other toxic organic compounds, hydrogen chloride and chlorine. 

The regulations also 1) specify when and how combustion sources must comply with the 

emission standards and operating requirements, 2) prescribe detailed monitoring requirements to

show continuous compliance with the emission standards, and 3) prescribe performance testing 

requirements to demonstrate compliance with the emission standards (see 40 CFR part 63,

subpart EEE).

To ensure continuous compliance with the emission limits, hazardous waste combustors 

are required to establish limits on 1) the feedrate of metals (including mercury), chlorine, and 

(for some types of hazardous waste combustors) ash; 2) combustor operating parameters such as

minimum combustion chamber temperature; and 3) operating parameters of the air pollution 

control device. For mercury, continuous compliance requirements would generally include a 

limit on the total feedrate of mercury in all feedstreams to the combustion unit, limits on the 

operation of a wet scrubber (depending on the species of mercury in the combustion gases, wet 

scrubbers can be efficient at removing mercury), and operating limits on the activated carbon 

injection or carbon bed system, if such systems are used.

 

74 Combustors that burn hazardous waste include the following types of combustion units: incinerators, cement 

kilns, lightweight aggregate kilns, industrial boilers and process heaters, and hydrochloric acid production furnaces.
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In addition, RCRA directs permitting authorities to impose additional terms and 

conditions on a site-specific basis as may be necessary to protect human health and the 

environment (see § 270.32(b)). Thus, if the mercury emission limits specified above previously 

are not protective in an individual instance, the permit writer will establish permit limits that are 

protective.

Nevertheless, EPA is aware that some stakeholders are concerned about the risks 

associated with incinerating mercury-bearing hazardous wastes and we encourage healthcare 

facilities and pharmaceutical reverse distributors to consider the use of treatment technologies 

other than incineration for meeting the numeric treatment standards for mercury-bearing 

hazardous waste pharmaceuticals. ThimerasolThimerosal-containing pharmaceuticals are 

expected to be non-wastewaters as defined by § 268.2, because they have more than 1% total 

organic carbon. For low mercury non-wastewaters, the numeric treatment standard can be 

achieved by stabilization/solidification, either with or without subsequent encapsulation.75

9. Shipments of Non-creditable Hazardous Waste Pharmaceuticals Off-site From Healthcare 

Facilities

The Agency is proposing to maintain the current RCRA Subtitle C tracking requirement 

by requiring that a hazardous waste manifest be prepared for each off-site shipment of noncreditable hazardous waste pharmaceuticals from healthcare facilities. Accordingly, each off-site 

shipment of hazardous waste pharmaceuticals must be transported to an interim status or 

permitted TSDF via a hazardous waste transporter. However, the Agency is proposing that for 

 

75 EPA is not aware of any testing done to demonstrate the effectiveness of this treatment method specifically for 

thimerasolthimerosal-containing hazardous wastes, so vendors performing such treatment may need to do 

treatability studies to identify optimal use of stabilization/solidification treatment technologies
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hazardous waste pharmaceuticals shipped by healthcare facilities, the RCRA hazardous waste 

codes do not need to be listed on the manifest. This is intended to accommodate the fact that 

healthcare providers generating the hazardous waste pharmaceuticals are generally unfamiliar 

with RCRA and are focused on providing healthcare to patients. One function of the hazardous 

waste codes is to determine the appropriate hazardous waste treatment standards under the land 

disposal restrictions (part 268). However, virtually all hazardous waste pharmaceuticals sent for 

off-site treatment are sent to hazardous waste incinerators, even when the treatment standard 

does not require incineration. The fact that EPA is proposing to not require hazardous waste 

codes for shipping hazardous waste pharmaceuticals is not intended to alter or impact any 

Department of Transportation (DOT) requirements for the shipment of these hazardous wastes.

For a more detailed discussion of these proposed requirements, as well as the basis for these 

requirements, please see Section V.F.1 of this noticedocument. 

10. Rejected Shipment from Healthcare Facilities of Non-creditable Hazardous Waste 

Pharmaceuticals

In rare circumstances, a healthcare facility may send its non-creditable hazardous waste 

pharmaceuticals to a designated facility that is unable to manage the hazardous waste. For such 

situations, we are proposing that healthcare facilities follow the same procedures listed in 40 

CFR part 262 (see § 262.23(f)). Specifically, if a designated facility is unable to accept the 

hazardous waste pharmaceuticals, and it returns the hazardous waste pharmaceuticals to the 

healthcare facility, the healthcare facility must sign the manifest that was used to return the 

shipment, provide the transporter a copy of the manifest, send a copy of the manifest within 

thirty days to the designated facility that returned the shipment and retain a copy of the manifest 
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for three years from the date of delivery of the returned shipment. EPA believes that it is 

appropriate to continue current practices for rejected shipments that are part of the generator 

regulations of 40 CFR part 262 because rejected shipments are relatively rare and the procedures 

currently used for rejected shipments is relatively straightforward. In addition, healthcare 

facilities should be familiar with these procedures already.

11. Reporting Requirements for Healthcare Facilities Managing Non-Creditable Hazardous 

Waste Pharmaceuticals

The Agency is proposing that healthcare facilities managing non-creditable hazardous 

waste pharmaceuticals have reporting requirements similar to SQGs s regulated under 40 CFR 

part 262—that is, the exception reporting requirement under § 262.44(b) and the additional 

reporting requirement under § 262.44(c). In addition, we are proposing that healthcare facilities 

that are LQGs would no longer be required to include their hazardous waste pharmaceuticals on 

their biennial report (BR). Each of these reporting requirements for healthcare facilities is 

discussed below.

First, as part of the current RCRA Subtitle C generator requirements, healthcare facilities 

that are LQGs must submit a BR to the Regional Administrator by March 1st of every even 

numbered year (see §262.41). Among other requirements, the BR must include a description 

(EPA hazardous waste number and DOT hazard class) and quantity of each hazardous waste 

shipped off-site to a TSDF during each odd numbered year. If a healthcare facility is an LQG due 

to its non-pharmaceutical hazardous waste, it will continue to be required to submit a BR. 

However, it need not include its hazardous waste pharmaceuticals in its BR. As discussed 

abovepreviously, the Agency is no longer requiring healthcare facilities to count hazardous waste 
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pharmaceuticals when determining their generator category. Instead, all healthcare facilities,

with the exception of CESQGs, will be subject to this proposed rule. The Agency has determined 

that it does not need the information to be included in the BR because this proposed rule will 

bring a consistent approach to managing pharmaceutical hazardous wastes. Nevertheless, the 

Agency is soliciting public comment on whether the Agency should require healthcare 

facilities—that is, all healthcare facilities subject to the 40 CFR part 266, subpart P 

requirements—to submit a BR, and if so, the type of information that should be included. 

Second, the Agency is proposing that healthcare facilities follow the same reporting 

procedures for exception reporting that generators operating under the 40 CFR part 262 must 

follow. We are proposing to incorporate the generator exception reporting procedures in this new

subpart. Specifically, if a healthcare facility does not receive a copy of the hazardous waste 

manifest from the designated facility within 60 days, the healthcare facility must submit to the 

EPA Regional Administrator a copy of the manifest with a statement that the healthcare facility 

did not receive confirmation of the hazardous waste pharmaceuticals’ delivery along with an 

explanation of the efforts taken to locate the hazardous waste pharmaceuticals and the results of 

those efforts. Likewise, if a shipment of hazardous waste pharmaceuticals from a healthcare 

facility is rejected by the designated facility and it is shipped to an alternate facility and if the 

healthcare facility does not receive a signed copy of the hazardous waste manifest from the 

alternate facility within 60 days, it must submit to the EPA Regional Administrator a copy of the 

hazardous waste manifest with a statement that the healthcare facility did not receive 

confirmation of the hazardous waste pharmaceuticals’ delivery along with an explanation of the 

efforts taken to locate the hazardous waste pharmaceuticals and the results of those efforts. 
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Again, the Agency believes it is advantageous to use established procedures that should be 

familiar to healthcare facilities, especially given that rejected shipments are relatively rare.

Finally, the Agency proposes that the Administrator may require healthcare facilities to 

furnish additional reports concerning the quantities and disposition of hazardous waste 

pharmaceuticals. This is already the case for generators operating under the 40 CFR part 262

requirements. As with 40 CFR part 262, it is a codification of statutory authority under §§

2002(a) and 3002(a)(6) that provides the Agency some flexibility in what reports may be 

required. The Agency solicits public comment on the proposed reporting requirements for 

healthcare facilities managing their hazardous waste pharmaceuticals in accordance with the 

standards proposed in this noticedocument. 

12. Recordkeeping Requirements for Healthcare Facilities Managing Non-creditable Hazardous 

Waste Pharmaceuticals

The Agency is proposing that healthcare facilities managing non-creditable hazardous 

waste pharmaceuticals maintain records similar to the records that must be kept by generators 

regulated under 40 CFR part 262 (see § 262.40). Specifically, healthcare facilities must keep a 

signed copy of each hazardous waste manifest as a record for three years from the date that the 

non-creditable hazardous waste pharmaceutical was accepted by the initial hazardous waste 

transporter. If the healthcare facility is required to file an exception report because it does not 

receive a signed copy of the manifest from the designated facility within 60 days of the date that 

the hazardous waste pharmaceutical was accepted by the initial transporter, then the healthcare 

facility must keep a copy of the each exception report for a period of at least three years from the 
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due date of the report.76 In addition, EPA is proposing that a healthcare facility must keep 

records of any test results, waste analyses or other determinations made on hazardous waste 

pharmaceuticals regarding which pharmaceuticals are hazardous wastes for three years from the 

date of the test, analysis, or other determination. 

The Agency is also proposing that any of the above retention periods be extended during 

the course of enforcement actions against any activity associated with hazardous waste 

pharmaceutical management or as requested by the Administrator to ensure that the appropriate 

records are available and can be reviewed as part of any enforcement action. The Agency solicits 

public comment on the proposed recordkeeping requirements for healthcare facilities managing 

their non-creditable hazardous waste pharmaceuticals in accordance with the standards proposed 

in this noticedocument. 

13. Response to Releases by Healthcare Facilities Managing Non-creditable Hazardous Waste 

Pharmaceuticals

For hazardous waste pharmaceuticals generated and managed by healthcare facilities 

under the proposed standards, the Agency is proposing basic release responses, including the 

requirement that healthcare facilities immediately contain all releases of, and other residues 

from, hazardous waste pharmaceuticals. In addition, this proposal would require healthcare 

facilities to determine whether any material, residue, or debris resulting from the release is or 

 

76 §262.40 requires that generators keep a copy of each BR for a period of at least three years from the due date of 

the report. However, since we are not requiring a healthcare facility to include its hazardous waste pharmaceuticals 

on its a BR, the Agency is also not including in subpart P a requirement that a BR be kept at the healthcare facility. 

If healthcare facility must submit a BR due to its non-pharmaceutical hazardous waste, the §262.40 recordkeeping 

requirements will apply (Seesee the discussion under Reporting Requirement for Healthcare Facilities Managing 

Non-creditable Hazardous Waste Pharmaceuticals for the Agency’s basis of not requiring healthcare facilities to 

include hazardous waste pharmaceuticals on the BR. 
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contains a hazardous waste pharmaceutical and, if so, to manage it under the management 

standards for hazardous waste pharmaceuticals proposed in this noticedocument. These 

proposed release response procedures are the same as those under the Universal Waste program

(see § 273.17 for small quantity universal waste handlers, and § 273.37 for large quantity 

universal waste handlers). Commenters to the 1993 proposed rule that established the Universal 

Waste program overwhelmingly supported the release response measures (60 FR 25528; May 

11, 1995). Thus, we believe it is appropriate to include it again in this proposal.

Any releases of hazardous waste pharmaceuticals not cleaned up immediately would 

generally constitute illegal disposal, which may result in further action by EPA or an authorized 

state under RCRA. In addition, hazardous wastes under RCRA are included in the definition of 

hazardous substances for purposes of the Comprehensive Environmental Response 

Compensation, and Liability Act (CERCLA) (see CERCLA Section 101(14)77). Thus, any 

releases into the environment of hazardous substances above the reportable quantity (RQ) 

thresholds must be reported under CERCLA (see CERCLA Section 103). That is, since 

hazardous waste pharmaceuticals are hazardous wastes and, hazardous substances under 

CERCLA, reporting for hazardous waste pharmaceutical releases is required when RQs are 

exceeded (see 40 CFR 302.4 for a list of RQs and hazardous substances). Such reports provide 

notification to the Agency (through the National Response Center) concerning releases into the 

environment and help inform whether EPA should take action, if necessary, under either RCRA 

or CERCLA.

The Agency solicits comment regarding the proposed standard for the response to 

releases of hazardous waste pharmaceuticals at healthcare facilities. 

 

77 http://www.epw.senate.gov/cercla.pdf
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14. Long-Term Care Facilities Managing Non-creditable Hazardous Waste Pharmaceuticals

Long-term care facilities differ in one respect from other types of healthcare facilities 

subject to these proposed standards. Unlike hospitals, who own the pharmaceuticals they 

dispense to patients, many of the hazardous waste pharmaceuticals generated at long-term care 

facilities belong to the residents of the facility. That is, the pharmaceuticals are dispensed under 

the patient’s name. However, as previously discussed in this preamble, EPA is proposing to no

longer allow hazardous waste pharmaceuticals generated at long-term care facilities (as defined 

under this proposed regulation) to be eligible for the household hazardous waste exemption. As a 

result, long-term care facilities must manage all hazardous waste pharmaceuticals generated onsite, regardless of ownership, in accordance with these same proposed management standards for 

healthcare facilities. EPA understands that while long-term care facilities often maintain each 

individual’s pharmaceuticals in a centralized location, such as a pharmaceutical cart, there are 

instances where some individuals may keep and self-administer their own pharmaceuticals. EPA 

is proposing that the long-term care facilities collect and manage all hazardous waste 

pharmaceuticals generated at their facilities in accordance with these proposed requirements. 

This requirement means that in addition to the hazardous waste pharmaceuticals kept in the 

centralized location, long-term care facilities will need to collect all other hazardous waste 

pharmaceuticals from individuals that self-administer these pharmaceuticals and manage them in 

accordance with these proposed standards, which, among other things, prohibits the sewering of 

hazardous waste pharmaceuticals. Although long-term care facilities would not be required under 

this rule to collect non-hazardous waste pharmaceuticals, EPA recommends that long-term care 

facilities collect all waste pharmaceuticals to ensure proper management, avoid flushing, and 
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minimize the potential for accidental poisonings, misuse or abuse. See Section E.2 of the 

preamble for a discussion of the requirements for long-term care facilities that collect hazardous 

waste pharmaceuticals that are also controlled substancesThe Agency solicits comment on the 

extent to which long-term care facilities keep an inventory of the pharmaceuticals that 

individuals self-administer, as this would facilitate the collection of the hazardous waste 

pharmaceuticals for proper disposal.

Although long-term care facilities would not be required under this rule to collect nonhazardous waste pharmaceuticals, or hazardous waste pharmaceuticals from the independent 

living portion of a continuing care facility, EPA recommends that long-term care facilities collect 

all waste pharmaceuticals to ensure proper management, avoid flushing, and minimize the 

potential for accidental poisonings, misuse or abuse. As discussed later in this preamble, DEA 

regulations govern the management of controlled substances (see Section V.E.2.a of the 

preamble for a discussion of DEA's 2014 final rule for the disposal of controlled substances and 

the implications of that rule and this proposed rule for long-term care facilities.78) Also discussed 

later in more detail, EPA is proposing to exempt from RCRA those hazardous waste 

pharmaceuticals that are also controlled substances, provided they are combusted at a permitted 

or interim status hazardous waste incinerator or permitted municipal solid waste incinerator and 

managed in compliance with applicable DEA regulations (see Section V.E.2 of the preamble for 

a detailed discussion of the exemption).

The Agency solicits comment regarding this requirement, and specifically requests 

comment on the various approaches that long-term care facilities use, or could use in collecting 

hazardous waste pharmaceuticals from individuals that self-administer their pharmaceuticals. 

 

78 DEA's final rule for disposal of controlled substances: 79 FR 53520; September 9, 2104.
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15. Healthcare Facilities that Accept Hazardous Waste Pharmaceuticals from Off-site 

Conditionally Exempt Small Quantity Generators (CESQGs)79

Typically, hazardous waste pharmaceuticals from healthcare facilities are transported 

either to a reverse distributor, if it is potentially creditable,80 or to a permitted or interim status 

hazardous waste TSDF. However, stakeholders have informed EPA that in some cases, 

hazardous waste pharmaceuticals are transported to another healthcare facility. We are aware of 

at least two situations in which this is occurring. First, patients at long-term care facilities who 

receive their pharmaceuticals from an off-site long-term care pharmacy sometimes return their 

unused pharmaceuticals to the long-term care pharmacy.81 Upon return, the long-term care 

pharmacy sorts through the returned pharmaceuticals to determine whether they will be disposed 

or restocked for reuse. Due to many factors, such as Medicare regulations and the cost of the 

pharmaceutical as compared to the cost of repackaging and restocking, only a small fraction of 

the returned pharmaceuticals are restocked for potential reuse. However, oneOne long-term care 

pharmacy estimated that only approximately 10 percent of the pharmaceuticals it sends to longterm care facilities come back as returns.82 Some portion of the returns would be considered 

hazardous waste pharmaceuticals when discarded.83 In the second situation, the Army has 

 

79 Unlike other sub-sections of Section V.C., which discusses the proposed standards for healthcare facilities 

managing non-creditable hazardous waste pharmaceuticals, this sub-section addresses both non-creditable and 

creditable hazardous waste pharmaceuticals. 

80 Potentially creditable hazardous waste pharmaceuticals include pharmaceuticals that are: (1) unused or unadministered, (2) unexpired or less than one year past the expiration date; or (3) in unopened or opened packaging or 

containers.

81 DEA controlled substances can be returned to a long-term care pharmacy only if they are subject to a recall (see 

21 CFR 1317.85(a)).

82 See notes from 11-15-12 site visit to Omnicare, Inc. in the docket for this proposed rule (EPA-HQ-RCRA-2007-

0932).

83 Due to the DEA regulations, none of thea DEA registered long term care pharmacy may not accept returns can 

beof a controlled substances. DEA regulations define “reverse distribute” and reverse distributor” in 21 CFR 
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established off-post health clinics to provide easier access to healthcare for military personnel, 

including veterans. The pharmacies at the off-post clinics receive their pharmaceutical products 

via couriers that deliver the pharmaceuticals from the on-post, main pharmacy. The off-post 

pharmacies also return their unused pharmaceuticals to the on-post, main pharmacy via courier.

EPA understandsdata indicates that the majority of long-term care facilities are 

CESQGs84 and the Army has informed EPA that their off-post clinics are generally CESQGs, as 

well.85 The existing CESQG regulations do not allow a generator to send its hazardous waste offsite to another hazardous waste generator, unless the receiving generator is also one of the seven 

types of facilities listed in § 261.5(f)(3) for acute hazardous waste or §261.5(g)(3) for hazardous 

waste, including municipal and non-municipal non-hazardous solid waste landfills. The Agency 

does not think that disposal in landfills is the best option for hazardous waste pharmaceuticals. 

Limited studies have shown active pharmaceutical ingredients are present in landfill leachate that 

is collected in municipal solid waste landfill leachate collection systems.86,87 Landfill leachate is 

then typically transported to a wastewater treatment plant for treatment; however, active 

pharmaceutical ingredients can pass through the treatment system and into our Nation’s waters. 

 

1300.01. A pharmacy is not authorized to accept returns of controlled substances from patients or reverse distribute 

(see 21 CFR 1301.13(e)(1)(iv)). 

84 Under these proposed requirements, hazardous waste pharmaceuticals will not count towards a facility’s generator 

category. Therefore, EPA expects that long-term care facilities will remain CESQGs, even though the Agency is 

proposing that all hazardous waste pharmaceuticals generated on the premises must be managed in accordance with 

these proposed requirements.

85 See notes from 11-28-12 meeting with U.S. Army Institute of Public Health in the docket for this proposed rule 

(EPA-HQ-RCRA-2007-0932).

86 Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio, M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and 

Barber, L. B. (2004), Pharmaceuticals and Other Organic Waste Water Contaminants Within a Leachate Plume 

Downgradient of a Municipal Landfill. Groundwater Monitoring & Remediation, 24: 119–126

87 Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., Zaugg, S.D., and Meyer, M.T. ( June 2009), WasteIndicator and Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water near Elkhart, Indiana, 2000–

2002. Bulletin of Environmental Contamination and Toxicology, V82.6 :635-659
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EPA thinks it would be preferable to allow healthcare facilities that are CESQGs to send 

their hazardous waste pharmaceuticals to another healthcare facility rather than send it to a 

municipal or non-municipal non-hazardous solid waste landfill. Therefore, EPA is proposing to 

allow healthcare facilities that are CESQGs operating under this subpart to send their hazardous 

waste pharmaceuticals to an off-site healthcare facility, without a hazardous waste manifest, 

provided four conditions are met. First, the receiving healthcare facility must be contracted to 

supply pharmaceutical products to the CESQG long-term care facility, or the CESQG healthcare 

facility and the receiving healthcare facility must both be under the control88 of the same person, 

as defined by §260.10 (e.g., the Army). Second, the receiving healthcare facility must be 

managing its hazardous waste pharmaceuticals in accordance with the regulations of this 

proposed rule.

89 Third, the hazardous waste pharmaceuticals from the CEQSG must be managed 

by the receiving healthcare facility as hazardous waste pharmaceuticals in accordance with the 

regulations of this proposed rule once it arrives at the receiving healthcare facility. Fourth, the 

receiving healthcare facility must keep and maintain records of the hazardous waste 

pharmaceuticals received from the off-site CESQG healthcare facilities for three years from 

receipt of shipment. These conditions should ensure the proper management of the hazardous 

waste pharmaceuticals, in that once they are received by the healthcare facility, they are subject 

to the same management standards EPA is proposing for hazardous waste pharmaceuticals 

managed by healthcare facilities that are LQGs and SQGs, while at the same time would not 

impose an undue burden on healthcare facilities that are CESQGs, especially since these 

 

88 For purposes of this provision, “control” means the power to direct the policies of the healthcare facility, whether 

by the ownership of stock, voting rights, or otherwise, except that contractors who operate facilities on behalf of a 

different person shall not be deemed to control such healthcare facility. 

89 This condition is only applicable if the receiving healthcare facility is also a CESQG, since healthcare facilities 

that are SQGs and LQGs must comply with the requirements proposed in 40 CFR part 266 subpart P.
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healthcare facilities always have the option of sending their hazardous waste pharmaceuticals to 

a municipal or non-municipal solid waste landfill. 

The Agency solicits comment on this new provision under this subpart, including 

whether any additional conditions should be imposed. In recommending any additional 

conditions, the Agency requests that commenters provide their rationale for the additional 

condition(s), as well as why such additional condition(s) would not pose an undue burden on 

healthcare facilities that are CESQGs. In addition, the Agency solicits comment on whether it 

might be appropriate to allow facilities, other than those meeting the proposed definition of a 

healthcare facility, to accept hazardous waste pharmaceuticals from an off-site CESQG (e.g., a 

military medical logistics facility).

D. How Does this Proposed Rule Address Healthcare Facilities that Accumulate Potentially 

Creditable Hazardous Waste Pharmaceuticals Prior to Shipment to Pharmaceutical Reverse 

Distributors?

1. Potentially Creditable Hazardous Waste Pharmaceuticals are not Products

One difference between this proposal and the 2008 Pharmaceutical Universal Waste

proposal is the proposed interpretation of how RCRA applies to pharmaceuticals that are 

returned to reverse distributors to obtain manufacturers’ credit. Two previous agency policy 

memos set out EPA’s existing understanding of the status of these “creditable” pharmaceuticals. 

The first, a letter to Merck Sharp & Dohme in 1981, explained that pharmaceuticals sent for 

credit may be reclaimed and are not wastes since the decision to discard a particular material 
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does not occur until after the product has been returned to the manufacturing plant.90 The second, 

a letter to BFI Pharmaceutical Services, Inc. in 1991 states, “to the extent that the materials 

involved are unused commercial chemical products with a reasonable expectation of being 

recycled in some way when returned, the materials are not considered as wastes until a 

determination has been made to discard them.”91 In addition to these letters, EPA’s 2008 

Pharmaceutical Universal Waste proposal stated, “Because unused or expired pharmaceuticals 

are returned (via the reverse distributor) for possible manufacturer’s credit, they still have 

potential value to the pharmacy or hospital and are thus not considered wastes.”92

In this action, we are proposing to modify EPA’s position regarding the waste status of 

creditable pharmaceuticals. Because we understand that many participants in this sector have 

relied on the interpretations in the two letters and the 2008 Pharmaceutical Universal Waste 

preamble, we are providing notice of a change in EPA’s position and providing an opportunity 

for public comment. Until this rule is final and effective, however, EPA’s previous 

interpretations will continue to be in effect. 

In terms of the concept that returned pharmaceuticals have value and are not waste, EPA 

confirms the general rule under RCRA that materials that are discarded are solid wastes,

regardless of the economics of the system in which those discarded materials are handled.

Therefore, the fact that a material may have monetary value (e.g., through a manufacturer’s 

credit) does not determine whether that material is a solid waste. Rather, the “decision point” on 

 

90 Alan Corson to Steven Wittner on May 13, 1981 (RCRA Online #11012) 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/B630CD51DC85EDC58525670F006B

CE84/$file/11012.pdf.

91 Sylvia Lowrance to Mark J. Schulz on May 16, 1991 (RCRA Online #11606) 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/A3A7A7A8F297438B8525670F006BE

5D8/$file/11606.pdf.

92 73 FR 73525; December 2, 2008.
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whether a pharmaceutical is a solid waste is when it has been discarded, or the decision has been 

made to discard the material. That is, a discarded pharmaceutical may retain value in the reverse 

distribution system, but still be considered a solid waste. Additionally, the economic value of 

hazardous waste can be one important consideration in determining whether a hazardous waste is 

legitimately recycled (see, for example, the discussion of Useful Economic Information in the 

2008 Definition of Solid Waste final rule, 73 FR 84706-07, October 30, 2008) and therefore 

excluded from being a solid waste. The definition of legitimate recycling is codified at 40 CFR 

260.43 and is discussed in the 2015 Definition of Solid Waste final rule (80 FR 1694, January 

13, 2015).

Commenters to the 2008 Pharmaceutical Universal Waste proposal, the 2014 Retail 

Notice of Data Availability (NODA), stakeholders, and pharmaceutical reverse distributors 

themselves have informed EPA that pharmaceuticals transported to reverse distributors to 

receive credit are rarely, if ever, repurposed, recycled, or reused. One commenter wrote, 

“...EPA’s belief that reverse distributors first arrange to transport and receive the drugs, and then 

determine whether the drugs are useful products or wastes, is pure fiction.”93 Another commenter 

wrote, “...the vast majority of the returned pharmaceuticals are to be collected for disposal or 

destruction once credit has been given.”94 A third commenter wrote, “...drugs sent through 

reverse distribution are not reused or recycled due to economic and safety reasons.”95

Regulations pertaining to the repurposing of pharmaceuticals vary by state, as they are 

established by each state’s Board of Pharmacy. However, stakeholders have overwhelmingly 

declared that state Boards of Pharmacy only allow pharmaceuticals to be repurposed under very 

 

93 Comment EPA-HQ-RCRA-2007-0932-0125.

94 Comment EPA-HQ-RCRA-2007-0932-0068.

95 Comment EPA-HQ-RCRA-2012-0426-0025.
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narrow circumstances—that is, when a specific set of conditions are followed to ensure the 

viability and integrity of the pharmaceutical. The set of conditions vary by state; however, states 

have some restrictions in common when it comes to repurposing drugs. According to the 

National Conference of State Legislatures (NCSL), “Virtually all [state] laws include some 

restrictions designed to assure purity, safety and freshness of the products. Unless otherwise 

noted, all programs require:

 All donated drugs must not be expired and must have a verified future expiration 

date. 

 Controlled substances, defined by the federal Drug Enforcement Administration 

(DEA) usually be excluded and prohibited.

 A state-licensed pharmacist or pharmacy to be part of the verification and 

distribution process.

 Each patient who is to receive a drug must have a valid prescription form 

in his/her own name.”

96

Thus, in most, if not all cases, pharmaceuticals that are transported back to a reverse distributor 

for credit are discarded by the reverse distributor.

97

 ThereforeFor that reason, the decision to 

send a pharmaceutical to a reverse distributor is essentially a decision to discard the 

pharmaceutical.

 

96 Content is copied from http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-andrecycling.aspx (accessed May 13, 2015).

97 Any facility, including a pharmaceutical manufacturer engaged in processing pharmaceutical hazardous waste for 

facilitation or verification of manufacturer’s credit would be considered a pharmaceutical reverse distributor under 

the proposed rule with respect to those operations, and would be subject to the proposed regulations for 

pharmaceutical reverse distributors. 
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Therefore, EPA is proposing to reinterpret its position such that the decision to send a 

pharmaceutical to a reverse distributor is the point at which a decision has been made to discard 

the pharmaceutical. ThereforeAs a result, once the decision is made to send a hazardous waste 

pharmaceutical to a reverse distributor, it is a solid waste at the healthcare facility. In this 

noticedocument, EPA is proposing to define the term “potentially creditable hazardous waste 

pharmaceutical.” A portion of the potentially creditable pharmaceuticals at healthcare facilities 

that are transported to reverse distributors will likely meet the definition of hazardous waste. Of 

the set of pharmaceuticals that are hazardous wastes, only “potentially creditable” hazardous 

waste pharmaceuticals may be transported to a reverse distributor for manufacturer’s credit (see 

definition Section V.A.3). 

The Agency notes that the management standards discussed below

pertain only to potentially creditable hazardous waste pharmaceuticals that are managed via 

reverse distribution and do not apply to the reverse distribution or reverse logistics systems that 

may exist for other consumer products. In addition to the standards discussed in this section, 

EPA is proposing standards for shipping potentially creditable hazardous waste pharmaceuticals 

to pharmaceutical reverse distributors as well as associated recordkeeping (see Section V.F.2. of 

the preamble).

2. Hazardous Waste Determination for Potentially Creditable Hazardous Waste Pharmaceuticals

As with non-creditable hazardous waste pharmaceuticals discussed abovepreviously, a 

healthcare facility must determine which potentially creditable pharmaceuticals are listed or 

characteristic hazardous wastes, in order to determine which potentially creditable 

pharmaceuticals are subject to regulation under this subpart. Potentially creditable hazardous 
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waste pharmaceuticals must be managed under this subpart, while pharmaceuticals that do not 

meet the definition of hazardous waste but are potentially creditable, do not have to be managed 

under this subpart. However, a healthcare facility may choose to manage all of its potentially 

creditable pharmaceuticals (both hazardous and non-hazardous) as potentially creditable 

hazardous waste pharmaceuticals while accumulating on-site and when shipping off-site. If a 

healthcare facility chooses this approach, it would not need to make individual hazardous waste 

determinations, but would have made a generic decision that all of their potentially creditable 

waste pharmaceuticals are hazardous and manage them as potentially creditable hazardous waste 

pharmaceuticals in accordance with the proposed requirements in 40 CFR part 266, subpart P. 

3. Accumulation Time, Container Management, and Labeling for Potentially Creditable 

Hazardous Waste Pharmaceuticals at Healthcare Facilities

Typically, EPA requires specific management standards for containers that hold 

hazardous waste. However, potentially creditable hazardous waste pharmaceuticals appear to 

pose lower environmental risk of release than patient care hazardous waste pharmaceuticals or 

traditional industrial hazardous waste. The risk of release is lower for several reasons. First, 

potentially creditable hazardous waste pharmaceuticals that are prepared for shipment to a 

reverse distributor are usually in their original containers as well as outer packaging, providing 

two layers of protection from leaks or spills.98 Second, potentially creditable hazardous waste 

pharmaceuticals are typically generated in the pharmacy area of a healthcare facility where there 

is restricted access, creating a layer of security for these pharmaceuticals. Third, EPA has been 

informed that it is common practice at healthcare facilities for potentially creditable 

 

98 See 73 FR 73529; December 2, 2008.
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pharmaceuticals that are destined for a reverse distributor to be taken from the shelves of the 

pharmacy periodically and promptly boxed for off-site shipment. EPA anticipates that this 

relatively quick timing is largely driven by the economic value of the manufacturer’s credit for 

the returned pharmaceuticals. Therefore, because of the lower risk these pharmaceuticals pose, 

EPA is not proposing specific management standards for healthcare facilities that accumulate 

containers of potentially creditable hazardous waste pharmaceuticals. For the same reasons, we 

also are not proposing a limit on how long healthcare facilities may accumulate containers of 

potentially creditable hazardous waste pharmaceuticals. EPA requests comment on the 

assumption that healthcare facilities promptly remove potentially creditable hazardous waste 

pharmaceuticals from pharmacy shelves and send them to reverse distributors. EPA asks for 

comment on whether the expectation of credit provides sufficient incentive to ensure that the 

hazardous waste pharmaceuticals will be managed appropriately or whether it is necessary to 

establish management standards and/or a maximum time limit for the accumulation of potentially 

creditable hazardous waste pharmaceuticals prior to off-site shipment.

In the 2008 Pharmaceutical Universal Waste proposal, EPA specifically solicited 

comment on whether stakeholders have knowledge of problems with mixing incompatible 

pharmaceuticals during accumulation. In response, one commenter indicated that there were no 

issues encountered with the compatibility of pharmaceuticals during storage.99 Since then, a 2011 

article by Charlotte Smith states, “oxidizers, acids, and bases also are incompatible, but they 

occur infrequently as finished dosage forms.”100 It is important to note that the accumulation of 

some potentially creditable hazardous waste pharmaceuticals, such as liquids and aerosols, may 

 

99 Commenter # EPA-HQ-RCRA-2007-0932-0091.

100 Charlotte Smith, RPH, MS; Managing Pharmaceutical Waste: A New Implementation Blueprint; Pharmacy 

Practice News, Special Edition, 2011.
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pose more of a risk than solid pills due to possible spillage or leakage. However, EPA believes 

that the small quantities in which the liquid and aerosol potentially creditable hazardous waste 

pharmaceuticals are generated, along with the DOT packaging requirements (49 CFR parts 173, 

178, and 179180), would likely obviate these risks. In addition, to further mitigate the potential 

for spillage or leakages, as a best management practice, EPA encourages healthcare facilities to 

place the original containers and packaging containing liquids and aerosols pharmaceuticals in 

separate individual containers, such as a sealed storage bag before placing them in the container 

that will be shipped.

EPA also is proposing not to require specific labeling standards for containers holding 

potentially creditable hazardous waste pharmaceuticals, while they accumulate on-site. EPA does 

not want to deter the practice of co-mingling potentially creditable hazardous waste 

pharmaceuticals with potentially creditable non-hazardous waste pharmaceuticals since both are 

typically transported to a reverse distributor together. 

In addition, due to concerns regarding diversion of pharmaceuticals, EPA believes that it 

is safer not to call attention to the fact that these containers hold pharmaceuticals. Unlike floor 

waste or patient care pharmaceutical waste, or most hazardous waste, the hazardous waste 

pharmaceuticals returned to a reverse distributor often have high street value that makes them 

susceptible to diversion. Thus, EPA is not proposing to require a label for potentially creditable 

hazardous waste pharmaceuticals during accumulation at a healthcare facility. The Agency seeks 

comment on its proposal not to require specific accumulation, container management or labeling 

standards for potentially creditable hazardous waste pharmaceuticals that will be transported to a 

reverse distributor, including no specific labeling standards for containers holding potentially 

creditable hazardous waste pharmaceuticals on-site prior to shipment off-site.
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E. What Are the Proposed Novel Prohibitions, Exemptions and Other Unique Management 

Requirements for Hazardous Waste Pharmaceuticals?

1. Sewer Disposal Prohibition

a. Regulatory background on the domestic sewage exclusion. Under RCRA and the 

Subtitle C hazardous wastes regulations, if a material is not a solid waste, then it cannot be 

considered a hazardous waste. Under § 261.4(a)(1)(ii) of the RCRA regulations, “Any mixture of 

domestic sewage and other wastes that passes through a sewer system to a publicly-owned 

treatment works for treatment” is not a solid waste for purposes of Subtitle C regulation. This 

exclusion was finalized by EPA on May 19, 1980, based on the reasoning that “Mixed waste 

streams that pass through sewer systems to publicly-owned treatment works (POTW’s) will be 

subject to controls under the Clean Water Act. The Agency’s construction grants program 

provides financial assistance for the proper treatment of these wastes. In addition, the Agency’s 

pretreatment program provides a basis for EPA and the local communities to ensure that users of 

sewer and treatment systems do not dump wastes in the system that will present environmental 

problems” (45 FR 33097).

In 1984, Congress enacted the Hazardous and Solid Waste Amendments (HSWA) to the 

Solid Waste Disposal Act (SWDA), as amended by RCRA. HSWA included a new Section

3018, entitled Domestic Sewage. This section directed EPA to do two things with respect to the 

261.4(a)(1)(ii) exclusion for mixtures of domestic sewage and other wastes: 1) submit a Report 

to Congress (RTC) that describes the types, size and number of generators which dispose of such 

wastes in this manner, the types and quantities of wastes disposed of in this manner, and identify 

significant generators, wastes and waste constituents not regulated under existing Federal law or 
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regulated in a manner sufficient to protect human health and the environment; and 2) based on 

the report, revise the existing regulations that are necessary to “ensure that substances...which 

pass through a sewer system to a publicly owned treatment works are adequately controlled to 

protect human health and the environment.”

EPA submitted its Report to Congress on February 7, 1986 (Domestic Sewage Study).

Subsequent to the Report to Congress, EPA issued an advance notice of proposed rulemaking 

(ANPR) on August 22, 1986 (51 FR 30166); a response to comments on the ANPR on June 22, 

1987 (52 FR 23477); a notice of proposed rulemaking (NPR) on November 23, 1988 (53 FR 

47632); and a final rule on July 24, 1990 (55 FR 30082). That final rule prohibits the discharge 

of pollutants which create a fire or explosion hazard in the POTW, which includes, but is not 

limited to, wastestreams with a closed cup flashpoint of less than 140 degrees Fahrenheit or 60 

degrees Celsius using the test methods specified in 40 CFR 261.21” (55 FR 30087). Although 

the exclusion for mixtures of domestic sewage and other wastes is found under the RCRA 

regulations in § 261.4(a)(1)(ii), the sewer ban of liquid ignitable hazardous wastes (i.e., with the 

hazardous waste code D001) was established under 40 CFR 403.5(b)(1), which is under the 

Clean Water Act (CWA) regulations. The Agency seeks comment on whether it would be 

helpful to incorporate in 40 CFR 261.4(a)(1)(ii), a cross-reference to the CWA regulations 

prohibiting the sewering of liquid ignitable hazardous wastes.

b. Prevalence of flushing in lieu of hazardous waste management. In the preamble to the 

July 1990 final rule, EPA stated its intent “to carefully review the effect of this rule and 

promulgate in the future any additional regulations that experience reveals are necessary to 

improve control over hazardous waste and other industrial user discharges to POTWs” (55 FR 
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30084). Since then, studies have found that many healthcare facilities, particularly long termcare facilities, use drain disposal as a routine disposal method for pharmaceutical wastes in lieu 

of collection and shipment off-site for management. For example, 

 A 2008 study of 59 long-term care facilities showed that 46 percent of the longterm care facilities dispose of their pharmaceuticals by dumping them down the 

drain.101

 A 2003 King County, Washington survey of healthcare facilities showed that the 

vast majority of liquids, and nearly half of the pills, were disposed of down the 

drain.102

 In a study by The Albany Medical Center, funded by an EPA Pollution Prevention 

Grant, the author states, “up to now, toilet wasting has been the common practice 

for drug wasting by patient care staff.”103

 In a detailed study about the waste management practices within the healthcare 

industry, EPA’s Office of Water also found that sewering of waste 

pharmaceuticals was common practice.104

 EPA staff from the Office of Research and Development (ORD) have published 

numerous articles on the subject of active pharmaceutical ingredients (APIs) in 

the environment. One such paper states that “unit-packaged pills are probably not 

frequently disposed via toilets, whereas liquids are probably routinely poured 

 

101 Kansas State University. January 31, 2008. Nancy J. Larson. Pharmaceutical Waste Outreach Project.

102 King County Pharmaceutical Waste Survey Final Report. King County, Washington. April 2003.

103 The Albany Medical Center, October 29, 2009, Russell F. Mankes, Progress Report on the Source Reduction 

Demonstration Project, EPA Grant #X9-97256506-0.

104 Health Services Industry Study: Management and Disposal of Unused Pharmaceuticals (Interim Technical 

Report) August 2008; EPA-821-R-08-013.
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down drains,” although the authors acknowledge that “gaining an understanding 

of the types and quantities of APIs introduced directly and purposefully to the 

environment by the disposal of unwanted, leftover drugs has been more 

problematic because of a dearth of comprehensive or reliable data.”105

c. Inadequacy of POTW treatment to remove pharmaceuticals. Under the Clean Water 

Act (CWA), EPA establishes national regulations (called effluent limitations guidelines and 

pretreatment standards) to reduce discharges of pollutants from industries to surface waters and

POTWs. However, there are currently no national effluent limitations or pretreatment standards 

that apply to discharges of pharmaceuticals by healthcare facilities to POTWs. Furthermore, 

traditional wastewater treatment operations implemented in the 1970s and 1980s at POTWs are 

designed to remove conventional pollutants, such as suspended solids and biodegradable organic 

compounds. They are not designed to remove pharmaceuticals that are present in discharges 

from medical and veterinary facilities. While some POTWs may have implemented advanced 

treatment technologies at their facilities, these technologies are also not designed to remove 

pharmaceuticals. EPA released a study in 2009 in which over 100 chemicals (including some 

pharmaceuticals) were analyzed in the influent and effluent at nine POTWs.106 Although it was a 

limited study and difficult to generalize the results to all POTWs, it does indicate that the 

capabilities of treatment technologies currently employed by POTWs does not include treatment 

 

105 Ruhoy and Daughton; Beyond the medicine cabinet: An analysis of where and why medications accumulate; 

Environment International 34(2008) 1157-1169

106 EPA, Occurrence of Contaminants of Emerging Concern in Wastewater from Nine Publicly Owned Treatment 

Works, August 2009; EPA-821-R-09-009.
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to remove APIs.

107 In addition, as stated in the Health Services Industry study, “synthetic 

compounds, such as pharmaceuticals, are often manufactured to be resistant to metabolic 

transformation. As a result, some pharmaceutical compounds that are present in the influent to 

POTWs may pass through treatment systems at conventional POTWs and discharge to receiving 

waters.” 108

d. Adverse impacts to human health and the environment due to pharmaceuticals in the 

environment. The pharmaceuticals entering the environment, through flushing or other means, 

are having a negative effect on aquatic ecosystems and on fish and animal populations. The

Regulatory Impact Analysis for this proposed rulemaking summarizes the scientific literature 

with regard to ecological effects (see the Regulatory Impact Analysis in the docket for this 

proposed rule EPA-HQ-RCRA-2007-0932). The scientific research with regard to human health 

effects due to pharmaceuticals in the environment is still ongoing. Nevertheless, the important 

features and risks of the problem can be summarized as follows:109

1) Pharmaceuticals are intrinsically bioactive compounds; therefore, they are

potentially able to impact living systems.

2) There is a continuous and worldwide increase in their use and, thus, on their 

subsequent input into the environment.

 

107 Eggen RI, Hollender J, Joss A, Schärer M, Stamm C, “Reducing the Discharge of Micropollutants in the Aquatic 

Environment: The Benefits of Upgrading Wastewater Treatmnet Plant.” Environmental Science and Technology 

2014, 48(14) 7683-7689.

108 Health Services Industry Study: Management and Disposal of Unused Pharmaceuticals (Interim Technical 

Report) August 2008; EPA-821-R-08-013.

109 A. Ginebreda et al, Environmental risk assessment of pharmaceuticals in rivers: Relationships between hazard 

indexes and aquatic macroinvertebrate diversity indexes in the Llobregat River (NE Sapin). Environ Int. (2009), 

doi:10.1016/j.envint.2009.10.003.
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3) Many of the hundreds of frequently prescribed pharmaceuticals are known for 

targeted effects and adverse off-target side effects, a problem that can be 

exacerbated by interactive effects during therapy involving co-administration. 

e. Banning sewering of hazardous waste pharmaceuticals. Given the demonstrated 

negative ecological effects and the potential for negative human health effects, EPA is proposing 

to impose a sewer ban on all hazardous waste pharmaceuticals managed by healthcare facilities 

and pharmaceutical reverse distributors that are subject to this proposed rule—that is, they are 

prohibited from disposing of pharmaceuticals that are listed hazardous waste and/or exhibit one 

or more of the four hazardous waste characteristics (i.e., ignitability, corrosivity, reactivity, or 

toxicity) by putting them down a drain (e.g., sink, toilet, or floor drain). 

In addition, while healthcare facilities that are CESQGs are generally not subject to this 

proposed rule, EPA is proposing that the sewer ban of hazardous waste pharmaceuticals also

apply to healthcare facilities that are CESQGs. The vast majority of healthcare facilities are 

CESQGs (84 percent). Some particular types of healthcare facilities have an even larger 

proportion of CESQGs: over 94 percent of dental offices are CESQGs, and 94 percent of 

continuing care retirement communities are CESQGs (see the Regulatory Impact Analysis in the 

docket for this proposed rule EPA-HQ-RCRA-2007-0932. 

EPA is concerned that these smaller healthcare facilities are more likely to dispose of 

their hazardous waste pharmaceuticals via the sewer. EPA estimates that there are more than

145,000 healthcare facilities that are CESQGs. Given this large number, the combined impact of 

sewer disposal by healthcare facilities that are CESQGs has an even greater potential to provide 

a substantial impact on the environment, as well as human health. 
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EPA solicits comment on EPA’s proposal to ban the sewer disposal of hazardous waste 

pharmaceuticals at all healthcare facilities, including healthcare facilities that are CESQGs that 

generate such wastes. As part of its solicitation of comments, the Agency especially requests 

comment on the risk-risk tradeoffs inherent in prohibiting sewer disposal, which extends the life 

cycle of pharmaceutical waste, resulting in additional opportunities for diversion and increasing 

the possibility of inadvertent exposures for certain workers (and possibly even patients or 

visitors) as a tradeoff for a reduction in aquatic risks. EPA also solicits comment on whether the 

ban on sewer disposal should be limited to those healthcare facilities that are currently LQGs and 

SQGs, and not extended to CESQGs.

Under 40 CFR 403.12(p) of the CWA regulations, industrial users that discharge a 

substance to a POTW that, if otherwise disposed of, would be a hazardous waste, must notify in 

writing the POTW, the EPA Regional Waste Management Division Director and State hazardous 

waste authorities. POTWs should be made aware that under this proposal, if made final, the 

notifications they receive from healthcare facilities will no longer include hazardous waste 

pharmaceuticals since the healthcare facilities will be prohibited from sewering their hazardous 

waste pharmaceuticals.

We note that EPA’s proposed ban on sewering hazardous waste pharmaceuticals is

consistent with other federal and state actions. For example, the Drug Enforcement 

Administration (DEA) has finalized new regulations to implement the Secure and Responsible 

Drug Disposal Act of 2010 (September 9, 2014; 79 FR 53520). DEA’s new regulations require a 

“non-retrievable” method of destruction of controlled substances. The preambles to DEA’s

proposed and final rules state that flushing does not meet the non-retrievable standard for 
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destruction.

110 According to the preamble of the DEA final rule, DEA received 20 comments 

supporting their position against flushing controlled substances.111 The comments supporting the 

prohibition against sewering came from states, regional and local hazardous waste management 

programs, recycling associations, non-governmental organizations (NGOs), trade associations 

and environmental organizations. Many of these commenters noted that wastewater treatment 

systems do not eliminate many of the drugs that are flushed into the sewers and requested that 

DEA clearly state in the regulatory language, not just preamble, that sewering is not allowable as 

a means of destruction.

In addition, three states and the District of Columbia have taken action to limit the 

sewering of pharmaceuticals and a third has introduced a bill. In 2009, Illinois passed the Safe 

Pharmaceutical Disposal Act, which prohibits healthcare facilities from flushing any unused 

medication into public sewers or septic systems.112 In 2012, New Jersey passed a similar law 

that prohibits healthcare facilities from discharging prescription medications into public sewers 

or septic systems.113 In 2002, California banned the use of lindane in pharmaceuticals after it 

found that lindane was adversely impacting wastewater quality. The authors of the paper 

“Outcomes of the California Ban on Pharmaceutical Lindane: Clinical and Ecologic Impacts 

state that “This is the first time that a pharmaceutical has been outlawed to protect water 

quality.”114 After researching and documenting environmental benefits of the ban, the authors 

conclude, “This ban serves as a model for governing bodies considering limits on the use of 

 

110 Proposed rule: December 21, 2012; 77 FR 75784 (see page 75803) and Final rule: September 9, 2014; 79 FR 

53520 (see page 53548).

111 September 9, 2014; 79 FR 53520 (see page 53548).

112 Illinois Public Act 096-0221.

113 Nicknamed Bateman’s Law, after Senator Christopher “Kip” Bateman (R-Somerset) that sponsored the 

legislation. 

114 Humphreys, et al. Environmental Health Perspectives. 2008 March; 116(3) 297-302.
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lindane or other pharmaceuticals.” And the District of Columbia has promulgated municipal 

regulations, effective January 1, 2011, that prohibits healthcare facilities from flushing 

pharmaceutical products.115 The Connecticut legislature has also considered a bill to ban the 

discharge of medication into public or private waste water collection systems or septic systems, 

although it has not yet become law.116

Finally, we would note that although the sewer ban is limited to pharmaceuticals that are 

RCRA hazardous wastes, EPA strongly recommends as a best management practice to not sewer

any waste pharmaceutical (i.e., hazardous or non-hazardous), except when sewering is 

specifically directed by FDA guidance (as noted on pharmaceutical packaging).117

For household pharmaceutical waste, we refer the public to the guidelines developed by 

the U.S. Office of National Drug Control Policy (ONDCP), the FDA, and EPA for the disposal 

of unwanted household pharmaceuticals. In summary, these guidelines are as follows:

1) Use a drug take-back event or program, when available;

2) Dispose in household trash, after mixing the unwanted medicines with an 

undesirable substance such as kitty litter or coffee grounds and placing in a sealed 

container; and

3) Only if the drug label specifically instructs you to, flush the unwanted medicine

down the toilet.118

 

115 Title 22-B Chapter 5 Safe Disposal of Unused Pharmaceuticals in Health Care Facilities

116 State of Connecticut General Assembly, January Session 2013, Raised Bill No. 6439. An Act Concerning the 

Disposal and Collection of Unused Medication.

117

http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUse

ofMedicine/SafeDisposalofMedicines/UCM337803.pdf

118

http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUse

ofMedicine/SafeDisposalofMedicines/UCM337803.pdf
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2. Conditional Exemption for Hazardous Waste Pharmaceuticals That Are Also Controlled 

Substances

When a pharmaceutical that is discarded is both a hazardous waste and a controlled 

substance, its management and disposal is regulated under both the RCRA Subtitle C hazardous 

waste regulations, which is under EPA’s or the authorized state’s purview, and the Controlled 

Substances Act (CSA) and its implementing regulations, which is under DEA’s purview. EPA 

understands that only a handful of pharmaceuticals are in common usage that are both hazardous 

waste and controlled substances and therefore subject to dual regulation by both EPA and the 

DEA. These are identified in Table 5 below:

Table 5: Pharmaceuticals Still Used in Healthcare that Are DEA Controlled Substances & 

RCRA Hazardous Wastes

Name of 

Drug

Other Name(s) Medical Uses RCRA 

HW 

Code

DEA CS 

Schedule

Comment

Chloral; 

chloral 

hydrate

Acetaldehyde, 

trichloro-; 

Aquachloral, 

Noctec, Somnote, 

Supprettes

Sedative U034

toxic

IV Used in hospital 

pediatric units;

common 

ingredient in vet 

anesthetics

Fentanyl 

sublingual 

spray

Subsys Analgesic D001 

ignitable

II Ignitable due to 

alcohol content 

Phenobarbital Bellergal-S, 

Donnatal, Luminal, 

Anticonvulsant D001

ignitable

IV Ignitable due to 

alcohol content

Testosterone 

gels

Androgel, Fortesta, 

Testim

Hormone D001 

ignitable

III Ignitable due to 

gel base

Valium 

injectable

Diastat, Diazepam, Anti-anxiety D001 

ignitable

IV Ignitable due to 

alcohol content

Chloral hydrate, U034, is the only dually regulated hazardous waste/controlled substance 

that is a listed hazardous waste. It is listed for toxicity (note that EPA’s U034 listing includes 
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chloral hydrate, see memo dated April 6, 1998; Brandes to Knauss, RCRA Online #14175). On 

the other hand, the remaining four dually regulated hazardous wastes/controlled substances in 

common use are considered hazardous because they exhibit the characteristic of ignitibility 

(D001). However, the active ingredient is not ignitable, but these particular forms of the 

pharmaceuticals are ignitable because they are prepared in ignitable solutions, such as alcohol. 

EPA is aware of three additional hazardous waste pharmaceuticals that are DEA 

controlled substances, but it is our understanding that they are no longer in common usage, 

although there may be legacy supplies remaining in healthcare facilities. See Table 6 below.

Table 6: DEA Controlled Substances & RCRA Hazardous Wastes Pharmaceuticals that 

Are Not in Common Use

Name of 

Drug

Other Name(s) Medical Uses RCRA 

HW Code

DEA CS 

Schedule

Comment

Paraldehyde 1,3,5-Trioxane, 

2,4,6-trimethyl-; 

Paral

Anticonvulsant U182

toxic

IV No longer in 

common use

Paregoric camphorated tincture 

of opium

Analgesic, 

expectorant, 

antidiarrheal

D001 

ignitable

III No longer in 

common use

Opium 

Tincture

Laudanam Analgesic,

antidiarrheal

D001 

ignitable

II No longer in

common use

Similarly, as noted in Table 7, phentermine is a controlled substance, but the medical form is a 

phentermine salt, and the salts are no longer considered to be within the scope of the P046 listing 

(see memo dated February 17, 2012; from Devlin to RCRA Division Directors, RCRA Online 

#14831).

Table 7: Pharmaceuticals that are DEA Controlled Substances & RCRA Hazardous 

Wastes Salt(s) No Longer Considered Hazardous Waste

Name of 

Drug

Other Name(s) Medical Uses RCRA 

HW Code

DEA CS 

Schedule

Comment

Phentermine alpha, alphaDimethylphenethylAppetite 

suppressant

P046 IV If in salt form, 

it does not 
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Name of 

Drug

Other Name(s) Medical Uses RCRA 

HW Code

DEA CS 

Schedule

Comment

amine; 

Benzeneethanamine, 

alpha,alphadimethyl-; 

Adipex-P, 

Atti Plex P, Fastin, 

Ionamin, Kraftobese, 

Panshape M, ObeNix, Pentercot, 

Phentride, Pro-Fast, 

Raphtre, Supramine, 

Tara-8, Termene, 

Termine, Zantryl

Acutely 

toxic

meet the P046 

listing and 

medical dosage 

forms are salts

EPA requests comment on whether these are, indeed, the only pharmaceuticals in 

common usage that are regulated both as DEA controlled substances, and when discarded, 

RCRA hazardous waste.

Common practices that healthcare facilities have used in the past in order to comply with 

the DEA regulations for destroying controlled substances include sewering and incineration. 

However, DEA’s new regulation requires that controlled substances must be destroyed, such that 

they are “non-retrievable.” As discussed abovepreviously, the preambles for DEA’s proposed 

and final rules state that flushing will not meet their new non-retrievable standard, a position 

which EPA fully supports. However, EPA is concerned that flushing will continue to be used by 

healthcare facilities for eliminating their controlled substances. In part, this concern is due to a 

2009 EPA report which concluded, “controlled substances are the pharmaceuticals most 

commonly poured down the drain, especially the partially-used IVs containing controlled 

substances.”119 In addition, stakeholders have informed EPA that it is expensive and difficult to 

 

119 Pathways for Environmental Releases of Unused Pharmaceuticals, October 12, 2009, Memo from ERG to EPA, 

EPA-HQ-OW-2008-0517-0518.
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manage controlled substances that are also hazardous wastes under both DEA and EPA 

regulatory schemes and therefore the unintended consequence is that they are often sewered onsite in order to avoid the expense of complying with dual regulation en route to incineration. 

EPA wants to eliminate the flushing of pharmaceuticals in order to reduce potential 

environmental contamination. Sewering hazardous wastes that are ignitable (D001) is already 

banned and EPA is now proposing to eliminate the sewering of all other hazardous waste 

pharmaceuticals.120 To eliminate duplicative regulation and thereby further reduce the incidence 

of flushing, EPA is proposing to conditionally exempt from RCRA Subtitle C regulation those 

hazardous wastes that are also DEA controlled substances. Specifically, EPA is proposing that 

hazardous wastes that are also controlled substances will be exempt from theall RCRA Subtitle C 

requirements, including 40 CFR part 266, subpart P, provided they meet two conditions: (1) they 

are combusted at a permitted large or small municipal waste combustor or a permitted or interim 

status hazardous waste combustor (incinerator or cement kiln), and (2) they are managed and 

disposed of in compliance with all applicable DEA regulations for controlled substances. 

The first condition is to ensure that the controlled substances are destroyed in an 

environmentally protective manner by a high-temperature combustor, such as a large or small 

municipal waste combustor or a permitted or interim status hazardous waste combustor 

(incinerator or cement kiln). The majority of the hazardous wastes that are also controlled 

substances are hazardous because they exhibit the characteristic of ignitability. The best 

demonstrated available technology (BDAT) developed for ignitable hazardous waste under the 

LDRs includes combustion (see § 268.40). In addition, although chloral hydrate (U034) is listed 

 

120 See 40 CFR 403.5 for specific pretreatment prohibitions 
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because of its toxicity, its BDAT is also combustion. Therefore, in an effort to eliminate the 

sewering of these dually regulated hazardous wastes/controlled substances, and because 

combustion of these pharmaceuticals is a suitable technology for destruction, EPA is proposing 

to allow the few hazardous wastes pharmaceuticals that are also controlled substances to be 

combusted at municipal solid waste combustors, although as noted abovepreviously, a hazardous 

waste incinerator (permitted or interim status) would also be allowed. 

We realize that DEA may allow a technology other than combustion to be used to destroy 

controlled substances. However, if the RCRA hazardous waste pharmaceuticals that are DEA 

controlled substances are exempt from RCRA, the other destruction technologies may lack 

environmental controls and permits. Therefore, combustion of the hazardous wastes/controlled 

substances, which requires permitting, operating and monitoring standards, is a condition of the 

exemption. EPA requests comment on whether there are additional technologies that would be 

appropriate to include for the destruction of hazardous waste pharmaceuticals that are also 

controlled substances. Under this proposal, if DEA allows a technology other than incineration 

for the destruction of controlled substances, it would be allowed only for DEA controlled 

substances, but not for those that are also RCRA hazardous wastes. 

The second condition is to ensure that dually regulated hazardous wastes/controlled 

substances are managed under another rigorous regulatory program since they will not be 

managed in accordance with the RCRA Subtitle C regulations. Although developed for different 

reasons, both EPA’s hazardous waste and DEA’s controlled substance regulatory programs are 

designed to track the regulated material from cradle to grave. DEA regulations have 

requirements similar to EPA’s hazardous waste manifest. In particular, DEA Schedulein order to 

ship a schedule II controlled substances may not be shipped without prior authorization from 
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DEA. In order to receive authorizationsubstance, a DEA registrant must submit a DEA Form 222 

to the DEA, which must include a detailed inventorysupplier of the contentsschedule II 

controlled substance. The DEA Form 222 is a numerically controlled form issued by the DEA to 

authorized registrants, containing certain pre-printed information. The supplier must indicate on 

the DEA Form 222, the quantity of packages shipped and the date the packages were shipped. 

Like a hazardous waste manifest, a copy of Form 222 must accompany the shipment and it must 

be kept atby both the facilitysupplier and purchaser for at least two years (copies of manifests 

must be kept for three years). Suppliers and distributors may utilize the electronic version of the 

DEA Form 222, which requires the same information and retention period. Similarly, DEA 

Schedule III, IV and V controlled substances must be accompanied by an invoice, which also 

must include a detailed inventory of the contents shipped. Prior to shipment, the shipper must 

send a copy of the invoice to DEA to obtain approval. A copy of the invoice must also be 

retained by the facility shippingsupplier and purchaser of the controlled substances for a period 

of two years. EPA believes that the DEA tracking and shipping requirements are sufficient to act 

in lieu of the RCRA hazardous waste manifest and hazardous waste transporter requirements. 

EPA requests comment on this assessment.

DEA has previously stated that controlled substance "pharmaceutical wastage" may be 

disposed of in accordance with applicable federal, state, and local laws, regulations, and 

healthcare facility policies, to include sewering or putting down the drain.121 The term 

"pharmaceutical wastage" refers to leftover, unadministered pharmaceuticals ("e.g., some of the 

substance remains in a vial, tube, transdermal patch, or syringe after administration but cannot or 

 

121 See DEA letter to registrants re: clarifying disposal of pharmaceutical wastage dated Oct 17, 2014; 

http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf
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may not be further utilized"

122). EPA is proposing that the few hazardous waste pharmaceuticals 

that are also controlled substances would be exempt from RCRA, but only on the condition that 

they are incinerated at a permitted hazardous waste or municipal solid waste incinerator and 

managed in accordance with DEA regulations. As a result, if pharmaceutical wastage is both 

hazardous waste and controlled substance it would not be allowed to be sewered; it would have 

to be incinerated. Prior to incineration, the pharmaceutical wastage would be exempt from 

RCRA and could be collected in a container at the healthcare facility. As an alternative, we 

request comment on whether to allow the sewering of the pharmaceutical wastage for the five 

hazardous wastes that are also controlled substances. We are concerned, however, that this 

alternative approach will lead to the sewering of all pharmaceutical wastage as healthcare 

providers are unlikely to keep track of which hazardous waste pharmaceuticals are allowed to be 

sewered and which are not. We request comment on these approaches for pharmaceutical 

wastage and request data on the impact on healthcare facilities of not allowing pharmaceutical 

wastage to be sewered.

a. Long-term care facilities and the DEA final rule. As discussed previously, EPA is 

proposing that hazardous waste from long-term care facilities will no longer be considered 

exempt as household hazardous waste. Instead it will need to be managed as regulated hazardous 

waste. This interpretation will apply to all the hazardous waste generated by a long-term care 

facility, not just its hazardous waste pharmaceuticals, although the Agency expects that much of 

the hazardous waste generated by long-term care facilities consists of hazardous waste 

pharmaceuticals. However, there are two exceptions. First, hazardous waste pharmaceuticals that 

are also controlled substances will not be subject to RCRA, provided they meet two conditions:

 

122 Ibid.
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(1) they are combusted at a permitted large or small municipal waste combustor or a permitted or 

interim status hazardous waste combustor (incinerator or cement kiln), and (2) they are managed 

and disposed of in compliance with all applicable DEA regulations for controlled substances. 

Second, as discussed previously, EPA estimates that only 28% of long-term care facilities

generate hazardous waste pharmaceuticals and of those, 85% generate small enough quantities of 

hazardous waste that they will qualify as CESQGs and will be subject to the reduced regulatory 

requirements of 40 CFR 261.5, and only the sewer ban provision of this new subpart.123

DEA’s new regulations to implement the Secure and Responsible Drug Disposal Act of 

2010 are expected to help alleviate the problem that long-term care facilities face when 

discarding hazardous wastes that are also controlled substances. DEA’s new regulations allow 

retail pharmacies and hospital/clinics with an on-site pharmacy that are DEA registrants and that 

get additional authorization to bemodify their registrations and become “collectors” to place 

collection receptacles at long-term care facilities (or at the retail pharmacy itselfor hospital/clinic 

with an on-site pharmacy) for the collection of controlled substances from ultimate users (i.e., 

consumers). 

Under the new DEA regulations, long-term care facilities have three options, two of 

which are new, for managing their patients’ controlled substances. First, if a DEA registered 

retail pharmacy or hospital/clinic with an on-site pharmacy places a collection container at a 

long-term care facility, the staff from the long-term care facility may place the patients’ 

controlled substances in the collection containersreceptacles. Second, although long-term care 

facilities will not be able to conduct collection events for their patients’ controlled substances for 

 

123 See the docket for this rulemaking for data about long-term care facilities which was developed using data in the 

economic analysis: EPA-HQ-RCRA-2007-0932.
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mail-back programs, they will be allowed to assist patients who choose to use a mail-back 

program for their own controlled substances, on an individual-by-individual basis. And third, law 

enforcement will continue to be allowed to pick up patients’ controlled substances for disposal. 

With these changes to DEA’s regulation, long-term care facilities can now dispose of hazardous 

waste pharmaceuticals in a more environmentally protective waypatients’ controlled substances

in a more environmentally protective way. Because we are proposing that hazardous waste 

pharmaceuticals that are also controlled substances are conditionally exempt from RCRA, these 

wastestreams may also be managed in any of these three ways allowed by DEA, provided the 

waste is managed to meet the conditions of the RCRA conditional exemption.

The new DEA regulations do not mandate the placement of collection receptacles or 

patient participation in mail-back programs or take-back events. However, if long-term care 

facilities are prohibited from disposing of pharmaceuticals down the toilet or drain under RCRA 

(and as a method of destruction under DEA regulations), then the only way for patients at longterm care facilities to lawfully dispose of DEA controlled substances that are also RCRA 

hazardous wastes would be through participation in one of DEA’s proposed collection methods.

Long-term care facilities are allowed to place only thosepatients’ hazardous waste

pharmaceuticals that are controlled substances in the DEA collection receptacles; the other 

hazardous waste pharmaceuticals generated by long-term care facilities must be managed under 

the proposed RCRA management standards for healthcare facilities. However, we note that if the 

long-term care facility is a CESQG, we are proposing as an acceptable method of disposal of the 

long-term care facility’s hazardous waste pharmaceuticals would be to place them in a DEA 

collection receptacle, even if they are not controlled substances (see § 266.504(b)). DEA already 

allows controlled substances to be co-mingled with non-controlled substances. Therefore, EPA
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believes it is consistent to allow CESQG hazardous waste pharmaceuticals that are not controlled 

substances to be placed in DEA collection receptacles with controlled substances. EPA believes 

that management of CESQGs’ hazardous wastes as DEA controlled substances is preferable to 

management as municipal solid waste because it provides greater protection to patients, visitors 

and workers at long-term care facilities to have the hazardous waste pharmaceuticals in DEA 

collection receptacles rather than in the regular trash. See Table 8 for a summary of the 

intersection of RCRA and DEA regulations for the disposal of hazardous waste pharmaceuticals 

at long-term care facilities:

Table 8: RCRA & DEA Regulations at Long-Term Care Facilities

Types of Pharmaceutical Waste 

at Long-Term Care Facilities

Regulatory Requirements

RCRA

DEA Authorized 

Collection Methods 

Allowed for 

Patients’

Pharmaceuticals

Hazardous Waste Pharmaceuticals 

that are also Controlled Substances

Conditionally exempt 

from RCRA Yes

Hazardous Waste Pharmaceuticals 

that are not Controlled Substances 

if LTCF is a CESQG 261.5 and sewer ban Yes

if LTCF is not a CESQG Part 266, subpart P No

b. Household hazardous waste collected in DEA authorized collection receptacles. In 

response to questions that EPA has received since the DEA rule was published, we are taking 

this opportunity to clarify the current RCRA regulatory status of the pharmaceuticals collected in 

DEA authorized collection receptacles. DEA’s regulations allow the co-mingling of controlled 

substances and non-controlled substances in its collection receptacles. In some instances, the 

pharmaceuticals that are collected by retail pharmacies and law enforcement in DEA authorized 

collection receptacles may contain pharmaceuticals that are RCRA hazardous waste. However,
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as household wastes, these hazardous waste pharmaceuticals would be excluded from regulation 

by § 261.4(b)(1) because the exclusion applies even when the household hazardous wastes are 

collected. It is important to note that in order to maintain the exclusion, a retail pharmacy (or 

other DEA authorized collector pharmacy) can use the DEA authorized collection receptacle to 

collect waste generated only at households and brought to the store for collection. The hazardous 

waste generated by the retail pharmacy and store, including hazardous waste pharmaceuticals, 

are not excluded household wastes under RCRA and may not be placed in the DEA authorized 

receptacle.124 Furthermore, states generally regulate non-hazardous waste and they may have 

licensing or permitting requirements for the collection of solid waste. Because EPA would like to 

see the use of DEA authorized collection receptacles become widespread, we encourage states to 

streamline any requirements that may create a barrier to the use of the collection receptacles.

Under this proposal, pharmaceuticals collected in DEA authorized collection receptacles 

will continue to be excluded from regulation as household hazardous waste, with some 

conditions. The Agency has a long-standing recommendation that household hazardous waste 

collection programs manage the collected waste as hazardous waste. We strongly believe that if a 

program goes to the expense of collecting the waste, including waste pharmaceuticals, it should 

manage the waste as hazardous waste, rather than manage it as municipal solid waste, which the 

household could do absent the collection program. However, the current household waste 

exemption does not require an entity that hosts a household hazardous waste collection event to 

manage the collected waste as hazardous waste. Typically, the parties conducting household 

hazardous waste collection events have been government entities—municipalities and counties. 

 

124 DEA regulations also prohibits retail pharmacy stock/inventory from being placed in the collection receptacle or 

mail-back envelopes (see 21 CFR 1317.05(a)).
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It is relatively new that retail pharmacies and others are becoming interested in performing this 

function. To encourage this practice, while at the same time ensuring that collection programs 

are managing the collected waste properly, we are proposing that pharmaceuticals that are 

household hazardous waste (i.e., “household waste pharmaceuticals”) and are collected in DEA 

authorized collection receptacles where they may be co-mingled125 with controlled substances

continue to be excluded from RCRA regulation, provided they are:

(1) combusted at a municipal solid waste or hazardous waste combustor, and

(2) managed in accordance with all applicable DEA regulations (see §266.506(a)(2)). 

The Agency solicits comments on all these provisions.

On a separate, but related matter, EPA has received a number of inquiries about the 

exemption in the Clean Air Act regulations for Other Solid Waste Incinerator (OSWI) "units that 

combust contraband or prohibited goods" (see the exemption at 40 CFR 60.2887(p) for new 

OSWIs and 40 CFR 60.2993(p) for existing OSWIs).126 As indicated in a previous guidance 

memo, EPA does not consider pharmaceuticals, voluntarily collected from ultimate users in a 

take-back program, to be contraband or prohibited goods.127 Likewise, EPA will not consider 

pharmaceuticals that are voluntarily dropped off at collection receptacles to be contraband or 

prohibited goods. Therefore, the OSWI exemption does not apply and law enforcement may not 

destroy voluntarily collected pharmaceuticals in the same way that it is allowed to destroy 

contraband or prohibited goods. The Agency solicits comments on all these provisions.

 

125 DEA does not prohibit co-mingling of controlled substances with non-controlled substances provided they are all 

then managed as controlled substances. 

126 Rudzinski to RCRA Division Directors, September 26, 2012, RCRA Online #14833.

127 Rudzinski to RCRA Division Directors, September 26, 2012, RCRA Online #14833 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/fcb11dd6f61d4b1685257afe005eb5ce!

OpenDocument.

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3. Management of Residues in Pharmaceutical Containers

a. Regulatory background. Over the years, EPA has received numerous inquiries 

regarding the regulatory status of various types of containers that once held pharmaceuticals that 

are considered hazardous waste when discarded because of the hazardous waste residue in the 

containers. Stakeholders have been particularly concerned about containers that once held 

pharmaceuticals that are on the “P-list” of acutely hazardous commercial chemical products in

§261.33(e) because a generator becomes an LQG if it generates more than 1 kg of acute 

hazardous waste per calendar month or accumulates more than 1 kg of acute hazardous waste at 

any time.128 The current regulatory status of acute and non-acute commercial chemical product

residues remaining in a container are specifically addressed in §261.33:

The following materials or items are hazardous wastes if and when they are discarded or 

intended to be discarded...

(c) Any residue remaining in a container or in an inner liner removed from a container 

that has held any commercial chemical product or manufacturing chemical intermediate 

having the generic name listed in paragraphs (e) or (f) of this section, unless the container 

is empty as defined in §261.7(b). [emphasis added]

According to §261.7(b)(1), there are two ways a container that held a non-acute hazardous waste 

can be considered “empty”:

 

128 Additionally, acute hazardous wastes are included on the F-list of §261.31; however none of those acute 

hazardous wastes are pharmaceuticals.

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A container or an inner liner removed from a container that has held any hazardous 

waste, except a waste that is a compressed gas or that is identified as an acute hazardous 

waste listed in §§261.31 or 261.33(e) of this chapter is empty if:

(i) All wastes have been removed that can be removed using the practices commonly 

employed to remove materials from that type of container, e.g., pouring, pumping, 

aspirating, and

(ii) No more than 2.5 centimeters (one inch) of residue remain on the bottom of the 

container or inner liner, or

(iii)

(A) No more than 3 percent by weight of the total capacity of the container remains in 

the container or inner liner if the container is less than or equal to 119 gallons in size; or

(B) No more than 0.3 percent by weight of the total capacity of the container remains 

in the container or inner liner if the container is greater than 119 gallons in size.

Therefore, if the container that held the non-acute hazardous waste pharmaceutical does 

not have its contents removed by a commonly employed practice and either has one inch or less 

of residue remaining or has 3 percent or less by weight of the total capacity of the container 

remaining,129 then the container is not considered “RCRA empty,” even though the 

pharmaceutical may have been fully dispensed. If the container is not “RCRA empty,” then the 

residues are regulated as hazardous waste (since the residues are within the container, the 

container must be managed as hazardous waste, as well, even if it is not itself hazardous waste). 

On the other hand, if the contents of the container have been removed by a commonly employed 

practice and either have one inch or less of residue remaining, or 3 percent or less of weight of 

 

129 We are assuming that containers that hold pharmaceuticals are in containers less than 119 gallons in size. 
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the total capacity of the container remaining, then the container is considered “RCRA empty,” 

and may be managed as non-hazardous waste. 

Likewise, according to § 261.7(b)(3), there are three ways that a container that held an 

acute hazardous waste can be considered “empty”:

A container or an inner liner removed from a container that has held an acute hazardous 

waste listed in §§261.31 or 261.33(e) is “empty” if:

(i) The container or inner liner has been triple rinsed using a solvent capable of 

removing the commercial chemical product or manufacturing chemical intermediate; 

(ii) The container or inner liner has been cleaned by another method that has been 

shown in the scientific literature, or by tests conducted by the generator, to achieve 

equivalent removal; or

(iii) In the case of a container, the inner liner that prevented contact of the commercial 

chemical product or manufacturing chemical intermediate with the container, has been 

removed.

Therefore, if the container that held the P-listed pharmaceutical is not triple rinsed, or 

cleaned by another method that has been demonstrated to achieve equivalent removal, or had the 

inner liner removed, the container is not considered “RCRA empty,” even though the 

pharmaceutical may have been fully dispensed. If the container is not “RCRA empty,” then the 

residues are regulated as acute hazardous waste.
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In November 2011, EPA issued guidance about containers that once held P-listed 

pharmaceuticals (RCRA Online #14827)130 that provides three possible regulatory approaches 

for generators:

1) Count only the weight of the residue toward generator category

2) Demonstrate an equivalent removal method to render containers RCRA empty

3) In the case of warfarin, show that the concentration in the residue is below the Plisted concentration.

This guidance was intended as a short-term solution that worked within the confines of the 

existing RCRA hazardous waste regulations and EPA indicated at the time that a more 

comprehensive solution would require notice and public comment that occurs during a 

rulemaking. We are proposing to amend the regulations that pertain to containers that once held 

pharmaceuticals that are RCRA hazardous wastes. We are proposing different regulatory 

solutions for different types of containers found in healthcare settings. Specifically, we address 

the following three types of containers: (1) unit-dose containers (e.g., packets, cups, wrappers, 

blister packs, and delivery devices) and dispensing bottles and vials; (2) dispensed syringes; and 

(3) other containers, including delivery devices. If finalized, these new regulations for 

pharmaceutical containers would replace the November 2011 guidance; however, in the 

meantime, the guidance remains in effect.

 

130 A copy of the guidance can be found in the RCRA docket for this proposed rule (EPA-HQ-RCRA-2007-0932 ).

Rudzinski to RCRA Division Directors, November 11, 2011, RCRA Online #14827 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/57B21F2FE33735128525795F00610F

0F/$file/14827.pdf.
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b. Unit-dose containers. First, with regard to unit-dose containers and dispensing bottles 

and vials up to 1 liter or 1000 pills, we are proposing a conditional exemption from the empty 

container regulations of § 261.7 for containers from which the pharmaceuticals have been fully 

dispensed. Specifically, we are proposing that the removal of the pharmaceuticals from the unitdose containers, and dispensing bottles and vials (up to 1 liter or 1000 pills), is equivalent to 

rendering the container “RCRA empty.” Therefore, for containers that once held non-acute 

hazardous wastes, it will not be necessary to measure the remaining contents, and for containers 

that once held acute hazardous wastes, it will not be necessary to triple-rinse the containers or 

demonstrate an equivalent removal method. Rather, if the contents of the container have been

fully dispensed by removing all pharmaceuticals that can be removed using the practices 

commonly employed to remove materials from that type of container, the residues (and therefore 

the container) may be disposed of as non-hazardous waste. 

We are proposing this conditional exemption for two reasons. First, we want to eliminate 

the sewering of pharmaceuticals. We are particularly concerned that in a healthcare setting, when 

containers are triple rinsed, the rinsate will be poured down the drain which is not a good 

environmental practice. We think it is important that the residues be managed in a more 

controlled manner—such as municipal solid waste management—rather than poured down the 

drain. Second, although the “empty container” regulations of § 261.7 apply to all sizes of 

containers, they were developed with larger, industrial-sized containers in mind. For the most 

part, the containers that hold pharmaceuticals range in size from a few milliliters (e.g., packaging 

for nicotine gum, paper cups used to dispense pharmaceuticals to in-patients) to a liter (e.g., 

bottles that hold bulk quantities of pills). In rare circumstances, containers with pharmaceuticals 

are as large as two or three liters (e.g., powders that are reconstituted with water). This differs 
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significantly from the 55-gallon drums that are typically used in other sectors that generate 

hazardous waste. Consequently, the amount of residues in the containers was anticipated to be 

much more substantial than is the case for containers typically used for pharmaceuticals.

EPA has received data from three stakeholders demonstrating that there is very little 

residue remaining in fully dispensed containers of pharmaceuticals. In addition, EPA’s ORD 

conducted similar research. The results from each of the four sources are summarized below; the 

full results are included in the docket for this proposed rulemaking (EPA-HQ-RCRA-2007-

0932). 

i. Consulting Firm. One stakeholder, with a hazardous medical materials consulting firm, 

provided some laboratory testing. They had the residues from single-unit dose packaging of four 

different P-listed pharmaceuticals tested using gas chromatography/mass spectrometry (GC/MS) 

and high performance liquid chromatography/ultraviolet detector (HPLC/UV). The amount of 

active pharmaceutical ingredient in the residues remaining in containers was quantified and the 

results from containers that had been triple rinsed were compared with containers that had not 

been triple rinsed. For the containers that were triple rinsed, the active ingredient in the residues 

was non-detect in all cases. For the containers that were not triple rinsed, the highest level 

detected was 35.8 μg (or 0.0358 mg). The laboratory results submitted to EPA are summarized in 

Table 89; the full laboratory results are included in the docket for this rulemaking (EPA-HQRCRA-2007-0932).

Table 89: Active Pharmaceutical Ingredient in Residues in Single-Unit Dose Packaging

Drug

(packaging type)

HW 

Code

Active 

pharmaceutical 

ingredient in

Triple-Rinsed 

Packaging (μg)

Active 

pharmaceutical 

ingredient in

Non-TripleRinsed Packaging 

(μg)

Reporting 

Limit

(μg)

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Nicotine gum*

(blister pack) P075 ND ND 0.00005

Nicotine patch*

(single use packet) P075 ND 35.8 0.00005

Warfarin**

(blister pack) P001 ND 6.4 5.0

Physostigmine**

(ampoule) P204 ND ND 100

*Method EPA 8720B

**HPLC/UV

ND = non-detect

ii. Large Retailer. The second stakeholder that submitted data to EPA was a large retailer. 

Their data provide the weight of active pharmaceutical ingredient residues remaining in bulk 

containers (i.e., 100-count) of various dosage strengths of warfarin. The residues were quantified 

using HPLC-UV/Vis (high performance liquid chromatography/ultraviolet/visible light detector). 

The data are summarized in Table 910; the full results submitted to EPA are included in the 

docket for this proposed rulemaking (EPA-HQ-RCRA-2007-0932).

Table 910: Warfarin Residues in 100-Count Dispensing Bottles

Warfarin Dose Number of 

Bottles Tested

Total Warfarin 

Residue in all 

Containers (mg)

Average

Warfarin Residue/Bottle

(mg)

Low (1 - 3 mg) 17 2.638 0.155

Medium (5 - 7.5 mg) 18 12.820 0.712

High (10 mg) 18 21.530 1.196

The results from each of the first two stakeholders reflect only the weight of the active 

pharmaceutical ingredient, not the full weight of the hazardous waste residues. Since it is the 

Agency's position that it is the full weight of the hazardous waste residues and not just the weight 

of the active pharmaceutical ingredients that must be counted in determining generator status, we 

have used the results to calculate the weight of the total residues. In the retailer’s case, they have 

informed EPA that a typical pill with a 10 mg dose of Coumadin (brand name of warfarin) 

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weighs 200 mg. The active ingredient represents 10 mg, or 5% of the weight of the pill, while 

190 mg, or 95% of the weight of the pill, consists of ingredients other than the active ingredient.

As indicated in Table 910, the average weight of warfarin residue remaining in a fully dispensed 

bottle of the high dose of warfarin (10 mg) is 1.196 mg. If we assume that the residue in the 

container has the same proportions of ingredients (i.e., 5% of the residue is warfarin and 95% of 

the residue are other ingredients), then there would be an average of 23.92 mg of total hazardous 

waste residue remaining in a 100-count bottle of 10 mg pills of warfarin. The amount of 

hazardous waste residue remaining in a 100-count bottle of pills is very small compared with the 

residue that would remain in a 55-gallon drum, which is what the regulations for container 

residues envisaged. 

iii. Riverside County. The third stakeholder that provided data to EPA was the Riverside 

County Department of Environmental Health, Hazardous Materials Management Branch. The 

county received a grant from the California Certified Unified Program Agency (CUPA) Forum 

Board to conduct a study of residues remaining in pharmaceutical containers. Researchers at the 

University of California, Riverside (UCR) conducted the study and provided their results in a 

report to Riverside County entitled, Residue Analysis of P-Listed Pharmaceutical Containers for 

Warfarin and Nicotine. The results are summarized below, but UCR’s full results are in the 

docket for this proposed rulemaking (EPA-HQ-RCRA-2007-0932).

131

The intent of the study was to investigate the third regulatory approach suggested in the 

November 2011 memo discussed abovepreviously. That is, the study investigated whether the 

concentration of warfarin in the residues of warfarin pill bottles was greater than 0.3% and 

 

131 See Exhibit 2 of the CUPA Forum Board Trust Fund Grant Report submitted by the Riverside County 

Department of Environmental Health at the conclusion of the grant. 

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therefore met the listing criteria for P001 or whether the residues were at or below 0.3% and 

therefore met the listing criteria for U248. Although nicotine is not a concentration-based Plisting, packaging from nicotine-containing products were also investigated to determine total 

remaining residues. 

The researchers collected a total of 59 samples containers, including 44 sample 

containers that had held warfarin pills but had been fully dispensed and another 15 sample 

containers from nicotine-containing products. The samples included warfarin and nicotine from 

several manufacturers, in a range of dose strengths and in various container types. The residues 

were solvent-extracted and then dried by rotary evaporation to determine the total weight of 

residues. Subsequently, the residues were re-dissolved in methanol and analyzed using HPLC to 

determine the concentration of the active pharmaceutical within the residues. 

The majority of warfarin containers were plastic bottles, but some containers were blister 

packs and three samples were 30-pill blister packs, sometimes referred to as a “bingo card.” The 

results indicate that the concentration of the active pharmaceutical ingredient warfarin in the 

residues in plastic bottles was usually over the 0.3% concentration. However, the concentration 

of warfarin in the residues on blister packs, including the 30-pack blister pack, was consistently 

below 0.3%. Overall, in the majority of cases, the warfarin within the residues was present at a 

high enough concentration to be considered P001 (33 of 44 samples, 75 percent of the samples).

However, the results also confirm the results from the first two stakeholders. That is, the 

total weight of residues remaining in the containers after they were emptied of the warfarin pills 

is negligible. For the plastic bottles, the total weight of residue ranged from 4.3–82.3 mg. For the 

single-dose blister packs, the total weight of residue ranged from 3.5–7.6 mg. And for the 30-

pack blister pack, the total weight ranged from 134.8–273 mg. Taking the smallest amount of 
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residue of 3.5 mg, it would take close to 300,000 containers per month to exceed the 1 kg 

threshold to be an LQG. Even on the conservative side, taking the largest amount of residue of 

273 mg, it would take close to 4000 containers per month to exceed the 1 kg threshold to be an 

LQG. 

The results for nicotine residues were similar. For containers of gum and patches, the 

weight of total residues ranged from 9–111.2 mg, although the two containers of liquid nicotine 

solution contained more residues—1301 and 1616 mg. Although nicotine is not a concentrationbased listing, it is worth noting that the active pharmaceutical ingredient of nicotine in the 

residues was below the quantifiable limit of 1.5 μg/ml in 8 of the 15 samples and for the other 7 

samples, the concentration of nicotine ranged from 0.01–0.09%.

iv. EPA’s Office of Research and Development. Finally, EPA’s ORD conducted an 

analysis to evaluate whether simply removing a drug from the container is equivalent to triple 

rinsing the container. ORD’s results are summarized belowin Table 11, but the Final Project 

Report containing the full results is in the docket for this proposed rulemaking (EPA-HQ-RCRA2007-0932). ORD analyzed three different P-listed pharmaceuticals: warfarin, nicotine and 

physostigmine salicylate. Table 1011 lists the 18 different combinations of active pharmaceutical 

ingredients, form, dosage strengths and packaging combinations that ORD analyzed.

Table 1011: Pharmaceutical Combinations Tested by EPA’s ORD

Active 

Pharmaceutical 

Ingredient

Manufacturer/

Brand Name Form Dosage Packaging Type

Warfarin

Taro Pharmaceutical 

Industries, Ltd.

Tablet 1 mg Plastic bottle

Tablet 5 mg Plastic bottle

Tablet 10 mg Plastic bottle

Tablet 2 mg Single-dose blister pack

Upsher-Smith/

Jantoven

Tablet 1 mg Single-dose blister pack

Tablet 10 mg Single-dose blister pack

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Active 

Pharmaceutical 

Ingredient

Manufacturer/

Brand Name Form Dosage Packaging Type

Nicotine

GlaxoSmithKline/

Nicorette

Gum 2 mg Single-dose blister pack

Gum 4 mg Single-dose blister pack

Rugby Laboratories Gum 2 mg Single-dose blister pack

Gum 4 mg Single-dose blister pack

GlaxoSmithKline/

Nicorette

Lozenge 2 mg Plastic vial

Lozenge 4 mg Plastic vial

Rugby Laboratories Patch 7 mg Peel-off plastic

Habitrol Patch 14 mg Peel-off plastic

Rugby Laboratories Patch 21 mg Peel-off plastic

Pfizer/Nicotrol Spray 10 mg/ml Glass vial

Inhaler 10 mg Plastic container

Physostigmine 

Salicylate Akron Inc. Liquid 1 mg/ml Glass ampoule

All combinations in Table 1011 were analyzed in triplicate using the following three-step 

approach:

1) After removing the tablets, gum, lozenges, etc from the containers, the amount of 

total residuals remaining in the container was determined using a sensitive 

balance to weigh the container before and after triple rinsing, 

2) The “maximum possible weight of residual drug/total residual /container” was 

calculated for each compound and packaging combination. This calculated result 

was used to infer a theoretical upper limit for the amount of active pharmaceutical 

compound in the total residue remaining in the container, and

3) Thermal gravimetric analysis (TGA) was used to qualitatively evaluate the 

presence of active pharmaceutical ingredient in the residuals removed from the 

containers before and after triple-rinsing.
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With respect to the weight of the remaining residuals in the containers, ORD’s results are 

similar to the results from the first three sources. That is, the weight of the total residuals 

remaining in the packaging of P-listed pharmaceuticals is minimal. For single-dose blister packs, 

lozenge vials and the peel-off plastic from nicotine patches the weight of the residuals was 

negligible and within the range of error of the balance, but all results were below 0.0002 grams. 

For plastic containers that held tablets, the weight of residuals were higher, but still very low, 

ranging from 0.0152–0.0157 grams. For containers that held liquids, the weight of residuals was 

the highest, but still very low, ranging from 0.0472 grams for glass vials of nicotine spray, to 

0.0651 grams for glass ampoules that held liquid physostigmine salicylate. The residuals in the 

nicotine inhaler were not experimentally determined; rather, the manufacturer (Pfizer) states on 

the packaging that the 10 mg cartridge delivers a 4 mg dose, so the residuals are assumed to be 6 

mg (or 0.006 grams). 

132

Unlike the quantitative results from the HPLC analyses from outside stakeholders, the 

results from the TGA are qualitative only. That is, the TGA was only intended to evaluate the 

presence of the API and compare the results from containers that had been triple rinsed with 

those that had not been triple rinsed. Using TGA, the API was not detected in the residuals, with 

one exception: the liquid nasal spray (note that TGA was not used on the nicotine inhaler 

residuals). In most cases, the TGA detected other, unspecified ingredients in the residuals, but 

not the active pharmaceutical ingredient on the P-list. The total weight of the residues was well 

 

132 Optimizing drug dose is a major factor in improving the sustainability of healthcare. The prescriber needs to be 

cognizant that prescribed treatments can have unanticipated, collateral impacts that reach far beyond the healthcare 

setting. See: Daughton and Ruhoy, Lower-dose prescribing: minimizing “side effects” of pharmaceuticals on 

society and the environment; Sci Total Environ, 443(2013), pp. 324-336 , which presents a critical examination of 

the multi-faceted potential role of drug dose in reducing the ambient levels of APIs in the environment and in 

reducing the incidence of drug wastage, which ultimately necessitates disposal of leftovers. 

(http://sciencedirect.com/science/article/pii/S004896712013927#)
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under a gram and the active pharmaceutical ingredient is a small proportion of the total weight of 

the tablet, gum, etc. As a result, with the exception of the nicotine nasal spray, the TGA was not 

sensitive enough to detect the presence of the active pharmaceutical ingredient, regardless of 

whether the container had been triple rinsed or not. 

EPA is aware that there are certain limitations with the data from the four sources. For 

instance, in the case of the consulting firm, no replicate samples were tested. In the case of the 

retailer, only warfarin residues were tested. However, given the size of the containers involved 

and the nominal quantities of residues involved, the Agency is proposing to allow the residues in 

single-unit dose containers/packaging and dispensing bottles, vials and vialsampules that once 

held pharmaceuticals to be managed as non-hazardous waste pharmaceuticals provided the

pharmaceutical product has been fully dispensed (e.g., all pills have been removed). EPA is 

soliciting comment on whether these studies are representative of the spectrum of formulations 

and containers that might be encountered. 

Finally, we note that the Agency is concerned about the potential for diversion of the 

pharmaceutical containers that may occur when the pharmaceutical residues and containers are 

discarded in the municipal waste stream. In such instances, we are concerned that the containers 

could be diverted from the municipal waste stream and used for illicit purposes, such as 

packaging counterfeit pharmaceuticals. Therefore, EPA is proposing that “RCRA empty” 

pharmaceutical containers that are original pharmaceutical packages (and therefore are 

susceptible to diversion) should be destroyed prior to placing them in the trash. These types of 

containers would include dispensing bottles or, vials or ampules typically used in pharmacies, 

but would not include paper or plastic cups, or blister packs used for dispensing singles doses to 

patients. The means of destruction could include crushing or shredding the container. We do not 
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believe that simply defacing the label would be sufficient to avoid diversion, since labels could 

be replaced if the container is intact.

We request comment on these proposed provisions, including whether it is necessary to 

limit the size of the dispensing bottle to which this provision would apply. In our observation, 

EPA has rarely seen pharmaceutical dispensing bottles that are larger than 1000-count, which are 

approximately 1 liter in size. EPA requests comment on whether larger containers are used for 

dispensing pharmaceuticals and, if so, which pharmaceuticals they are used for and what RCRA 

hazardous waste codes apply. We also seek comment as to whether “RCRA empty” 

pharmaceutical containers that are the original pharmaceutical packages should be destroyed 

prior to placing them in the trash. 

c. Dispensed syringes. With regard to dispensed syringes, EPA is proposing a conditional 

exemption for syringes that have been used to administer pharmaceuticals that are listed or 

characteristic hazardous waste when discarded. The residues remaining in a dispensed syringe 

would not be regulated as hazardous waste provided the syringe has been used to administer a 

pharmaceutical to a patient and the syringe is placed in a sharps container (if appropriate) and is 

managed in accordance with all applicable state and federal medical waste regulations. This 

would apply to syringes used to administer pharmaceuticals that are P- or U-listed, or exhibit a 

hazardous waste characteristic.
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EPA issued guidance regarding the regulatory status of residues in syringes in December 

1994 (RCRA Online # 13718)133 and April 14, 2008 (RCRA Online 14788)..

134 In the December 

1994 RCRA/Superfund Hotline Q&A about whether epinephrine in a discarded syringe would be 

P042, EPA stated, “Drug residues often remain in a dispensing instrument after the instrument is 

used to administer medication. EPA considers such residues remaining in a dispensing 

instrument to have been used for their intended purpose. The epinephrine remaining in the 

syringe, therefore, is not a commercial chemical product and not a P042 hazardous waste. The 

epinephrine could be a RCRA hazardous waste, however, if it exhibits a characteristic of 

hazardous waste.”

135

In the April 2008 memo to Sure-Way Systems, Inc.,, EPA clarified that the 1994 

interpretation extends to other P- and U-listed pharmaceuticals that have been used to administer 

the pharmaceutical by syringe.136 This proposed conditional exemption for syringes, in large 

part, would maintain the existing interpretation. The primary difference is that under the 

proposed conditional exemption, healthcare facilities would not be required to determine if the 

residues in the syringes meet a listing description or exhibit a hazardous waste characteristic.

EPA believes this conditional exemption is important to minimize the potential for 

exposures to healthcare workers, which can happen if they are accidentally stuck with a needle.

 

133 December 1994, RCRA Online #13718 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/1C1DEB3648A62A868525670F006B

CCD2/$file/13718.pdf.

134 Memo from Dellinger to Chilcott, April 14, 2008, RCRA Online #14788 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/6A5DEDF2FBA24FE68525744B0045

B4AF/$file/14788.pdf.

135 Note that since this Q&A was issued, EPA issued guidance indicating that epinephrine salts are not included in 

the scope of the P042 listing and therefore, most, if not all, medical applications of epinephrine are not P042 

(October 15, 2007; RCRA Online #14778)

136 Memo from Dellinger to Chilcott; April 14, 2008, RCRA Online #14788; 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/6A5DEDF2FBA24FE68525744B0045

B4AF/$file/14788.pdf
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Typically, sharps containers are more readily available to a medical practitioner than a hazardous 

waste container. Therefore, the used syringe will be discarded more quickly into a sharps 

container and there will be less opportunity for accidental sticks to occur en route to disposing 

the sharp.

However, we also note that syringes in sharps containers are typically autoclaved prior to 

disposal. EPA is concerned that the residues remaining in the syringes could be aerosolized 

during autoclaving and inadvertently expose workers to the aerosolized hazardous waste 

residues, posing risks (via pulmonary exposure) to those present during venting of the autoclave. 

Research suggests that autoclaving may even increase the toxicity of certain drugs.

137 EPA seeks 

comment on the extent of risks associated with autoclaving hazardous waste residues leftover in 

syringes and whether it is necessary to place a limit on the volume of residue or the volume of 

the syringe to which this conditional exemption would apply or whether any other conditions 

would be appropriate. For instance, stakeholders have informed us that they will squirt the 

residues remaining in a syringe onto a gauze pad prior to placing the syringe in the sharps 

container. Then, if the residues on the gauze pad are hazardous waste, the gauze pad is managed 

as hazardous waste, while allowing the syringe to be fully dispensed before placing it in the 

sharps container. In EPA’s view, this method of managing excess residues is preferred over 

another practice that is commonly used: the disposal of excess residues down the drain.

d. Other containers, including delivery devices. With regard to other containers, 

including delivery devices, EPA is proposing that the residues remaining in unused or used 

 

137 Daughton CG, Drugs and the Environment: Stewardship & Sustainability, National Exposure Research 

Laboratory, Environmental Sciences Division, US EPA, Las Vegas, NV; NERL-LV-ES 10/081, EPA/600/R-10/106; 

September 2010 (http://www.epa.gov/nerlesd1/bios/daughton/APM200-2010.pdf)
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containers (such as IV bags and tubing, inhalers, aerosols, nebulizers, tubes of ointment, gels, or 

creams) would be regulated as hazardous waste if the residues are a P- or U-listed hazardous 

waste or exhibit a hazardous waste characteristic. In some cases, such as with IV bags, the 

volume of hazardous waste is much larger than with residues contained in syringes or unit-dose 

containers. Stakeholders have stated that it is common practice for the leftover contents of IV 

bags and tubing to be emptied into a sink, which is a practice we are striving to eliminate. It is 

extremely difficult to determine how much residue remains in tubes of ointment, gel or cream. In 

the case of aerosols, it would be inadvisable to remove the contents of the container. Since 

hazardous waste pharmaceuticals managed under this proposed rule would not be counted 

towards a facility’s generator category, managing these residues and containers as hazardous 

waste under proposed 40 CFR part 266, subpart P should not pose the same burden that 

generators currently face with keeping track of the monthly amount of residues in containers that 

are not “RCRA empty.” Further, comments on the 2008 Pharmaceutical Universal Waste

proposal indicated that stakeholders prefer clear distinctions in regulating the hazardous waste 

from healthcare facilities and this proposed standard for container residues responds to that 

comment. EPA seeks comment on whether these proposed provisions address stakeholder 

concerns, while protecting human health and the environment.

F. What are the Proposed Standards for Shipping Hazardous Waste Pharmaceuticals?

1. Shipping Standards for Non-Creditable Hazardous Waste Pharmaceuticals and Evaluated 

Hazardous Waste Pharmaceuticals to Treatment, Storage, and Disposal Facilities

a. Shipping standards for non-creditable hazardous waste pharmaceuticals from healthcare 

facilities to TSDFs
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Typically, hazardous waste pharmaceuticals generated in a healthcare facility fall into 

two categories: (1) non-creditable (e.g., patient care) hazardous waste pharmaceuticals and (2) 

potentially creditable hazardous waste pharmaceuticals. This section discusses the proposed 

requirements for shipping of non-creditable, patient care/floor hazardous waste pharmaceuticals. 

For information regarding the shipment of potentially creditable hazardous waste 

pharmaceuticals from healthcare facilities and pharmaceutical reverse distributors, see Section 

V.F.2 of the preamble. 

Generally, patient care/floor hazardous waste pharmaceuticals differ from potentially 

creditable hazardous waste pharmaceuticals in that they have been partially administered and

often are not in their original packaging. In addition, patient care/floor hazardous waste 

pharmaceuticals cannot receive manufacturer’s credit and therefore may not be shipped to a 

reverse distributor. EPA is proposing that patient care/floor hazardous waste pharmaceuticals

generated at healthcare facilities, when shipped off-site, must be shipped to a designated facility 

(i.e., an interim status or permitted hazardous waste TSDF), as currently required (unless the 

healthcare facility has interim status or a RCRA permit to store or treat hazardous waste). 

Specifically, EPA proposes that non-creditable hazardous waste pharmaceuticals must continue 

to comply with the existing pre-transport requirements for packaging, labeling and marking, and 

that the non-creditable hazardous waste pharmaceuticals must continue to be shipped using a 

hazardous waste transporter and tracked with a hazardous waste manifest. However, to avoid

unnecessarily burdening the healthcare facility staff, who are unfamiliar with RCRA, EPA 

proposes that the hazardous waste numbers (often called hazardous waste codes) are not required 

to be entered into the hazardous waste manifest for non-creditable hazardous waste 

pharmaceuticals. In lieu of hazardous waste codes, EPA is proposing that the words, “hazardous 
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waste pharmaceuticals” must be entered in the “special handling and additional information” box 

on the manifest (box # 14). All existing RCRA recordkeeping requirements regarding hazardous 

waste manifesting continue to apply, as well (see Section V.C.12).), as well as all applicable 

DOT shipping requirements. EPA requests comment on this proposed approach for manifesting 

non-creditable hazardous waste pharmaceuticals from a healthcare facility.

b. Shipping standards for evaluated hazardous waste pharmaceuticals from pharmaceutical 

reverse distributors to TSDFs

For pharmaceutical reverse distributors, once potentially creditable hazardous waste 

pharmaceuticals have been deemed non-creditable or credit has been issued and they do not 

require any additional verification of credit, EPA is proposing that the hazardous waste 

pharmaceuticals be referred to as “evaluated hazardous waste pharmaceuticals.” As with 

shipping non-creditable hazardous waste pharmaceuticals, when evaluated hazardous waste 

pharmaceuticals are shipped off-site, EPA is proposing that they must be shipped in accordance 

with the existing pre-transport requirements for packaging, labeling and marking, and that 

evaluated hazardous waste pharmaceuticals must be shipped via a hazardous waste transporter 

using a hazardous waste manifest to a designated facility. This continues current practices under 

existing regulations for this type of hazardous waste pharmaceutical and does not represent an 

increase in burden. EPA believes that use of a hazardous waste manifest and a hazardous waste 

transporter are appropriate at this point for two reasons. First, once credit for the hazardous waste 

pharmaceuticals has been issued and verified, the potential for mismanagement is greater. This is 

because the pharmaceuticals have lost their value and will cost the reverse distributor money to 

dispose. Second, TSDFs are accustomed to receiving hazardous waste via a hazardous waste 
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transporter with a hazardous waste manifest and it would place administrative and compliance 

burdens on the receiving TSDF to accept shipments of hazardous waste with alternative tracking. 

EPA is proposing that the pharmaceutical reverse distributor list the appropriate 

hazardous waste codes on the manifest (even though the healthcare facility is not required to 

provide such information to the reverse distributor). Hazardous waste pharmaceuticals received 

by pharmaceutical reverse distributors are in their original packaging with their label, so the 

information to determine the appropriate hazardous waste codes should be readily available. 

Also, reverse distributors are currently required to include hazardous waste codes on the manifest

and it is expected that they have the necessary expertise in the management of these hazardous 

wastes that healthcare workers lack. As described in Section V.G.3 (pharmaceutical reverse 

distributor management standards), reverse distributors must keep copies of hazardous waste 

manifests for three years from the date of shipment. 

EPA requests comment regarding the proposed manifest and transportation requirements 

for non-creditable hazardous waste pharmaceuticals from healthcare facilities and evaluated 

hazardous waste pharmaceuticals from pharmaceutical reverse distributors. 

c. Importing/exporting non-creditable or evaluated hazardous waste pharmaceuticals

Under the existing regulations, a healthcare facility or pharmaceutical reverse distributor 

may not import hazardous waste pharmaceuticals unless it has a RCRA permit or interim status 

that allows it to accept hazardous waste from off-site and complies with the requirements for 

importing hazardous waste in 40 CFR part 262, subpart F. This proposal does not change the 

regulations as they apply to the import of non-creditable or evaluated hazardous waste 

pharmaceuticals. Likewise, under existing regulations, a healthcare facility or pharmaceutical 

reverse distributor may not export (non-creditable or evaluated) hazardous waste 
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pharmaceuticals unless it complies with requirements for exporting hazardous waste in 40 CFR 

part 262, subpart E. This proposal also does not change the regulations as they apply to the 

export of (non-creditable or evaluated) hazardous waste pharmaceuticals.138

EPA requests comment on the likelihood that non-creditable hazardous waste 

pharmaceuticals that are shipped from a healthcare facility to a domestic TSDF, would then be 

exported to a TSDF in a foreign country. In addition, EPA does not anticipate that hazardous 

waste pharmaceuticals would be destined for transboundary shipments for purposes of recovery 

operations and therefore potentially subject to 40 CFR part 262, subpart H; however, we also 

request comment on whether this is the case. 

2. Shipping Standards for Potentially Creditable Hazardous Waste Pharmaceuticals

This section discusses the proposed requirements for shipping potentially creditable 

hazardous waste pharmaceuticals from healthcare facilities to pharmaceutical reverse distributors 

and between pharmaceutical reverse distributors. The return of potentially creditable 

pharmaceuticals (hazardous and non-hazardous) to reverse distributors can involve multiple 

shipping steps before the pharmaceuticals are transported for ultimate treatment and disposal. In 

comments on the 2008 Pharmaceutical Universal Waste proposal and in response to EPA’s 

request for information,139 pharmaceutical reverse distributors explained various scenarios that 

require extra shipping steps. For example, a healthcare facility typically sends pharmaceuticals to 

the reverse distributor with which it has a contract. However, some manufacturers will only 

provide manufacturer’s credit after the pharmaceuticals have been returned to the reverse 

 

138 The Controlled Substances Import and Export Act prohibits controlled substances from being imported or 

exported unless permitted by DEA, even when the controlled substances are wastes. See 21 USC 952 and 953.

139 EPA sent nine pharmaceutical reverse distributors a letter asking for more information about their business 

practices in an effort to more fully understand reverse distribution of pharmaceuticals. The seven responses 

representing the views of eight reverse distributors can be found in the docket of this proposed rulemaking (EPAHQ-RCRA-2007-0932).
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distributor with which the manufacturer has a contract. Thus, if the reverse distributor with 

which the healthcare facility has a contract differs from the reverse distributor with which the 

manufacturer has a contract, then the healthcare facility’s reverse distributor must send the 

pharmaceuticals on to the manufacturer’s reverse distributor for the manufacturer’s credit to be 

given to the healthcare facility. In some cases, a pharmaceutical manufacturer may require the 

reverse distributor to ship the returned pharmaceuticals to the manufacturer so that the 

manufacturer itself can verify pharmaceutical amounts and credits. The estimate of the amount of 

pharmaceuticals transported from reverse distributors to manufacturers for verification varies. 

Based on our request for information, reverse distributors have indicated that the percent of 

potentially creditable pharmaceuticals transported to manufacturers ranged from an estimated 25 

percent to 93 percent, depending on the contractual agreement between the reverse distributor 

and the manufacturer. Both of the scenarios described above previously happen routinely and are 

part of the business of returning pharmaceuticals to reverse distributors (including 

manufacturers) for manufacturer’s credit. 

As explained in Section V.D.1, EPA is proposing that pharmaceuticals transported to 

pharmaceutical reverse distributors for credit are solid wastes, some of which will also be 

considered hazardous wastes. Under the current RCRA Subtitle C regulations, hazardous waste, 

including hazardous waste pharmaceuticals must be manifested to a permitted or interim status 

TSDF and shipped using a hazardous waste transporter to ensure the cradle-to-grave system of 

RCRA is maintained. However, compared to other hazardous wastes, EPA believes that the risk 

of environmental release posed by most potentially creditable hazardous wastes pharmaceuticals 

during accumulation and transport are relatively low. The risk is low because of the form and 

packaging of most potentially creditable hazardous waste pharmaceuticals, which is typically in 
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small, individually packaged doses (such as with many tablets and capsules) or small vials.

These small volumes of individually wrapped or packaged pharmaceuticals, when aggregated in 

a larger container, are unlikely to spill or be released into the environment since they are 

essentially double-packed when transported to a reverse distributor.140 Potentially creditable 

hazardous waste pharmaceuticals that are in liquid and aerosol forms may pose more of a risk 

during accumulation and transport due to possible spillage or leakage, but the small quantities in 

which they are generated, along with the DOT packaging requirements of 49 CFR parts 173, 

178, and 179180, would likely mitigate this risk (see EPA’s recommendation regarding liquids 

and aerosols in Section V.D.2.). Further, the 2008 Pharmaceutical Universal Waste proposal 

specifically sought comment regarding the risks of transportation of hazardous waste 

pharmaceuticals and no commenters identified environmental risks.

Due to the low risk of release to the environment described abovepreviously, EPA is 

proposing to allow potentially creditable hazardous waste pharmaceuticals to be shipped without

a hazardous waste manifest and without the use of hazardous waste transporters. However, this 

exemption from manifesting and use of hazardous wastes transporters only applies if the 

healthcare facility is sending potentially creditable hazardous waste pharmaceuticals to a 

pharmaceutical reverse distributor, or if a pharmaceutical reverse distributor is sending 

potentially creditable hazardous waste pharmaceuticals to another pharmaceutical reverse 

distributor. Further, DOT shipping requirements continue to apply to shipments of potentially 

creditable hazardous waste pharmaceuticals.

In lieu of requiring a hazardous waste manifest and the use of hazardous waste 

transporters, EPA is proposing an alternate type of tracking for potentially creditable hazardous 

 

140 Pharmaceutical Universal Waste proposal, Vol 73 FR 73529; December 2, 2008.
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waste pharmaceuticals—with two requirements. First, for each shipment, healthcare facilities 

and pharmaceutical reverse distributors must provide in writing (via letter or electronic 

communication), advance notice of the shipment to the pharmaceutical reverse distributor. 

Second, for each shipment, the receiving pharmaceutical reverse distributors must provide 

confirmation to the healthcare facility or pharmaceutical reverse distributor that initiated the 

shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has 

arrived. One way to comply with this requirement would be for the receiving reverse distributor 

to require the healthcare facility or pharmaceutical reverse distributor that initiates the shipment 

of potentially creditable hazardous waste pharmaceuticals to utilize some form of “delivery 

confirmation” mechanism that is provided by the shipper that confirms that a shipment to a 

reverse distributor has reached its destination and is under the custody and control of the 

recipient (e.g. delivery confirmation tracking with return receipt). This “delivery confirmation” 

notice can be paper-based or electronic. As part of the delivery confirmation system, a signature 

(paper or electronic) or other confirmation from a representative of the receiving pharmaceutical 

reverse distributor would be required. The signature by the pharmaceutical reverse distributor 

would provide assurance that the shipment was received by the reverse distributor. Without the 

signature or other confirmation of a representative of the pharmaceutical reverse distributor, it is 

possible for the shipper to state that delivery to the location has occurred, but it would not 

necessarily indicate that the recipient was there to receive the shipment. This proposed 

requirement is in direct response to concerns expressed by commenters over the lack of tracking 

of pharmaceuticals in the 2008 Pharmaceutical Universal Waste proposal. 

Alternatively, EPA has learned that some stakeholders use bar-coding on the 

pharmaceuticals or on the boxes to track shipments. The barcodes contain detailed information, 
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including the exact quantities and types of pharmaceuticals included in the shipment. Typically, 

when a reverse distributor receives a barcoded shipment, it will scan in the shipment and the 

sender will receive electronic notification that the shipment has arrived. This type of bar-code 

tracking would meet the delivery confirmation requirement of this proposed rule, but other 

mechanisms of “delivery confirmation” that are offered by common carriers, such as the U.S. 

Postal Service, FedEx or United Parcel Service (UPS), would also be acceptable.

Under this proposal, healthcare facilities and reverse distributors may use common 

carriers, such as the U.S. Postal Service, United Parcel Service, or FedEx141 for shipments of 

potentially creditable hazardous waste pharmaceuticals to and between pharmaceutical reverse 

distributors. EPA believes that common carriers are able to provide safe shipment since these 

potentially creditable hazardous waste pharmaceuticals present low transportation risk. We note 

that healthcare facilities and pharmaceutical reverse distributors must meet the applicable 

DOTPipeline and Hazardous Materials Safety Administration (PHMSA) Hazardous Materials 

Regulation (HMR; 49 CFR Parts 171-180) shipping requirements of 49 CFR parts 172–180, 

including preparing proper shipping papers when shipping potentially creditable hazardous waste 

pharmaceuticals. However,A RCRA hazardous waste that does not meet DOT classhazard 

classes 1-8 in the HMR, are only Class 9 hazardous materials only includewhen defined as a

RCRA hazardous wastes if they requirethat requires a manifest.

142 Because we are proposing that 

potentially creditable hazardous waste pharmaceuticals will not be manifested to pharmaceutical 

reverse distributors, they will not be considered DOT class 9 hazardous materials. As a result, the 

DOT shipping requirements will apply when potentially creditable hazardous waste

 

141 Note EPA is not endorsing the use of any of the shipping companies cited above.

142 See the definition of “hazardous waste” in 49 CFR 171.8; and the definition of “class 9” in 49 CFR 173.140.

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pharmaceuticals are shipped to pharmaceutical reverse distributors only when the hazardous 

wastes are DOT class 1-8 hazardous materials. 

EPA notes that a pharmaceutical reverse distributor is not required to sort the potentially 

creditable hazardous waste pharmaceuticals from the potentially creditable non-hazardous waste 

pharmaceuticals when they are destined for another reverse distributor. However, if the 

potentially creditable pharmaceuticals are not sorted, the pharmaceutical reverse distributor must 

follow the tracking procedures in this proposal for the entire shipment. On the other hand, if a 

pharmaceutical reverse distributor chooses to sort the potentially creditable hazardous waste 

pharmaceuticals from the creditable non-hazardous waste pharmaceuticals prior to shipping to 

another reverse distributor, only the potentially creditable hazardous waste pharmaceutical 

portion would have to be shipped according to these proposed standards. EPA asks for comment 

on whether the proposed tracking system and controls are sufficient to protect human health and 

the environment. 

a. What happens if a healthcare facility or pharmaceutical reverse distributor initiates a 

shipment and does not get confirmation of delivery?

If a healthcare facility or pharmaceutical reverse distributor initiates a shipment of 

potentially creditable hazardous waste pharmaceuticals to a reverse distributor and does not 

receive delivery confirmation from the intended recipient within seven calendar days, EPA is 

proposing that the healthcare facility or pharmaceutical reverse distributor that initiated the 

shipment must contact the shipper and the intended recipient promptly to 1) report that the 

confirmation was not received and 2) to determine the status and whereabouts of the potentially 

creditable hazardous waste pharmaceuticals that were shipped. The Agency requests comment on 
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whether any additional requirements, such as reporting to the implementing agency, are 

necessary in such cases.

b. Importing/exporting potentially creditable hazardous waste pharmaceuticals

If a healthcare facility or pharmaceutical reverse distributor imports potentially creditable 

hazardous waste pharmaceuticals, then it must comply with the proposed requirements for the 

shipment of potentially creditable hazardous waste pharmaceuticals. The proposed requirements 

would be in lieu of those for manifested hazardous waste imports found at 40 CFR part 262,

subpart F. EPA requests comment on whether potentially creditable hazardous waste 

pharmaceuticals are imported into the U.S. and, if so, how they are currently declared to customs 

when imported.

If a healthcare facility or pharmaceutical reverse distributor exports potentially creditable 

hazardous waste pharmaceuticals then it must generally comply with 40 CFR part 262, subpart 

E, except that it is not required to manifest the potentially creditable hazardous waste 

pharmaceuticals. 143

c. Recordkeeping for shipments of potentially creditable hazardous waste pharmaceuticals

EPA is proposing to require healthcare facilities and reverse distributors to keep records 

of the shipments of potentially creditable hazardous waste pharmaceuticals to reverse 

distributors. Specifically, we are proposing that healthcare facilities and reverse distributors that 

initiate a shipment to another pharmaceutical reverse distributor keep 1) records of advance 

notification regarding shipments of potentially creditable hazardous waste pharmaceuticals, 2) 

shipping papers, and 3) confirmation of receipt of shipment for three years after the shipment 

 

143 The Controlled Substances Import and Export Act prohibits controlled substances from being imported or 

exported unless permitted by DEA, even when the controlled substances are wastes. See 21 USC 952 and 953.
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was initiated. These records are necessary to ensure that potentially creditable hazardous waste 

pharmaceuticals are reaching their intended destination and not diverted. In most cases, retaining 

records for 3 years should be sufficient for inspection purposes; however, we are proposing that 

the periods of retention are automatically extended during unresolved enforcement activity, or at 

the request of the EPA Regional Administrator. The Agency seeks comment on whether 

additional recordkeeping is necessary to document the cases when the pharmaceutical reverse 

distributor does not receive a shipment of potentially creditable pharmaceuticals within 7 

calendar days and the steps must be taken to locate the shipment.

G. What are the Proposed Standards for Pharmaceutical Reverse Distributors?

1. Background on Pharmaceutical Reverse Distributor Operations

Pharmaceutical reverse distributors act as intermediaries between healthcare facilities and 

pharmaceutical manufacturers. They receive shipments of potentially creditable hazardous waste 

pharmaceuticals from healthcare facilities and, on behalf of manufacturers, facilitate the process 

of crediting healthcare facilities for these pharmaceuticals. From stakeholder input and EPA site 

visits, EPA’s understanding is that when a pharmaceutical reverse distributor receives a shipment 

of potentially creditable hazardous waste pharmaceuticals, the reverse distributor sorts through 

the shipment and often uses barcodes to scan items into its computer system. Based on 

manufacturers’ return goods policies, the pharmaceutical reverse distributors determine which 

potentially creditable hazardous waste pharmaceuticals can be credited, as well as which must be 

sent on to another reverse distributor for completion of the crediting process. 

In many cases, there is more than one reverse distributor involved in establishing and 

verifying manufacturer’s credit for a particular potentially creditable hazardous waste 
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pharmaceutical. For instance, reverse distributors may have contracts with specific 

pharmaceutical manufacturers such that only a specific pharmaceutical reverse distributor may 

facilitate credit for a particular manufacturer’s pharmaceuticals. If the receiving reverse 

distributor has a contract with the healthcare facility, but not with the pharmaceutical 

manufacturer, then the receiving pharmaceutical reverse distributor sends the returned 

pharmaceutical on to the reverse distributor that has a contract with the pharmaceutical 

manufacturer in order to facilitate the credit process. 

Because manufacturers’ return goods policies change over time, sometimes a 

pharmaceutical reverse distributor receives a potentially creditable hazardous waste 

pharmaceutical that is not eligible for credit immediately, and the pharmaceutical reverse 

distributor retains the potentially creditable hazardous waste pharmaceutical on-site until it is 

credit eligible. EPA requests comment on how often this happens and how long the potentially 

creditable hazardous waste pharmaceuticals are kept on-site at reverse distributors to await 

changes in manufacturers’ return goods policies.

In some cases, even after the pharmaceutical reverse distributor has awarded credit, a 

pharmaceutical manufacturer may request that the hazardous waste pharmaceuticals be 

transported back to the manufacturer to inventory and verify the amount of pharmaceuticals and 

credit. In developing this proposed rule, EPA considered all of the above previous scenarios as 

part of the crediting process.

On the other hand, if the potentially creditable hazardous waste pharmaceuticals are not 

sent onward to another pharmaceutical reverse distributor, the pharmaceutical reverse distributor 

awards the manufacturer’s credit to the healthcare facility and then manages the hazardous waste 

pharmaceuticals on-site until they are sent off-site for treatment and disposal. As discussed 
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previously in this proposal, after a potentially creditable hazardous waste pharmaceutical has 

been evaluated and either credited or deemed non-creditable and no additional pharmaceutical 

reverse distributors will be involved in the crediting process, EPA proposes to use the term 

“evaluated hazardous waste pharmaceutical.” This is to distinguish between the potentially 

creditable hazardous waste pharmaceuticals awaiting determination within the reverse 

distribution system versus credited and non-creditable hazardous waste pharmaceuticals that 

have been through the reverse distributor process and are destined to be managed by a permitted 

or interim status TSDF. Both are considered hazardous waste pharmaceuticals, but they are 

managed differently under the proposed regulations.

EPA is not aware of any pharmaceutical reverse distributors that facilitate manufacturer’s 

credit that also has interim status or a permit to treat or dispose of hazardous waste on-site. 

Therefore, EPA anticipates that pharmaceutical reverse distributors eventually send all evaluated 

hazardous waste pharmaceuticals off-site for treatment and disposal. EPA requests comment on 

whether the processes described above previously are representative of the pharmaceutical 

reverse distribution process.

2. EPA’s Rationale for Proposing New RCRA Management Standards for Pharmaceutical 

Reverse Distributors

This proposed rule is establishing standards for the management of both potentially 

creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that 

pharmaceutical reverse distributors receive and manage. The Agency notes that the management 

standards discussed below nextin this section apply only to reverse distributors of potentially 

creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals and 
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do not apply to reverse distribution or reverse logistics systems that may exist for other consumer 

products.

The current federal RCRA hazardous waste regulations at 40 CFR part 262 provide that 

only RCRA- permitted and interim status TSDFs may receive hazardous waste from off-site for 

treatment, storage, or disposal. However, the Agency does not believe it is necessary for 

pharmaceutical reverse distributors to obtain permits or have interim status to store hazardous 

waste pharmaceuticals in order to protect human health and the environment. Thus, EPA 

proposes a new category under RCRA called a “pharmaceutical reverse distributor,” which we 

proposed to define as any person that receives and accumulates potentially creditable hazardous 

waste pharmaceuticals for the purpose of facilitating or verifying manufacturer’s credit. The 

definition specifies that any person, including forward distributors and pharmaceutical 

manufacturers, which processes pharmaceuticals for the facilitation or verification of 

manufacturer’s credit is considered a pharmaceutical reverse distributor. EPA is proposing that 

pharmaceutical reverse distributors are not required to have interim status or a RCRA permit to 

accumulate hazardous waste pharmaceuticals and they may only accept potentially creditable 

hazardous waste pharmaceuticals from off-site provided they comply with the proposed 

standards in this rule. Pharmaceutical reverse distributors may not treat or dispose of hazardous 

waste on-site unless authorized to do so as a RCRA-permitted or interim status TSDF.

As discussed previously, EPA’s existing interpretation allows pharmaceutical reverse 

distributors to be generators of hazardous waste pharmaceuticals after a decision is made about 

whether the pharmaceuticals will be repurposed. As a generator, a pharmaceutical reverse 

distributor currently must comply with the LQG, SQG, or CESQG generator requirements, 

depending on the total volume of hazardous waste generated in a calendar month. Some smaller 
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pharmaceutical reverse distributors might stay under the hazardous waste quantity limits for 

CESQGs, which would mean that under the federal RCRA requirements, these CESQG 

pharmaceutical reverse distributors would not have to notify EPA as a generator and their 

hazardous waste pharmaceuticals could be disposed of with municipal and non-municipal solid 

waste (see § 261.5). However, the Agency has concerns with CESQG pharmaceutical reverse 

distributors not notifying EPA that they are managing hazardous waste. EPA is even more 

concerned about pharmaceutical reverse distributors that currently qualify as CESQGs placing 

the hazardous waste pharmaceuticals into the municipal and non-municipal solid waste stream 

and sending them to non-hazardous waste landfills. Some limited studies have shown active 

pharmaceutical ingredients present in landfill leachate that is collected in municipal solid waste 

landfill leachate systems.144, 145 Landfill leachate is generally transported to a wastewater 

treatment plant to be treated before discharge; however, some pharmaceutical compounds pass 

through treatment and are discharged, becoming a potential contributor of the pharmaceutical 

compounds detected in our nation’s waters. 

EPA is proposing to revise its position regarding potentially creditable hazardous waste 

pharmaceuticals, such that they will be first considered discarded at the healthcare facilities, not 

at the reverse distributors. This revision is based on new information demonstrating to EPA that 

pharmaceuticals returned to a reverse distributor are rarely, if ever, recycled or reused, and 

therefore the decision to send a potentially creditable hazardous waste pharmaceutical to a 

pharmaceutical reverse distributor is a decision to discard the pharmaceutical (as discussed above 

 

144 Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio, M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and 

Barber, L. B. (2004), Pharmaceuticals and Other Organic Waste Water Contaminants Within a Leachate Plume 

Downgradient of a Municipal Landfill. Groundwater Monitoring & Remediation, 24: 119–126.

145 Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., Zaugg, S.D., and Meyer, M.T. (2009), Waste-Indicator 

and Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water near Elkhart, Indiana, 2000–2002. 

Bulletin of Environmental Contamination and Toxicology, 82.6 :635-659.
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previously in Section V.D.1). Other comments on the December 2008 Pharmaceutical Universal 

Waste proposal indicated that notification to EPA by pharmaceutical reverse distributors and 

tracking of shipments of potentially creditable hazardous waste pharmaceuticals are critical and 

must be included in any regulatory scheme to ensure the safe management of potentially 

creditable hazardous waste pharmaceuticals. 

As previously discussed, only between 2-6 percent of the potentially creditable hazardous 

wastes that are received by pharmaceutical reverse distributors are listed or characteristic 

hazardous wastes.146 Therefore, the vast majority of the potentially creditable pharmaceutical 

waste that a pharmaceutical reverse distributor receives is not considered a characteristic or listed 

hazardous waste pharmaceutical under the existing definition of hazardous waste. This stands in 

contrast to a typical TSDF, which primarily manages hazardous waste. As a result, a 

pharmaceutical reverse distributor generally manages a smaller volume of hazardous waste than 

a typical permitted TSDF.

In addition, because the pharmaceuticals in the reverse distribution system are receiving 

credit, they are moved through the system efficiently. In fact, one national pharmacy retail chain 

informed EPA that the value of the credit they receive from manufacturers for returned 

pharmaceuticals is approximately $1 billion a year.147 Healthcare facilities and reverse 

distributors have a vested interest in having potentially creditable hazardous waste 

pharmaceuticals processed and credited quickly and managed appropriately so money is not lost 

in the process. 

 

146 See EPA’s request of information from reverse distributors, as well as their responses to EPA in the docket for 

this rulemaking: EPA-HQ-RCRA-2007-0932

147 Meeting with representatives from CVS/Caremark (November 8, 2012); see the docket for meeting notes (EPAHQ-RCRA-2007-0932).
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Furthermore, potentially creditable hazardous waste pharmaceuticals generally present a 

low risk of release to the environment as they typically are still in the manufacturer’s packaging. 

Since there is a low human health and environmental risk of release associated with the low 

volumes of potentially creditable hazardous waste pharmaceuticals shipped to reverse 

distributors for crediting purposes, and because EPA is not aware of any incidents of 

mismanagement resulting in environmental harm or releases of hazardous waste pharmaceuticals 

by reverse distributors, EPA believes that is not necessary to require reverse distributors to 

obtain RCRA hazardous waste storage permits with respect to typical reverse distribution 

operations, such as receiving, sorting, consolidating, and reshipping potentially creditable 

hazardous waste pharmaceuticals.

Thus, EPA is proposing to take a “middle-of-the-road” approach to regulating 

pharmaceutical reverse distributors by regarding them as a new type of RCRA hazardous waste 

entity—a pharmaceutical reverse distributor. This proposed approach addresses comments that 

EPA received on the December 2008 Pharmaceutical Universal Waste proposal and reflects 

EPA’s proposed revised interpretation that the point of generation for potentially creditable 

hazardous waste pharmaceuticals is at the healthcare facility, not the reverse distributor.

EPA proposes to establish management standards for pharmaceutical reverse distributors 

in 40 CFR part 266, subpart P. These entities would not be subject to 40 CFR parts 262, 264, or 

265. Generally, EPA is proposing that pharmaceutical reverse distributors comply with standards 

that are similar to the current federal LQG standards, in combination with certain requirements 

that permitted or interim status hazardous waste TSDFs must meet. We are establishing one set 

of requirements for all pharmaceutical reverse distributors, regardless of the amount of 

potentially creditable hazardous waste pharmaceuticals they receive. EPA believes this uniform 
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set of standards will make it easier for pharmaceutical reverse distributors to comply with the 

new proposal, since the burden of having to count hazardous waste pharmaceuticals on a 

monthly basis, especially the 1 kg of acute hazardous waste pharmaceuticals, will be removed.

EPA proposes that a pharmaceutical reverse distributor will not be required to have a 

hazardous waste permit or interim status for on-site accumulation of creditable and evaluated 

hazardous waste pharmaceuticals provided it follows the proposed pharmaceutical reverse 

distributor standards. However, for activities such as treatment or disposal of hazardous waste 

pharmaceuticals or other hazardous waste, a pharmaceutical reverse distributor must either 

obtain a RCRA permit or have interim status. This proposal requires pharmaceutical reverse 

distributors to comply with standards that are similar to LQG standards for on-site accumulation 

of hazardous waste that are found in § 262.34(a) and (b). We are proposing these requirements 

because, as discussed aboveprevoiusly, the value of the potentially creditable pharmaceuticals 

creates an incentive for proper management and the risk of release is low. Furthermore, many 

pharmaceutical reverse distributors are already LQGs and therefore this proposed rule should not 

represent a large shift in current practices or increased burden. However, once credit is provided, 

the value of the pharmaceuticals is eliminated and therefore the evaluated hazardous waste 

pharmaceuticals have a greater potential for mismanagement. As a result, we are proposing that 

pharmaceutical reverse distributors have additional standards for the management of evaluated 

hazardous waste pharmaceuticals. Note that while the LQG accumulation standards are found in 

§§ 262.34(a) and (b), these generator regulations reference many interim status TSDF standards 

in part 265. However, in the regulatory text and preamble for this rule, we reference the 

standards in part 265 directly for the applicable accumulation standards for pharmaceutical 

reverse distributors (rather than § 262.34(a) which would then simply refer the reader to part 
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265). However, the Agency requests comment as to whether we should include the regulatory 

standard directly in 40 CFR part 266, subpart P, instead of providing a cross-reference to the 

standard in 40 CFR part 265 in an effort to make the rules easier to follow and comply with.

3. Detailed Discussion of Proposed Pharmaceutical Reverse Distributor Standards

The proposed standards for pharmaceutical reverse distributors are organized into three 

sections. The first section applies to the pharmaceutical reverse distributor for the management 

of all potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste 

pharmaceuticals. The second section includes additional standards that would apply to the 

management of the potentially creditable hazardous waste pharmaceuticals that will be sent to 

another pharmaceutical reverse distributor for further evaluation or verification of credit and 

therefore continue to be regulated as potentially creditable hazardous waste pharmaceuticals. The 

third section includes additional standards that apply to the management of the evaluated 

hazardous waste pharmaceuticals that will not be sent to another pharmaceutical reverse 

distributor, but instead will be sent to a permitted or interim status TSDF. 

a. Standards for pharmaceutical reverse distributors

This portion of the preamble discusses the proposed standards that apply to 

pharmaceutical reverse distributors for the management of all hazardous waste pharmaceuticals 

on-site. Unlike the following two sections, the standards discussed in this section apply to all 

pharmaceutical reverse distributors, regardless of the subsequent destination of the hazardous 

waste pharmaceuticals. We note that a pharmaceutical reverse distributor must follow the 

proposed standards for the management of hazardous waste pharmaceuticals even if it generates 

other, non-pharmaceutical hazardous waste that is managed under 40 CFR part 262. 
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i. Notification. The first proposed requirement is that a pharmaceutical reverse distributor 

must notify EPA of its hazardous waste pharmaceutical activities via the Site ID form (EPA form 

8700-12). Under the current RCRA Subtitle C program, both LQGs and TSDFs must submit a 

Site ID form to EPA. Thus, EPA believes it is appropriate, and in line with comments received 

on the 2008 Pharmaceutical Universal Waste proposal, to require pharmaceutical reverse 

distributors to notify EPA. A pharmaceutical reverse distributor that does not have an EPA ID 

number will be required to submit the Site ID form to obtain one. If this proposal is finalized, the

Agency plans on revising the Site ID form to include a box to allow notifications by 

pharmaceutical reverse distributors. For those pharmaceutical reverse distributors that already 

have an EPA ID number, they will need to re-notify EPA as a pharmaceutical reverse distributor. 

Some pharmaceutical reverse distributors may also be generators of other types of hazardous 

waste (e.g., from cleaning and maintenance operations). Therefore, it is possible that a 

pharmaceutical reverse distributor may notify on the same notification form as both a generator 

of hazardous waste and as a pharmaceutical reverse distributor. 

ii. Inventory. EPA is proposing a new provision that is specific to pharmaceutical reverse 

distributors: the requirement is to keep an inventory of the potentially creditable hazardous waste 

pharmaceuticals and evaluated hazardous waste pharmaceuticals that are on-site. The inventory 

must include the identity (e.g., name or national drug code (NDC)) and quantity of each 

potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste 

pharmaceuticals. EPA also recommends as a best management practice that pharmaceutical 

reverse distributors also keep an inventory of their non-hazardous waste pharmaceuticals as well. 

An inventory is a key requirement to protect public health by helping to prevent the diversion of 

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hazardous waste pharmaceuticals. An inventory will allow the pharmaceutical reverse distributor 

to know which pharmaceuticals they have on-site at any time. The Agency believes that in many 

cases, pharmaceutical reverse distributors already maintain inventories and this proposed 

requirement is not expected to be burdensome for the pharmaceutical reverse distributors to 

implement. In fact, according to responses from pharmaceutical reverse distributors to a request 

for information, four out of eight of them indicated that they already keep inventories as best 

management practices or because it is required by the boardBoard of pharmacyPharmacy in their 

state.148 However, EPA requests comment on whether this practice is already commonly 

followed. 

iii. Security of the pharmaceutical reverse distributor. EPA is proposing that 

pharmaceutical reverse distributors must meet a performance-based security requirement which 

is based on the existing interim status TSDF security requirements found at § 265.14. 

Specifically, due to increased thefts of narcotics from pharmacies reported in recent years in 

major media outlets,149 EPA is concerned that pharmaceutical reverse distributors could also face 

such thefts since they accumulate unused pharmaceuticals or those that have exceeded their 

expiration date. Further, commenters on the 2008 Pharmaceutical Universal Waste proposal 

suggested that pharmaceutical universal waste handlers should meet the TSDF facility security 

requirement. EPA agrees with the commenters that the requirements that appear in the interim 

status TSDF security regulations would be appropriate to adopt and apply to pharmaceutical 

reverse distributors to prevent the illicit use of these pharmaceuticals and safeguard human 

 

148 See all the responses EPA received from pharmaceutical reverse distributors in the docket for this proposed 

rulemaking (EPA-HQ-RCRA-2007-0932).

149 “Pharmacies Besieged by Addicted Thieves” by Abby Goodnough Published: February 6, 2011

http://www.nytimes.com/2011/02/07/us/07pharmacies.html

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health and thus, has included this requirement for pharmaceutical reverse distributors. The 

security of the facility requirement of § 265.14(a) requires a facility to “prevent the unknowing 

entry, and minimize the possibility for the unauthorized entry, of persons or livestock onto the 

active portion of his facility.” EPA is proposing a similar requirement for pharmaceutical reverse 

distributors: they must prevent unknowing entry, and minimize the possibility for the 

unauthorized entry into the portion of the facility where potentially creditable and evaluated 

hazardous waste pharmaceuticals are kept (e.g., a receiving area and accumulation area). 

Based on site visits, EPA recognizes that many pharmaceutical reverse distributors may 

already meet the proposed security standard through the use of key cards that allow only 

authorized personnel into specific areas of the pharmaceutical reverse distributor, camera 

surveillance systems, and cages for storing pharmaceuticals. Some pharmaceutical reverse 

distributors may use fences and signs. EPA is including several examples of acceptable security 

measures in the regulatory text, but pharmaceutical reverse distributors are not limited to the 

examples provided. Further, if a pharmaceutical reverse distributor already meets the 

performance-based security standard by complying with other regulations, such as DEA's 

regulations, then the pharmaceutical reverse distributor would not need to install additional 

security. 

iv. Maximum 90 days for on-site accumulation and petition for an extension of 

accumulation time.

EPA is proposing that, like LQGs, pharmaceutical reverse distributors may accumulate 

potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste 

pharmaceuticals on-site for up to 90 calendar days without having interim status or a permit. 

However, because of the value of the potentially creditable hazardous waste pharmaceuticals, 

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and the low risk these materials present, the Agency has decided not to propose specific 

container management standards. 

The 90-day time limit begins when the potentially creditable hazardous waste 

pharmaceuticals initially arrive at the pharmaceutical reverse distributor. The 90-day time limit 

follows the potentially creditable pharmaceutical, even after it becomes an evaluated hazardous 

waste pharmaceutical. That is, there is a single 90-day accumulation limit for the hazardous 

waste pharmaceutical at each pharmaceutical reverse distributor. However, some potentially

creditable hazardous waste pharmaceuticals travel through more than one pharmaceutical reverse 

distributor to receive manufacturer’s credit. In such cases, each pharmaceutical reverse 

distributor that receives the potentially creditable hazardous waste pharmaceuticals has a new 90-

day accumulation limit. EPA requests comment on the 90-day timeframe and whether this 

timeframe is sufficient, or whether an alternative timeframe should be allowed.

As discussed abovepreviously, EPA is proposing that a pharmaceutical reverse distributor 

must inventory potentially creditable hazardous waste pharmaceuticals upon arrival. Many 

pharmaceutical reverse distributors utilize barcoding and scanners to log potentially creditable 

pharmaceuticals into a database upon arrival or soon after a shipment arrives. Current inventory 

systems may be adapted to provide verification of the time limits. For example, if a 

pharmaceutical reverse distributor includes the date of arrival in the inventory, then the 

pharmaceutical reverse distributor will be able to use the inventory to verify that potentially 

creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are 

not accumulated on-site for more than 90 calendar days. EPA is not proposing a specific method 

that pharmaceutical reverse distributors must use to document that accumulation does not exceed 

90 calendar days. We anticipate that most pharmaceutical reverse distributors would use the 
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inventory system to verify the 90-calendar day timeframe rather than using an additional 

requirement of labeling containers with dates for verification, but we request comment on this 

issue. We also request comment on whether EPA needs to specify a method of documenting that 

90 calendar days is not exceeded.

Pharmaceutical reverse distributors have informed EPA that there are times when 

pharmaceutical returns may need to be consolidated for longer periods because they are subject 

to litigation and the pharmaceutical reverse distributor is not allowed to move them.

Pharmaceutical reverse distributors may also need to handle large recalls of hazardous waste 

pharmaceuticals and might not be able to process all of the returned items within 90 calendar 

days. Therefore, EPA is proposing to allow a pharmaceutical reverse distributor to request from 

EPA an extension of the 90-day accumulation time limit for situations when the hazardous waste 

pharmaceuticals are involved in litigation, a recall, or in unforeseen circumstances beyond the 

control of the pharmaceutical reverse distributor. A pharmaceutical reverse distributor seeking an 

extension must submit a written request to the EPA Regional Administrator (in writing or 

electronically), explaining the reason for the extension, the approximate volume or weight of the 

hazardous waste pharmaceuticals that will be stored for more than 90-days and the amount of 

additional time requested. Under the existing RCRA subtitle C regulations, the extension of time 

typically allowed is limited to an extra 30 days for LQGs. However, due to the complex nature of 

pharmaceutical litigation and recalls, EPA is proposing to allow the EPA Regional Administrator 

to grant a time extension at their discretion on a case-by-case basis. EPA requests comment on 

whether it is necessary to place a limit on the length of time for which an extension may be 

granted.
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v. Contingency plan and emergency procedures. The Agency is proposing to require that 

pharmaceutical reverse distributors meet standards that are the same as those that appear in the 

federal LQG regulations for developing a contingency plan and emergency procedures at 40 

CFR part 265, subpart D. These standards cover the applicable emergencies and EPA believes 

that a pharmaceutical reverse distributor should be prepared to respond to potential emergencies 

just like LQGs and TSDFs. Since many pharmaceutical reverse distributors are already LQGs, 

they should already have contingency plans to address the hazards on-site. It may be possible 

that the pharmaceutical reverse distributors will have to amend their contingency plans to include 

the potentially creditable hazardous waste pharmaceuticals, which have been considered 

products, not hazardous waste, but we believe that such modifications should not impose much 

burden.

vi. Closure. Due to the generally low risk of release of the hazardous waste 

pharmaceuticals that pharmaceutical reverse distributors will accumulate on-site, as well as the 

value of the hazardous waste pharmaceuticals, EPA is proposing to require a performance-based 

closure standard that is based on the federal LQG closure standard found at § 265.111. 

Specifically, when a pharmaceutical reverse distributor closes its operations related to hazardous 

waste pharmaceuticals, it must control or minimize post-closure releases of hazardous waste 

constituents into the environment. This will entail removing the containers of hazardous waste 

pharmaceuticals (both potentially creditable hazardous waste pharmaceuticals as well as 

evaluated hazardous waste pharmaceuticals) from the facility before closure.

vii. Reporting. In some instances, a pharmaceutical reverse distributor may receive a 

shipment from a healthcare facility that includes items that are not potentially creditable 

pharmaceuticals. These shipments can include wastes that are clearly not eligible to receive 

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credit, such as patient care waste (e.g., IV tubing), contaminated personal protective equipment 

(PPE), medical waste, or other inappropriate wastes. Pharmaceutical reverse distributors are not 

the appropriate waste management facility for medical or infectious wastes and these wastes 

must be managed and transported from the healthcare facility directly to an appropriate waste 

disposal facility. In some cases, these non-creditable wastes may be hazardous waste. These noncreditable hazardous wastes are prohibited from being transported from a healthcare facility to a 

pharmaceutical reverse distributor; rather they should be manifested to a designated facility, such 

as a permitted or interim status TSDF. Nevertheless, a healthcare facility might incorrectly ship 

non-creditable hazardous wastes to a pharmaceutical reverse distributor. 

EPA is proposing that if a pharmaceutical reverse distributor receives a shipment from a 

healthcare facility that includes hazardous waste that it is not authorized to receive, such as noncreditable hazardous waste or hazardous waste that is not a pharmaceutical, the pharmaceutical 

reverse distributor must submit an unauthorized waste report to the EPA Regional Administrator 

within 15 days of receiving the hazardous waste. We have adapted the existing requirement for

situations when permitted and interim status TSDFs receive unmanifested hazardous waste (§ 

264.76 and § 265.76, respectively) to make it appropriate for pharmaceutical reverse distributors 

that receive unauthorized hazardous waste. However, we are also proposing two additional 

requirements for pharmaceutical reverse distributors that receive inappropriate hazardous waste. 

First, the pharmaceutical reverse distributor must send a copy of the unauthorized hazardous 

waste report to the healthcare facility that sent the unauthorized hazardous waste. This 

requirement is intended to alert the healthcare facility of its mistake in order to prevent further 

shipments of non-creditable hazardous waste or non-pharmaceutical hazardous waste. Second, 

the pharmaceutical reverse distributor must manage the unauthorized hazardous waste that it 
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receives in accordance with all applicable regulations. The Agency expects that the 

pharmaceutical reverse distributor will likely pass these additional costs (e.g., medical waste 

incineration) on to the healthcare facility for the management of the hazardous waste and this 

will act as an incentive for the healthcare facility to take measures to prevent further shipments 

of unauthorized hazardous waste. We request comment on whether EPA’s understanding 

regarding this type of situation is representative.

In order to prevent exposing employees to unnecessary risk, EPA recommends as a best 

management practice that pharmaceutical reverse distributors avoid sorting through shipments 

that contain non-creditable waste since the shipment may include hazardous waste, including 

infectious or radioactive healthcare waste. As a result, it is possible that a pharmaceutical reverse 

distributor receiving a shipment that includes non-creditable waste may be unsure whether the 

shipment includes hazardous waste. In such cases, EPA recommends that the pharmaceutical 

reverse distributor assume the shipment includes hazardous waste and submit an unauthorized 

waste report. Further, we recommend that pharmaceutical reverse distributors work with their 

clients to reduce the occurrence of inappropriate shipments. 

viii. Recordkeeping. EPA is proposing three recordkeeping requirements to provide

transparency for the movement of potentially creditable hazardous waste pharmaceuticals and as 

a means of verification upon inspection. First, a pharmaceutical reverse distributor must keep a 

copy of its notification (EPA form 8700-12) to EPA to indicate that it is a pharmaceutical reverse 

distributor operating under 40 CFR part 266, subpart P. A pharmaceutical reverse distributor 

must keep the record of notification for as long as it is subject to these requirements. Second, a 

pharmaceutical reverse distributor must keep copies of the records associated with shipments of 

potentially creditable hazardous waste pharmaceuticals that it receives. This includes a copy of 

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the advance notification from the healthcare facility or other pharmaceutical reverse distributor, a

copy of delivery confirmation, as well as shipping papers and any unauthorized waste reports. 

We propose that these shipping records must be kept for three years from the date the 

pharmaceutical reverse distributor receives the shipment. We request comment on whether 

additional recordkeeping is necessary to document cases when shipments of potentially 

creditable hazardous waste pharmaceuticals do not reach their intended destination within 7 

calendar days. Third, a pharmaceutical reverse distributor must keep a copy of its current 

inventory at all times as long as the pharmaceutical reverse distributor remains in operation. The 

inventory is a living document that will constantly be updated and must be available for 

inspection. Finally, we propose that periods of record retention indicated above previously for a 

pharmaceutical reverse distributor will be automatically extended during an enforcement action, 

or as requested by the EPA Regional Administrator to ensure that the appropriate records are 

available and can be reviewed as part of any enforcement action.

Note that additional recordkeeping requirements may also pertain to pharmaceutical 

reverse distributors. For example, a pharmaceutical reverse distributor that manifests its nonpharmaceutical hazardous waste is subject to the manifest recordkeeping requirements of § 

262.40. Further, as discussed in subsequent sections, there are additional recordkeeping 

requirements that apply to pharmaceutical reverse distributors for the management of potentially 

creditable hazardous waste pharmaceuticals destined for another pharmaceutical reverse 

distributor and others that apply to pharmaceutical reverse distributors for the management of 

evaluated hazardous waste pharmaceuticals.

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Based on stakeholder input and site visits, EPA has learned that when a pharmaceutical reverse 

distributor receives a shipment of potentially creditable hazardous waste pharmaceuticals, the 

reverse distributor sorts through the shipment and often uses barcodes to scan items into its 

system. The pharmaceutical reverse distributor then determines which potentially creditable 

hazardous waste pharmaceuticals must be transported to another reverse distributor and which 

ones will be credited and then sent off-site for treatment and disposal. EPA is proposing that this 

evaluation process must be completed within 21 days of arriving at the pharmaceutical reverse 

distributor. Likewise, if the pharmaceutical reverse distributor is a manufacturer, EPA is 

proposing that the manufacturer must finish verifying the appropriate credit within 21 calendar 

days of receiving the shipment of potentially creditable hazardous waste pharmaceuticals. 

EPA has chosen to propose 21 calendar days to ensure that the pharmaceutical reverse 

distributor has a long enough of time to make the evaluation, yet a short enough time to ensure 

that potentially creditable hazardous waste pharmaceuticals do not linger awaiting evaluation. 

The Agency requests comment on this timeframe and whether it should be shortened or 

lengthened. We also want to emphasize that the 21 calendar days for evaluating the potentially 

creditable hazardous pharmaceuticals counts as part of the total 90 calendar days that the 

hazardous waste pharmaceuticals are allowed to accumulate on-site. 

Once an evaluation is made on the incoming potentially creditable hazardous waste 

pharmaceuticals, if they are destined for another pharmaceutical reverse distributor, they are still 

considered potentially creditable hazardous waste pharmaceuticals. There are additional 

regulations in this proposal at § 266.510(b) that pertain to these potentially creditable hazardous 

waste pharmaceuticals (discussed in Section V.G.3.b. below). If, however, they are destined for 

an interim status or permitted TSDF, they are considered “evaluated hazardous waste 
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pharmaceuticals.” There are additional regulations in this proposal at § 266.510(c) that pertain to 

these evaluated hazardous waste pharmaceuticals (discussed in Section V.G.3.c. below).

b. Additional standards for pharmaceutical reverse distributors managing potentially 

creditable hazardous waste pharmaceuticals destined for another pharmaceutical reverse 

distributor.

This section discusses the additional standards that apply to a pharmaceutical reverse 

distributor for the management of potentially creditable hazardous waste pharmaceuticals that 

require further evaluation or verification of manufacturer’s credit at another pharmaceutical 

reverse distributor. These hazardous waste pharmaceuticals continue to be considered potentially 

creditable hazardous waste pharmaceuticals. Until manufacturer’s credit is finalized, the 

potentially creditable hazardous waste pharmaceuticals retain their value and there is greater 

incentive to manage them carefully in order to receive full manufacturer’s credit. Therefore, EPA 

is proposing few regulatory standards for the management of the potentially creditable hazardous 

waste pharmaceuticals that are destined for another pharmaceutical reverse distributor.

i. Where potentially creditable hazardous waste pharmaceuticals can be sent. The proposed 

regulations for pharmaceutical reverse distributors are structured so that there is a limit to the

number of transfers of potentially creditable hazardous waste pharmaceuticals that may occur 

before they are ultimately transported to a TSDF for treatment and disposal. Stakeholders 

expressed concern that the 2008 Pharmaceutical Universal Waste proposal would have allowed

hazardous waste pharmaceuticals to be shipped repeatedly and indefinitely from one universal 

waste handler to another. From discussions with pharmaceutical reverse distributors and 

reviewing information submitted via EPA’s request for information, the Agency believes a 

reasonable limit is three transfers of potentially creditable hazardous waste pharmaceuticals 

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before the pharmaceutical hazardous waste is ultimately transported to a TSDF. The three 

possible types of transfers are150: 

1) a healthcare facility may send potentially creditable hazardous waste pharmaceuticals to a 

pharmaceutical reverse distributor, which may or may not be a manufacturer; 

2) the first pharmaceutical reverse distributor may send the potentially creditable hazardous 

waste to another pharmaceutical reverse distributor, which may or may not be a 

manufacturer 

3) the second pharmaceutical reverse distributor can only send the potentially creditable 

hazardous waste pharmaceuticals on to a pharmaceutical reverse distributor that is a 

manufacturer.

EPA anticipates that healthcare facilities that are CESQGs will send their potentially 

creditable hazardous waste pharmaceuticals directly to pharmaceutical reverse distributors, and 

that the accumulation mechanism that we are proposing will be used to send only non-creditable 

hazardous waste pharmaceuticals to off-site healthcare facilities (see Section V.C.15.). However, 

EPA requests comment on whether CESQG healthcare facilities would benefit from being able 

to consolidate potentially creditable hazardous waste pharmaceuticals off-site, as well. 

Depending on comments, EPA will consider allowing a fourth transfer (for this limited situation) 

when potentially creditable hazardous waste pharmaceuticals are sent from a CESQG healthcare 

facility to an off-site healthcare facility for accumulation, as would also be allowed by proposed 

§ 266.504(a). 

 

150 A healthcare facility or pharmaceutical reverse distributor also has the option of sending its hazardous waste 

pharmaceuticals to a RCRA permitted or interim status TSDF.
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This chain of transfers ensures that the potentially creditable hazardous waste 

pharmaceuticals will be accumulated for no more than 270 days in total after leaving a healthcare 

facility and before being transported to a RCRA-permitted or interim status TSDF for treatment 

and disposal (assuming no accumulation time extensions are granted). EPA requests comment as 

to whether the three-transfer and 90-day limits are appropriate and whether more or fewer 

transfers are necessary for verification of manufacturer’s credit.

Put another way, if a pharmaceutical reverse distributor receives potentially creditable 

hazardous waste pharmaceuticals from a healthcare facility, the pharmaceutical reverse 

distributor must send those potentially creditable hazardous waste pharmaceuticals to another 

pharmaceutical reverse distributor (which may or may not be a manufacturer) or must manage 

them as evaluated hazardous waste pharmaceuticals under proposed § 266.510(c). However, a 

pharmaceutical reverse distributor that receives potentially creditable hazardous waste 

pharmaceuticals from another pharmaceutical reverse distributor is more limited in where it can 

send the potentially creditable hazardous waste pharmaceuticals. It can send potentially 

creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor that is the 

manufacturer or else must manage them as evaluated hazardous waste pharmaceuticals under § 

266.510(c). 

Regardless of the destination, each pharmaceutical reverse distributor must make an 

evaluation of the hazardous waste pharmaceuticals within 21 calendar days and may only 

accumulate the hazardous waste pharmaceuticals on-site for a maximum of 90 calendar days, 

unless an extension is granted by the Regional Administrator before it ships them off-site to 

another pharmaceutical reverse distributor or a RCRA-permitted or interim status TSDF. In 

addition, all shipments of evaluated hazardous waste pharmaceuticals are subject to proposed § 
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266.508 and shipments of all potentially creditable hazardous waste pharmaceuticals are subject 

to proposed § 266.509.

ii. Recordkeeping for pharmaceutical reverse distributors shipping of potentially 

creditable hazardous waste pharmaceuticals to another pharmaceutical reverse distributor.

Pharmaceutical reverse distributors must keep records (paper or electronic) for each shipment of 

potentially creditable hazardous waste pharmaceuticals that it initiates to another pharmaceutical 

reverse distributor (whether it is a manufacturer or not). This includes a copy of the advance 

notification provided to the other pharmaceutical reverse distributor, a copy of delivery 

confirmation, as well as shipping papers or bill of lading. We propose that these shipping records 

must be kept for 3 years from the date it initiates the shipment. 

c. Additional standards for pharmaceutical reverse distributors managing evaluated 

hazardous waste pharmaceuticals.

This section discusses the additional standards that apply to a pharmaceutical reverse 

distributor for the management of evaluated hazardous waste pharmaceuticals (i.e., the hazardous 

waste pharmaceuticals thata hazardous waste pharmaceutical that was a potentially creditable 

hazardous waste pharmaceutical but has been evaluated by a pharmaceutical reverse distributor 

to establish whether it is eligible for manufacturer’s credit and will not be sent to another 

pharmaceutical reverse distributor for further evaluation or verification of manufacturer’s credit,

but rather will be sent to a RCRA-permitted or interim status TSDF for treatment and disposal).).

Evaluated hazardous waste pharmaceuticals have been through the entire crediting process. In 

order to minimize the potential for their mismanagement, EPA believes it is necessary to have 

additional standards for the evaluated hazardous waste pharmaceuticals.

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i. Accumulation area. As discussed abovepreviously, EPA is proposing that a 

pharmaceutical reverse distributor must complete its evaluation of a potentially creditable 

hazardous waste pharmaceuticals within 21 calendar days of arriving at the pharmaceutical 

reverse distributor. Once the evaluation has been completed and the pharmaceutical reverse 

distributor knows that it is destined for treatment and disposal at a RCRA-permitted or interim 

status TSDF, rather than another pharmaceutical reverse distributor, the pharmaceutical is 

considered an evaluated hazardous waste pharmaceutical. Under the proposal, a pharmaceutical 

reverse distributor must establish an on-site accumulation area where it will accumulate these 

evaluated hazardous waste pharmaceuticals. An on-site accumulation area is needed so that the 

evaluated hazardous waste pharmaceuticals are segregated and clearly distinguished from the 

potentially creditable hazardous waste pharmaceuticals. 

ii. Weekly inspections. EPA is proposing that the accumulation area for evaluated 

hazardous waste pharmaceuticals must be inspected at least weekly to ensure containers are not 

leaking and that diversion of the hazardous waste pharmaceuticals is not occurring. Under the 

recordkeeping requirements for pharmaceutical reverse distributors, we are proposing that a 

pharmaceutical reverse distributor must keep a log of the weekly inspections of the on-site 

accumulation area and that the log must be retained for at least three years from the date of 

inspection. The log is necessary to validate the weekly inspections.

iii. Personnel training. EPA is proposing to require that pharmaceutical reverse 

distributors meet the same federal classroom or on-the-job personnel training requirements that 

LQGs must meet (§ 265.16). However, we specify in this proposal that the personnel that need to 

be trained are those persons who handle the evaluated hazardous waste pharmaceuticals in the 

on-site accumulation area. EPA believes that these personnel are the individuals handling and 

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managing the hazardous waste pharmaceuticals and must have appropriate hazardous waste 

training. The Agency requests comment on whether the training standards are appropriate for the 

specific reverse distributor personnel.

iv. Labeling and management of containers in on-site accumulation area. EPA is 

proposing container labeling similar to what was proposed under the 2008 pharmaceutical 

universal waste proposed rule. While containers of hazardous waste pharmaceuticals are in the 

accumulation area, they must be marked with the words, "Hazardous Waste Pharmaceuticals." 

We are proposing this term in order to distinguish them from the non-hazardous waste 

pharmaceuticals and from the hazardous waste pharmaceuticals that are still considered 

potentially creditable. We are not proposing to require an accumulation start date on the label for 

the containers, because the reverse distributor’s inventory will likely be used to verify the 

accumulation start date. However, a pharmaceutical reverse distributor may choose an alternate 

method, such as marking the date on each container as it arrives, to ensure that the hazardous 

waste pharmaceuticals are not accumulated at the pharmaceutical reverse distributor for more 

than 90 days, provided an extension is not granted. As explained abovepreviously, EPA prefers 

to allow a performance-based standard that allows flexibility to verify the 90-day accumulation 

time rather than require dating on the container labels, but we request comment regarding this 

requirement and whether it is necessary to specify a method for how a pharmaceutical reverse 

distributor must verify that the 90-day maximum accumulation time is not exceeded.

In terms of container management standards, the Agency is proposing requirements that 

are similar to the container management standards for LQGs—that is, the standards in 40 CFR 

part 265, but the Agency is also proposing to include some additional management requirements 

specific to hazardous waste pharmaceuticals. Specifically, under 40 CFR 262.34(a)(1)(i), LQGs 

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must comply with the container management standards in 40 CFR part 265, subpart I, which

includes a requirement that containers of hazardous waste must be kept closed, except when 

adding or removing waste. In this noticedocument, EPA is proposing to require that only 

containers with hazardous waste pharmaceuticals that are liquids or gels be kept closed during 

accumulation due to the low potential for release for those hazardous waste pharmaceuticals that 

are in a solid form. However, because most potentially creditable hazardous waste 

pharmaceuticals are in their original packaging, if the original packaging for gels or liquids is 

intact and sealed or the pharmaceuticals have been repackaged (e.g., for unit dosing) and the 

repackaged packaging for gels and liquids is intact and sealed, they are considered to meet the 

closed container standard. EPA requests comment on whether additional forms of hazardous 

waste pharmaceuticals (other than liquids and gels) need to be specified in the regulations and 

subject to the closed container requirement.

EPA is also proposing that containers of hazardous waste pharmaceuticals must be 

maintained in good condition to prevent leaks and the container material must be compatible 

with the hazardous waste pharmaceuticals placed in the container. In addition, we are proposing 

to require that a pharmaceutical reverse distributor that manages ignitable or reactive evaluated 

hazardous waste pharmaceuticals or that mixes or comingles incompatible evaluated hazardous 

waste pharmaceuticals must manage the container to prevent dangerous situations, such as fire, 

explosion, or release of toxic fumes.

Similar to healthcare facilities that accumulate non-creditable hazardous waste 

pharmaceuticals, pharmaceutical reverse distributors that accumulate evaluated hazardous waste 

pharmaceuticals must segregate the pharmaceuticals that are prohibited from being combusted 
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because of the dilution prohibition of § 268.3(c) and accumulate them in separate containers 

from other evaluated hazardous waste pharmaceuticals.

There are also several existing LQG accumulation unit management standards in § 

262.34(a) that EPA believes are not necessary to include for the management of evaluated 

hazardous waste pharmaceuticals. For instance, this proposal only sets standards for the 

accumulation of evaluated hazardous waste pharmaceuticals in containers. EPA does not think it 

is necessary to include accumulation units such as tanks, containment buildings, or drip pads 

because pharmaceutical reverse distributors do not currently use these types of accumulation 

units. However, if EPA is mistaken in this understanding and commenters indicate they would 

like to be able to use tanks, containment buildings, or drip pads, EPA would consider including 

in this proposal the LQG standards for accumulation in these units. The Agency solicits 

comment on this matter.

In addition, the Agency is not proposing to require pharmaceutical reverse distributors to 

meet the air emission standards found in 40 CFR part 265, subpart CC as required in §

262.34(a)(1)(i) because we anticipate that they will not be applicable. Specifically, § 265.1083(c) 

exempts tanks, surface impoundments, and containers from the organic air emission standards if 

the hazardous waste entering the accumulation unit has an average volatile organic concentration 

of less than 500 parts per million by weight, while § 265.1080(b)(2) exempts containers with a 

capacity of less than 0.1 m3(26 gallons) from the standards. EPA understands that the only 

evaluated hazardous waste pharmaceuticals that have the potential for air emissions are liquids

and gels, but they generally do not contain volatile organics. Thus, they do not release organic air 

emissions, which is what the 40 CFR part 265, subpart CC, air emission standards for tanks, 

surface impoundments, and containers were promulgated to control. Moreover, because 
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hazardous waste pharmaceuticals are often in their original packaging, and we are proposing to 

require that liquid and gel hazardous waste pharmaceuticals must be in intact, sealed packaging 

or otherwise in closed containers, EPA believes that the container air emission standards are 

unnecessary. In addition, the Agency anticipates that the packaging and containers for hazardous 

waste pharmaceuticals will often have a capacity less than 0.1 m3(26 gallons) further limiting 

the applicability of the container air emission standards.

Similarly, EPA does not anticipate that the 40 CFR part 265, subpart AA—air emissions 

standards for process vents—and subpart BB—air emission standards for equipment leaks—are 

applicable to the activities of a pharmaceutical reverse distributor and its management of 

hazardous waste pharmaceuticals. Therefore, like 40 CFR part 265, subpart CC discussed 

abovepreviously, EPA is not proposing to require that 40 CFR part 265, subparts AA and BB 

apply to pharmaceutical reverse distributors. EPA requests comments on whether its current 

understanding is correct and whether the 40 CFR part 265, subparts AA, BB, and CC RCRA air 

emission standards should be applied to pharmaceutical reverse distributors..

v. Hazardous waste numbers (codes). EPA is proposing to require that the containers of 

evaluated hazardous waste pharmaceuticals be labeled with the appropriate RCRA hazardous 

waste numbers. The hazardous waste numbers may be placed on the container label at any time 

during on-site accumulation, but they must be added prior to when the evaluated hazardous 

waste pharmaceuticals are transported off-site. The hazardous waste numbers must be marked on 

the container label in order to ensure that it is readily visible and cannot be separated from the 

hazardous waste. The hazardous waste numbers are necessary so that transporters, transfer 

facilities, and TSDFs to know how to properly transport, consolidate, treat, store and dispose of 

the hazardous waste in compliance with the applicable RCRA regulations. We are not requiring 
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that the pharmaceutical reverse distributor be the party that adds the hazardous waste numbers to 

the containers. The proposed regulations allow a vendor to perform this duty on behalf of the 

pharmaceutical reverse distributor. In practice, however, if a vendor is responsible for assigning 

hazardous waste numbers, personnel from the pharmaceutical reverse distributor may need to 

assist in the process.

vi. Shipping evaluated hazardous waste pharmaceuticals

Although it is already stated in § 266.508(a) under the section of the regulations that 

pertains to shipping standards, for clarity, we propose to repeat in § 266.510 (the pharmaceutical 

reverse distributor section of the regulations) the requirement that pharmaceutical reverse 

distributors that ship evaluated hazardous waste pharmaceuticals off-site must do so in 

accordance with the proposed shipping requirements in § 266.508(a). This includes the 

applicable DOT packaging, marking and labeling requirements, as well as the requirement to 

utilize the hazardous waste manifest when shipping the evaluated hazardous waste to a 

designated facility.

vii. Rejected shipments. The Agency is proposing to require in § 266.510(c)(7) that 

pharmaceutical reverse distributors meet the same procedures as LQGs must meet for rejected 

shipments in §262.42(c). If a designated permitted or interim status TSDF identified on the 

hazardous waste manifest cannot accept a shipment of evaluated hazardous waste 

pharmaceuticals from a pharmaceutical reverse distributor and the TSDF returns the shipment to 

the pharmaceutical reverse distributor, the pharmaceutical reverse distributor must sign the 

applicable item on the manifest. In addition, the pharmaceutical reverse distributor may 

consolidate the rejected hazardous waste pharmaceuticals on-site for up to 90 days provided they 

are managed in the on-site accumulation area and in accordance with this proposal’s 

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pharmaceutical reverse distributor standards for evaluated hazardous waste pharmaceuticals. The 

reporting requirements associated with rejected shipments are discussed separately under the 

reporting section.

viii. Land disposal restrictions. EPA is proposing in § 266.510(c)(8) that pharmaceutical 

reverse distributors are subject to the same land disposal restrictions (LDRs) that apply to LQGs

with respect to their evaluated hazardous waste pharmaceuticals. In addition, EPA is proposing 

to amend the testing, tracking, and recordkeeping requirements for generators, treaters and 

disposal facilities at §268.7 to add the words, “pharmaceutical reverse distributors” to the title of 

that section to make the applicability of the treatment standards clear.

ix. Reporting by a pharmaceutical reverse distributor for evaluated hazardous waste 

pharmaceuticals.

(1) Biennial report. EPA is proposing that pharmaceutical reverse distributors submit a 

BR for the evaluated hazardous waste pharmaceuticals that are transported to a TSDF in order 

for the Agency to have as complete a picture of the amount of hazardous waste generated, 

treated, stored, or disposed of annually. However, the BR should only include the evaluated 

hazardous waste pharmaceuticals, and not the potentially creditable hazardous waste 

pharmaceuticals that a pharmaceutical reverse distributor sends to another pharmaceutical 

reverse distributor. Specifically, we are proposing in § 266.510(c)(9)(i) that a pharmaceutical 

reverse distributor comply with the LQG BR requirements in § 262.41, except for § 262.41(a)(7), 

which includes the requirement to report changes in volume and toxicity of waste achieved 

during the year in comparison to previous years. The reason we are not requiring the 

pharmaceutical reverse distributor to provide such information is that they do not have control of 

the volume or toxicity of the hazardous waste pharmaceuticals it receives from the healthcare 

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facility, and thus have no ability to reduce the volume or toxicity of the hazardous waste

pharmaceuticals. Thus, EPA is not requiring the pharmaceutical reverse distributor to report this 

information in its BR. 

(2) Exception reporting. For the reasons that EPA requires exception reporting 

generally—that is, to maintain the cradle to grave tracking system, EPA is proposing in §

266.510(c)(9)(ii)(A) that pharmaceutical reverse distributors provide an exception report when a 

TSDF does not return the hazardous waste manifest to the pharmaceutical reverse distributor for 

shipments of hazardous waste pharmaceuticals to a designated facility. Likewise, we are 

proposing in § 266.510(c)(9)(ii)(B) that pharmaceutical reverse distributors meet LQG exception 

reporting when a shipment from a pharmaceutical reverse distributor is rejected by the 

designated facility and forwarded onto an alternate facility. 

x. Recordkeeping by a pharmaceutical reverse distributor for evaluated hazardous waste 

pharmaceuticals. Many of the proposed recordkeeping requirements that pertain to evaluated 

hazardous waste pharmaceuticals have been discussed in the sections abovepreviously, but for 

clarity, it is useful to restate them in this recordkeeping section, so that pharmaceutical reverse 

distributors can refer to one section to determine their recordkeeping requirements related to 

evaluated hazardous waste pharmaceuticals. In particular, we are proposing five recordkeeping 

requirements that pertain to evaluated hazardous waste pharmaceuticals at pharmaceutical 

reverse distributors. First, EPA is proposing that a pharmaceutical reverse distributor keeps a log 

(written or electronic) of its weekly inspections of the on-site accumulation area. The other four 

recordkeeping requirements that we are proposing in § 266.510(c)(10) for pharmaceutical 

reverse distributors are the same as the LQG recordkeeping requirements that appear in §§ 

262.40-42 and § 265.16; these include hazardous waste manifest records, records of biennial 

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reports, exception reporting and training documentation. EPA believes that these recordkeeping 

requirements are appropriate for pharmaceutical reverse distributors, many of whom are 

currently LQGs, but requests comment on this requirement. 

EPA asks commenters to review the standards EPA is proposing for pharmaceutical 

reverse distributors and provide specific comment on whether the standards are appropriate and 

sufficient to protect human health and the environment.

d. When a pharmaceutical reverse distributor must have a RCRA hazardous waste permit

EPA is proposing to not require that a pharmaceutical reverse distributor have a RCRA

permit or interim status for accumulating potentially creditable and evaluated hazardous waste 

pharmaceuticals, provided that the pharmaceutical reverse distributor follows all the conditions 

of the permitting exemption in § 266.510. In other words, a pharmaceutical reverse distributor 

would be subject to regulation as a TSDF and require a RCRA permit (or interim status) if it 

does not meet the conditions of § 266.510. In addition, a pharmaceutical reverse distributor must 

have a RCRA permit (or interim status) if it treats or disposes of hazardous waste on-site or if it 

accepts manifested hazardous waste from off-site. A pharmaceutical reverse distributor is 

required to reject shipments of manifested hazardous waste that it may inadvertently receive 

from off-site because a pharmaceutical reverse distributor is not a designated facility and 

therefore is not eligible to receive hazardous waste via a manifest. EPA believes that this 

approach to regulation of pharmaceutical reverse distributors that accumulate hazardous waste 

pharmaceuticals strikes an appropriate balance because it recognizes that pharmaceutical reverse 

distributors are different from typical hazardous waste TSDFs for permitting purposes, while it 
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still imposes certain conditions for exemption from permitting requirements that provide the 

necessary environmental protection.

VI. Implementation and Enforcement

A. Healthcare Facilities 

1. Determining Whether a Healthcare Facility is Subject to Part 266, Subpart P

EPA is proposing that healthcare facilities that are currently considered LQGs or SQGs

are subject to the new 40 CFR part 266, subpart P requirements for the management of 

hazardous waste pharmaceuticals. Thus, a healthcare facility that generates (or accumulates)

more than 100 kg hazardous waste per calendar month, or more than 1 kg of acute hazardous 

waste per calendar month, or more than 100 kg of any residue or contaminated soil, waste, or 

other debris resulting from the clean-up of a spill, into or on any land or water, of any acute 

hazardous wastes listed in §§ 261.31, or 261.33(e), must manage its hazardous waste 

pharmaceuticals in compliance with the 40 CFR part 266, subpart P requirements. In addition, 

healthcare facilities that are CESQGs are subject to the prohibition on sewering hazardous waste 

pharmaceuticals in § 266.5052

To determine whether a healthcare facility is a CESQG regulated under § 261.5 (or not a 

CESQG, in which case it would be subject to 40 CFR part 266, subpart P), it, or a CESQG 

regulated under § 261.5, a healthcare facility must count all the hazardous waste –

pharmaceutical and non-pharmaceutical – it generates in a calendar month. In counting the 

amount of hazardous waste generated per calendar month, we note that EPA is proposing to 

change which pharmaceuticals will be considered hazardous wastes (i.e., potentially creditable 

hazardous waste pharmaceuticals). Specifically, EPA is proposing that potentially creditable 
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hazardous waste pharmaceuticals transported to a pharmaceutical reverse distributor will be 

considered solid waste from the point of generation at the healthcare facility and therefore must 

be counted when determining whether the healthcare facility is a CESQG regulated under § 

261.5, or whether it is regulated under 40 CFR part 266, subpart P. This differs from current 

practice where, although a healthcare facility must count the non-creditable hazardous waste 

pharmaceuticals it generates each calendar month toward its hazardous waste generator category,

it does not count the potentially creditable hazardous waste pharmaceuticals it sends to a 

pharmaceutical reverse distributor. Therefore, although a healthcare facility currently may be 

considered a CESQG, when it begins counting its potentially creditable hazardous waste 

pharmaceuticals toward its generator category, it may no longer be a CESQG. In that case, the 

healthcare facility would be subject to the 40 CFR part 266, subpart P requirements.

2. Healthcare Facilities Managing Hazardous Waste Pharmaceuticals under Part 266, Subpart P

EPA is proposing that all healthcare facilities, with the exception of CESQGs, will be 

subject to the same regulations for the management of their hazardous waste pharmaceuticals, 

regardless of the quantity of hazardous waste pharmaceuticals generated. A healthcare facility 

that generates both pharmaceutical and non-pharmaceutical hazardous waste must manage the 

non-pharmaceutical hazardous waste pursuant to part 262, but need not count its hazardous waste 

pharmaceuticals toward the facility’s monthly hazardous waste generator category. In addition, if 

a healthcare facility does not want to keep track of the amount of hazardous waste it generates to 

ensure it does not exceed the CESQG quantity limits, it could choose to operate under this 

proposed rule. If it chooses to operate under this proposed rule, however, a healthcare facility 
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must comply with all the requirements of this subpart for the management of its hazardous waste 

pharmaceuticals.

B. Pharmaceutical Reverse Distributors 

1. Pharmaceuticals Sent to Pharmaceutical Reverse Distributors are Solid Wastes

One difference between this proposal and the 2008 Pharmaceutical Universal Waste

proposal is how RCRA would apply to pharmaceuticals returned to pharmaceutical reverse 

distributors to obtain manufacturer’s credit. EPA is proposing to change its existing position on 

this issue. If this rule is finalized, this change would mean that the decision by a healthcare 

facility to send a pharmaceutical to a pharmaceutical reverse distributor is the decision to discard 

the pharmaceutical. Therefore, under this proposed rule, once the healthcare facility makes the 

decision to send a pharmaceutical to a pharmaceutical reverse distributor for credit, it is a solid 

waste at the healthcare facility. It is likely that a portion of the potentially creditable solid waste 

pharmaceuticals at healthcare facilities that are destined for a pharmaceutical reverse distributor 

will also meet the definition of hazardous waste and as a result, these potentially creditable 

hazardous waste pharmaceuticals would need to be managed in accordance with the standards 

proposed in this noticedocument. However, until this rule is final and effective, EPA’s current 

position will remain in effect. 

In addition, the Agency notes that the proposed change in EPA’s position concerning 

reverse distribution and the management standards discussed in this notice document pertain

only to the reverse distribution of hazardous waste pharmaceuticals and does not apply to reverse 

distribution or reverse logistics systems that may exist for other consumer products. This 
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limitation is because EPA has studied and collected data for reverse distribution systems for 

hazardous waste pharmaceuticals, and not all consumer products.151

2. Pharmaceutical Reverse Distributors Managing Hazardous Waste Pharmaceuticals under Part 

266, Subpart P

Under this proposal, all pharmaceutical reverse distributors are subject to 40 CFR part 

266, subpart P and will be subject to the same standards with respect to their hazardous waste 

pharmaceuticals, regardless of the amount of hazardous waste pharmaceuticals they manage. 

Even pharmaceutical reverse distributors that are currently CESQGs will be regulated under 40 

CFR part 266, subpart P for the management of their hazardous waste pharmaceuticals. 

Therefore, as with healthcare facilities, a pharmaceutical reverse distributor subject to 40 CFR 

part 266, subpart P will no longer have to keep track of the amount of hazardous waste 

pharmaceuticals that it generates on a monthly basis. 

C. Healthcare Facilities and Pharmaceutical Reverse Distributors Managing Nonpharmaceutical Hazardous Waste in Accordance with 40 CFR Part 262 or Part 273

Most, if not all, healthcare facilities and pharmaceutical reverse distributors generate 

hazardous wastes other than pharmaceuticals. These, non-pharmaceutical hazardous wastes will 

continue to be regulated under 40 CFR part 262 (and other applicable Subtitle C regulations). 

However, because a healthcare facility or pharmaceutical reverse distributor operating under 40 

CFR part 266, subpart P no longer has to count its hazardous waste pharmaceuticals, including 

 

151 EPA is examining the reverse logistics of non-pharmaceutical hazardous wastes as part of its analysis of 

comments received on the Retail Notice of Data Availability that was published on February 14, 2014 (79 FR 8926).
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acute hazardous waste pharmaceuticals such as warfarin, it could result in a change in the 

facility’s overall generator category and thus change how its non-pharmaceutical hazardous 

waste must be managed. For example, the generator category for a healthcare facility or 

pharmaceutical reverse distributor may be reduced from an LQG to an SQG or even a CESQG, 

when it stops counting its hazardous waste pharmaceuticals, especially acute hazardous waste 

pharmaceuticals, toward its generator category. 

If finalized, the standards established by this rulemaking apply only to the management 

of hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse 

distributors. Healthcare facilities and pharmaceutical reverse distributors likely generate or 

manage other types of wastes. For example, hospitals may generate non-pharmaceutical 

hazardous wastes, such as solvents in their diagnostic laboratories; those hazardous wastes must 

still be managed in accordance with the RCRA Subtitle C requirements (such as the RCRA 

satellite accumulation regulations (§ 262.34(c)), or if it is a teaching hospital, the Academic 

Laboratories Rule (if it has opted into part 262, subpart K). Retail pharmacies in retail stores and 

grocery stores may have non-pharmaceutical hazardous wastes on-site as well, which must be 

managed in accordance with the 40 CFR part 262 requirements and all other applicable RCRA 

Subtitle C regulations. For example, fluorescent bulbs may be managed under the universal 

waste program (40 CFR part 273). For pharmaceutical reverse distributors, this proposed rule 

only applies to the management of potentially creditable hazardous waste pharmaceuticals and 

evaluated hazardous waste pharmaceuticals. Some pharmaceutical reverse distributors may 

generate other non-pharmaceutical hazardous wastes from activities, such as cleaning and 

maintenance; other RCRA requirements will apply to those non-pharmaceutical hazardous 

wastes.
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D. State Enforcement Activities and Interpretations

States have taken a variety of approaches regarding pharmaceutical hazardous wastes. 

One major goal of this proposed rule is to provide clarity on this topic, and thereby promote 

national consistency, which, in turn, should promote better compliance among healthcare 

facilities, including pharmacies.

California has taken numerous enforcement actions against national retail chains with 

pharmacies for not complying with the RCRA hazardous waste regulations. In recent years, the 

state took enforcement actions and imposed fines on the following chains: Kmart (2009), 

Walmart (2010), Target (2011), CVS (2012), Costco (2012), Walgreens (2012) and Rite-Aid 

(2013). In at least two settlement agreements, California directed the defendants (CVS and 

Costco) to “initiate work with appropriate stakeholders from business and government, including 

the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the 

DTSC [Department of Toxic Substances Control], and thereafter either directly or through trade 

associations or informal coalitions of interested parties, undertake to promote federal regulatory 

reform regarding the proper management of nondispensable pharmaceuticals, including over-thecounter medications, through “reverse distribution.” 152 Through these settlement agreements, 

California is seeking clarity from EPA about its longstanding interpretation about the regulatory 

status of pharmaceuticals that are routed through pharmaceutical reverse distribution systems. 

 

152 http://www.calepa.ca.gov/enforcement/orders/2012/CVSStipFinal.pdf and 

http://www.calepa.ca.gov/enforcement/orders/2012/CostcoFinal.pdf or see the docket for this rulemaking EPA-HQRCRA-2007-0932.
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In 2012, Connecticut’s Department of Energy and Environmental Protection (DEEP) 

took enforcement actions at seven CVS stores for violations of the RCRA hazardous waste 

regulations. Consent orders from Connecticut DEEP direct CVS stores in the state to follow a set 

of best management practices.

153 A number of the practices developed in these consent orders 

mirror some of the practices we are proposing in this rule, particularly with regard to 

pharmaceuticals destined for a pharmaceutical reverse distributor. Connecticut DEEP asserts 

RCRA jurisdiction over the pharmaceuticals destined for pharmaceutical reverse distributors by 

applying specific practices to their management. For example, CVS must maintain records of 

each shipment of non-dispensable pharmaceuticals to a pharmaceutical reverse distributor, 

including confirmation of receipt of the non-dispensable pharmaceuticals from the 

pharmaceutical reverse distributor receiving them. The best practices also include procedures for 

addressing situations when CVS does not receive delivery confirmation of shipment to a 

pharmaceutical reverse distributor. Further, the consent order sets out separate, more 

comprehensive practices for the non-dispensable pharmaceuticals that are not suitable for 

pharmaceutical reverse distribution. 

Aside from best management practices developed by Connecticut as part of a consent 

order, at least two other states have developed guidance documents that apply conditions to the 

management of hazardous wastes pharmaceuticals in exchange for enforcement discretion. In 

particular, in 2008, the Washington State Department of Ecology issued guidance titled, Interim 

Enforcement Policy: Pharmaceutical Waste in Healthcare.

154 Like Connecticut’s consent orders 

 

153 http://www.ct.gov/deep/lib/deep/enforcement/consentorder/COWSWDH13005.pdf. or see the docket for this 

rulemaking EPA-HQ-RCRA-2007-0932.

154 See the interim enforcement policy in the docket for this rulemaking (EPA-HQ-RCRA-2007-0932) or see it 

online at 

https://fortress.wa.gov/ecy/publications/publications/0704024.pdfhttps://fortress.wa.gov/ecy/publications/documents

/0704024.pdf
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with CVS, this enforcement discretion policy has some elements in common with this proposed

rule for hazardous waste pharmaceuticals. For instance, a healthcare facility must notify the 

Department of Ecology that it is operating under the policy and must train its staff involved in 

pharmaceutical waste management. Only a time limit, rather than a quantity limit, applies to the 

accumulation of the hazardous waste pharmaceuticals on-site. Of particular note is that 

Washington State prohibits disposing of most hazardous waste pharmaceuticals down the toilet 

or drain. . 

In 2011, Minnesota’s Pollution Control Agency (MPCA) issued a fact sheet titled 

Reverse Distribution of Pharmaceuticals: Guidance for Minnesota Healthcare Providers.

155 In 

this guidance, Minnesota states, “Whether a pharmaceutical is eligible for return credit does not 

affect its product or waste status. In Minnesota, if a pharmaceutical is not used or reused for its 

intended purpose, it is a waste. The MPCA considers health care practitioners and pharmacies to 

be generators of these pharmaceutical wastes. Nevertheless, the MPCA believes that the 

established reverse distribution system provides an environmentally protective method for 

handling waste pharmaceuticals. Therefore, it will allow Minnesota health care practitioners and 

pharmacies to manage certain pharmaceuticals through reverse distribution, subject to additional 

requirements discussed in this fact sheet.” This is similar to the approach that EPA is proposing 

for potentially creditable hazardous waste pharmaceuticals. For example, like EPA’s proposed 

rule, MPCA does not require hazardous waste pharmaceuticals destined for a pharmaceutical 

reverse distributor to be counted toward determining a healthcare facility’s generator category, 

and MPCA does not require hazardous waste pharmaceuticals to be accompanied by a hazardous 

 

155 See the guidance document in the docket for this rulemaking (EPA-HQ-RCRA-2007-0932) or see it online at 

http://www.pca.state.mn.us/index.php/view-document.html?gid=4004
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waste manifest when shipped to a pharmaceutical reverse distributor. By adopting a rule that is 

consistent with state approaches, EPA is bringing national consistency to the management of

hazardous waste pharmaceuticals, while avoiding disruption to practices already in place. 

VII. Request for Comment on EPA’s Efforts to Identify Additional Pharmaceutical 

Hazardous Wastes

Some of the comments EPA received in response to the 2008 Universal Waste proposal 

recommended that EPA add additional pharmaceutical wastes to the P and U hazardous waste 

lists (see §261.33). Some commenters suggested that EPA assess the hazards from all discarded 

pharmaceuticals (especially chemotherapy drugs) that have come into the market since the 

promulgation of the original P and U hazardous waste lists156 and that EPA update these lists to 

include discarded pharmaceuticals that are hazardous. In response to these comments, the 

Agency began gathering and reviewing information related to pharmaceuticals that may exhibit 

hazardous properties. EPA identified 204 drugs, which include 172 drugs that the National 

Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health 

Administration (OSHA) identified as hazardous, and 32 drugs that NIOSH proposed for addition 

to its hazardous drug list.157 EPA also collected toxicity data and other information for these 204 

drugs. These findings, along with additional information regarding the management of 

pharmaceutical wastes, are presented in the final report entitled Data Collection on the Toxicity, 

 

156 May 19, 1980 Federal Register (45 FR 33084) and November 25, 1980 Federal Register (45 FR 78525).

157 See NIOSH’s Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare 

Settings (http://www.cdc.gov/niosh/docs/2004-165/) and OSHA Technical Manual Section VI: Chapter 2 –

Controlling Occupational Exposure to Hazardous Drugs 

(https://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html). Note that the “hazardous” classification used by 

NIOSH and OSHA is not the same as the definition of hazardous under the RCRA subtitle C regulations.
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Use, and Disposal of Hazardous Drugs Report (September 2011) placed in the docket for this 

proposed rulemaking (EPA-HQ-RCRA-2007-0932).

Commenters specifically referred to EPA’s P and U hazardous waste lists under the 

RCRA subtitle C regulations. Generally, in its hazardous waste determinations, EPA has 

evaluated both “production wastes” (from specific or non-specific sources; see §§261.31 and 

261.32) and “commercial chemical products” that, when discarded, become wastes (§261.33). 

This latter category (commercial chemical products that are discarded) is the most relevant of the 

listed hazardous wastes to the pharmaceuticals wastes discussed elsewhere in this preamble, and 

to which commenters referred in the 2008 Universal Waste proposal. As discussed in Section 

IV.A. of this preamble, commercial chemical products listed in §261.33 are (when discarded) 

defined as either P-listed “acute” hazardous wastes, or U-listed (non-acute) hazardous wastes. 

The criteria for listing a solid waste as hazardous under RCRA Subtitle C are described in 

§261.11. A waste may be identified as a P-listed waste if it is shown to be fatal to humans or 

animals at low doses (see §261.11(a)(2)). Thus, lethality data for any chemical is the principal 

factor for making a determination that a discarded commercial chemical product is a P-listed 

hazardous waste.158

In contrast, a waste may be identified as a U-listed waste if it contains any of the toxic 

constituents listed in Appendix VIII of 40 CFR part 261, and if, after examining each of 10

factors in §261.11(a)(3), it is determined that the waste is capable of posing a “substantial 

 

158 §261.11(a)(2) states “The Administrator shall list a solid waste as a hazardous waste only upon determining that 

the solid waste...has been found to be fatal to humans in low doses or, in the absence of data on human toxicity, it 

has been shown in studies to have an oral LD 50 toxicity (rat) of less than 50 milligrams per kilogram, an inhalation 

LC 50 toxicity (rat) of less than 2 milligrams per liter, or a dermal LD 50 toxicity (rabbit) of less than 200 

milligrams per kilogram or is otherwise capable of causing or significantly contributing to an increase in serious 

irreversible, or incapacitating reversible, illness. (Waste listed in accordance with these criteria will be designated 

Acute Hazardous Waste.)”
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present or potential hazard to human health or the environment when improperly treated, stored, 

transported, or disposed of, or otherwise managed.”

159 Examples of these 10 factors include the 

toxicity and concentration of the hazardous constituent in the waste, the plausible types of 

improper management to which the waste could be subjected, the quantities of the waste 

generated at individual generation sites or on a regional or national basis, the nature and severity 

of the human health and environmental damage that has occurred as a result of the improper 

management of wastes, and action taken by other governmental agencies or regulatory programs 

based on the health or environmental hazard posed by the waste or waste constituent. EPA may 

only revise either of these lists of commercial chemical products through notice-and-comment 

rulemaking.

In its September 2011 report, EPA found that 11 drugs on the NIOSH or OSHA lists of 

hazardous drugs meet the specific criteria for acute toxicity in § 261.11(a)(2) (identified as “Tier 

1” drugs in the report). An additional 114 drugs on the NIOSH or OSHA lists did not meet the 

specific criteria in § 261.11(a)(2) for acute toxicity, but did have lethal doses for other animals or 

humans (“Tier 2” drugs). The remaining 79 drugs had limited human or animal toxicity data, and 

no lethality data, and were designated “Tier 3” in the report. Thus, the vast majority of the 

NIOSH/OSHA hazardous drugs evaluated in the EPA 2011 report do not meet the criteria for 

listing as acute hazardous waste under RCRA subtitle C.160 As discussed previously, to include a 

drug on the U-list, the Agency must demonstrate that a discarded drug would be “capable of 

 

159 The Agency cannot list hazardous wastes under section §261.11(a)(3) based on inherent toxicity alone without 

considering exposure factors, particularly the likelihood of mismanagement. That is, EPA needs to examine each of 

the 10 factors and, to the extent it does not use one or more of them, must explain why they are irrelevant or 

unimportant. See Dithiocarbamate Task Force v. EPA (No. 95-1249).

160 EPA emphasizes that this finding reflects the manner in which EPA defines acute hazardous waste under the 

RCRA subtitle C program; the NIOSH/OSHA lists are based upon different criteria related to preventing 

occupational exposure to these drugs.
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posing a substantial present or potential hazard to human health or the environment when 

improperly treated, stored, transported, or disposed of, or otherwise managed.” Therefore, for the 

NIOSH/OSHA drugs that do not meet the listing criteria for inclusion on the P-list, the Agency 

would have to examine the 10 factors in § 261.11(a)(3) to determine whether a drug meets the 

criteria to be included on the U-list. In addition to toxicity data (which is lacking in particular for 

the drugs identified as Tier 3), the types of information that would be relevant include waste 

volumes, plausible management scenarios, exposure potential, damage cases, and actions taken 

by other governmental agencies or regulatory programs. To obtain this information for this class 

of materials poses a challenge. While EPA has some information – the September 2011 report 

includes summaries of drug management practices and references to others – there remain 

significant gaps.

In addition, as discussed in Section IV.D. of this preamble, the EPA’s OIG has 

recommended that EPA identify and review existing pharmaceuticals to determine whether they 

qualify for regulation as hazardous waste, and establish a process to review new pharmaceuticals 

to determine whether they qualify for regulation as hazardous waste. While EPA has an existing 

process generally for defining whether or not a solid waste is a listed hazardous waste (i.e., EPA 

has regulatory criteria for defining listed hazardous waste described abovepreviously; EPA has 

established policies for evaluating risk and other factors in making listing determinations;161 and 

EPA must use the notice-and-comment rulemaking process when proposing listing 

determinations), the OIG observed that EPA’s hazardous waste program has not kept pace with 

the large number of pharmaceuticals that have been developed since 1980. EPA plans to 

 

161 EPA’s policy statement on hazardous waste listing determinations is contained in the Federal Register preamble 

to the first proposed Dyes and Pigments Listing Determination (59 FR 66072, December 22, 1994).
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regularly review the NIOSH/OSHA lists of hazardous drugs, as they represent a source of 

valuable information on pharmaceuticals that have already been identified as having the 

possibility of posing risks that might warrant regulation as hazardous waste.

EPA is also exploring ways to identify new sources of information, along with alternative 

approaches that can most efficiently address these concerns. EPA is using the opportunity in this 

preamble to seek stakeholders’ input on the best course of action concerning regulation of 

additional pharmaceuticals as hazardous wastes. It is also an opportunity for stakeholders to 

provide additional information that they may have about potentially hazardous pharmaceuticals. 

Thus, before deciding on a possible proposal to list additional pharmaceuticals as hazardous 

wastes, we request comment on the September 2011 final report, and solicit information 

regarding additional potentially hazardous pharmaceuticals. We request information on the 

sources and identity of additional potentially hazardous pharmaceuticals along with annual 

product generation data, annual waste generation data, use information, toxicity data, waste 

storage and handling information, and disposal information.

In addition, we request stakeholder input for alternative approaches to making hazardous 

waste listing determinations for pharmaceuticals that do not meet the acute hazardous criteria. 

Based on the existing listing determination process described above previously for non-acute 

wastes, there is no single toxicity effect (e.g., LD50) to readily determine whether or not the 

waste is hazardous under RCRA subtitle C. As such, we are seeking ideas on alternative 

approaches to more efficiently evaluate potentially hazardous non-acute discarded 

pharmaceuticals. For example, should EPA develop and promulgate new criteria specific to 

discarded pharmaceuticals that would allow it to establish a single hazardous waste listing for all 

discarded pharmaceuticals that meet the new criteria? Such approaches could also include 
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consideration of whether discarded pharmaceuticals are already managed under a regulatory 

scheme that prevents mismanagement that a hazardous waste designation would otherwise 

address (similar to the hazardous waste listing factor that takes into account “actions taken by 

other governmental agencies or regulatory programs”). We also are seeking information on any 

innovative processes or programs that states may have for identifying, reviewing, and making a 

hazardous waste determination for discarded pharmaceuticals.

The Agency emphasizes that no regulatory action is being proposed with respect to 

expanding the number of pharmaceuticals that are considered hazardous waste. We will use the 

comments we receive to help inform how to proceed with evaluating discarded pharmaceuticals 

as listed or characteristic hazardous wastes. Any action taken would be part of a separate, 

proposed rulemaking in the future. 

VIII. Request for Comment on EPA’s Efforts to Amend the Acute Hazardous Waste 

Listing for Nicotine and Salts (Hazardous Waste No. P075)

A. Background

In 1980, as part of its final and interim final regulations implementing Section 3001 of 

RCRA, EPA promulgated the list of commercial chemical products or manufacturing chemical 

intermediates (40 CFR 261.33) that are hazardous wastes if they are discarded or intended to be

discarded, which included nicotine and salts (45 FR 33124; May 19, 1980). The phrase 

“commercial chemical product or manufacturing chemical intermediate” refers to a “chemical 

substance which is manufactured or formulated for commercial or manufacturing use which 

consists of the commercially pure grade of the chemical, any technical grades of the chemical 

that are produced or marketed, and all formulations in which the chemical is the sole active 
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ingredient” (see the Comment following 40 CFR 261.33(d)). A chemical substance is listed in 40 

CFR 261.33(e) as an acutely hazardous waste if it meets any of the criteria in 40 CFR 

261.11(a)(2), which states that the waste “has been found to be fatal to humans in low doses or, 

in the absence of data on human toxicity, it has been shown in studies to have an oral LD 50 

toxicity (rat) of less than 50 milligrams per kilogram, an inhalation LC 50 toxicity (rat) of less 

than 2 milligrams per liter, or a dermal LD 50 toxicity (rabbit) of less than 200 milligrams per 

kilogram or is otherwise capable of causing or significantly contributing to an increase in serious 

irreversible, or incapacitating reversible, illness.”

B. Basis for Original Listing

EPA listed nicotine and salts (referred to commonly as just nicotine) as acutely hazardous 

waste (P075) in § 261.33(e) based on an estimated oral LD50 toxicity to humans of 1 mg/kg and 

a dermal LD50 toxicity to rabbits of 50 mg/kg.162 As discussed abovepreviously, for humans, 

the standard in the regulations for acute toxicity is “fatal to humans in low doses” (see § 

261.11(a)(2)). EPA’s Background Document for Section 261.33 from 1981 provides a basis for 

what is meant by “fatal to humans in low doses” for chemicals that have been given through the 

oral route (“fatal to humans upon ingestion of ≤100 mg/kg”). The estimated oral LD50 to 

humans of 1 mg/kg falls within the criteria for “fatal to humans in low doses.” However, the 

background listing document and its references do not provide sufficient detail to determine the

concentration of nicotine that was used to establish the estimated oral LD50 in humans. 

 

162 See EPA’s listing Background Document for Section 261.33, April 1981, in the docket for this proposed rule 

(EPA-HQ-RCRA-2007-0932).
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C. Rationale for EPA’s Efforts to Amend the P075 Listing 

On February 14, 2014, EPA published a Notice of Data Availability (NODA) and 

Request for Comment (79 FR 8926) entitled "Hazardous Waste Management and the Retail 

Sector: Providing and Seeking Information on Practices to Enhance Effectiveness to the RCRA 

Program." EPA received 44 comments in response to this NODA, many of which included 

comments related to pharmaceuticals, in particular comments concerning expired or returned 

low-concentration nicotine-containing smoking cessation products and e-cigarettes. The most 

detailed comments concerning the unsold low-concentration nicotine products were jointly 

submitted by the Retail Industry Leaders Association (RILA), the Food Marketing Institute 

(FMI), the National Association of Chain Drug Stores (NACDS), the National Retail Federation, 

and their members (referred to as the retail associations, retailers, or commenters).163 In their 

comments, the retail associations, representing a broad range of retailers within the retail 

industry, asked EPA to undertake a rulemaking to remove low-concentration nicotine products 

from the acute hazardous waste P075 classification under RCRA. The retailers believe these 

products do not meet RCRA’s requirements for acute hazardous waste. Thus, according to the 

retailers, the acute hazardous classification is inappropriately making them subject to RCRA's 

LQG requirements, which become applicable when someone generates more than 1 kg/month of 

acute hazardous waste. The retailers also expressed concern that they are subject to increased 

economic burdens and reporting requirements because they are subject to RCRA's LQG 

requirements.

 

163 See comments by the retail associations in response to EPA's Retail NODA in the docket for the Retail NODA 

(EPA-HQ-RCRA-2012-0426-0019).
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The commenters, to support their request to EPA, state that EPA’s listing for nicotine and 

salts warrants a reevaluation, because in more recent literature concerning nicotine toxicity, 

doubts have been expressed about the estimated oral LD50 toxicity to humans of 1 mg/kg, used 

as a key basis for the listing. According to information provided by commenters, the estimated 

oral LD50 toxicity to humans of 1 mg/kg was based on extrapolations from toxicological effects 

observed as result of “self-experiments” performed with nonfatal doses of nicotine. However, 

according to the commenters, there are doubts about the 1 mg/kg estimate because people have 

survived after ingesting much larger amounts of nicotine. 

The commenters also state that in 1980, when EPA listed nicotine and salts as acute 

hazardous wastes, the nicotine products in the market contained a high concentration of the 

chemical (e.g., pesticides which contained 40 percent nicotine sulfate), but that these products 

are no longer on the market. The commenters stressed that the current nicotine products on the 

market are low-concentration nicotine products that do not meet the regulatory criteria for 

acutely hazardous wastes. The low-concentration nicotine-containing products that are currently 

on the market were identified by commenters as nicotine replacement therapy products (e.g., 

gums, lozenges, patches, inhalers, and nasal sprays) and e-cigarettes. These products, according 

to the commenters, generally contain less than 3 percent nicotine.

While it may be reasonable for the commenters to conclude that toxicity is higher at 

higher concentrations of a chemical and lower at lower concentrations of a chemical, EPA 

currently lacks sufficient information to conclude that low-concentration nicotine-containing 

products are not acutely toxic as defined under 40 CFR 261.11(a)(2). In addition, except for 

warfarin and zinc phosphide, the listings for commercial chemical products under 40 CFR 

261.33(e) are not concentration-based listings. The warfarin and zinc phosphide listings were 
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changed to concentration-based listings because companies using products containing lower 

concentration formulations of warfarin and zinc phosphide petitioned EPA to amend the listings 

and provided LD50 data for animals for the lower concentration products to support their petition 

(see 49 FR 19922; May 10, 1984). The Agency does not think that linear extrapolations from 

toxicity levels determined using higher-concentration nicotine products can be used to 

characterize the acute toxicity of low-concentration nicotine-containing products. Furthermore, 

although nicotine pesticides are no longer available, high concentration nicotine products still 

exist. For example, manufacturers of nicotine-containing products, such as e-cigarettes, buy 

concentrated nicotine solutions and dilute them for consumer use.

In summary, nicotine and salts are P075 listed acute hazardous wastes if the waste arises 

from the discard of an unused commercial chemical product, manufacturing chemical 

intermediate, or off-specification material. Additionally, the P075 waste code applies only if the 

nicotine is present in pure or technical grade form, or is the sole active ingredient in the chemical 

formulation when discarded. As such, unused (unsold, expired, or returned) nicotine-containing 

products, including patches, gums, lozenges164, inhalers, nasal sprays and e-cigarettes165, are 

classified as P075 listed acute hazardous wastes when discarded. When discarded, these unsold 

products are causing many retailers to notify and operate as LQGs, which has resulted in 

increased economic burdens and reporting requirements for retailers. EPA is aware that this is 

an issue of great concern to the retail associations and their members and would like to address 

the issue, if possible, by amending the P075 listing to conditionally exempt certain low-

 

164 See memo from Dellinger to Smith, dated August 23, 2010, RCRA Online # 14817 regarding unused patches, 

gums and lozenges.

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/209444BADDA4ECDC852577ED006

24E8F/$file/14817.pdf.

165 See memo from Johnson to DeWitt, dated [insert date and RCRA Online # when memo is signed]May 8, 2015,

regarding e-cigarettes, RCRA Online # 17850.
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concentration nicotine-containing products. The Agency is considering two possible approaches, 

described below, for amending the P075 listing.

D. Two Possible Approaches for Amending the P075 Listing

1. Exemption from P075 Listing for FDA-Approved Over-the-Counter Nicotine-Containing 

Smoking Cessation Products

The over-the-counter (OTC) nicotine-containing smoking cessation products, referred to 

also as nicotine replacement therapy (NRT) products (i.e., nicotine patches, gums, and lozenges) 

are approved by the Food and Drug Administration (FDA), which ensures that the risk to the 

public using these products have been evaluated. EPA is currently trying to obtain the risk 

evaluation data for these products from FDA, which may provide data on the exact concentration 

of nicotine in the NRT products and any animal and/or human toxicity data associated with use 

of these products. The Agency is also trying to gather any publicly available animal and/or 

human toxicity data for these products, in particular toxicity data that could be compared to 

EPA’s acute toxicity criteria under § 261.11(a)(2). If the Agency is successful in obtaining the 

toxicity data to support the conclusion that FDA-approved over-the-counter nicotine-containing 

smoking cessation products do not meet the criteria for listing as an acutely hazardous waste, 

then the Agency will propose to exempt these products from the P075 listing.

Since e-cigarettes have not been approved by the FDA as smoking cessation products, we 

do not anticipate being able to obtain animal or human toxicity data from the FDA on nicotine 

concentrations in e-cigarettes. To complicate matters, the concentration of nicotine in ecigarettes is not limited by any regulation or approval process and is therefore unpredictable. As 

a result, this option would likely be limited to excluding FDA-approved over-the-counter 
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nicotine-containing smoking cessation products from the P075 listing and would not include ecigarettes.

2. Concentration-Based Exemption from P075 Listing for Low-Concentration NicotineContaining Products 

The comments from the retail associations have stressed that the low concentration 

nicotine products currently in the market (generally containing less than 3 percent nicotine) 

should not be classified as acutely hazardous wastes under RCRA. However, they did not submit 

any human toxicological data or animal LD50 data for these products to demonstrate that these 

products are not acutely toxic as defined under § 261.11(a)(2). Without these data, it is difficult 

for the Agency to justify exempting these products from the P075 listing. Furthermore, in order 

for the Agency to consider a concentration-based exemption for low-concentration nicotinecontaining products from the P075 listing, the Agency needs human toxicological data and 

animal LD50 data for nicotine-containing products at maximum concentrations of nicotine in 

these products (e.g., 3 percent nicotine). If the toxicological data for nicotine-containing products 

at maximum concentrations of nicotine in these products show that these products are not acutely 

toxic as defined under § 261.11(a)(2), then the Agency could propose a concentration-based 

exemption for these products (including e-cigarettes) from the P075 listing. However, depending 

on the toxicity data, the Agency may also propose to list the P075 exempt nicotine-containing 

products as non-acute hazardous wastes (U-listed wastes) under 40 CFR 261.33(f). In that case, 

the concentration-based exemption for nicotine-containing products from the P075 listing would 

be similar to what the Agency proposed for warfarin and zinc phosphide listings (see 48 FR

7714; February 23, 1983).
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E. Request for Comments

EPA invites comments on all possible approaches to amend the acute hazardous waste 

listing for nicotine and salts, including the two approaches discussed above in Section VIII.D. 

We also request toxicity information for low-concentration nicotine-containing products that 

could help determine whether or not these products meet the criteria for acute hazardous wastes 

under § 261.11(a)(2). The Agency emphasizes that no actionregulatory language is currently 

being proposed with respect to amending the P075 listing to exempt the low-concentration 

nicotine-containing products. Any action taken would be part ofHowever, depending on the 

information received during the comment period, EPA could finalize one of the approaches 

discussed abovepreviously without a separate proposed rulemaking in the future.

In addition, we request comments on whether we should exempt other low-concentration 

nicotine-containing smoking cessation products, such as inhalers and nasal sprays, from the P075 

listing under approach 1, described in the Section VIII.D, above. These products are also FDAapproved, but require a prescription to purchase. The nicotine-containing patches, gums, and 

lozenges are sold over-the-counter, so they do not require a prescription for purchase. We are 

interested in finding out what the differences are between nicotine-containing smoking cessation 

products requiring a prescription and those products that do not require a prescription (e.g., in 

concentrations of nicotine, amount of nicotine delivered over time, health effects). 

Finally, we request comment on whether we should include e-cigarettes and nicotinecontaining e-liquids for the e-cigarettes within the scope of the definition of pharmaceutical. As 

described in this proposal, pharmaceutical hazardous wastes do not count toward generator 

category. Therefore, since e-cigarettes and nicotine-containing e-cigarette refill liquids 

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(sometimes referred to as e-liquids or e-juice) are P075, if they are considered pharmaceuticals, 

they would not impact the hazardous waste generator category of the retailers. The retailers, 

however, would have to manage e-cigarettes and nicotine-containing liquids as hazardous waste 

pharmaceuticals under part 266, subpart P. We will use the comments we receive to help us 

decide whether and how to proceed with amending the scope of the definition of pharmaceutical 

to include e-cigarettes and nicotine-containing e-liquids.

IX. State Authorization

A. Applicability of Rules in Authorized States

Under Section 3006 of RCRA, EPA may authorize a qualified State to administer its own 

hazardous waste program within the State in lieu of the Federal program. Following 

authorization, EPA retains enforcement authority under Sections 3008, 3013, and 7003 of 

RCRA, although authorized States have primary enforcement responsibility. The standards and 

requirements for State authorization are found at 40 CFR part 271.

Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a 

State with final RCRA authorization administered its hazardous waste program entirely in lieu of 

EPA administering the Federal program in that State. The federal requirements no longer applied 

in the authorized State, and EPA could not issue permits for any facilities in that State, since only 

the State was authorized to issue RCRA permits. When new, more stringent federal requirements 

were promulgated, the State was obligated to enact equivalent authorities within specified time 

frames. However, the new federal requirements did not take effect in an authorized State until 

the State adopted the federal requirement as State law.
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In contrast, under RCRA Section 3006(g) (42 U.S.C. 6926(g)), which was added by 

HSWA, new requirements and prohibitions imposed under HSWA authority take effect in 

authorized States at the same time that they take effect in unauthorized States. The statute directs 

EPA to implement these requirements and prohibitions in authorized States, including the 

issuance of permits, until the State is granted authorization to do so. While the State must still 

adopt HSWA related provisions as State law in order to retain final authorization, EPA 

implements the HSWA provisions in authorized States until the States do so.

Authorized States are required to modify their program only when EPA enacts federal 

requirements that are more stringent or broader in scope than the existing federal requirements. 

RCRA Section 3009 allows the States to impose standards more stringent than those in the 

federal program (see also §271.1).

166 Therefore, authorized States may, but are not required to, 

adopt federal regulations, both HSWA and non-HSWA, that are considered less stringent than 

previous federal regulations.

B. Effect on State Authorization

This action proposes to add a new subpart P to 40 CFR part 266, and it is being proposed 

in part under the authority of HSWA and in part under non-HSWA authority. The bulk of 40 

CFR part 266, subpart P is being proposed under non-HSWA authority. Thus, when finalized, 

the amendments promulgated under non-HSWA authority would be applicable on the effective 

date only in those states that do not have final authorization of their base RCRA programs. 

However, the prohibition of sewering pharmaceutical hazardous wastes (§ 266.504) is being

 

166 EPA notes that decisions regarding whether a state rule is more stringent or broader in scope than the federal 

program are made when the Agency authorizes state programs.
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proposed under HSWA authority in section 3018 of RCRA. Thus, when finalized, the 

amendments promulgated under the authority of HSWA would be applicable on the effective 

date of the final rule in all states. Moreover, authorized states are required to modify their 

programs only when EPA promulgates federal regulations that are more stringent or broader in 

scope than the authorized state regulations. This proposed rule is considered, on the whole, to be 

more stringent than the current federal standards. Therefore, authorized states will be required to 

modify their programs to adopt the amendments, when finalized. When a state adopts this new 

subpart, if elements of the state program are more stringent than this new subpart, the state has 

the option of retaining those more stringent elements. Likewise, when a state adopts this new 

subpart, the state has the option of adding elements that are more stringent or broader in scope 

than this new subpart.

C. Effect on State Authorization in States that Have Added Pharmaceuticals to the Universal 

Waste Program

The Universal Waste program allows states to add wastestreams to their own state 

program, even when the waste stream has not been added to the federal Universal Waste 

program, provided the state has adopted and been authorized for the petition process in §§260.20 

and 260.23. Two states have added hazardous waste pharmaceuticals to their Universal Waste 

programs: Florida and Michigan. Because this proposed rule is considered more stringent than 

either the “traditional RCRA” standards or the Universal Waste program, both Florida and 

Michigan will be required to modify their programs to adopt an approach at least as stringent as 

the amendments, if this rule is finalized. Furthermore, because the Agency has determined that it 

is not appropriate to add hazardous waste pharmaceuticals to the Universal Waste program, both 
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Florida and Michigan must remove hazardous waste pharmaceuticals from their Universal Waste 

program when they adopt this new subpart, although they may continue to regulate nonhazardous waste pharmaceuticals under the Universal Waste program, to the extent allowed 

under state law. In addition, states may not add hazardous waste pharmaceuticals to their 

Universal Waste program in the future.

X. Adding and Reserving Part 266, Subpart O

In addition to proposing new standards for the management of hazardous waste 

pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors, EPA is 

proposing to add and reserve 40 CFR part 266, subpart O. Specifically, on May 22, 2001, EPA 

finalized a Project XL rule in 40 CFR part 266, subpart O (66 FR 28066) for US Filter Recovery 

Services. However, on July 2, 2008, EPA published a rule that withdrew 40 CFR part 266,

subpart O (73 FR 37858). Generally, in order to avoid the potential for confusion that might be 

caused by reusing a subpart, EPA reserves a subpart that has already been used and removed. In 

2008, when we removed 40 CFR part 266, subpart O, we neglected to reserve it. Consequently, 

we are proposing to add and reserve 40 CFR part 266, subpart O. 

XI. Statutory and Executive Order Reviews

A. Summary of Regulatory Impact Analysis

In order to meet the Office of Management and Budget (OMB) Circular A-4 requirement 

that EPA analyze the costs and benefits of regulations, we conducted an economic analysis of the 

proposed rule. The economic analysis follows OMB guidelines and estimates the costs and 

benefits of the rule. The economic analysis is titled “Regulatory Impact Analysis for EPA’s 

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Proposed Healthcare Facility-Specific Regulations for the Management of Hazardous Waste 

Pharmaceuticals” and is hereafter referred to as the Regulatory Impact Analysis (RIA). The RIA 

is summarized here while the full RIA can be found at regulations.gov under docket number 

EPA-HQ-RCRA-2007-0932.

This proposed rule may affect several different types of healthcare facilities, including 

hospitals, physicians’ offices, dentists’ offices, outpatient care centers, pharmacies, veterinary 

clinics, nursing care facilities, coroners’ offices, other health practitioners, other ambulatory care 

services, and pharmaceutical reverse distributors. Based on data from the 2007 Economic Census 

and a limited number of states, the RIA estimates that the rule will affect approximately 174,000 

facilities. Table 1112 lists the number of facilities (by NAICS code) expected to be affected by 

the proposed rule. The vast majority of these (83.6 %) are CESQGs, followed by SQGs (13.4 %), 

and LQGs (3.0 %). 

TABLE 1112: PROPOSED PHARM ECU TI C ALS R ULE FAC ILITIES 

CLASSIFIED BY NA IC S COD ES A ND TYPE OF FACILITY

NAICS FACILITY TYPE

NUMBER OF 

FACILITIES

HELTHCARE FACILITIES AS DEFINED BY THIS PROPOSED RULE

44611 Pharmacies 11,617

54194 Veterinary Clinics 7,847

6211 Physicians’ Offices 60,823

6212 Dentists’ Offices 35,106

6213 Other Health Practitioners (e.g., 

chiropractors) 34,555

6214 Outpatient Care Centers 8,227

6219 Other Ambulatory Health Care Services 2,586

622 Hospitals 6,505

6231 Nursing Care Facilities 4,508

623311 Continuing Care Retirement Communities 1,641
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Subset of 

92219 Medical Examiners and Coroners’ Offices 552

Reverse Distributors

Various 

NAICS Reverse Distributors 56

TOTAL 174,023

We estimate that there is a total of approximately 139,000 tons of RCRA hazardous 

waste generated by healthcare facilities annually. Approximately 36,200 tons (26 %) of this total 

are hazardous waste pharmaceuticals. 

1. Costs of the Proposed Rule

The estimated costs of the proposed rule are the incremental costs over and above the 

“baseline” (i.e., assumptions about the way in which healthcare facilities currently dispose of 

their hazardous waste pharmaceuticals). The base case set of baseline assumptions reflects “full 

compliance” with the current RCRA hazardous waste requirements for the management of 

hazardous waste pharmaceuticals. A sensitivity analysis of baseline assumptions was also 

conducted that reflects only “partial compliance” with current regulations. To see the results for 

the partial compliance baseline sensitivity analysis, please see the RIA.

The estimated cost of the proposed rule, including the proposed prohibition on sewering 

of hazardous waste pharmaceuticals is estimated at $37 million annually under the full 

compliance baseline. However, there are also significant cost savings under the proposed rule--$: 

$24.3 million annually under the full compliance baseline. Therefore the net cost of the rule is 

$13 million annually ($37million cost minus $24.3 million cost savings = $13 million net costs).

Please see the RIA for more detailed analysis and results regarding the cost of the rule and the 

regulatory options analyzed.

2. Benefits of the Proposed Rule

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The proposed rule for the management of hazardous waste pharmaceuticals is expected to 

yield a range of environmental benefits as hospitals, medical clinics, and other healthcare 

facilities divert hazardous waste pharmaceuticals currently disposed in sewers, municipal solid 

waste landfills (MSWLFs), municipal waste combustors (MWCs), and medical waste autoclaves 

and incinerators, to hazardous waste incinerators. The rule reduces the amount of hazardous 

waste pharmaceuticals sewered into waterways, provides regulatory clarity for industry and 

provides healthcare facilities and pharmaceutical reverse distributors with cost savings.

The largest quantified benefit is from avoided sewering of hazardous waste 

pharmaceuticals. Disposal of hazardous waste pharmaceuticals through sewering is believed to 

be a widespread practice of disposal. Sewering is believed to be one of the most deleterious 

disposal methods because active pharmaceutical ingredients (APIs) entering surface waters, 

often untreated by municipal wastewater treatment plants, pose the potential for adverse human 

health and environmental effects since they may be absorbed by humans and other organisms. 

Under the proposed rule, the Agency anticipates preventing approximately 6,400 tons of 

hazardous waste pharmaceuticals annually into waterways via a sewering ban. While the Agency 

was not able to quantify the human health and environmental benefits of reducing or eliminating 

the sewering of hazardous waste pharmaceuticals, EPA did estimate the cost savings of 

eliminating the wastewater treatment costs associated with sewering such pharmaceuticals. The 

estimated cost savings of eliminated wastewater treatment related to the prevented sewering of 

hazardous waste pharmaceuticals is estimated to be $4.3 million annually. 

The proposed rule will yield other benefits beyond the reduction in sewering of 

hazardous waste pharmaceuticals. For example, under the proposed rule, healthcare facilities will 

no longer be required to count hazardous waste pharmaceuticals toward their RCRA generator 
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category. This, in turn, will lead to changes in a healthcare facility’s generator category, enabling 

them to realize an additional cost savings. The extent to which such changes in generator 

category will occur under the proposed rule is uncertain, but these changes would be most likely 

for those healthcare facilities for which hazardous waste pharmaceuticals make up a large 

portion of their overall hazardous waste generation. Please see the RIA for a breakout of cost 

savings by regulatory requirement. 

B. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: 

Improving Regulation and Regulatory Review 

Under Executive Order 12866 (58 FR 51735; October 4, 1993), this action is a 

"significant regulatory action” because it is likely to raise novel legal or policy issues under 

section 3(f)(4). Accordingly, EPA submitted this action to the Office of Management and Budget 

(OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821; January 21, 2011) and 

any changes made in response to OMB recommendations have been documented in the docket 

for this action (EPA-HQ-RCRA-2007-0932).

Findings for the RIA indicate that the rule, as proposed, is projected to result in an 

aggregate annual cost of approximately $37 million based on a discount rate of 7 %. However, 

the proposed rule will also achieve an annual cost savings, which is estimated to be $24.3 

million. Therefore, the net cost of the rule is estimated at $13 million annually. The costs, which 

represents annualized incremental costs relative to the full compliance baseline, is below the 

$100 million threshold established under part 3(f)(1) of the Order. 

In addition to calling for an assessment of regulatory costs, Executive Order 12866 also 

requires Federal agencies to assess benefits and, “recognizing that some costs and benefits are 
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difficult to quantify, propose or adopt a regulation only upon a reasoned determination that the 

benefits of the intended regulation justify its costs.” As discussed abovepreviously, the cost 

savings for the rule are estimated to be $24.3 million annually. These cost savings are considered 

benefits of the rule. Also, EPA estimates that the proposed rule will lead to the diversion of 

approximately 6,441440 tons annually of hazardous waste pharmaceuticals from sewer disposal 

to alternate forms of disposal. This reduction in sewering will likely reduce the concentration of 

active pharmaceutical ingredients in the nation’s waterways, potentially benefiting both 

ecosystems and human populations. Please see the RIA for more details on the benefits of the 

proposed rule.

C. Paperwork Reduction Act (PRA)

The information collection activities in this proposed rule have been submitted for 

approval to the Office of Management and Budget (OMB) under the PRA. The Information 

Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 

2486.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized 

here.

EPA is proposing in this rule, under a new subpart P to 40 CFR part 266, new and revised 

reporting and recordkeeping requirements for healthcare facilities and pharmaceutical reverse 

distributors managing hazardous waste pharmaceuticals. These proposed requirements, which 

are also identified in the ICR supporting this action, will enable EPA and state regulatory 

agencies to identify the universe of healthcare facilities managing hazardous waste 

pharmaceuticals. The healthcare facilities must keep records of any test results, waste analyses or 

other determinations made on hazardous waste pharmaceuticals for three years from the date of 

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analyses. In addition, the proposed requirements include provisions for improved tracking of 

hazardous waste pharmaceuticals that are routed through pharmaceutical reverse distributors.

EPA will use the collected information to ensure that hazardous waste pharmaceuticals

are being managed in a protective manner. The tracking requirements ensure that these wastes 

arrive at their intended destinations rather than diverted for illicit purposes or managed at 

facilities not equipped to manage these wastes. These tracking requirements will also help 

facilities identify shipments that do not arrive at their destination as planned, allowing generators 

to take corrective action that will ensure that future shipments are transported to the appropriate 

location. In addition, during a facility inspection, information kept in facility records will help 

EPA and state environmental regulatory agencies determine whether or not regulatory 

requirements are being followed. Information marked on containers of hazardous waste 

pharmaceuticals will assist handlers and transporters in ensuring proper management during 

storage and shipment.

EPA has carefully considered the burden imposed upon the regulated community by the 

proposed regulations. EPA is confident that those activities required of respondents are necessary 

and, to the extent possible, has attempted to minimize the burden imposed. EPA believes 

strongly that if the minimum requirements specified under the proposed regulations are not met, 

neither the facilities nor EPA can ensure that hazardous waste pharmaceuticals are managed in a 

manner protective of human health and the environment.

EPA estimates that the total annual respondent burden for the new paperwork 

requirements in the proposed rule is approximately 53,60254,857 hours, and the annual 

respondent cost for the new paperwork requirements in the rule is approximately 

$3,388,492457,478. The estimated annual hourly burden ranges from 0.1 to 3.5 hours per 
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response for the 28,637 respondents. However, in addition to estimating the annual respondent 

burden associated with new paperwork requirements in the proposed rule, the Agency also 

estimated the annual benefits (hours and cost savings) to respondents from the new paperwork 

requirements in comparison to complying with the existing RCRA hazardous waste information 

collection requirements for hazardous waste pharmaceuticals (e.g., preparation of biennial 

reports, recordkeeping, etc.). Taking both the new proposed and existing RCRA requirements 

into account, EPA expects the proposed rule would result in a net annual paperwork burden to 

the 28,637 respondents of approximately 28,693660 hours or $2,308,206301,873. The net cost to 

EPA of administering the rule is expected to be negligible, since the Agency is not required to 

review and approve any information submitted by respondents. Burden is defined at 5 CFR 

1320.3(b).

Respondents/affected entities: Private entities

Respondent’s obligation to respond: Mandatory per 40 CFR part 266, subpart P

Estimated number of respondents: 28,637

Frequency of response: Once. 

Total estimated burden: 53,60254,857 hours

Total estimated cost: $ 3,388,492457,478, includes $0 annualized capital or operation & 

maintenance costs. 

An Agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a currently valid OMB control number. The OMB 

control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Submit your comments on the Agency’s need for this information, the accuracy of the provided 

burden estimates and any suggested methods for minimizing respondent burden to the EPA using 
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the docket identified at the beginning of this rule. You may also send your ICR-related 

comments to OMB’s Office of Information and Regulatory Affairs via email to 

oria_submissions@omb.eop.gov, Attention: Desk Officer for the EPA. Since OMB is required to 

make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive

comments no later than [insert date 30 days after publication in the Federal Register]. The 

EPA will respond to any ICR-related comments in the final rule.

D. Regulatory Flexibility Small Business Analysis 

I certify that this action will not have a significant economic impact on a substantial 

number of small entities under the RFA. The small entities subject to the requirements of this 

action are indicated in Table 1213 below. The Agency has determined that costs of the regulation 

for a facility are less than 1 percent of annual revenue. 

To assess the number of small entities in the regulated universe, EPA consulted NAICSlevel data from the 2007 Economic Census and tallied the number of facilities, by NAICS code, 

owned by entities with revenues below SBA’s threshold for consideration as small. Entities in 

revenue categories above the SBA threshold are not considered small. See Table 12 below for 

the SBA thresholds and revenues.

TABLE 12 13: SBA 20 122014 SM ALL BUSINE SS SIZESI ZE STAN D AR DS ( USIN G 

20 07 N AIC S C OD ES)

FACILITY TYPE

SBA SIZE 

STANDARD

(FIRM-LEVEL, 

ANNUAL 

REVENUE)

PERCENTAGE OF 

FACILITIESGENERAT

ORS CONSIDERED 

“SMALL” UNDER SBA 

STANDARD

NUMBER OF 

FACILITIESG

ENERATORS

THAT ARE 

SMALL

Pharmacies $2527.5 million 46% 9,0015,390

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TABLE 12 13: SBA 20 122014 SM ALL BUSINE SS SIZESI ZE STAN D AR DS ( USIN G 

20 07 N AIC S C OD ES)

FACILITY TYPE

SBA SIZE 

STANDARD

(FIRM-LEVEL, 

ANNUAL 

REVENUE)

PERCENTAGE OF 

FACILITIESGENERAT

ORS CONSIDERED 

“SMALL” UNDER SBA 

STANDARD

NUMBER OF 

FACILITIESG

ENERATORS

THAT ARE 

SMALL

Veterinary Clinics $7.05 million 95% 12,3847,416

Physicians’ Offices $1011.0 million 88% 89,46753,577

Dentists’ Offices $7.05 million 97% 56,66333,932

Other Health Practitioners (e.g., 

chiropractors) $7.05 million 93% 53,49632,036

Outpatient Care Centers (exkidney dialysis centers) $1015.0 million 6568% 7,6324,787

Outpatient Care Centers (kidney 

dialysis centers) $3438.5 million 14% 269161

Other Ambulatory Health Care 

Services $715.0 million 6166% 2,6311,707

Hospitals $3438.5 million 25% 1,621634

Nursing Care Facilities (e.g., 

assisted living facilities, nursing 

homes, U.S. veterans domiciliary 

centers)

$13.515.0 million 44% 3,3441,985

Continuing Care Retirement 

Communities $1327.5 million 5462% 1,489023

Medical Examiners and Coroners' 

Offices

Size standards not 

established 100% 922552

Reverse Distributors Various NAICS 50% 28

Total Number of Small Facilities 238,947144,228

Source:

U.S. Small Business Administration, Table of Small Business Size Standards Matched to North American 

Industry Classification System Codes, effective November 5, 2010.July 14, 2014.

The percentage of facilities that qualify as small under SBA’s thresholds were estimated 

for each industry affected by the proposed rule. These percentages were applied to the number of 

facilities in the regulatory universe, as presented in the RIA. After estimating the number of 

small entities by NAICS code, the average cost per small entity was estimated based on the 

model facility costs presented in the RIA. Next, the EPA determined whether the per facility 

costs incurred by small entities represent more than 1 % of annual revenues, which required 

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estimating small entities’ average annual revenues. For each NAICS code, the average per 

facility revenue of entities considered small under the SBA standard was estimated based on data 

from the 2007 Economic Census.

The proposed rule is expected to impact a total of 143,753144,228 small entities 

(1,621634 hospitals, 142,104566 other healthcare facilities (i.e., healthcare facilities that are not 

hospitals) and 28 pharmaceutical reverse distributors). The highest cost impact to small entities is 

estimated to be 0.013% of revenues at other healthcare facilities and 0.002% of revenues at 

hospitals. Because pharmaceutical reverse distributers are in various NAICS codes, the Agency 

was not able to obtain revenue data for pharmaceutical reverse distributors. However the 

estimated cost impact to small entity pharmaceutical reverse distributors is estimated at $45,300 

annually, which the Agency does not anticipate will cause significant hardship on 

pharmaceutical reverse distributors that are small entities. However, the Agency requests 

comment on the cost impacts on small entity pharmaceutical reverse distributors that process 

creditable hazardous waste pharmaceuticals.

In the RIA, small entity impacts are presented incremental to the full compliance 

baseline. The annual per facility costs incremental to both baselines are estimated to be much 

less than 1 % of average annual revenues. Since the incremental impact to the smallest healthcare 

facilities in terms of revenue is less than 1 % of average annual revenues, the proposed rule is not 

expected to cause a significant impact to a substantial number of small businesses. Please see the 

RIA for a detailed analysis of cost impacts on small entities. 

Although this proposed rule will not have a significant economic impact on a substantial 

number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small 
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entities. We continue to be interested in the potential impacts of the proposed rule on small 

entities and welcome comments on issues related to such impacts.

E. Unfunded Mandates Reform Act (UMRA)

This rule does not contain an unfunded mandate of $100 million or more as described in 

UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. As 

indicated abovepreviously, the annual net cost is estimated to be $13 million annually after cost 

savings ($37 million cost minus $24.3 million in cost savings). Thus, this proposed rule is not 

subject to the requirements of sections 202 or 205 of UMRA.

This proposed rule is also not subject to the requirements of section 203 of UMRA 

because it contains no regulatory requirements that might significantly or uniquely affect small 

governments. While some hospitals and coroners’ offices are publicly owned, the requirements 

affecting those facilities are not unique in that they are the same as those affecting all facilities in 

the proposed rule. Also, using data on revenues of hospitals owned by state and local 

governments, EPA estimated that the costs of the rule borne by state and local governments 

represent less than 0.001 % of their revenues. Therefore, the costs incurred by small 

governments are not expected to be significant.

F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct 

effects on the States, on the relationship between the national government and the States, or on 

the relationship between the national government and the states, or on the distribution of power 

and responsibilities among the various levels of government.
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G. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

This action may have tribal implications. However, it will neither impose substantial 

direct compliance costs on tribal governments, nor preempt tribal law. 

To assess the potential tribal implications of the proposed rule, EPA compiled data on the 

number of tribally run healthcare facilities in the U.S. and estimated the costs of the proposed 

rule for these facilities. Estimates of tribally run healthcare facilities were obtained from the U.S. 

Department of Health and Human Services’ Indian Health Service (IHS), as summarized in 

Table 1314.

167

 Data were not readily available on the size or hazardous waste generation 

amounts for the tribally run healthcare facilities identified by the IHS. To estimate the potential 

costs of each regulatory option, per facility costs derived in the RIA were applied to the IHS 

facility counts. Based on these values, Table 1314 summarizes the costs that tribally run 

healthcare facilities are expected to incur under the proposed rule. OMB has not issued guidance 

on what constitutes a substantial burden on tribal governments under this executive order. The 

relatively low costs estimated for tribally run healthcare facilities in Table 13Table14, however, 

suggest that the proposed rule will not impose a substantial burden on tribal governments. EPA 

welcomes comments on the proposed rule’s impact on tribal governments. EPA specifically 

solicits additional comment on this proposed action from tribal officials.

TABLE 1314: COST IMPACTS FOR HEALTHCARE FACILITIES OWNED AND 

OPERATED BY NATIVE AMERICAN TRIBES USING A 7 PERCENT DISCOUNT 

RATE (MILLIONS OF YEAR 2011$)

FACILITY TYPE

NUMBER OF 

FACILITIES1 PROPOSED RULE 

Total Annual Costs Incremental to 

Full Compliance Baseline

Hospitals 16 $0.019

Tribal Operated Facilities 16 $0.088

Health Centers 258

 

167 Indian Health Service (IHS), U.S. Department of Health and Human Services, IHS Year 2013 Profile, available 

at http://www.ihs.gov/PublicAffairs/IHSBrochure/Profile.asp, accessed December 20, 2012.
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Alaska Village Clinics 164

Health Stations 75

TOTAL 529 $0.107

Notes: 

1. Indian Health Service (HIS), U.S. Department of Health and Human 

Services, IHS Year 2013 Profile, available at 

http://www.ihs.gov/PublicAffairs/IHSBrochure/Profile.asp, accessed 

December 20, 2012.

2. Estimate reflects annual cost impact for tribal operated facilities, health 

centers, Alaska village clinics, and health stations combined.

The EPA consulted with tribal officials under the EPA Policy on Consultation and 

Coordination with Indian Tribes early in the process of developing this regulation to permit them 

to have meaningful and timely input into its development. A summary of that consultation is 

provided in the docket for this proposed rule (see EPA-HQ-RCRA-2007-0932).

As required by section 7(a), the EPA’s Tribal Consultation Official has certified that the 

requirements of the executive order have been met in a meaningful and timely manner. A copy 

of the certification is included in the docket for this proposed rule (see EPA-HQ-RCRA-2007-

0932).

H. Executive Order 13045: Protection of Children from Environmental Health Risks and 

Safety Risks 

This proposed rule is not subject to Executive Order 13045 because it is not 

economically significant as defined in Executive Order 12866, and because the Agency 

does not believe the environmental health or safety risks addressed by this action present 

a disproportionate risk to children. 
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To examine whether the proposed rule has a disproportionate impact on children, the RIA 

uses a geographic analysis of demographics near wastewater treatment plants and hazardous 

waste combustion facilities. Table 1415 summarizes the results of this analysis. As indicated in 

the table, this analysis finds that children (i.e., individuals under the age of 18) account for a 

slightly larger share of the population (28.5 %) in the one-mile radius around wastewater 

treatment plants than they account for nationally (25.3 %). Among the catchment zones of 

wastewater treatment plants, however, children make up a much smaller portion of the 

population (9.8 %). Within both the one- and three-mile buffers around hazardous waste 

combustion facilities, children’s share of the population slightly exceeds their share nationally.

These data suggest that the proposed rule will not result in a disproportionate adverse 

impact on children. Because the children’s share of the population near hazardous waste 

combustion facilities is near the national average, any increase in the combustion of hazardous 

waste combustion that occurs as a result of the proposed rule is unlikely to have a significant 

disproportionate impact on children’s health. The data in Table 1415 also show that the number 

of children living in close proximity to wastewater treatment plants, in areas likely to benefit 

from the rule, far exceeds the number of children who live near hazardous waste combustion 

facilities. This suggests that the diversion of hazardous waste pharmaceuticals from wastewater

treatment plants to combustion facilities will benefit a much greater number of children than it 

may put at greater risk of adverse health effects. See Table 1415 for the demographics of 

children surrounding wastewater treatment plants and hazardous waste combustion facilities. 

Please see the RIA for a detailed methodology of the children’s health analysis.

TABLE 14 15: SUMM ARY OF CHILDREN'S HEALTH ASSESSM ENT
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GEOGRAPHIC AREA

NUMBER OF CHILDREN

IN AREA

NATIONAL % OF 

POPULATION UNDER THE

AGE OF 18

Wastewater treatment plants, one-mile 

radius

7.8 million

(28.5%)1

25.3%

Wastewater treatment plants, catchment 

areas 

4.4 million

(9.8%)1

Hazardous waste combustion facilities, 

one-mile radius

5,012 

(26.1%)1

Hazardous waste combustion facilities, 

three-mile radius

64,710 

(25.6%)1

GEOGRAPHIC AREA

NUMBER OF FACILITIES WHERE CHILDREN’S SHARE 

OF THE LOCAL POPULATION EXCEEDS NATIONAL

AVG. %

Wastewater treatment plants, one-mile 

radius 8,908

Wastewater treatment plants, catchment 

areas

5,171

Hazardous waste combustion facilities, 

one-mile radius 13

Hazardous waste combustion facilities, 

three-mile radius 11

GEOGRAPHIC AREA

NUMBER OF FACILITIES WHERE CHILDREN’S SHARE 

OF THE LOCAL POPULATION EXCEEDS STATE AVG. 

%

Wastewater treatment plants, one-mile 

radius 8,992

Wastewater treatment plants, catchment 

areas

5,149

Hazardous waste combustion facilities, 

one-mile radius 14

Hazardous waste combustion facilities, 

three-mile radius 11

Notes:

1. Values in parentheses represent children’s proportion of the population.

Sources: RTI International, U.S. Synthesized Population 2005–2009 Version 2.0, August 2012; U.S. EPA 

Clean Watershed Needs Database; and U.S. EPA, Assessment of the Potential Costs, Benefits, & Other Impacts 

of the Hazardous Waste Combustion MACT Final Rule Standards, September 2005.

I. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy 

Supply, Distribution or Use

This action is not a “significant energy action” as defined in Executive Order 13211, (66 

FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the 

supply, distribution, or use of energy.
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The proposed rule does not directly regulate energy production or consumption. In 

addition, with annual costs of approximately $37 million (based on a discount rate of 7 %), the 

costs of this proposed rule are not considered economically significant under Executive Order 

12866. As such, the rule is not subject to Executive Order 13211. Changes in the management of 

hazardous waste pharmaceuticals stipulated in the proposed rule are not expected to impact 

energy production or distribution. Similarly, the management requirements outlined in the 

proposed rule will have minimal impact on energy consumption (e.g., from transporting 

hazardous waste pharmaceuticals that otherwise would have been sewered). Because the changes 

in energy production and consumption under the proposed rule are likely to be minimal, the 

proposed rule is not expected to have a significant adverse effect on energy supply, distribution, 

or use. In addition, no measurable adverse impacts are expected on energy prices or foreign 

supplies.

J. National Technology Transfer and Advancement Act (NTTAA)

This proposed rulemaking does not involve technical standards. 

K. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations

The EPA believes the human health or environmental risk addressed by this action will 

not have potential disproportionately high and adverse human health or environmental effects on 

minority, low-income or indigenous populations. The results of this evaluation are summarized 

belowin the following paragraphs. The evaluation is contained in the Regulatory Impact 
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Analysis (RIA), which can be found at regulations.gov under docket number EPA-HQ-RCRA2007-0932.

To meet the requirements of Executive Order 12898, EPA analyzed potential 

environmental justice impacts associated with the diversion of hazardous waste pharmaceuticals 

from sewer disposal to hazardous waste combustion facilities. Populations living near and 

downstream from wastewater treatment plants may also benefit from the elimination of sewering 

of hazardous waste pharmaceuticals. To the extent that minority and/or low-income populations 

near or downstream from wastewater treatment plants make up a disproportionately high portion 

of the overall population, the proposed rule may result in positive environmental justice impacts. 

See Table 1516 for the results of the Environmental Justice analysis.

Overall, EPA expects that the proposed rule may positively affect U.S. environmental 

justice populations, although the size of the impact will vary by wastewater treatment plant. As 

suggested by Table 1516, the reduction in sewering expected under the proposed rule may 

benefit relatively large minority and low-income populations in close proximity to or 

downstream from wastewater treatment plants. The diversion of hazardous waste 

pharmaceuticals to combustion facilities, however, may increase the environmental burden borne 

by environmental justice populations near these combustion facilities. Although these effects 

offset each other to a certain degree, the number of minority and low-income individuals near 

wastewater treatment facilities greatly exceeds the number near hazardous waste combustion 

facilities. This suggests that, on the whole, the proposed rule may benefit environmental justice 

populations.

TABLE 15 16 : DEM OGRAPHICS FOR POPULATIONS NEAR WASTEWATER 

TREATM ENT FACILITIES & COMMERCIAL HAZARD OUS WASTE COM BUSTION 

FACILITIES
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GEOGRAPHIC AREA

MINORITY 

POPULATION

LOW-INCOME 

POPULATION

% OF NATIONAL 

POPULATION

RACIAL & 

ETHNIC 

MINORITIES 

LOWINCOME 

POPULATI

ON

Wastewater treatment plants, 

one-mile radius

6.2 million

(22.6%)1

3.8 million

(14.0%)1

24.7% 11.4%

Wastewater treatment plants, 

catchment areas 

3.8 million

(8.6%)1

2.2 million

(4.9%)1

Hazardous waste combustion 

facilities, one-mile radius

3,578

(18.7%)1

3,130 

(16.3%)1

Hazardous waste combustion 

facilities, three-mile radius

67,329

(26.6%)1

42,782

(16.9%)1

GEOGRAPHIC AREA

NO. OF FACILITIES EXCEEDING:

NATIONAL AVG. MINORITY %.

NATIONAL AVG. 

LOW-INCOME %.

Wastewater treatment plants, onemile radius 3,233 7,886

Wastewater treatment plants 

catchment areas 3,151 7,358

Hazardous waste combustion 

facilities, one-mile radius 6 4

Hazardous waste combustion 

facilities, three-mile radius 7 4

GEOGRAPHIC AREA

NO. OF FACILITIES EXCEEDING:

STATE AVG. MINORITY %. STATE AVG. LOW-INCOME%.

Wastewater treatment plants, onemile radius 3,596 7,949

Wastewater treatment plants, 

catchment areas 3,562 7,391

Hazardous waste combustion 

facilities, one-mile radius 7 13

Hazardous waste combustion 

facilities, three-mile radius 8 16

Notes:

1. Values in parentheses represent the proportion of the population considered a racial or ethnic minority or below 

the Federal Poverty Level.

Sources: RTI International, U.S. Synthesized Population 2005–2009 Version 2.0, August 2012; U.S. EPA Clean 

Watershed Needs Database; and U.S. EPA, Assessment of the Potential Costs, Benefits, & Other Impacts of the 

Hazardous Waste Combustion MACT Final Rule Standards, September 2005.

List of Subjects

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40 CFR Part 261

Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping 

requirements.

40 CFR Part 262

Environmental protection, Exports, Hazardous materials transportation, Hazardous waste, 

Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements.

40 CFR Part 266

Environmental protection, Energy, Hazardous Waste, Recycling, Reporting and recordkeeping 

requirements.

40 CFR Part 268

Environmental protection, Hazardous waste, Reporting and recordkeeping requirements.

40 CFR Part 273

Environmental protection, Hazardous materials transportation, Hazardous waste.

Dated:
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Gina McCarthy, 

Administrator.

For the reasons stated in the preamble, Title 40, chapter I, of the Code of Federal 

Regulations is proposed to be amended as follows:

Part 261—IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

1. The authority citation for part 261 continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.

2. Amend § Section 261.5 by adding paragraph (c)(8), to read as follows:

§ 261.5 Special requirements for hazardous waste generated by conditionally exempt 

small quantity generators.

* * * * *

(c) * * * 

(8) Is a hazardous waste pharmaceutical managed under 40 CFR part 266, subpart P.

* * * * *

3. Amend § Section 261.7 by adding paragraph (c), to read as follows:

§ 261.7 Residues of hazardous waste in empty containers.
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* * * * *

(c) Healthcare facilities and pharmaceutical reverse distributors operating under 40 CFR part 

266, subpart P are subject to § 266.507 for the management of hazardous waste pharmaceutical 

residues in containers, in lieu of this section.

PART 262—STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS 

WASTE

4. The authority citation for part 262 continues to read as follows:

Authority: 42 U.S.C 6906, 6912, 6922-6925, 6937, and 6938.

5. Amend § Section 262.10 by adding paragraphs (m) and (n), to read as follows:

§ 262.10 Purpose, scope and applicability.

* * * * *

(m) All pharmaceutical reverse distributors (as defined in § 266.500) are subject to 40 CFR 

part 266, subpart P for the management of hazardous waste pharmaceuticals in lieu of this part. 

(n) Each healthcare facility (as defined in § 266.500) must determine whether it is subject to 

40 CFR part 266, subpart P for the management of hazardous waste pharmaceuticals, based on 

the total hazardous waste it generates per calendar month (including pharmaceutical hazardous 

waste and non-pharmaceutical hazardous waste). Healthcare facilities that generate (or 

accumulate) more than 100 kg (220 pounds) of hazardous waste per calendar month, or more 

than 1 kg (2.2 pounds) of acute hazardous waste per calendar month, or more than 100 kg (220 

pounds) per calendar month of any residue or contaminated soil, waste, or other debris, resulting 

from the clean-up of a spill, into or on any land or water, of any acute hazardous wastes listed in 

§§ 261.31 or 261.33(e), are subject to 40 CFR part 266, subpart P for the management of 

hazardous waste pharmaceuticals in lieu of this part.
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* * * * *

PART 266—STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS 

WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT 

FACILITIES

6. The authority citation for part 266 continues to read as follows:

Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905, 6906, 6912, 6921, 6922, 

6924-6927, 6934, and 6937.

7. Amend Part 266 by:

a. aAdding and reserving subpart O; and

b. adding subpart P.:

PART 266 – STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS 

WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT 

FACILITIES

* * * * *

Subpart O [Reserved]

8. Amend Part 266 by adding subpart P, as follows: 

PART 266 – STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS 

WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT 

FACILITIES

* * * * *

Sec.

266.500 Definitions for this subpart.

266.501 Applicability.

266.502 Standards for healthcare facilities managing non-creditable hazardous waste 

pharmaceuticals. 
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266.503 Standards for healthcare facilities managing potentially creditable hazardous 

waste pharmaceuticals. 

266.504 Healthcare facilities that are conditionally exempt small quantity generators 

(CESQGs).

266.505 Prohibition of sewering hazardous waste pharmaceuticals.

266.506 Conditional exemption for hazardous waste pharmaceuticals that are also 

controlled substances.

266.507 Management of hazardous waste pharmaceutical residues in containers.

266.508 Shipping non-creditable hazardous waste pharmaceuticals from a healthcare 

facility or evaluated hazardous waste pharmaceuticals from a pharmaceutical reverse 

distributor.

266.509 Shipping potentially creditable hazardous waste pharmaceuticals from a 

healthcare facility or a pharmaceutical reverse distributor to a pharmaceutical reverse 

distributor.

266.510 Standards for the management of potentially creditable hazardous waste 

pharmaceuticals and evaluated hazardous waste pharmaceuticals at pharmaceutical 

reverse distributors.

Subpart P — Hazardous Waste Pharmaceuticals

§ 266.500 Definitions for this subpart.

The following definitions apply to this subpart:

Evaluated hazardous waste pharmaceutical means a hazardous waste pharmaceutical that 

was a potentially creditable hazardous waste pharmaceutical but has been evaluated by a 

pharmaceutical reverse distributor to establish whether it is eligible for manufacturer’s credit and 

will not be sent to another pharmaceutical reverse distributor for further evaluation or 

verification.

Hazardous waste pharmaceutical means a pharmaceutical that is a solid waste, as defined 

in § 261.2, and is listed in part 261, subpart D, or exhibits one or more characteristics identified 

in part 261, subpart C.

Healthcare facility means any person that (1) provides preventative, diagnostic, 

therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or 
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procedure with respect to the physical or mental condition, or functional status, of a human or 

animal or that affects the structure or function of the human or animal body; or (2) sells or 

dispenses over-the-counter or prescription pharmaceuticals. This definition includes, but is not 

limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, 

physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, 

ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, 

mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and 

hospitals.

Household waste pharmaceutical means a pharmaceutical that is a solid waste, as defined 

in § 261.2, but is exempt from being a hazardous waste under § 261.4(b)(1).

Long-term care facility means a licensed entity that provides assistance with activities of 

daily living, including managing and administering pharmaceuticals to one or more individuals 

at the facility. This definition includes, but is not limited to, assisted living, hospices, nursing 

homes, skilled nursing facilities, and the assisted living and skilled nursing care portions of 

continuing care retirement communities. Not included within the scope of this definition are 

group homes, independent living communities, and the independent living portions of continuing 

care retirement communities.

Non-creditable hazardous waste pharmaceutical means a hazardous waste 

pharmaceutical that is not expected to be eligible for manufacturer’s credit. 

Non-hazardous waste pharmaceutical means a pharmaceutical that is a solid waste, as 

defined in § 261.2, and is not listed in 40 CFR part 261, subpart D, and does not exhibit a

characteristic identified in 40 CFR part 261, subpart C.
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Non-pharmaceutical hazardous waste means a solid waste, as defined in § 261.2, that is 

listed in 40 CFR part 261, subpart D, or exhibits one or more characteristics identified in 40 CFR 

part 261, subpart C, but is not a pharmaceutical, as defined in this section. 

Pharmaceutical means any chemical or biological product that is intended for use in the 

diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other 

animal; or any chemical or biological product that is intended to affect the structure or function 

of the body of a human or other animal. This definition includes, but is not limited to: dietary 

supplements as defined by the Federal Food, Drug and Cosmetic Act, prescription drugs, overthe-counter drugs, residues of pharmaceuticals remaining in containers, personal protective 

equipment contaminated with pharmaceuticals, and clean-up material from spills of 

pharmaceuticals.

Pharmaceutical reverse distributor means any person that receives and accumulates 

potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or 

verifying manufacturer’s credit. Any person, including forward distributors and pharmaceutical 

manufacturers, that processes pharmaceuticals for the facilitation or verification of 

manufacturer’s credit is considered a pharmaceutical reverse distributor. 

Potentially creditable hazardous waste pharmaceutical means a hazardous waste 

pharmaceutical that has the potential to receive manufacturer’s credit and is: (1) unused or unadministered; and (2) unexpired or less than one year past expiration date. The term does not 

include “evaluated hazardous waste pharmaceuticals,” residues of pharmaceuticals remaining in 

containers, contaminated personal protective equipment, and clean-up material from the spills of 

pharmaceuticals.

§ 266.501 Applicability.
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(a) A healthcare facility that is a conditionally exempt small quantity generator remains

subject to § 261.5 and is not subject to this subpart, except for §§ 266.504, 266.505 and 

266.505.507(a) and (b).

(b) A healthcare facility that is a conditionally exempt small quantity generator has the 

option of complying with this subpart for the management of its hazardous waste 

pharmaceuticals, as an alternative to complying with the conditional exemption of § 261.5.

(c) A healthcare facility or pharmaceutical reverse distributor remains subject to all 

applicable hazardous waste regulations with respect to the management of its nonpharmaceutical hazardous waste.

(d) With the exception of healthcare facilities identified in subsection (a), a healthcare 

facility is subject to:

(1) Sections 266.502 and 266.504 –through 266.508 of this subpart with respect to the 

management of:

(i) non-creditable hazardous waste pharmaceuticals, and 

(ii) potentially creditable hazardous waste pharmaceuticals if they are not destined for a 

pharmaceutical reverse distributor.

(2) Sections 266.503 through– 266.507 and 266.509 of this subpart with respect to the 

management of potentially creditable hazardous waste pharmaceuticals that are destined for a 

pharmaceutical reverse distributor.

(e) A pharmaceutical reverse distributor is subject to § § 266.505 –through 266.510 of 

this subpart with respect to the management of hazardous waste pharmaceuticals.
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(f) This subpart does not apply to the management of hazardous waste pharmaceuticals 

that are generated or managed by entities other than healthcare facilities and pharmaceutical 

reverse distributors.

§ 266.502 Standards for healthcare facilities managing non-creditable hazardous waste 

pharmaceuticals. 

(a) Notification and withdrawal from this subpart for healthcare facilities managing noncreditable hazardous waste pharmaceuticals. 

(1) Notification. A healthcare facility must notify the EPA Regional Administrator, using 

the Site Identification Form (EPA form 8700-12), that it is a healthcare facility operating under 

this subpart. A healthcare facility is not required to fill out Box 11 (Description of Hazardous 

Waste) of the Site Identification Form with respect to its hazardous waste pharmaceuticals. A 

healthcare facility must submit a separate notification (Site Identification Form) for each site or 

EPA Identification Number.

(i) A healthcare facility that already has an EPA identification number must re-notify the 

EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a 

healthcare facility as part of its next Biennial Report, if it is required to submit one; or if not 

required to submit a Biennial Report, within 60 days of the effective date of this subpart, or 

within 60 days of becoming subject to this subpart.

(ii) A healthcare facility that does not have an EPA identification number must obtain one 

by notifying the EPA Regional Administrator, using the Site Identification form (EPA form 

8700-12), that it is a healthcare facility as part of its next Biennial Report, if it is required to 

submit one; or if not required to submit a Biennial Report, within 60 days of the effective date of 

this subpart, or within 60 days of becoming subject to this subpart.
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(iii) A healthcare facility must keep a copy of its notification on file for as long as the 

healthcare facility is subject to this subpart.

(2) Withdrawal. A healthcare facility that operated under this subpart but is no longer 

subject to this subpart, because it is a conditionally exempt small quantity generator under § 

261.5, and elects to withdraw from this subpart, must notify the appropriate EPA Regional

Administrator using the Site Identification Form (EPA form 8700-12) that it is no longer 

operating under this subpart. A healthcare facility is not required to fill out Box 11 (Description 

of Hazardous Waste) of the Site Identification Form with respect to its hazardous waste 

pharmaceuticals. A healthcare facility must submit a separate notification (Site Identification 

Form) for each EPA Identification Number.

(i) A healthcare facility must submit the Site Identification Form notifying that it is 

withdrawing from this subpart before it begins operating under the conditional exemption of § 

261.5(b).

(ii) A healthcare facility must keep a copy of its withdrawal on file for three years from 

the date of signature on the notification of its withdrawal.

(b) Training of employees managing non-creditable hazardous waste pharmaceuticals at 

healthcare facilities. A healthcare facility must ensure that all employees that manage noncreditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling 

and emergency procedures relevant to their responsibilities during normal facility operations and 

emergencies. 

(c) Hazardous waste determination for non-creditable hazardous waste pharmaceuticals 

at healthcare facilities. A healthcare facility that generates a solid waste that is a pharmaceutical 

must determine whether the solid waste pharmaceutical is a hazardous waste pharmaceutical 
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(i.e., it exhibits a characteristic identified in 40 CFR part 261, subpart C or is listed in 40 CFR 

part 261, subpart D) in order to determine whether the waste is subject to this subpart. A 

healthcare facility may choose to manage its solid waste pharmaceuticals as hazardous waste 

pharmaceuticals under this subpart even if the solid waste pharmaceuticals do not exhibit a 

characteristic identified in 40 CFR part 261, subpart C and are not listed in 40 CFR part 261,

subpart D.

(d) Standards for containers used to accumulate non-creditable hazardous waste 

pharmaceuticals at healthcare facilities.

(1) A healthcare facility must place non-creditable hazardous waste pharmaceuticals in a 

container that is structurally sound, compatible with its contents, and that lacks evidence of 

leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. 

(2) A healthcare facility that manages ignitable or reactive hazardous waste 

pharmaceuticals, or that mixes or commingles incompatible hazardous waste pharmaceuticals 

must manage the container so that it does not have the potential to:

(iA) Generate extreme heat or pressure, fire or explosion, or violent reaction;

(iiB) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to 

threaten human health;

(iiiC) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a 

risk of fire or explosions;

(ivD) Damage the structural integrity of the container of hazardous waste 

pharmaceuticals; or 

(vE) Through other like means threaten human health or the environment. 
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(3) A healthcare facility must keep containers of non-creditable hazardous waste 

pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents. 

(4) A healthcare facility may accumulate hazardous waste pharmaceuticals and nonhazardous pharmaceutical waste in the same container, except that hazardous waste 

pharmaceuticals prohibited from being combusted because of the dilution prohibition of § 

268.3(c) must be accumulated in separate containers.

(e) Labeling containers used to accumulate non-creditable hazardous waste 

pharmaceuticals at healthcare facilities. A healthcare facility must label or clearly mark each 

container of hazardous waste pharmaceuticals with the phrase “Hazardous Waste 

Pharmaceuticals.” 

(f) Maximum accumulation time for non-creditable hazardous waste pharmaceuticals at 

healthcare facilities.

(1) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals 

on-site for one year or less without a permit or having interim status. A healthcare facility may 

accumulate for more than one year without a permit or having interim status, only if the 

requirements of paragraph (3) of this section are met.

(2) A healthcare facility that accumulates non-creditable hazardous waste 

pharmaceuticals on-site must demonstrate the length of time that the hazardous waste 

pharmaceuticals have been accumulating, starting from the date it first becomes a waste. A 

healthcare facility may make this demonstration by any of the following methods:

(i) Marking or labeling the container of non-creditable hazardous waste pharmaceuticals 

with the date that hazardous waste pharmaceuticals became a waste;
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(ii) Maintaining an inventory system that identifies the date the non-creditable hazardous 

waste pharmaceutical being accumulated first became a waste;

(iii) Placing the non-creditable hazardous waste pharmaceuticals in a specific area and 

identifying the earliest date that any of the non-creditable hazardous waste pharmaceuticals in 

the area became a waste; or

(iv) Any other method which clearly demonstrates the length of time that the noncreditable hazardous waste pharmaceuticals have been accumulating from the date it first became 

a waste. 

(3) A healthcare facility may request from the EPA Regional Administrator an extension 

beyond the one year accumulation time limit for non-creditable hazardous waste pharmaceuticals 

involved in litigation, a recall, or unforeseen circumstances beyond the control of the healthcare 

facility.

(i) A request must be sent to the EPA Regional Administrator in writing (paper or 

electronic). The request for an extension must include an explanation of the reason an extension 

is requested, the approximate volume or weight of the hazardous waste pharmaceuticals that will 

be accumulated more than 90 days, and the amount of additional time requested.

(ii) The amount of time extension granted is at the discretion of the EPA Regional 

Administrator on a case-by-case basis. 

(g) Land disposal restrictions for non-creditable hazardous waste pharmaceuticals. The 

hazardous waste pharmaceuticals generated by a healthcare facility are subject to the Land 

Disposal Restrictions of 40 CFR part 268. A healthcare facility that generates hazardous waste 

pharmaceuticals must comply with the land disposal restrictions in accordance with § 268.7(a) 

requirements, except that it is not required to identify the hazardous waste numbers (codes).
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(h) Procedures for healthcare facilities for managing rejected shipments of noncreditable hazardous waste pharmaceuticals. A healthcare facility that sends a shipment of noncreditable hazardous waste pharmaceuticals to a designated facility and later receives that 

shipment back as a rejected load in accordance with the manifest discrepancy provisions of § 

264.72 or § 265.72 of this chapter, may accumulate the returned hazardous waste 

pharmaceuticals on-site for up to an additional 90 days provided the rejected or returned 

shipment is managed in accordance with paragraphs (d) and (e) of this section. Upon receipt of 

the returned shipment, the healthcare facility must:

(1) Sign either:

(i) Item 18c of the original manifest, if the original manifest was used for the returned 

shipment; or

(ii) Item 20 of the new manifest, if a new manifest was used for the returned shipment; 

(2) Provide the transporter a copy of the manifest; 

(3) Within 30 days of delivery of the rejected shipment, send a copy of the manifest to the 

designated facility that returned the shipment to the healthcare facility; and

(4) Transport or offer for transport the returned shipment in accordance with the shipping 

standards of § 266.508(a).

(i) Reporting by healthcare facilities for non-creditable hazardous waste 

pharmaceuticals.

(1) Biennial report by healthcare facilities. Healthcare facilities are not subject to 

biennial reporting requirements under § 262.41, with respect to non-creditable hazardous waste 

pharmaceuticals managed under this subpart.

(2) Exception report by healthcare facilities for a missing copy of the manifest. 
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(i) For shipments from a healthcare facility to a designated facility: If a healthcare facility 

does not receive a copy of the manifest with the handwritten signature of the owner or operator 

of the designated facility within 60 days of the date the non-creditable hazardous waste 

pharmaceuticals were accepted by the initial transporter, the healthcare facility must submit:

(A) A legible copy of the original manifest, indicating that the healthcare facility has not 

received confirmation of delivery, to the EPA Regional Administrator for the Region in which 

the healthcare facility is located, and

(B) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, 

stating that the return copy was not received and explaining the efforts taken to locate the noncreditable hazardous waste pharmaceuticals and the results of those efforts.

(ii) For shipments rejected by the designated facility and shipped to an alternate facility: 

If a healthcare facility does not receive a copy of the manifest for a rejected shipment of the noncreditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an 

alternate facility (using appropriate manifest procedures), with the handwritten signature of the 

owner or operator of the alternate facility within 60 days of the date the waste was accepted by 

the initial transporter forwarding the shipment of non-creditable hazardous waste 

pharmaceuticals from the designated facility to the alternate facility, the healthcare facility must 

submit:

(A) A legible copy of the original manifest, indicating that the healthcare facility has not 

received confirmation of delivery, to the EPA Regional Administrator for the Region in which 

the healthcare facility is located, and
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(B) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, 

stating that the return copy was not received and explaining the efforts taken to locate the noncreditable hazardous waste pharmaceuticals and the results of those efforts.

(3) Additional reports. The EPA Regional Administrator may require healthcare facilities 

to furnish additional reports concerning the quantities and disposition of non-creditable 

hazardous waste pharmaceuticals.

(j) Recordkeeping by healthcare facilities for non-creditable hazardous waste 

pharmaceuticals.

(1) A healthcare facility must keep a copy of each manifest signed in accordance with § 

262.23(a) for three years or until it receives a signed copy from the designated facility which 

received the non-creditable hazardous waste pharmaceuticals. This signed copy must be retained 

as a record for at least three years from the date the waste was accepted by the initial transporter.

(2) A healthcare facility must keep a copy of each exception report for a period of at least 

three years from the date of the report.

(3) A healthcare facility must keep records of any test results, waste analyses, or other 

determinations made to support its hazardous waste determination(s) for at least three years from 

the date of the test, analysis, or other determination.

(4) The periods of retention referred to in this section are extended automatically during 

the course of any unresolved enforcement action regarding the regulated activity, or as requested 

by the EPA Regional Administrator.

(k) Response to releases of non-creditable hazardous waste pharmaceuticals at 

healthcare facilities.
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(1) A healthcare facility must immediately contain all releases of non-creditable 

hazardous waste pharmaceuticals and other residues from non-creditable hazardous waste 

pharmaceuticals.

(2) A healthcare facility must determine whether any material resulting from the release 

is a non-creditable hazardous waste pharmaceutical, and if so, must manage the non-creditable 

hazardous waste pharmaceutical residues and spill clean-up materials in accordance with the 

requirements of this subpart.

(l) Long-term care facilities that manage non-creditable hazardous waste 

pharmaceuticals. A healthcare facility that is a long-term care facility and that has individuals 

that administer their own pharmaceuticals must collect any unused non-creditable hazardous 

waste pharmaceuticals from those self-administering individuals and manage them in accordance 

with this subpart.

(m) Accepting creditable and non-creditable hazardous waste pharmaceuticals from an 

off-site healthcare facility that is a CESQG. A healthcare facility may accept creditable and noncreditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a

conditionally exempt small quantity generator under § 261.5, without a permit or without having 

interim status, provided the receiving healthcare facility:

(1) is under the control of the same person, as defined in § 260.10, as the conditionally 

exempt small quantity generator healthcare facility that is sending the hazardous waste 

pharmaceuticals off-site or has a contractual relationship whereby the receiving healthcare 

facility supplies pharmaceuticals to the conditionally exempt small quantity generator healthcare 

facility, 
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(2) is operating under this subpart for the management of its hazardous waste 

pharmaceuticals,

(3) manages the non-creditable hazardous waste pharmaceuticals that it receives from 

off-site in compliance with this subpart, and

(4) keeps records of the hazardous waste pharmaceuticals shipments it receives from offsite for 3 years from the date that the shipment is received.

§ 266.503 Standards for healthcare facilities managing potentially creditable hazardous 

waste pharmaceuticals. 

(a) Hazardous waste determination for creditable hazardous waste pharmaceuticals 

at the healthcare facility. A healthcare facility that generates a solid waste that is a potentially 

creditable pharmaceutical must determine whether the potentially creditable solid waste 

pharmaceutical is a potentially creditable hazardous waste pharmaceutical (i.e., it listed in 40 

CFR part 261, subpart D or exhibits a characteristic identified in 40 CFR part 261, subpart C). A 

healthcare facility may choose to manage its potentially creditable solid waste pharmaceuticals 

as potentially creditable hazardous waste pharmaceuticals under § 266.509 even if the solid 

waste pharmaceuticals do not exhibit a characteristic identified in 40 CFR part 261, subpart C 

and are not listed in 40 CFR part 261, subpart D.

(b) Healthcare facilities are prohibited from sending hazardous wastes other than 

potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor.

(c) Biennial Report by healthcare facilities. Healthcare facilities are not subject to 

biennial reporting requirements under § 262.41, with respect to potentially creditable hazardous 

waste pharmaceuticals managed under this subpart.

(d) Recordkeeping.
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(1) A healthcare facility that initiates a shipment of potentially creditable hazardous waste 

pharmaceuticals to a pharmaceutical reverse distributor must keep the following records (paper 

or electronic) for each shipment of potentially creditable hazardous waste pharmaceuticals for 3 

years from the date of shipment:

(i) A copy of the advance notification provided to the pharmaceutical reverse distributor;

(ii) The confirmation of delivery; and

(iii) The shipping papers or bill of lading.

(2) The periods of retention referred to in this section are extended automatically during 

the course of any unresolved enforcement action regarding the regulated activity, or as requested 

by the EPA Regional Administrator.

§ 266.504 Healthcare facilities that are conditionally exempt small quantity generators 

(CESQGs).

(a) Potentially creditable hazardous waste pharmaceuticals. A healthcare facility that is a 

conditionally exempt small quantity generator may send its potentially creditable hazardous 

waste pharmaceuticals to a pharmaceuticals reverse distributor.

(b) Off-site collection of hazardous waste pharmaceuticals generated by a healthcare 

facility that is a CESQG. A healthcare facility that is a conditionally exempt small quantity 

generator may send its hazardous waste pharmaceuticals off-site to another healthcare facility, 

provided the receiving healthcare facility meets the conditions in 266.502(m) of this subpart.

(c) Long-term care facilities that are CESQGs. A long-term care facility that is a 

conditionally exempt small quantity generator may dispose of its hazardous waste 

pharmaceuticals in a collection receptacle of an authorized collector (as defined by the Drug 
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Enforcement Administration) that is registered with the Drug Enforcement Administration 

provided the contents are collected, stored, transported, destroyed and disposed of in compliance 

with all applicable Drug Enforcement Administration regulations for controlled substances.

§ 266.505 Prohibition of sewering hazardous waste pharmaceuticals.

All healthcare facilities and pharmaceutical reverse distributors are prohibited from 

discharging hazardous waste pharmaceuticals to a sewer system that passes through to a 

publicly-owned treatment works. The exclusion in § 261.4(a)(1)(ii) for mixtures of domestic 

sewage and other wastes that pass through a sewer system to a publicly-owned treatment works 

does not apply to a hazardous waste pharmaceutical. 

§ 266.506 Conditional exemption for hazardous waste pharmaceuticals that are also 

controlled substances.

(a) The following are exempt from 40 CFR parts 260-273, provided the conditions of 

paragraph (b) of this section are met:

(1) A hazardous waste pharmaceutical that is also listed on a schedule of controlled 

substances by the Drug Enforcement Administration in 21 CFR part 1308, and

(2) An authorized collector (as defined by the Drug Enforcement Administration) 

registered with the Drug Enforcement Administration that collects controlled substances 

collected from an ultimate user (as defined by the Drug Enforcement Administration) and comingles them with hazardous waste pharmaceuticals that are exempt as a household waste under 

§ 261.4(b)(1).

(b) Conditions for exemption. The hazardous waste pharmaceuticals must be collected, 

stored, transported, destroyed and disposed of in compliance with all applicable Drug 
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Enforcement Administration regulations for controlled substances, and combusted at one of the 

following:

(1) A permitted large municipal waste combustor (LMWC), subject to 40 CFR part 62,

subpart FFF for existing LMWCs, or 40 CFR part 60, subparts Ea and Eb for new LMWCs, or

(2) A permitted small municipal waste combustor (SMWC), subject to 40 CFR part 62,

subpart JJJ for existing SMWCs, or 40 CFR part 60, subparts AAAA and BBBB for new 

SMWCs, or

(3) A unit that has a permit or interim status to burn hazardous waste and is covered by 

40 CFR part 63, sSubpart EEE. A unit that is exempt from 40 CFR part 63, sSubpart EEE as 

specified in § 63.1200(b) of this chapter is not covered by Ssubpart EEE.

§ 266.507 Management of hazardous waste pharmaceutical residues in containers.

(a) Dispensing and unit-dose containers. A dispensing bottle, vial, or vialampule (not to 

exceed 1 liter or 1000 pills); or a unit-dose container, (e.g., a unit-dose packet, cup, wrapper, 

blister pack, or delivery device) is considered empty and the residues are not regulated as 

hazardous waste provided:

(1) all pharmaceuticals have been removed from the dispensing bottle, vial or vialampule; 

or the unit-dose container, (e.g., unit-dose packet, cup, wrapper, blister pack, or delivery device) 

using the practices commonly employed to remove materials from that type of container, and

(2) any dispensing bottle or unit-dose container that is an original manufacturer’s product 

package is destroyed prior to disposal in such a manner as would prevent further use of the 

container.

(b) Dispensed syringes. The residues remaining in a syringe are not regulated as 

hazardous waste provided:
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(1) the syringe has been used to administer the pharmaceutical to a patient, and

(2) the syringe is placed in a sharps container that is managed in accordance with all 

applicable federal, state, and local medical waste requirements.

(c) Other containers, including delivery devices. The residues remaining in all other types 

of unused or used containers that once held pharmaceuticals must be managed as hazardous 

waste pharmaceuticals, if the residues are listed in 40 CFR part 261, subpart D or exhibit a 

characteristic identified in 40 CFR part 261, subpart C. This includes, but is not limited to, the 

residues in intravenous (IV) bags and tubing, inhalers, aerosols, nebulizers, tubes of ointment, 

gels or creams. 

§ 266.508 Shipping non-creditable hazardous waste pharmaceuticals from a healthcare 

facility or evaluated hazardous waste pharmaceuticals from a pharmaceutical reverse 

distributor.

(a) A healthcare facility or pharmaceutical reverse distributor that ships either noncreditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, 

respectively, off-site to a designated facility (such as a permitted or interim status treatment, 

storage, or disposal facility), must comply with:

(1) The following pre-transport requirements, before transporting or offering for transport 

off-site:

(i) Packaging. Package the waste in accordance with the applicable Department of 

Transportation regulations on packaginghazardous materials under 49 CFR parts 173, 178, and 

179180.

(ii) Labeling. Label each package in accordance with the applicable Department of 

Transportation regulations on hazardous materials under 49 CFR part 172, subpart E.
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(iii) Marking.

(A) Mark each package of hazardous waste pharmaceuticals in accordance with the 

applicable Department of Transportation regulations on hazardous materials under 49 CFR part 

172, subpart D;

(B) Mark each container of 119 gallons or less used in such transportation with the 

following words and information in accordance with the requirements of 49 CFR 172.304:

HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or 

public safety authority or the U.S. Environmental Protection Agency.

Healthcare Facility’s or Pharmaceutical Reverse Distributor’s Name and Address _____.

Healthcare Facility’s or Pharmaceutical Reverse Distributor’s EPA Identification Number_____.

Manifest Tracking Number _____.

(iv) Placarding. Placard or offer the initial transporter the appropriate placards according 

to Department of Transportation regulations for hazardous materials under 49 CFR part 172, 

subpart F.

(v) Shipping papers. Prepare shipping papers in accordance with 4049 CFR part 172,

subpart C.

(2) The manifest requirements of 40 CFR part 262, subpart B, except that:

(i) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is not 

required to list hazardous waste codes in box 13 of EPA Form 8700-22.

(ii) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals must 

write the words “hazardous waste pharmaceuticals” in Box 14 (the special handling instructions 

and additional information) of EPA Form 8700-22.

(b) Exporting non-creditable hazardous waste pharmaceuticals or evaluated hazardous 

waste pharmaceuticals. A healthcare facility or pharmaceutical reverse distributor that exports 
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non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals 

is subject to 40 CFR part 262, subpart E.

(c) Importing non-creditable hazardous waste pharmaceuticals or evaluated hazardous 

waste pharmaceuticals. Any person that imports non-creditable hazardous waste pharmaceuticals 

or evaluated hazardous waste pharmaceuticals is subject to 40 CFR part 262, subpart F. A 

healthcare facility or pharmaceutical reverse distributor may not accept imported non-creditable 

hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, unless they 

have a permit or interim status that allows them to accept hazardous waste from off-site.

§ 266.509 Shipping potentially creditable hazardous waste pharmaceuticals from a 

healthcare facility or a pharmaceutical reverse distributor to a pharmaceutical reverse 

distributor.

(a) A healthcare facility or a pharmaceutical reverse distributor who transports or offers 

for transport potentially creditable hazardous waste pharmaceuticals off-site to a pharmaceutical 

reverse distributor must:

(1) Provide advance notice (paper or electronic) to the pharmaceutical reverse distributor

of the intent to ship potentially creditable hazardous waste pharmaceuticals to the receiving 

pharmaceutical reverse distributor before each shipment of potentially creditable hazardous 

waste pharmaceuticals is sent, and

(2) Comply with the pre-transport requirements of §266.508(a)(1)(i) – (v).

(b) Upon receipt of each shipment of potentially creditable hazardous waste 

pharmaceuticals, the receiving pharmaceutical reverse distributor must provide confirmation

(paper or electronic) to the healthcare facility or pharmaceutical reverse distributor that initiated
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the shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has 

arrived.

(c) If a healthcare facility or pharmaceutical reverse distributor initiates a shipment of 

potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor 

and does not receive delivery confirmation within seven calendar days from the date that the 

shipment of potentially creditable hazardous waste pharmaceuticals was sent, the healthcare 

facility or pharmaceutical reverse distributor that initiated the shipment must contact the shipper 

and the intended recipient (i.e., the pharmaceutical reverse distributor) promptly to report that the 

confirmation was not received and to determine the status of the potentially creditable hazardous 

waste pharmaceuticals.

(d) Exporting potentially creditable hazardous waste pharmaceuticals. 

(1) A healthcare facility or pharmaceutical reverse distributor that sends potentially 

creditable hazardous waste pharmaceuticals to a foreign destination must comply with the 

following requirements in addition to paragraphs (a) – (c) of this section:

(i) Comply with the requirements applicable to a primary exporter at 40 CFR 262.53, 

262.56(a)(1) through (4), (6) and (b) and 262.57;

(ii) Export such potentially creditable hazardous waste pharmaceuticals only upon 

consent of the receiving country and in conformance with the EPA Acknowledgement of 

Consent as defined in 40 CFR part 262, subpart E; and

(iii) Provide a copy of the EPA Acknowledgement of Consent for the shipment to the 

transporter transporting the shipment for export.

(2) A transporter of potentially creditable hazardous waste pharmaceuticals to a foreign 

destination other than those OECD countries specified 40 CFR 262.58(a)(1) (in which case the 
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transporter is subject to the requirements of 40 CFR part 262, subpart H) may not accept a 

shipment if the transporter knows the shipment does not conform to the EPA Acknowledgment 

of Consent. In addition the transporter must ensure that:

(i) A copy of the EPA Acknowledgment of Consent accompanies the shipment; and

(ii) The shipment is delivered to the facility designated by the person initiating the 

shipment.

(e) Importing potentially creditable hazardous waste pharmaceuticals. Any person that 

imports potentially creditable hazardous waste pharmaceuticals into the United States is subject 

to paragraphs (a)-(c) of this section in lieu of 40 CFR part 262, subpart F.

§ 266.510 Standards for the management of potentially creditable hazardous waste 

pharmaceuticals and evaluated hazardous waste pharmaceuticals at pharmaceutical 

reverse distributors.

A pharmaceutical reverse distributor may accept potentially creditable hazardous waste 

pharmaceuticals from off-site and accumulate potentially creditable hazardous waste 

pharmaceuticals or evaluated hazardous waste pharmaceuticals on-site without a permit or 

without having interim status, provided that it complies with the following conditions:

(a) Standards for pharmaceutical reverse distributors managing potentially creditable 

hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.

(1) Notification. A pharmaceutical reverse distributor must notify the EPA Regional 

Administrator, using the Site Identification Form (EPA form 8700-12), that it is a pharmaceutical 

reverse distributor operating under this subpart.

(i) A pharmaceutical reverse distributor that already has an EPA identification number 

must re-notify the EPA Regional Administrator, using the Site Identification Form (EPA form 
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8700-12), that it is a pharmaceutical reverse distributor, as defined in § 266.500, within 60 days 

of the effective date of this subpart, or within 60 days of becoming subject to this subpart.

(ii) A pharmaceutical reverse distributor that does not have an EPA identification number 

must obtain one by notifying the EPA Regional Administrator, using the Site Identification Form 

(EPA form 8700-12), that it is a pharmaceutical reverse distributor, as defined in § 266.500, 

within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this 

subpart.

(2) Inventory by the pharmaceutical reverse distributor. A pharmaceutical reverse 

distributor must maintain an inventory of all the potentially creditable hazardous waste 

pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on-site.

(i) A pharmaceutical reverse distributor must inventory each potentially creditable

hazardous waste pharmaceutical upon arrival at the pharmaceutical reverse distributor.

(ii) The inventory must include the identity (e.g., name or national drug code (NDC)) and 

quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous 

waste pharmaceutical.

(3) Security at the pharmaceutical reverse distributor facility. A pharmaceutical reverse 

distributor must prevent unknowing entry and minimize the possibility for the unauthorized entry 

into the portion of the facility where potentially creditable hazardous waste pharmaceuticals and 

evaluated hazardous waste pharmaceuticals are kept.

(i) Examples of methods that may be used to prevent unknowing entry and minimize 

unauthorized entry include, but are not limited to:

(A) 24-hour continuous monitoring surveillance system;

(B) An artificial barrier such as a fence; or
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(C) Means to control entry, such as keycard access.

(ii) If the pharmaceutical reverse distributor already meets the security requirements of 

this paragraph because of other regulatory requirements, such as Drug Enforcement 

Administration regulations, the facility is not required to provide separate security measures 

pursuant to this section.

(4) Maximum accumulation time for hazardous waste pharmaceuticals at a 

pharmaceutical reverse distributor. A pharmaceutical reverse distributor may accumulate 

potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste 

pharmaceuticals on-site for 90 calendar days or less. The 90 days start when the potentially 

creditable hazardous waste pharmaceutical arrives at the pharmaceutical reverse distributor and 

applies to all hazardous waste pharmaceuticals accumulated on-site, regardless of whether they 

are destined for another pharmaceutical reverse distributor (i.e., potentially creditable hazardous 

waste pharmaceuticals), or a permitted or interim status treatment, storage or disposal facility 

(i.e., evaluated hazardous waste pharmaceuticals).

(5) Extension of 90-day accumulation time limit at a pharmaceutical reverse distributor.

A pharmaceutical reverse distributor may request an extension of its 90-day accumulation time 

limit for hazardous waste pharmaceuticals from the EPA Regional Administrator due to 

unforeseen circumstances beyond the control of the pharmaceutical reverse distributor, or if the

potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste 

pharmaceuticals are involved in litigation or a recall.

(i) A written request must be sent to the EPA Regional Administrator (paper or 

electronic). The request for an extension must include an explanation of the reason an extension 
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is requested, the approximate volume or weight of the hazardous waste pharmaceuticals that will 

be accumulated more than 90 days, and the amount of additional time requested. 

(ii) The amount of time granted for an extension is at the discretion of the EPA Regional 

Administrator on a case-by-case basis.

(6) Contingency plan and emergency procedures at a pharmaceutical reverse distributor.

A pharmaceutical reverse distributor that accepts potentially creditable hazardous waste 

pharmaceuticals from off-site must prepare a contingency plan and comply with the other 

requirements of 40 CFR part 265, subpart D.

(7) Closure of a pharmaceutical reverse distributor. When closing an area where a 

pharmaceutical reverse distributor accumulates potentially creditable hazardous waste 

pharmaceuticals or evaluated hazardous waste pharmaceuticals, the pharmaceutical reverse 

distributor must control, minimize, or eliminate to the extent necessary to protect human health 

and the environment, post-closure escape of hazardous waste, leachate, contaminated run-off, or 

hazardous waste decomposition products to the ground or surface waters or to the atmosphere.

(8) Reporting by a pharmaceutical reverse distributor.

(i) Unauthorized waste report. A pharmaceutical reverse distributor must submit an 

unauthorized hazardous waste report if the pharmaceutical reverse distributor receives hazardous 

waste from off-site that it is not authorized to receive (e.g., non-creditable hazardous waste 

pharmaceuticals, non-pharmaceutical hazardous waste). The pharmaceutical reverse distributor 

must prepare and submit an unauthorized waste report to the EPA Regional Administrator within 

15 days after receiving the unauthorized hazardous waste and the pharmaceutical reverse 

distributor must send a copy of the unauthorized waste report to the healthcare facility (or other 

entity) that sent the unauthorized hazardous waste. The pharmaceutical reverse distributor must 
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manage the unauthorized hazardous waste in accordance with all applicable regulations for 

generators of non-pharmaceutical hazardous waste. The unauthorized waste report must be 

signed by the owner or operator of the pharmaceutical reverse distributor, or his authorized 

representative, and contain the following information:

(A) The EPA identification number, name and address of the pharmaceutical reverse 

distributor;

(B) The date the pharmaceutical reverse distributor received the hazardous waste;

(C) The EPA identification number, name and address of the healthcare facility that 

shipped the hazardous waste, if available;

(D) A description and the quantity of each unauthorized hazardous waste the 

pharmaceutical reverse distributor received;

(E) The method of treatment, storage, or disposal for each unauthorized hazardous waste; 

and

(F) A brief explanation of why the waste was unauthorized, if known.

(ii) Additional reports. The EPA Regional Administrator may require pharmaceutical 

reverse distributors to furnish additional reports concerning the quantities and disposition of 

potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste 

pharmaceuticals.

(9) Recordkeeping by pharmaceutical reverse distributors. A pharmaceutical reverse 

distributor must keep the following records (paper or electronic):

(i) A copy of its notification on file for as long as the facility is subject to this subpart;

(ii) A copy of the advance notification, delivery confirmation and, the shipping papers or 

bill of lading for each shipment of potentially creditable hazardous waste pharmaceuticals that it 
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receives, and a copy of each unauthorized waste report, for at least three years from the date it 

receives the shipment;

(iii) A copy of its inventory for as long as the facility is subject to this subpart; and

(iv) The periods of retention referred to in this section are extended automatically during 

the course of any unresolved enforcement action regarding the regulated activity, or as requested 

by the EPA Regional Administrator.

(10) A pharmaceutical reverse distributor that is not a pharmaceutical manufacturer must 

evaluate a potentially creditable hazardous waste pharmaceutical within 21 calendar days of 

arriving at the pharmaceutical reverse distributor to establish whether it is destined for another 

pharmaceutical reverse distributor for further evaluation or verification of manufacturer’s credit 

or for a permitted or interim status treatment, storage or disposal facility. This 21 calendar days 

is part of the 90 calendar days allowed for on-site accumulation.

(i) A potentially creditable hazardous waste pharmaceutical that is destined for another 

pharmaceutical reverse distributor is still considered a “potentially creditable hazardous waste 

pharmaceutical” and must be managed in accordance with paragraph (b) of this section.

(ii) A potentially creditable hazardous waste pharmaceuticals that is destined for a 

permitted or interim status treatment, storage or disposal facility is considered an “evaluated 

hazardous waste pharmaceutical” and must be managed in accordance with paragraph (c) of this 

section.

(11) A pharmaceutical reverse distributor that is a pharmaceutical manufacturer must 

evaluate a potentially creditable hazardous waste pharmaceutical to verify manufacturer’s credit 

within 21 calendar days of arriving at the facility and must manage the evaluated hazardous 
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waste pharmaceuticals in accordance with paragraph (c) of this section. This 21 calendar days is 

part of the 90 calendar days allowed for on-site accumulation.

(b) Additional standards for pharmaceutical reverse distributors managing potentially 

creditable hazardous waste pharmaceuticals destined for another pharmaceutical reverse 

distributor. A pharmaceutical reverse distributor that does not have a permit or interim status 

must comply with the following conditions, in addition to the requirements in paragraph (a) of 

this section, for the management of potentially creditable hazardous waste pharmaceuticals that 

are destined for another pharmaceutical reverse distributor for further evaluation or verification 

of manufacturer’s credit:

(1) A pharmaceutical reverse distributor that receives potentially creditable hazardous 

waste pharmaceuticals from a healthcare facility must send those potentially creditable 

hazardous waste pharmaceuticals to another pharmaceutical reverse distributor within 90 days 

from when the potentially creditable hazardous waste pharmaceuticals arrived or follow 

paragraph (c) of this section for evaluated hazardous waste pharmaceuticals.

(2) A pharmaceutical reverse distributor that receives potentially creditable hazardous 

waste pharmaceuticals from another pharmaceutical reverse distributor must send those 

potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor 

that is a pharmaceutical manufacturer within 90 days from when the potentially creditable 

hazardous waste pharmaceuticals arrived or follow paragraph (c) of this section for evaluated 

hazardous waste pharmaceuticals.

(3) A pharmaceutical reverse distributor must ship potentially creditable hazardous waste 

pharmaceuticals destined for another pharmaceutical reverse distributor in accordance with § 

266.509.
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(4) Recordkeeping. A pharmaceutical reverse distributor must keep the following records 

(paper or electronic) for each shipment of potentially creditable hazardous waste pharmaceuticals 

that it initiates to another pharmaceutical reverse distributor, for at least three years from the date 

of shipment:

(i) A copy of the advance notification provided to the pharmaceutical reverse distributor;

(ii) The confirmation of delivery; and

(iii) The shipping papers or bill of lading.

(c) Additional standards for pharmaceutical reverse distributors managing evaluated 

hazardous waste pharmaceuticals. A pharmaceutical reverse distributor that does not have a 

permit or interim status must comply with the following conditions, in addition to the 

requirements of paragraph (a) of this section, for the management of evaluated hazardous waste 

pharmaceuticals:

(1) Accumulation area at the pharmaceutical reverse distributor. A pharmaceutical 

reverse distributor must designate an on-site accumulation area where it will accumulate 

evaluated hazardous waste pharmaceuticals.

(2) Weekly inspections of on-site accumulation area. A pharmaceutical reverse distributor 

must inspect its on-site accumulation area at least weekly, looking at containers for leaks and for 

deterioration caused by corrosion or other factors, as well as for signs of diversion.

(3) Personnel training at a pharmaceutical reverse distributor. Personnel at a 

pharmaceutical reverse distributor that handle evaluated hazardous waste pharmaceuticals are 

subject to the training requirements of § 265.16.
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(4) Labeling and management of containers at on-site accumulation area. A 

pharmaceutical reverse distributor accumulating evaluated hazardous waste pharmaceuticals in 

containers in an on-site accumulation area must:

(i) Label the containers with the words, "hazardous waste pharmaceuticals";

(ii) Ensure the containers are in good condition and managed to prevent leaks;

(iii) Use containers that are made of or lined with materials which will not react with, and 

are otherwise compatible with, the evaluated hazardous waste pharmaceuticals, so that the ability 

of the container to contain the waste is not impaired;

(iv) Keep containers closed, if holding liquid or gel evaluated hazardous waste 

pharmaceuticals. If the liquid or gel evaluated hazardous waste pharmaceuticals are in their 

original, intact, sealed packaging; or repackaged, intact, sealed packaging, they are considered to 

meet the closed container standard;

(v) A pharmaceutical reverse distributor that manages ignitable or reactive evaluated 

hazardous waste pharmaceuticals, or that mixes or commingles incompatible evaluated 

hazardous waste pharmaceuticals must manage the container so that it does not have the potential 

to:

(A) Generate extreme heat or pressure, fire or explosion, or violent reaction;

(B) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to 

threaten human health;

(C) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk 

of fire or explosions;

(D) Damage the structural integrity of the container of hazardous waste pharmaceuticals; 

or 
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(E) Through other like means threaten human health or the environment; and

(vi) Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from 

being combusted because of the dilution prohibition of § 268.3(c) (e.g., arsenic trioxide (P012)) 

in separate containers from other evaluated hazardous waste pharmaceuticals at the 

pharmaceutical reverse distributor.

(5) Hazardous waste numbers. Containers of evaluated hazardous waste pharmaceuticals 

must be marked with the applicable hazardous waste number(s) (i.e., hazardous waste code(s)) 

prior to transport off-site.

(6) Shipments. A pharmaceutical reverse distributor must ship evaluated hazardous waste 

pharmaceuticals that are destined for a permitted or interim status treatment, storage or disposal 

facility, in accordance with § 266.508(a).

(7) Procedures for a pharmaceutical reverse distributor for managing rejected 

shipments. A pharmaceutical reverse distributor who sends a shipment of evaluated hazardous 

waste pharmaceuticals to a designated facility with the understanding that the designated facility 

can accept and manage the waste, and later receives that shipment back as a rejected load in 

accordance with the manifest discrepancy provisions of § 264.72 or § 265.72 of this chapter, may 

accumulate the returned hazardous waste pharmaceuticals on-site for up to an additional 90 days 

in the on-site accumulation area provided the rejected or returned shipment is managed in 

accordance with paragraph (a) of this section. Upon receipt of the returned shipment, the 

pharmaceutical reverse distributor must:

(i) Sign either:

(A) Item 18c of the original manifest if the original manifest was used for the returned 

shipment; or
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(B) Item 20 of the new manifest if a new manifest was used for the returned shipment;

(ii) Provide the transporter a copy of the manifest;

(iii) Within 30 days of delivery of the rejected shipment of the evaluated hazardous waste 

pharmaceuticals, send a copy of the manifest to the designated facility that returned the shipment 

to the pharmaceutical reverse distributor; and

(iv) Transport or offer for transport the returned shipment of evaluated hazardous waste 

pharmaceuticals in accordance with the shipping standards of § 266.508(b).

(8) Land disposal restrictions. Evaluated hazardous waste pharmaceuticals are subject to 

the Land Disposal Restrictions of 40 CFR part 268. A pharmaceutical reverse distributor that 

accepts potentially creditable hazardous waste pharmaceuticals from off-site must comply with 

the land disposal restrictions in accordance with § 268.7(a) requirements.

(9) Reporting by a pharmaceutical reverse distributor for evaluated hazardous waste 

pharmaceuticals.

(i) Biennial report by a pharmaceutical reverse distributor. A pharmaceutical reverse 

distributor that ships evaluated hazardous waste pharmaceuticals off-site must prepare and 

submit a single copy of a biennial report to the EPA Regional Administrator by March 1 of each 

even numbered year in accordance with § 262.41, except § 262.41(a)(7).

(ii)Exception reporting by a pharmaceutical reverse distributor for a missing copy of the 

manifest.

(A) For shipments from a pharmaceutical reverse distributor to a designated facility:

(1) If a pharmaceutical reverse distributor does not receive a copy of the manifest with 

the handwritten signature of the owner or operator of the designated facility within 35 days of the 

date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter, the 
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pharmaceutical reverse distributor must contact the transporter or the owner or operator of the 

designated facility to determine the status of the evaluated hazardous waste pharmaceuticals.

(2) A pharmaceutical reverse distributor must submit an exception report to the EPA 

Regional Administrator for the Region in which the pharmaceutical reverse distributor is located 

if it has not received a copy of the manifest with the handwritten signature of the owner or 

operator of the designated facility within 45 days of the date the evaluated hazardous waste 

pharmaceutical was accepted by the initial transporter. The exception report must include:

(i) A legible copy of the manifest for which the pharmaceutical reverse distributor does 

not have confirmation of delivery; and

(ii) A cover letter signed by the pharmaceutical reverse distributor, or its authorized 

representative, explaining the efforts taken to locate the evaluated hazardous waste 

pharmaceuticals and the results of those efforts.

(B) For shipments rejected by the designated facility and shipped to an alternate facility:

(1) A pharmaceutical reverse distributor that does not receive a copy of the manifest with 

the handwritten signature of the owner or operator of the alternate facility within 35 days of the 

date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter must 

contact the transporter or the owner or operator of the alternate facility to determine the status of 

the hazardous waste. The 35 day timeframe begins the date the waste is accepted by the 

transporter forwarding the hazardous waste shipment from the designated facility to the alternate 

facility.

(2) A pharmaceutical reverse distributor must submit an Exception Report to the EPA 

Regional Administrator for the Region in which the pharmaceutical reverse distributor is located 

if it has not received a copy of the manifest with the handwritten signature of the owner or 
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operator of the alternate facility within 45 days of the date the hazardous waste was accepted by 

the initial transporter. The 45-day timeframe begins the date the hazardous waste is accepted by 

the transporter forwarding the hazardous waste shipment from the designated facility to the 

alternate facility. The Exception Report must include:

(i) A legible copy of the manifest for which the generator does not have confirmation of 

delivery; and

(ii) A cover letter signed by the pharmaceutical reverse distributor, or its authorized 

representative, explaining the efforts taken to locate the evaluated hazardous waste 

pharmaceuticals and the results of those efforts.

(10) Recordkeeping by a pharmaceutical reverse distributor for evaluated hazardous 

waste pharmaceuticals.

(i) A pharmaceutical reverse distributor must keep a log (written or electronic) of the 

weekly inspections of the on-site accumulation area, required by paragraph (c)(2) of this section. 

This log must be retained as a record for at least three years from the date of the inspection.

(ii) A pharmaceutical reverse distributor must keep a copy of each manifest signed in 

accordance with § 262.23(a) for three years or until it receives a signed copy from the designated 

facility which received the evaluated hazardous waste pharmaceutical. This signed copy must be 

retained as a record for at least three years from the date the evaluated hazardous waste 

pharmaceutical was accepted by the initial transporter.

(iii) A pharmaceutical reverse distributor must keep a copy of each biennial report for at 

least three years from the due date of the report.

(iv) A pharmaceutical reverse distributor must keep a copy of each exception report for at 

least three years from the submission of the report.
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(v) A pharmaceutical reverse distributor must keep records to document personnel 

training, in accordance with § 265.16.

(d) When a pharmaceutical reverse distributor must have a permit. A pharmaceutical 

reverse distributor is an operator of a hazardous waste treatment, storage or disposal facility and 

is subject to the requirements of 40 CFR parts 264, 265, and 267 and the permit requirements of 

40 CFR part 270, if the pharmaceutical reverse distributor:

(i) does not meet the conditions of this section,

(ii) accepts manifested hazardous waste from off-site, or

(iii) treats or disposes of hazardous waste on-site.

PART 268—LAND DISPOSAL RESTRICTIONS

9. The authority citation for part 268 continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921, and 6924.

10. Amend Section 268.7, as follows:

a. Revise the title of § 268.7 to read as set forth below; and

b. Revise the title of Section 268.7(a) to read as set forth below.

§ 268.7 Testing, tracking, and recordkeeping requirements for generators, 

pharmaceutical reverse distributors, treaters, and disposal facilities.

(a) Requirements for generators and pharmaceutical reverse distributors:

* * * 

* * * * *

11. Amend Section 268.50(a) by adding paragraphs (a)(4) and (a)(5), as follows:

§ 268.50 Prohibitions on storage of restricted wastes.

(a) * * * 
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(4) A healthcare facility accumulates such wastes in containers on-site solely for the purpose 

of the accumulation of such quantities of hazardous waste pharmaceuticals as necessary to 

facilitate proper recovery, treatment, or disposal and the healthcare facility complies with the 

requirements in § 266.502 of this chapter.

(5) A pharmaceutical reverse distributor accumulates such wastes in containers on-site solely 

for the purpose of the accumulation of such quantities of hazardous waste pharmaceuticals as 

necessary to facilitate proper recovery, treatment, or disposal and the pharmaceutical reverse 

distributor complies with § 266.510 of this chapter.

* * * * *

PART 273—STANDARDS FOR UNIVERSAL WASTE MANAGEMENT

12. The authority citation for part 273 continues to read as follows:

Authority: 42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.

13. Amend Section 273.80, as follows:

a. Revise paragraph (a) to read as set forth below; and

b. Add paragraph (d) to read as set forth below.

§ 273.80 General.

(a) Except as provided in paragraph (d), any person seeking to add a hazardous waste or 

category of hazardous waste to this part may petition for a regulatory amendment under this 

subpart and 40 CFR 260.20 and 260.23.

* * * * *

(d) Pharmaceutical hazardous waste is regulated by 40 CFR part 266, subpart P and may not 

be added as a category of hazardous waste for management under this part. 

* * * * *
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