Draft 

Guidance Document: Best Management 

Practices for Unused Pharmaceuticals at 

Health Care Facilities 

EPA-821-R-10-006 

26 August 2010

United States 

Environmental Protection 

Agency 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

Disclaimer 

The discussion in this document is intended solely as guidance. The statutory provisions and 

regulations of the U.S. Environmental Protection Agency (EPA) described in this document 

contain legally binding requirements. This document is not a regulation itself, nor does it change 

or substitute for those provisions and regulations. Thus, this document does not impose legally 

binding requirements on EPA, states or the regulated community. This document does not confer 

legal rights or impose legal obligations upon any member of the public. 

While EPA has made every effort to ensure the accuracy of the discussion in this document, the 

obligations of the regulated community are determined by statutes, regulations or other legally 

binding requirements. In the event of a conflict between the discussion in this document and any 

statute or regulation, this document would not be controlling. 

The general descriptions provided here reflect EPA's current views and may not apply to 

particular situations based upon the circumstances. Interested parties are free to raise questions 

and objections about the substance of this guidance and the appropriateness of the application of 

this guidance to a particular situation. EPA and other decision makers retain the discretion to 

adopt approaches on a case-by-case basis that differ from those described in this document where 

appropriate. 

Mention of trade names or commercial products does not constitute an endorsement or 

recommendation for their use. 

This document may be revised periodically without public notice. EPA welcomes public input on 

this document at any time. 

DRAFT August 26, 2010 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT i August 26, 2010 

CONTENTS 

Page 

1. INTRODUCTION .................................................................................................................... 1 

1.1 About this Best Management Practices (BMP) Guidance Document .................... 1 

1.2 Background............................................................................................................. 2 

2. CONDUCT AN INVENTORY OF PHARMACEUTICALS AND UNUSED PHARMACEUTICALS......... 3 

2.1 Develop a List of Pharmaceuticals Used at The Facility........................................ 3 

2.2 Identify the Unused Pharmaceuticals Generated and How They Are 

Currently Managed ................................................................................................. 4 

3. REDUCING OR AVOIDING UNUSED PHARMACEUTICALS....................................................... 5 

3.1 Review Purchasing Practices .................................................................................. 5 

3.2 Order Smaller Container Sizes or Emphasize Unit Dose Dispensing .................... 6 

3.2.1 Unit Dose Dispensing ................................................................................. 6 

3.2.2 Ordering Smaller Container Sizes .............................................................. 6 

3.2.3 Trial Prescriptions....................................................................................... 6 

3.3 Replace Pharmaceutical Samples with Vouchers................................................... 7 

3.4 On-Going Waste Reduction/Avoidance Practices: Inventory Control and 

Stock Rotation......................................................................................................... 7 

3.4.1 On-Going Inventory Control....................................................................... 7 

3.4.2 Stock Rotation............................................................................................. 7 

4. IDENTIFYING & MANAGING TYPES OF UNUSED PHARMACEUTICALS AND 

APPLICABLE DISPOSAL REGULATIONS................................................................................. 9 

4.1 Types of Unused Pharmaceuticals........................................................................ 10 

4.2 Nonwaste Medications – Pharmaceutical Reuse .................................................. 11 

4.3 Identifying Hazardous Vs. Nonhazardous Waste ................................................. 13 

4.3.1 Requirements for Managing Hazardous Waste ........................................ 16 

4.3.2 Recommended Management of Hazardous Pharmaceutical Waste.......... 17 

4.3.3 Definition of RCRA-Empty Containers.................................................... 18 

4.3.4 Proposed Universal Waste Rule................................................................ 19 

4.4 Recommended Management of Nonhazardous Unused Pharmaceuticals............ 20 

4.4.1 Chemotherapy Pharmaceuticals................................................................ 21 

4.4.2 Radioactive Pharmaceuticals .................................................................... 21 

4.5 Identifying Controlled Substances........................................................................ 21 

4.5.1 Requirements for Managing Controlled Substances................................. 22 

4.5.2 Recommended Management of Controlled Substances ........................... 23 

4.6 Additional Resources for Identifying Waste Types.............................................. 24 

5. STARTING A WASTE MANAGEMENT PROGRAM................................................................. 28 

5.1 Waste Segregation ................................................................................................ 28 

5.2 Training Staff in Proper Disposal Methods .......................................................... 28 

6. OTHER RESOURCES............................................................................................................ 29 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

CONTENTS (Continued) 

Page 

DRAFT ii August 26, 2010

Appendix A: STATE LAWS AND LOCAL ORDINANCES

Appendix B: SAMPLE UNUSED PHARMACEUTICAL TRACKING SHEET 

Appendix C: CONSIDERATIONS WHEN CONTRACTING WITH A SPECIALTY WASTE HAULER
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 1 August 26, 2010 

1. INTRODUCTION

1.1 About this Best Management Practices (BMP) Guidance Document

The U.S. Environmental Protection Agency (EPA) conducted outreach and identified that there 

is near-universal interest from stakeholders to better manage unused pharmaceuticals at health 

care facilities, as well as general interest in EPA’s guidance on managing unused 

pharmaceuticals. This guidance document describes Best Management Practices (BMPs) that 

EPA recommends to health care facilities, such as hospitals, long-term care facilities, medical 

clinics, and doctors’ offices, when managing and disposing of unused pharmaceuticals. 

Environmental managers at health care facilities can use these BMPs to minimize sewer disposal 

of pharmaceuticals and properly manage unused pharmaceuticals. EPA’s goal is to keep 

pharmaceuticals out of U.S. waters. EPA identified these BMPs after site visits at 12 health care 

facilities1; consulting with over 700 stakeholders including health care professionals, 

government entities, health care industry associations, and unused pharmaceutical management 

companies; review of disposal data from 20 hospitals and long-term care facilities; and review o

literature data, reports, and state recommendations. These practices are a combination of 

recommended and implemented practices with the goal of proper unused pharmaceutical 

manageme

f 

nt and disposal. 

uler. 

 

This document presents the steps that environmental managers of health care facilities can take 

to identify and properly manage unused pharmaceuticals. The steps include: 

 Conduct an inventory of pharmaceuticals and unused pharmaceuticals to quantify 

the amount of medication the facility is disposing of. 

 Reduce unused pharmaceuticals by reviewing purchasing practices, using limited 

dose or unit dose dispensing, replacing pharmaceutical samples with vouchers, 

and performing ongoing inventory control and stock rotation. 

 Properly manage unused pharmaceuticals by identifying types of pharmaceuticals 

and any federal and state requirements; when possible: reusing or donating 

unused pharmaceuticals, returning them to the pharmacy; sending them to a 

reverse distributor for credit and proper disposal; and using EPA recommended 

practices to dispose of pharmaceutical waste at the facility. 

 Segregate waste for disposal to ensure regulations are met and to reduce costs 

(e.g., nonhazardous pharmaceutical waste disposal in a solid waste landfill may be 

less expensive than disposal via hazardous waste hauler). 

 Train staff in proper disposal methods. 

This document also provides a list of other resources, such as EPA and industry association 

websites, list of current state repository programs2

, sample unused pharmaceutical tracking 

sheet, and considerations when contracting with a specialty waste ha

1

 EPA also visited a long-term care pharmacy, waste management vendor, and reverse distributor. 

2

 Current as of 2009. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 2 August 26, 2010 

1.2 Background

To date, scientists have identified numerous pharmaceutical compounds at discernable 

concentrations in our nation’s rivers, lakes, streams and drinking waters. As a result, the U.S. 

Environmental Protection Agency (EPA) initiated a study on unused pharmaceutical disposal 

practices at health care facilities. While EPA understands that there are many factors influencing 

the handling and disposal of pharmaceuticals by the health care industry, the focus of this study 

was on disposal to sewers. EPA decided to study medical facilities because the Agency believes 

that these facilities dispose large quantities of unused pharmaceuticals to sewers. 

Unused pharmaceuticals are dispensed prescriptions that patients do not use and medications that 

have expired. The term "unused pharmaceuticals" does not include excreted pharmaceuticals. 

Another source of unused pharmaceuticals is residue in used and partially-used dispensers, 

containers, and devices. Health care facilities may dispose of unused pharmaceuticals, especially 

residues, down the drain (e.g., intravenous (IV) bags emptied into the sink). For many years, a 

standard disposal practice at many health care facilities was to flush unused pharmaceuticals 

down the toilet or drain. EPA believes that facilities should not dispose of their pharmaceuticals 

down the drain. Pharmaceutical chemicals are also biologically excreted following patient use of 

drugs. Excretion is not addressed in this guidance. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 3 August 26, 2010 

2. CONDUCT AN INVENTORY OF PHARMACEUTICALS AND UNUSED PHARMACEUTICALS 

How many waste streams are generated? Before a facility can identify the best means for 

reducing waste and disposing of the waste, it must understand what the facility is throwing out. 

This section will help facilities to determine the unused pharmaceuticals being generated and 

disposed of. EPA recommends that facilities take two steps to understand their unused 

pharmaceutical generation: 

1. Develop a list of pharmaceuticals used at the facility. 

2. Identify the unused pharmaceuticals generated and how they are currently 

managed. 

2.1 Develop a List of Pharmaceuticals Used at The Facility

The first step in managing unused pharmaceuticals at health care facilities is to identify the types 

of pharmaceuticals that the facility uses. EPA recommends starting either at the on-site pharmacy 

or by contacting the pharmaceutical supplier. Most hospital pharmacies maintain a formulary—a 

list of pharmaceuticals approved for prescriptions to patients by attending physicians. The 

hospital pharmacy may also purchase pharmaceuticals not listed in the formulary to meet special 

circumstances. For this reason, purchasing records will provide a more complete list of what the 

pharmacy has in stock than the approved formulary alone. EPA suggests reviewing a 12-month 

summary of purchasing records. This initial review will assist the facility to most accurately 

categorize the unused pharmaceuticals. 

To develop a list of pharmaceuticals used at the facility, find the following information for all of 

the pharmaceuticals administered at the facility: 

 National drug code (NDC); 

 Brand name; 

 Generic name; 

 Manufacturer; 

 Dosage(s); 

 Form (i.e., liquid, tablet, cream, etc) – different forms of the same medication 

may expire more quickly or remain in stock longer; and 

 Package size. 

Using the list of pharmaceuticals prescribed at the facility, next determine how often those 

pharmaceuticals become waste. Once wasted pharmaceuticals are identified, the facility can use 

the BMPs recommended in Section 3 to reduce waste.3 In addition, by knowing what is being 

disposed of, the facility can reduce its disposal costs by finding ways to reduce waste. Also, the 

facility could reduce purchasing costs by reducing the pharmacy’s inventory of drugs that are 

identified as often being disposed. 

 

3

 Some health care facilities conduct their own inventory; others hire commercial services that have expertise in 

cataloging inventories and find that this is cost effective and less burdensome on existing staff. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 4 August 26, 2010 

2.2 Identify the Unused Pharmaceuticals Generated and How They Are Currently 

Managed

After the facility has a comprehensive list of the pharmaceuticals used, the next step in 

developing a waste management program is to identify the unused pharmaceuticals generated. 

Unused pharmaceuticals may be generated at numerous locations throughout the facility, for 

example at the pharmacy or on the nursing floor. At all possible waste locations, the facility 

should keep track of the following: 

 Pharmaceutical identification (see list in Section 2.1), including any manufacturer 

samples that need to be disposed. A good initial step is to document the amount 

and frequency of outdated (expired) samples or stock per out-patient clinic or 

medical practice area. 

 Reason for waste generation. At the pharmacy, reasons include expiration prior to 

use or spills. On the nursing floor, reasons include patient refusing medication, 

medication left behind when a patient leaves, or stopping of IV mid-stream. 

 Where the waste goes. For example, the facility might currently throw 

pharmaceuticals away in the trash, collect them for other disposal, drain them in 

the sink, or flush them down the toilet. 

EPA recommends that the facility keep track of the unused pharmaceuticals for two weeks to one 

month. This time period may differ depending on the variety and frequency of services that the 

facility provides. Seasonality may also play a role in the types and quantities of pharmaceuticals 

being used. For example, the length of time depends upon how often doctors’ offices dispose of 

expired pharmaceutical stock and samples, how often hospitals check their crash carts for 

expired medications, or how often long-term care facilities check their emergency kits for 

expired medications. Once the facility has the list of discarded pharmaceuticals, it can identify 

commonly wasted pharmaceuticals and identify reasons for the waste generation. Then, the 

facility can use the BMPs provided in Section 3 to reduce the amount wasted. See Appendix B of 

this document for a Sample Unused Pharmaceutical Tracking Sheet. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 5 August 26, 2010 

3. REDUCING OR AVOIDING UNUSED PHARMACEUTICALS

How can a health care facility reduce unused pharmaceuticals? The simplest and least expensive 

way to minimize pharmaceutical disposal is to reduce and avoid generating unused 

pharmaceuticals. During outreach activities, EPA heard many facilities give examples of the cost 

savings from smart pharmaceutical management. Buying medicine in smaller quantities means 

fewer expire. By using vouchers from pharmaceutical sales representatives instead of using free 

“sample” pharmaceuticals, facilities can eliminate an entire waste stream. This section walks 

through how many health care facilities have reduced their waste and cut costs at the same time. 

After completing a waste review as described in Section 2, the facility can determine the 

pharmaceuticals commonly wasted and the reasons. Depending on the reason for the waste 

generation, it can use the BMPs in this section to reduce waste. Typical reasons why 

pharmaceuticals become waste include the following: 

 Purchased medications expire before they are used; 

 Patient refuses the medication; 

 Pharmaceutical sales representatives leave samples that expire before they are 

used; 

 Patient dies or is transferred; 

 Patient has an adverse reaction, or is successfully treated, and stops medication; 

and 

 Dispensing or other medication error occurs. 

3.1 Review Purchasing Practices

Once the unused pharmaceutical profile is completed, the facility should review purchasing 

practices to determine ways to reduce waste. The review includes: 

 Identify any pharmaceuticals that commonly expire before use – buy less to 

reduce wasted amount. 

 Identify pharmaceuticals used by multiple departments – purchasing a standard 

package size, dose, or form can reduce waste. This allows multiple departments to 

use the same supply. 

Example: Using the same dosage form for medications used in different departments of a 

hospital can facilitate stock rotation. For example, Hennepin County Medical Center 

(HCMC) in Minnesota was using 15-gram glucose (dextrose) gel tubes in its crash boxes. 

It was also dispensing 45-gram tubes to diabetic patients. The facility’s Diabetics 

Committee recommends 30-gram doses; therefore a portion of the 45-gram tubes went 

unused. The facility switched all departments to 15-gram glucose gel tubes and was able 

to rotate short-dated tubes from crash boxes to departments with higher usage, potentially 

eliminating waste.4

 

4

 Reference: Minnesota Technical Assistance Program (MnTAP). Reducing pharmaceutical waste from patient-care 

settings. www.mntap.umn.edu/health/94-PharmWaste.htm. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 6 August 26, 2010 

3.2 Order Smaller Container Sizes or Emphasize Unit Dose Dispensing

Dispensed pharmaceuticals may go unused for a variety of reasons: patient refuses the 

medication, medicine is no longer needed or not effective, treatment or dosage changes, or 

patient is discharged. To reduce the quantity of unused pharmaceuticals, facilities may want to 

limit the number of doses dispensed to a patient at one time (unit dose packaging), use trial 

prescriptions or samples to determine medication effectiveness before writing a full prescription, 

and use smaller containers of pharmaceuticals at the pharmacy and on nursing floors. 

3.2.1 Unit Dose Dispensing 

The facility can purchase prepackaged unit doses, for example, in blister packs or bingo cards. It 

can also prepare unit doses at the on-site pharmacy for dispensing to patients (e.g., individually 

wrapped or dispensed via an automated dispensing system). By limiting the amount of 

medication dispensed to a patient at one time, unopened pharmaceuticals can more readily be 

restocked and reused. As long as the packaging is not opened and has been stored properly, the 

facility may be able to return medications to its pharmacy for reuse (i.e., prescribed to another 

patient). Reuse of unit doses to another patient is often possible at hospitals, but not always 

possible for facilities with off-site pharmacies, such as long-term care facilities. However, even if 

it is not possible for a medication to be dispensed to another patient, an off-site pharmacy will 

usually accept the return of the unused medications (excluding controlled substances) and 

dispose of them for the facility. 

Example: At the Walter Reed Army Medical Center in Washington, DC, approximately 

99 percent of the pharmaceuticals are dispensed as unit doses to reduce waste. The 

majority of unit doses are blister packs purchased from the manufacturer as unit doses. 

Other unit doses are packaged at the on-site pharmacy. For example, liquid medications 

are dispensed in 5, 15, and 30 milliliter (mL) doses. 

3.2.2 Ordering Smaller Container Sizes 

If a health care facility finds that portions of bottled liquid pharmaceuticals are going unused and 

require disposal, it may be able to purchase smaller bottles of liquid pharmaceuticals and reduce 

the amount wasted. Using smaller container sizes and reducing waste has the additional benefit 

of reducing the purchasing costs related to the pharmaceutical. 

Example: The Marshfield Clinic in Wisconsin uses lidocaine in small amounts. Rather 

than purchasing lidocaine in 50 milliliter (mL) bottles that need to be discarded 30 days 

after opening, the clinic began purchasing 15 mL vials or smaller to minimize wasted 

medication. This change also reduced the purchasing costs for lidocaine. 

3.2.3 Trial Prescriptions 

Certain medications have high incidences of side effects, and patients frequently stop taking the 

medication before the dispensed quantity is used. For these medications, EPA recommends that 

pharmacies use “trial prescriptions” in which only a small quantity (e.g., 7 to 14 day supply) is 

dispensed. If the patient stops taking the medication, the unused amount is reduced. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 7 August 26, 2010 

Title III of the Affordable Care Act (2010) includes Section 3310, “Reducing wasteful 

dispensing of outpatient prescription drugs in long-term care facilities under prescription drug 

plans and MA-PD (Medicare Advantage Prescription Drug) plans.” This section limits the 

number of days (no more than 7) that a long-term care facility can provide prescription supplies 

to residents. This amendment takes effect January 1, 2012. 

Example: MaineCare, the Medicaid health insurance program managed by the Maine 

Department of Health and Human Services, instituted a new 15-day limit on initial 

prescriptions for certain medications they identified as having high rate of waste. These 

are medications that have high side effect profiles, high discontinuation rates, or require 

frequent dose adjustments. In addition to reducing wasted medication, MaineCare’s 

policy aims to control health care costs. 

3.3 Replace Pharmaceutical Samples with Vouchers

Pharmaceutical sales representatives often provide sample medications to health care facilities. 

These samples can then be provided to patients at no cost as trial prescriptions. The use of 

sample medications is more common at doctors’ offices and clinics than at hospitals and longterm care facilities. If the samples expire prior to use, the health care facility must properly 

dispose of the unused pharmaceuticals. 

To reduce waste, EPA recommends that health care facilities replace the use of samples with 

manufacturer vouchers which the patient takes to the pharmacy for a free sample. This 

minimizes generation of waste from expired sample medications. Another approach is to accept 

only samples of the pharmaceuticals most frequently prescribed in each clinic. 

Example: The Marshfield Clinic in Wisconsin discourages their individual offices and 

clinics from accepting samples from pharmaceutical manufacturing company 

representatives. Instead, clinics and doctors’ offices provide their patients with vouchers, 

which the patients take to a retail pharmacy for a free sample. If the pharmaceutical 

manufacturing company does not have a voucher system in place, Marshfield Clinic 

requires that the company representative remove the samples from the clinic before their 

expiration date. 

3.4 On-Going Waste Reduction/Avoidance Practices: Inventory Control and Stock 

Rotation

3.4.1 On-Going Inventory Control 

Once the initial inventory review is complete, a periodic review of the inventory should be 

established. This periodic inventory review will allow the list of pharmaceuticals to be updated 

and will aid the facility in identifying pharmaceuticals nearing expiration. Finally, this review 

will allow the facility to determine whether its waste reduction practices are working. 

3.4.2 Stock Rotation 

Stock rotation is a practice to reduce expired pharmaceuticals. During the periodic inventory 

review, any short-dated pharmaceuticals are redistributed to other areas of the facility where they 

are needed and used immediately. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 8 August 26, 2010 

Example: Fairfax-Northern Virginia Hematology-Oncology is a network of six clinics in 

the Northern Virginia area. The Fairfax location houses the IV admixture service, which 

is the central pharmaceutical distribution point for all of the other facilities. Each satellite 

facility receives a daily delivery of patient-specific doses prepared in most cases the day 

before treatment. Any pharmaceuticals that are not used are returned to the admixture 

site. If possible based on stability and dose, the returned pharmaceuticals are used at a 

later date. 

Example: The Walter Reed Army Medical Center in Washington, DC uses an automated 

dispensing system to distribute 95% of all pharmaceuticals. These machines are primarily 

used to ensure patient safety and for tracking pharmaceutical distribution, but the facility 

has found that a secondary use is for inventory control and reduction of overstocking 

certain pharmaceuticals. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 9 August 26, 2010 

4. IDENTIFYING & MANAGING TYPES OF UNUSED PHARMACEUTICALS AND APPLICABLE 

DISPOSAL REGULATIONS

Can the facility send the unused pharmaceutical back to the pharmacy for reuse? How many of 

the facility pharmaceuticals are hazardous waste? How should the facility dispose of controlled 

substances? This section will help answer these questions. 

After waste reduction measures are taken, EPA recommends the following general practices for 

managing unused pharmaceuticals: 

 Reuse unopened pharmaceuticals where possible: either through the pharmacy or 

through state donation programs. 

 Send creditable pharmaceuticals to reverse distributors. Reverse distributors are 

private companies that provide a service to the health care industry by keeping 

track of manufacturer unused pharmaceutical reimbursement policies, and thus 

get facilities credit for the pharmaceuticals prior to sending them off-site for 

disposal. Reverse distributors are registered with the Drug Enforcement Agency 

(DEA) and are authorized under the Controlled Substances Act to handle 

controlled substances that are unused, outdated, or unwanted. Under current law, 

reverse distributors, however, are only permitted to accept controlled substances 

from other DEA registrants. EPA recommends that facilities consult with their 

state regulatory agency to ensure compliance with all state environmental 

regulations when unused pharmaceuticals are sent to reverse distributors. 

 Hospital/clinic’s and doctor’s controlled substance stock can be transferred to a 

reverse distributor for disposal. 

 Practice proper on-site waste management and waste disposal. Consider using a 

contracted waste management provider for pharmaceutical waste (specialty waste 

hauler). 

A facility must meet federal and state requirements for managing unused pharmaceuticals. There 

are federal statutes and programs that regulate the management and disposal of unused 

pharmaceuticals, including: 

 The Controlled Substances Act (CSA). Administered by the DEA, CSA 

provides a closed system for distributing controlled substances. As part of this 

system, DEA prohibits the return of controlled substances from end-users to 

nearly all DEA registrants, including pharmacies, hospital staff, and clinic 

employees. In certain cases, a full duty law-enforcement agent5

 is allowed to 

accept a controlled substance. Disposal of controlled substances by DEA 

registrants is carefully regulated to ensure that the substance is destroyed. 

Voluntary survey submittals, outreach meetings, and site visits indicate that 

disposing of controlled substances down the drain is a common practice to ensure 

 

5

 An agent is “any officer or employee of any state, or any political subdivision of agency thereof, who is engaged in 

the enforcement of any state or local law relating to controlled substances and is duly authorized to possess 

controlled substances in the course of his/her official duties.” 21 CFR 1301.24(a)(2) 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 10 August 26, 2010 

destruction of controlled substances due to its affordability and ease. However, 

EPA is recommending BMPs in this guidance to reduce and avoid drain disposal. 

 The Resource Conservation and Recovery Act (RCRA). RCRA gives EPA the 

authority to control hazardous waste from “cradle-to-grave.” This includes the 

generation, transportation, treatment, storage, and disposal of hazardous waste. 

Some pharmaceuticals may be considered RCRA hazardous wastes upon discard. 

As a result, health care facilities may have to comply with RCRA laws and 

regulations for the generation, transportation, storage, treatment, and ultimate 

disposal of some pharmaceuticals. Many states are authorized by EPA to 

implement their own hazardous waste programs in lieu of the federal RCRA 

program. States’ hazardous waste regulations may be broader or more stringent 

than the federal RCRA program. Therefore, health care facilities should contact 

their state environmental regulatory agency to ensure full compliance. 

 The Centers for Medicare & Medicaid Services (CMS). CMS is a federal 

agency within the Department of Health and Human Services (HHS) that 

administers the Medicare and Medicaid programs. Medicare provides health 

insurance to elderly and disabled Americans, while Medicaid provides health 

insurance for low income Americans, including long-term care coverage. While 

Medicare is a federal program, Medicaid is a state-run program that is partly 

funded by federal dollars. Therefore, many Medicaid requirements are set at the 

state level, including regulations for management of unused pharmaceuticals. The 

primary role of CMS is to pay for medical products and services through the 

Medicaid and Medicare programs. CMS does not directly regulate pharmaceutical 

disposal. These policies are determined by each state’s board of pharmacy and 

state health departments as well as any federal regulations. 

 The Health Insurance Portability and Accountability Act (HIPAA). The 

Department of HHS administers HIPAA, which provides protection for the 

privacy of certain individually identifiable health data, such as the names of 

medications taken by patients. Before a patient's unused pharmaceuticals are 

disposed of from the health care facility, personal information on the container 

should be removed or obscured. 

This section describes how to identify and properly manage waste under these federal laws. 

Appendix A provides additional information on state and local requirements and programs. Note 

that state and local requirements may be broader or more stringent than federal requirements, so 

it is important to check requirements for the corresponding state and locality. Each subsection 

provides guidance for managing and disposing of each type of unused pharmaceutical. Table 3 at 

the end of this section presents EPA’s recommended practices for unused pharmaceuticals by 

type and form. 

4.1 Types of Unused Pharmaceuticals 

Unused pharmaceuticals include expired medications, unwanted medications (e.g., 

patient/resident discontinues use), and waste medication (e.g., patient/resident refuses to take or 

spits out). Unused pharmaceuticals are generated at health care facilities before, during, and after 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

treatment, as well as during stocking activities needed to ensure sufficient materials are available 

for regular care. In order to properly manage unused pharmaceuticals, the facility needs to 

identify the types of materials on site, including: 

 Nonwaste (i.e., reusable or returnable medications); 

 Hazardous waste, including dual wastes (hazardous and biohazardous); 

 Nonhazardous waste; 

 Controlled substances; and 

 Chemotherapeutic pharmaceuticals. 

Figure 1 presents a summary flowchart to assist facilities in identifying proper management 

methods. The flowchart provides a summary of the unused pharmaceutical types and how to 

manage them; a more complete explanation of how to manage unused pharmaceuticals follows 

the chart. 

4.2 Nonwaste Medications – Pharmaceutical Reuse 

Many health care facilities return their unused pharmaceuticals, or at least a portion of them, to 

the dispensing pharmacy. Upon receipt, the pharmacy determines how the unused 

pharmaceuticals should be managed, including: 

 Credit and reuse of medication; 

 Donation of medication to state programs; 

 Credit and disposal of the unused pharmaceuticals; and 

 Disposal of the unused pharmaceuticals. 

To determine whether stock unused medication can be reused or donated following return to the 

facility’s pharmacy, ask the following questions: 

DRAFT 11 August 26, 2010 

 Is the medication in the original 

packaging or still in prepackaged 

unit doses from the pharmacy? 

Reuse of Medications 

When patients pay for part of the 

medication (and the remaining cost is 

covered by Medicare Part D and/or 

private insurance), long-term care facility 

pharmacies typically cannot give credit 

to the patient for returned medicines. 

They are unable to give partial credit to 

the patient under existing Medicare and 

private insurance financial tracking 

systems. Thus, the long-term care facility 

pharmacies can accept the returned 

medicines (excluding controlled 

substances

 Is the expiration date a future date at 

least six months out? 

 Is the label intact? Is all the 

information for the medication such 

as type, dose, and expiration date 

clearly marked? 

 Has the medication been properly 

stored, such as within the proper 

ranges for temperature, humidity, 

and light? ), but can not resell them.
Best Management Practices for Unused Pharmaceuticals at Health Care 

12 

Figure 1. Summary Unused Pharmaceutical Management Flow Chart 

DRAFT 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 13 August 26, 2010 

If the facility answers “yes” to all the above questions, it might be able to return the unused 

medication to the pharmacy for reuse, or the pharmacy may be able to donate the unused 

medication to charitable institutions, such as programs that assist lower-income patients (state 

repository programs). State boards of pharmacy set policies for the return and reuse of unused 

pharmaceuticals. Although the policies vary by state, most allow reuse of uncontaminated 

medications that have been in a controlled environment, excluding controlled substances. 

Medications that can be reused are typically solid doses such as pills, tablets, and capsules that 

do not require special handling for temperature such as refrigeration. The pharmacy must remove 

any patient-specific information from the medication before donating. 

If the facility answers “no” to any of the above questions, the pharmacy cannot reuse the unused 

medication. However, the pharmacy may accept returns of pharmaceuticals for credit or for 

proper disposal. To receive credit from the pharmaceutical manufacturer, pharmacies send the 

unused medication to a reverse distributor for potential credit and eventual disposal. The reverse 

distributor determines which medications can receive credit from the manufacturer and then 

arranges for disposal of the unused and/or expired medications. Health care facilities and 

pharmacies should confer with state and/or local environmental agencies to ensure regulatory 

compliance when using reverse distributors. 

If the health care facility cannot return the unused medication to the pharmacy and it must be 

discarded, the unused medication becomes waste and the facility must follow applicable federal, 

state, and local laws and ordinances for waste disposal. The following subsections describe 

management options for unused pharmaceuticals depending on their classification. 

4.3 Identifying Hazardous Vs. Nonhazardous Waste

Federal hazardous waste law (the Resource Conservation and Recovery Act, or RCRA), its 

implementing regulations, and state regulations define hazardous wastes. Some state hazardous 

waste requirements may be broader or more stringent than federal requirements. The discussion 

in this subsection is only for reference and is not intended to be used as a substitute for RCRA 

itself or its implementing regulations, contained in the Code of Federal Regulations (CFR). 

Finally, failing to comply with RCRA can result in the initiation of enforcement actions against 

the facility. 

To be classified as a hazardous waste under RCRA, the waste must be listed in EPA regulations 

at 40 CFR 261 or exhibit certain characteristics. Thus, a pharmaceutical waste may be considered 

hazardous under RCRA if: 

1. The pharmaceutical or its sole6

 active ingredient is specifically listed on 

— The P List: Acutely Hazardous Waste (40 CFR 261.33(e)) or 

— The U List: Discarded Commercial Chemical Products (40 CFR 

261.33(f)); and/or 

 

6

 Many pharmaceuticals have more than one active ingredient. If the pharmaceutical contains an active ingredient 

that is on the P List or U List AND the pharmaceutical has more than one active ingredient (i.e., not “sole” 

ingredient), then that pharmaceutical waste does not meet RCRA’s definition of a listed hazardous waste. However, 

the pharmaceutical waste may still be hazardous waste if it exhibits characteristics of hazardous waste. Although 

pharmaceutical waste with more than one active ingredient does not meet RCRA’s definition of a listed hazardous 

waste, EPA recommends that health care facilities still manage the waste as RCRA hazardous waste. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 14 August 26, 2010 

2. The waste exhibits one or more hazardous waste characteristic as defined in 40 

CFR 261.21-24, (ignitability, corrosivity, reactivity, or toxicity). 

Many health care facilities also use the National Institute for Occupational Safety and Health 

(NIOSH) list of hazardous materials to identify additional unused pharmaceuticals that should be 

handled similarly to waste defined as hazardous under RCRA. Although RCRA does not require 

facilities to manage NIOSH listed hazardous materials the same as RCRA hazardous waste, EPA 

recommends that the NIOSH-listed hazardous materials be managed using RCRA guidelines as a 

BMP. 

The P and U- Listings (40 CFR 261.33 (e) and (f)) 

A waste pharmaceutical can meet RCRA’s definition of hazardous waste if the pharmaceutical 

(including its generic name) or the sole active ingredient of the pharmaceutical is listed on 

RCRA’s P List or U List. P-listed and U-listed wastes fall under the hazardous waste definition 

included at 40 CFR 261.33, Discarded commercial chemical products, off-specification species, 

container residues, and spill residues thereof. Once the decision is made to discard of the unused 

pharmaceutical, the health care facility must identify whether or not the pharmaceutical 

(including its generic name) or the pharmaceutical’s sole-active ingredient appears on the P-List 

or U-List. 

If the pharmaceutical (including its generic name) or its sole active ingredient is a P- or U-listed 

waste, then the health care facility must manage that waste pharmaceutical as a hazardous waste 

in accordance with all applicable federal, state and local environmental regulations7

. 

Table 1 lists examples of P- and U-listed commercial chemical products that have 

pharmaceutical uses. 

Table 1. Examples of Active Pharmaceutical Ingredients that are Considered Hazardous 

Under RCRA (P-Listed and U-Listed) 

Pharmaceutical Name No. Pharmaceutical Name No. 

P-Listed 

Arsenic trioxide (chemotherapy drug) P012 Phentermine (controlled substance) P046 

Epinephrine (a) P042 Physostigmine P204 

Nicotine P075 Physostigmine salicylate P188 

Nitroglycerin (b) P081 Warfarin >0.3% P001 

U-Listed 

Azaserine (chemotherapy drug) U015 Mitomycin C (chemotherapy drug) U010 

Chloral hydrate (controlled substance) U034 Paraldehyde (controlled substance) U182 

Chlorambucil (chemotherapy drug) U035 Phenacetin U187 

Chloroform U044 Phenol U188 

Cyclophosphamide (chemotherapy drug) U058 Reserpine U200 

Daunomycin (chemotherapy drug) U059 Resorcinol U201 

 

7

 Note that the applicable regulations will depend on the quantity of waste generated each month, as described in 

Section 4.3.1. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 15 August 26, 2010 

Table 1. Examples of Active Pharmaceutical Ingredients that are Considered Hazardous 

Under RCRA (P-Listed and U-Listed) 

Pharmaceutical Name No. Pharmaceutical Name No. 

Dichlorodifluromethane U075 Saccharin U202 

Diethylstilbestrol U089 Selenium sulfide U205 

Hexachlorophene U132 Streptozotocin (chemotherapy drug) U206 

Lindane U129 Trichloromonofluromethane U121 

Melphalan (chemotherapy drug) U150 Uracil mustard (chemotherapy drug) U237 

Mercury U151 Warfarin <0.3% U248 

Source: Practice Greenhealth. 2008. Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care 

Facilities in the United States. Revised August 2008. Accessed online at: 

http://www.practicegreenhealth.org/page_attachments/0000/0102/PharmWasteBlueprint.pdf; Washington 

Department of Ecology Example RCRA Waste Codes for Pharmaceuticals. Accessed online at: 

http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/pages/pu_metals.html. For a complete listing of discarded 

commercial chemical products found on RCRA’s P- and U-lists, please see 40 CFR 261.33(e) and (f), respectively, 

at http://www.epa.gov/wastes/hazard/wastetypes/listed.htm. 

a – The Agency clarified its regulation at 40 CFR 261.33, explaining that epinephrine salts are not included in the 

epinephrine P042 listing; therefore, the waste epinephrine salt would be hazardous only if it exhibited one or more 

of the hazardous waste characteristics. Please confer with state and/or local environmental regulatory authorities to 

determine if this clarification is accepted in that state. (See “Scope of Hazardous Waste Listing P042(Epinephrine),” 

October 15, 2007, RCRA Online# 14778: http://yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/2f701627eb73b2ab852573d2005e0b4f!OpenDocument). 

b – Medicinal nitroglycerin may be excluded from the listing as it typically does not exhibit the characteristic of 

reactivity (for which nitroglycerin was listed). Please confer with state and/or local environmental regulatory 

authorities to determine if this exclusion is accepted in that state. (See “Regulation of Nitroglycerin Under Revised 

Mixture and Derived-From Rules,” March 18, 2003, RCRA Online# 14654: http://yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/7acfec572de8897f85256d1600748bcb!OpenDocument). 

RCRA Hazardous Waste Characteristics (40 CFR 261. 21-24) 

If it is determined that the waste pharmaceutical is not a listed hazardous waste, then the health 

care facility must determine if that waste pharmaceutical meets one of RCRA’s hazardous waste 

characteristics. The generator of the waste can either use a standardized test method or apply 

general knowledge of the waste’s properties in making this determination. Examples of RCRA 

hazardous waste characteristics exhibited by pharmaceutical wastes include the following8

: 

 Ignitability (D001): the presence of a flammable solvent is the most common 

reason pharmaceuticals meet this characteristic. For alcohol, RCRA sets a 

threshold limit of 24% (i.e., if the formulation contains more than 24% alcohol, 

then the waste is considered hazardous waste). Strong oxidizers, such as silver 

nitrate and potassium permanganate, in pharmaceutical formulations may also 

meet the definition of ignitability. 

 

8

 Source: Healthcare Environmental Resources Center, Pharmaceutical Wastes in Health Care Facilities. Accessed 

online at: http://www.hercenter.org/hazmat/pharma.cfm
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 16 August 26, 2010 

 Corrosivity (D002): applies to strong acids (pH≤2) or strong bases (pH≥12.5). In 

pharmaceutical compounding, glacial acetic acid and concentrated sodium 

hydroxide might be used. Their wastes are corrosive and thus considered 

hazardous. 

 Reactivity (D003): nitroglycerin, a P-listed hazardous waste, would fall into this 

category if used in bulk. However, dosage forms typically do not exhibit 

characteristics of reactivity9

: 

 Toxicity (D004 to D043): The toxicity characteristic (TC) identifies wastes that 

are likely to leach concentrations of any one of 40 different toxic chemicals in 

amounts above the specified regulatory levels. Examples of TC chemicals/heavy 

metals that have pharmaceutical uses and their toxicity threshold levels are: 

— Arsenic (D004): 5.0 mg/L; 

— Barium (D005): 100.0 mg/L; 

— Cadmium (D006): 1.0 mg/L; 

— Chloroform (D022): 6.0 mg/L; 

— Chromium (D007): 5.0 mg/L; 

— m-Cresol (D024): 200 mg/L; 

— Lindane (D013): 0.4 mg/L; 

— Mercury (D009): 0.2 mg/L; 

— Selenium (D010): 1.0 mg/L; and 

— Silver (D011): 5.0 mg/L. 

4.3.1 Requirements for Managing Hazardous Waste 

Any facility that generates a hazardous pharmaceutical waste is subject to the RCRA generator 

regulations at 40 CFR 262.10 Under the federal program there are three RCRA hazardous waste 

generator categories, and the extent of the requirements for each generator category is defined by 

the amount of hazardous waste generated in a calendar month. A facility that generates 1000 

kilograms (kg) or more of hazardous waste in a month, or greater than 1 kg of acute (P list) 

hazardous waste in a month is a large quantity generator (LQG). LQGs are subject to the full 

extent of the RCRA generator regulations (see 40 CFR 262). For example, LQGs must: 

 Obtain an EPA identification number; 

 Can store waste for only 90 days (accumulation requirement) or otherwise obtain 

a RCRA permit; 

 Meet manifest and reporting requirements; and 

 Comply with certain training requirements. 

 

9

 If a listed hazardous waste is listed solely because it exhibits the characteristics of ignitability, corrosivity and/or 

reactivity, and the waste at its point of generation no longer exhibits the characteristic for which it was listed, then it 

is not a hazardous waste (66 FR 27286, May 16, 2001). Since local and state regulations may be broader or more 

stringent than the federal regulations, EPA recommends the regulated community contact their local regulatory 

authorities to determine if this exemption applies in their states. 

10 For more information regarding the various federal RCRA generator requirements, please see the following links: 

http://www.epa.gov/epawaste/hazard/generation/summary.htm and 

http://www.epa.gov/epawaste/hazard/downloads/tool.pdf 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 17 August 26, 2010 

If a facility generates more than 100 kg but less than 1000 kg of hazardous waste in a month, 

then it is a small quantity generator (SQG). SQGs are subject to fewer requirements than LQGs. 

For example, SQGs do not need to complete a biennial report, and SQGs have fewer personnel 

training and contingency planning requirements than LQGs (see 40 CFR 262.34(d)(5)). 

Moreover, SQGs must meet the 180 day (rather than the 90 days for LQGs) accumulation 

requirements or otherwise obtain a RCRA permit. 

A facility generating no more than 100 kg of hazardous waste in a month, or no more than 1 kg 

of acutely hazardous waste (P list) in a month, is a conditionally-exempt small quantity generator 

(CESQG) under the federal program. CESQGs have the least stringent requirements of all 

generators (see 40 CFR 261.5). For example, CESQGs are not required to obtain an EPA 

identification number, manifest waste sent off-site for disposal, or meet any storage time limits. 

In addition, under the federal regulations, CESQGs can send hazardous wastes to either a stateapproved solid waste facility or to a hazardous waste disposal facility. States authorized to 

implement the RCRA hazardous waste program may have broader or more stringent generator 

requirements than the federal RCRA program, so facilities should contact their state 

environmental regulatory agency to ensure full compliance. 

The discussion on handling hazardous waste in this document assumes the health care facility is 

a SQG or LQG. Some health care facilities will fall into the CESQG category and certain federal 

RCRA hazardous waste requirements will not apply. For example, under federal regulations, a 

CESQG can send hazardous waste to certain nonhazardous waste facilities11. This document 

provides suggestions on how to best handle unused pharmaceuticals that are hazardous wastes, 

regardless of the generator size. 

Federal regulations also require that hazardous wastes from SQGs and LQGs be transported in 

approved containers by an authorized hazardous waste transporter and transported to permitted 

hazardous waste treatment, storage, and disposal facilities. RCRA also prohibits health care 

facilities that qualify as small quantity or large quantity generators of hazardous waste from 

disposing of hazardous pharmaceutical waste in solid waste landfills, solid waste incinerators, or 

hospital/medical/infectious waste incinerators (40 CFR 268). Hazardous waste from SQGs and 

LQGs cannot be collected with biohazardous (red bag) waste for sterilization as the 

sterilized waste is disposed in solid waste landfills. As a BMP, EPA recommends that all 

health care facilities, regardless of generator size, should not dispose of hazardous waste 

with red bag waste. Also, some states require hazardous waste that is also biohazardous 

(infectious) to be disposed of as “dual” wastes. Health care facilities should check state 

hazardous waste requirements as they may be broader or more stringent than the federal 

requirements. 

4.3.2 Recommended Management of Hazardous Pharmaceutical Waste 

Health care facilities must comply with RCRA requirements for the management and disposal of 

hazardous pharmaceutical waste. Waste may be disposed of via incineration at a hazardous waste 

incinerator or in a hazardous waste landfill after the waste is treated under the Land Disposal 

Restrictions program (see http://www.epa.gov/epawaste/hazard/tsd/ldr/resource.htm). Hazardous 

 

11 The EPA CESQG Landfill/Municipal Solid Waste Landfill regulations do not require state approval of a facility. 

The regulations apply to all facilities without state action, although in practice most states have permitting programs 

in place. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 18 August 26, 2010 

pharmaceutical waste is most commonly treated by hazardous waste incineration, with the 

resulting incinerator ash disposed in a permitted hazardous waste landfill. EPA recommends 

segregation of hazardous waste (rather than handling all waste as hazardous). Because only 

approximately 5% of all pharmaceutical waste is hazardous, it may be more expensive to dispose 

of all pharmaceutical waste (hazardous and nonhazardous) as hazardous waste. Facilities should 

then follow the applicable federal and state regulations for proper disposal. EPA also 

recommends that health care facilities collect, store, and package hazardous waste oxidizers 

separately from other hazardous waste. Links to state waste programs are available at: 

http://www.epa.gov/epawaste/wyl/stateprograms.htm. 

4.3.3 Definition of RCRA-Empty Containers 

Under 40 CFR 261.7, empty containers of hazardous waste are not subject to hazardous waste 

regulations under RCRA (40 CFR 261 through 265, 267, 268, 270, or to the notification 

requirements of section 3010). However, if the container does not meet the definition of “RCRAempty,” the container must be disposed of as a hazardous waste and meet all the RCRA 

requirements. Table 2 presents the definition of “empty containers” under RCRA. 

Table 2. RCRA Definition of “Empty Containers” 

Type of RCRA Waste RCRA Definition of Empty Container 

Acute Hazardous Waste (e.g., PListed) (i) The container or inner liner has been triple rinsed using a solvent 

capable of removing the commercial chemical product or manufacturing 

chemical intermediate a

 ; 

(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. 

Toxic Waste (U-Listed and 

Characteristic Hazardous Wastes) 

(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, and 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. 

Compressed Gas Containers A container that has held a hazardous waste that is a compressed gas is 

empty when the pressure in the container approaches atmospheric. 

Source: 40 CFR 261.7 

a – The rinsates from the triple-rinsing of containers which have held commercial chemical products listed in 40 

CFR 261.33(e) are also RCRA hazardous wastes (see 40 CFR 261.3(a)(2)(iv)). 

Triple rinsing at health care facilities is not always practical. Therefore, facilities often dispose of 

all vials, IVs, and other containers that have held P-listed pharmaceuticals as hazardous wastes 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 19 August 26, 2010 

even if “empty.” Some states exclude certain containers from inclusion as hazardous waste. 

These containers may include those that held solid pharmaceutical doses (i.e., tablets, capsules, 

and patches) and empty warfarin stock bottles and unit-dose packaging. 

For syringes containing P-listed or U-listed pharmaceuticals, used syringes do not need to 

be handled as hazardous waste as long as no characteristic hazard remains (i.e., ignitability, 

corrosivity, reactivity, or toxicity). EPA issued this interpretation in 1994 for the P-listed 

pharmaceutical epinephrine. In an April 2008 letter12, EPA extended this interpretation to all Plisted or U-listed pharmaceuticals. 

4.3.4 Proposed Universal Waste Rule 

In December 2008, EPA proposed adding hazardous pharmaceutical wastes to the Universal 

Waste Rule in order to provide an alternate system for management of hazardous pharmaceutical 

wastes that is protective of public health and the environment. The proposed addition is intended 

to make it easier for generators to collect and properly dispose of these items as hazardous 

wastes, resulting in a simpler and more streamlined waste management system. This proposed 

rule would apply to pharmacies, hospitals, doctors’ offices, dentists’ offices, outpatient care 

centers, ambulatory health care services, residential care facilities, veterinary clinics, and other 

facilities that generate hazardous pharmaceutical wastes. 

Under the proposed universal waste program, generators of hazardous pharmaceutical wastes 

will have the option of managing these wastes as “universal wastes.” If the facility chooses to 

manage its hazardous pharmaceutical waste under the proposed universal waste option once the 

rule is finalized and adopted by its state, then the facility will become a “handler” of 

pharmaceutical universal waste, rather than a “generator” of hazardous pharmaceutical waste. 

Compared to a generator of hazardous pharmaceutical waste, as a handler of pharmaceutical 

universal waste, the facility will have the following benefits: 1) an increased accumulation 

volume threshold for small quantity handlers; 2) an increased on-site accumulation time limit; 3) 

no manifest requirement; and 4) simplified training requirements. 

Currently, EPA is reviewing public comments received on the proposed rule. EPA expects that 

this rule will be finalized in 2011. This draft guidance document will be updated to reflect the 

final rule. 

 

12 Available online at: http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/

6A5DEDF2FBA24FE68525744B0045B4AF/$file/14788.pdf
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

4.4 Recommended Management of Nonhazardous Unused Pharmaceuticals

DRAFT 20 August 26, 2010 

Red Bags/Sharps Containers Should Not 

Be Used 

As a best management practice, unused 

pharmaceuticals should not be disposed of 

with biohazardous waste or red bag waste. 

Biohazardous waste is typically sterilized 

(e.g., in an autoclave) prior to disposal in 

landfills. The temperature achieved during 

autoclaving is insufficient to destroy most 

pharmaceutical ingredients. During 

sterilization, wastewater potentially 

containing pharmaceuticals may be 

generated and discharged to the sewer, 

through which it reaches waterways. 

EPA’s goal is to keep pharmaceuticals out 

of U.S. waters. 

Nonhazardous13 pharmaceuticals include both 

controlled and non-controlled substances. 

Section 4.5 outlines how EPA recommends that 

health care facilities manage controlled 

substances that are not hazardous waste under 

RCRA. For unused non-controlled 

pharmaceuticals, EPA recommends that health 

care facilities send the pharmaceuticals to a 

reverse distributor for potential credit and proper 

disposal14. For unused non-controlled 

pharmaceuticals that cannot be sent to a reverse 

distributor, EPA recommends that the facility 

segregate the nonhazardous pharmaceutical 

wastes from other solid wastes. Nonhazardous 

pharmaceutical waste should not be sewered, but 

rather should be disposed in a solid waste landfill 

or incinerated in a solid waste incinerator15. 

When commingling nonhazardous 

pharmaceutical waste with other solid waste, EPA recomm

Use of Specialty Waste Haulers by Hospitals 

The hospital pharmacies that EPA visited used 

specialty waste haulers for their segregated 

nonhazardous pharmaceutical waste. 

ends that the facility: 

 

1. Take the medication out of the original containers. 

2. Mix medication, either liquid or solid, with an undesirable substance. Undesirable 

substances include sand, coffee grounds, kitty litter, or other absorbent materials. 

3. Place the waste mixture in a 

sealable bag, empty can, or 

other container to prevent 

leakage. 

4. Dispose with the solid waste 

(i.e., regular trash). 

EPA also recognizes that there are drug disposal kits and drug removal technologies available for 

use by health care facilities. EPA does not recommend or endorse a particular product for health 

care facilities. EPA does acknowledge that these technologies may be effective. 

If the facility segregates and manages its unused pharmaceuticals separately from other solid 

wastes and uses a specialty waste hauler for the pharmaceutical waste, the facility may not need 

to mix medication with an undesirable substance. Any waste identified as hazardous should be 

disposed as discussed in Section 4.3. 

13 Nonhazardous: not a federally-listed or state-listed hazardous waste and does not meet a federal or state hazardous 

waste characteristic. 

14 EPA strongly recommends that the state regulatory agency is consulted to ensure compliance with all state 

environmental regulations when unused pharmaceuticals are sent to reverse distributors. 

15 Nonhazardous wastes (or solid wastes) are regulated at the state or local level. Please contact the state regulatory 

agency for restrictions on the disposal of nonhazardous pharmaceutical wastes in solid waste landfills. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 21 August 26, 2010 

4.4.1 Chemotherapy Pharmaceuticals 

Health care facilities generate trace chemotherapy waste (yellow bag waste), hazardous 

chemotherapy waste (sometimes referred to as bulk chemotherapy waste), and nonhazardous 

chemotherapy waste. Trace chemotherapy waste includes empty IV bags, tubings, gowns, etc. 

that may be contaminated with nonhazardous chemotherapy pharmaceuticals. Yellow bags with 

trace chemotherapy waste are typically picked up by a specialty waste hauler and disposed of via 

medical waste incineration. Hazardous waste from chemotherapy treatment and non-RCRAempty16 containers that once contained hazardous chemotherapy pharmaceuticals must be 

managed in accordance with applicable hazardous waste regulations, as described in Section 4.3. 

While not all chemotherapy pharmaceutical waste may be regulated as hazardous under the 

federal RCRA regulations, EPA recommends that facilities manage all unused chemotherapy 

pharmaceuticals as hazardous waste as a best management practice. 

4.4.2 Radioactive Pharmaceuticals 

Collect and store radioactive pharmaceutical waste in accordance with NRC regulations (10 CFR 

Part 20). Radioactive pharmaceuticals that are also RCRA hazardous wastes when disposed (i.e., 

mixed wastes) are regulated by multiple agencies. The hazardous portion is regulated by EPA or 

the authorized state, while the radioactive component of the waste is regulated under the Atomic 

Energy Act (AEA) by either the NRC or the Department of Energy (DOE).17 Section 1006 of 

RCRA states that if RCRA regulations are inconsistent with the AEA requirements, then the 

RCRA regulations do not apply. Therefore, if a facility managing a mixed hazardous 

pharmaceutical waste under RCRA subtitle C encounters RCRA requirements that are 

inconsistent with the AEA requirements, the AEA requirements apply. However, as 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 non-compliance with the other and 

relief from an inconsistency would be limited to that specific RCRA requirement, and that the 

determination of inconsistency would not relieve the generator from all other RCRA 

requirements. 

4.5 Identifying Controlled Substances

The Drug Enforcement Administration (DEA) regulates the distribution, shipping, and transfer 

of controlled substances. The Controlled Substances Act (CSA) includes requirements for 

transferring (recordkeeping) controlled substances (e.g., narcotics, opiates, and stimulants). For a 

list of controlled substances, go to the following DEA Office of Diversion Control website: 

http://www.deadiversion.usdoj.gov/schedules/index.html. Some example pharmaceuticals on the 

controlled substance list include the following: 

 Codeine; 

 Diazepam; 

 Dextropropoxyphene dosage forms (e.g., propoxyphene); 

 

16 See Section 4.3.2 for the definition of RCRA-empty. 

17 The NRC regulates radioactive wastes generated by commercial entities or non-DOE facilities, whereas DOE 

regulates radioactive wastes generated by DOE facilities. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 22 August 26, 2010 

 Fentanyl; 

 Hydrocodone; 

 Hydromorphone and Hydrocodone combination product; 

 Lorazepam; 

 Morphine; and 

 Oxycodone. 

4.5.1 Requirements for Managing Controlled Substances 

The CSA has specific requirements on how to handle controlled pharmaceuticals. These 

requirements prohibit the transfer or shipping of controlled substances from health care facilities 

to any other entity, unless the transfer occurs between DEA registrants. As a result, a health care 

facility can send unused stock of controlled substance pharmaceuticals to another facility for 

reuse or disposal if both facilities are DEA registrants. 

If the facility is a DEA registrant, such as a pharmacy, hospital, or a practitioner, the facility has 

options for disposing of an unused controlled substance. It may destroy the unused 

pharmaceutical in accordance with state guidance and with appropriate documentation; or send 

the waste to a DEA-registered reverse distributor18. 

If the facility is a non-DEA registrant, such as a long-term care facility, it must directly dispose 

of controlled substances, except that DEA allows returns when the storage, dispensing, and 

returning occurs using an automated dispensing system (ADS) operated by a DEA-registered 

pharmacy. 

A health care facility cannot return patient dispensed (even unit dosing) controlled substances. If 

pharmaceuticals have been dispensed under a prescription, the controlled substance cannot be 

sent to a registrant. Non-DEA registrants may dispose of controlled substances upon instruction 

by DEA Special Agents in Charge. This procedure involves the non-DEA registrant submitting a 

letter to the local DEA Special Agent in Charge. The letter must include: 

 Name and address of the person; 

 Name and quantity of each controlled substance to be disposed of; 

 How the applicant obtained the controlled substance, if known; and 

 Name, address, and registration number of the person who possessed the 

controlled substance prior to the applicant, if known. 

Provided such disposal is permissible under the CSA, the Special Agent in Charge shall 

authorize and instruct the applicant to dispose of the controlled substance through any of the 

following methods: 1) transfer of the substance to a person registered under the CSA and 

authorized to possess the substance; 2) delivery to an agent of the Administration or to the 

nearest office of the Administration; 3) by destruction in the presence of an agent of the 

Administration or other authorized person; or 4) by such other means as the Special Agent in 

Charge may determine to ensure that the substance does not become available to unauthorized 

persons. Though this is an option currently available to end users, it is used in extremely limited 

circumstances. 

 

18 Please confer with state and/or local environmental agencies to ensure regulatory compliance when using reverse 

distributors. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 23 August 26, 2010 

Typically, the facility needs to destroy the unused 

controlled substances on site, witnessed by two 

health care professionals, generally a pharmacist 

and a nurse or two nurses. Two-witness 

destruction practices that EPA identified in use at 

health care facilities include disposal down the 

drain and crushing and mixing the controlled 

substances with an undesirable material (e.g., 

absorbent material such as kitty litter, sand, or 

coffee grounds). For personnel safety reasons, 

EPA does not recommend that pharmaceuticals 

be crushed and recommends that medications be 

disposed of unaltered. 

Red Bags/Sharps Containers Should Not 

Be Used 

As a best management practice, unused 

pharmaceuticals should not be disposed of 

with biohazardous waste or red bag waste. 

Biohazardous waste is typically sterilized 

(e.g., in an autoclave) prior disposal in 

landfills. The temperature achieved during 

autoclaving is insufficient to destroy most 

pharmaceutical ingredients. During 

sterilization, wastewater potentially 

containing pharmaceuticals may be 

generated and discharged to the sewer, 

through which it reaches waterways. 

EPA’s goal is to keep pharmaceuticals out 

of U.S. waters. 

Facilities may use disposal down the drain sewer 

(or flushing) as an acceptable destruction option 

for controlled substances. However, EPA 

recommends that health care facilities use 

other destruction options (see below). 

4.5.2 Recommended Management of Controlled Substances 

For unused controlled pharmaceuticals, EPA recommends that health care facilities send the 

pharmaceuticals to a reverse distributor for potential credit and proper disposal19. Facilities may 

also send the unused stock of controlled pharmaceuticals back to their pharmacy for proper 

disposal. If the facility is not a DEA registrant, it can check with the regional DEA and state 

board of pharmacy to request approval to send controlled substances back to the pharmacy for 

disposal. How non-DEA registrants handle controlled substances may change based on an ongoing review by DEA (see 74 FR 3480, January 21, 2009). 

If the facility cannot send unused controlled substances back to the pharmacy or to a reverse 

distributor, follow the steps outlined below.

Controlled Substances that are RCRA Hazardous 

EPA strongly discourages the practice of sewer disposal for pharmaceuticals wastes that are both 

hazardous wastes under RCRA and controlled substances. Any controlled substance identified as 

hazardous should be managed in accordance with federal, state, and local hazardous waste 

regulations as well as the Controlled Substances Act and DEA regulations. 

Controlled Substances that are Nonhazardous 

For unused, nonhazardous controlled pharmaceuticals that cannot be sent to a reverse distributor 

or pharmacy for disposal (because the reverse distributor or pharmacy will not accept it), EPA 

recommends that the facility dispose of with solid waste (i.e., regular trash). For disposal with 

regular trash, EPA recommends that the facility: 

 

19 EPA strongly recommends that facilities consult with their state regulatory agency to ensure compliance with all 

state environmental regulations when unused pharmaceuticals are sent to reverse distributors. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 24 August 26, 2010 

1. Take the medication out of the original containers. 

2. Mix medication, either liquid or solid, with an undesirable substance. Undesirable 

substances include sand, coffee grounds, kitty litter, or other absorbent materials. 

3. Place the waste mixture in a sealable bag, empty can, or other container to prevent 

leakage. 

4. Dispose with the solid waste (i.e., regular trash). 

If the facility segregates controlled substances that are nonhazardous pharmaceuticals from other 

solid wastes, the mixing with an undesirable substance may not be necessary, but the waste must 

be managed in accordance with the Controlled Substances Act and DEA regulations. 

4.6 Additional Resources for Identifying Waste Types

The U.S. EPA’s hazardous waste website, http://www.epa.gov/osw/hazard/index.htm can help 

health care facilities correctly identify unused pharmaceutical types and proper disposal 

requirements. Other publications and websites may also provide assistance, such as Practice 

Greenhealth’s Managing Pharmaceutical Waste: A 10-Step Blueprint for Health Care Facilities 

in the United States and the Healthcare Environmental Resource Center (HERC). See Section 6 

for websites and other resources. Facilities can also purchase proprietary databases from 

commercial services (for example, PharmEcology’s PharmE® Inventory Analysis or 

PharmWaste Technology, Inc.’s Pharmaceutical Waste-ID SystemsTM)20. 

 

20 EPA does not endorse any of these services but has provided them as an additional resource. 
25 

Best Management Practices for Unused Pharmaceuticals at Health Care Facilities DRAFT 

Table 3. Recommended Management of Unused Pharmaceuticals 

Best Management Practices, Listed in Order of Prefe

(X – Recommended by EPA for type and form of pharma

Unused 

Pharmaceutical 

Stream 

Pharmaceutical 

Type Medication Form Donation a 

Reverse 

Distribution b

Management as 

Hazardous Waste c

Solid Waste 

Incineration d

L

Solid (tablet, capsule) X X X Liquid (IV, vials, drops) X X X Gels, creams, and lotions) X X X Patches X X EPA requests input 

on BMPs 

E

Non-Controlled Substance 

Orally inhaled and nasal drug products 

X X 

X (if pharmaceutical 

is a RCRA 

hazardous waste) 

EPA requests input on BMPs 

E

Solid X X X Liquid X X X Gels, creams, and lotions) X X X Patches X X EPA requests input 

on BMPs 

EP

Controlled Substance e

Orally inhaled and nasal drug products 

X X 

X (if pharmaceutical 

is a RCRA 

hazardous waste) 

EPA requests input on BMPs 

EP

Chemotherapy Pharmaceutical 

All X X X Syringe contents f Biohazardous X EPA requests input on any other form 

X 

Syringe contents f X 

Unopened/not yet expired 

Hazardous and biohazardous “dual” waste EPA requests input on any other form X 
26 

Best Management Practices for Unused Pharmaceuticals at Health Care Facilities DRAFT 

Table 3. Recommended Management of Unused Pharmaceuticals 

Best Management Practices, Listed in Order of Prefe

(X – Recommended by EPA for type and form of pharma

Unused 

Pharmaceutical 

Stream 

Pharmaceutical 

Type Medication Form Donation a 

Reverse 

Distribution b

Management as 

Hazardous Waste c

Solid Waste 

Incineration d

L

Solid X X Liquid X X Gels, creams, and lotions) X X Patches X EPA requests input 

on BMPs 

E

Non-Controlled Substance 

Orally inhaled and nasal drug products 

X 

X (if pharmaceutical 

is a RCRA 

hazardous waste) 

EPA requests input 

on BMPs 

E

Solid X X Liquid X X Gels, creams, and lotions) X X Patches X EPA requests input 

on BMPs 

E

Controlled Substance e

Orally inhaled and nasal drug products 

X 

X (if pharmaceutical 

is a RCRA 

hazardous waste) 

EPA requests input 

on BMPs 

E

Chemotherapy Pharmaceutical 

All X X Syringe contents f Biohazardous X EPA requests input on any other form 

X 

Syringe contents f X 

Unopened/ expired 

Hazardous and biohazardous “dual” waste EPA requests input on any other form X 
27 

Best Management Practices for Unused Pharmaceuticals at Health Care Facilities DRAFT 

Table 3. Recommended Management of Unused Pharmaceuticals 

Best Management Practices, Listed in Order of Prefe

(X – Recommended by EPA for type and form of pharma

Unused 

Pharmaceutical 

Stream 

Pharmaceutical 

Type Medication Form Donation a 

Reverse 

Distribution b

Management as 

Hazardous Waste c

Solid Waste 

Incineration d

L

Solid X Liquid X Gels, creams, and lotions) X Patches EPA requests input 

on BMPs 

E

Non-Controlled Substance 

Orally inhaled and nasal drug products 

 X 

(if pharmaceutical is 

a RCRA hazardous 

waste) 

EPA requests input 

on BMPs 

E

Solid X Liquid X Gels, creams, and lotions) X Patches EPA requests input 

on BMPs 

E

Controlled Substance e

Orally inhaled and nasal drug products 

X (if pharmaceutical 

is a RCRA 

hazardous waste) 

EPA requests input 

on BMPs 

E

Chemotherapy Pharmaceutical 

All X Syringe contents f Biohazardous X EPA requests input on any other form 

X 

Syringe contents f X 

Opened 

Hazardous and biohazardous “dual” waste EPA requests input on any other form X 

a – If allowed by the state. b – Reverse distribution of controlled substances is only permissible by 1) DEA registrants; or 2) with special permission from the state. EPA strongly contact their state regulatory agency to ensure compliance with all state environmental regulations when unused pharmaceuticals are sent to reverse dic – RCRA hazardous waste requirements depend on the quantity of waste generated in a month. If the facility qualifies as a conditionally-exempt sma

(CESQG), the waste may not need to be disposed of at a RCRA-permitted hazardous waste facility. d – Solid waste incineration includes incineration in units that are subject to 40 CFR 60 subpart Cb, Eb, AAAA, BBBB, CCCC, DDDD, EEEE, and Fe – Dispose in accordance with the Controlled Substances Act and DEA requirements. f – Empty syringe contents; dispose of empty syringe in red sharps container. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 28 August 26, 2010 

5. STARTING A WASTE MANAGEMENT PROGRAM

EPA recommends that health care facilities implement a waste management program that 

includes waste segregation to ensure that facilities meet all applicable regulations and potentially 

minimize costs. For example, by separating the nonhazardous pharmaceutical waste from 

hazardous pharmaceutical waste, facilities may minimize cost and still comply with applicable 

federal regulations. Another important part of the waste management program is to communicate 

with staff so all pharmaceuticals are disposed properly. 

5.1 Waste Segregation 

The waste management plan should include a process to segregate pharmaceutical waste by how 

the facility plans to dispose of them. The process can identify the type of pharmaceutical 

(controlled or non-controlled, hazardous or nonhazardous, chemotherapy) either at time of 

delivery or when waste is collected. For example, some facilities find it useful after delivery and 

during stocking, to apply color-coded stickers on supplies that match the disposal bin color 

placed at their facility to collect and segregate various types of waste (e.g., black color indicates 

hazardous waste). 

5.2 Training Staff in Proper Disposal Methods

After developing a waste management plan, the facility should train staff (pharmacy personnel, 

nurses on the patient floors, and others who will manage unused pharmaceuticals) to recognize 

the type of unused pharmaceutical and its proper disposal. The staff should recognize when 

unused pharmaceuticals should be returned to the pharmacy and when they should be disposed of 

and how. Training should be revisited to update and refresh staff on proper unused 

pharmaceutical management and waste handling. Staff can also provide feedback on how the 

program is working and ways to improve the process. 

Posters and signs should also be placed near disposal areas to remind staff of disposal policies. 

During periodic pharmaceutical stock inventory, consider auditing waste disposal practices to 

determine how well facility staff is following the waste management plan. With the audit 

findings, the facility can identify where additional training is needed. 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 29 August 26, 2010 

6. OTHER RESOURCES

U.S. Drug Enforcement Administration (DEA) website: http://www.deadiversion.usdoj.gov 

U.S. EPA RCRA hazardous waste website: http://www.epa.gov/osw/hazard/

The following is a list of various RCRA documents that pertain to pharmaceutical wastes. These 

documents are publicly available in the RCRA Online database: 

http://www.epa.gov/epawaste/inforesources/online/index.htm

 Scope of P042 (epinephrine) listing memo (RCRA Online #14778): 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/2F70

1627EB73B2AB852573D2005E0B4F/$file/14778.pdf

 Epinephrine residue in a syringe is not P042 (RCRA Online #13718): 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/1C1

DEB3648A62A868525670F006BCCD2/$file/13718.pdf

 Syringes containing P- or U-listed residues are not hazardous waste (RCRA 

Online #14788): 

http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/6A5

DEDF2FBA24FE68525744B0045B4AF/$file/14788.pdf

 Regulation of medicinal nitroglycerine (RCRA Online #14654): 

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

FEC572DE8897F85256D1600748BCB/$file/14654.pdf

 Hazardous Waste Generator Regulations: A User-Friendly Reference Document 

(RCRA Online #51186): 

http://www.epa.gov/epawaste/hazard/downloads/tool.pdf

 Hazardous Waste Listings: A User-Friendly Reference Document: 

http://www.epa.gov/epawaste/hazard/wastetypes/pdfs/listing-ref.pdf

NIOSH Pocket Guide to Chemical Hazards: http://www.cdc.gov/niosh/npg/default.html 

U.S. Department of Health and Human Services – HIPAA Privacy Rule: 

http://www.hhs.gov/ocr/privacy/

National Association of Boards of Pharmacy: http://www.nabp.net/

American Society of Consultant Pharmacists: http://www.ascp.com/ 

American Society of Health-System Pharmacists: http://www.ashp.org/ 

State Waste Programs, including hazardous waste (links): 

http://www.epa.gov/epawaste/wyl/stateprograms.htm
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT 30 August 26, 2010 

State Medical Waste Programs and Regulations (links): 

http://www.epa.gov/osw/nonhaz/industrial/medical/programs.htm

Example of State Guidance: 

 Minnesota Technical Assistance Program (MNTAP): http://www.mntap.umn.edu/

 Kansas’ Disposal Options for Expired or Surplus Medications/Pharmaceuticals: 

http://www.kdheks.gov/waste/techguide/sw07-01.pdf

Healthcare Environmental Resource Center: http://www.hercenter.org/index.cfm

 State program locator for hazardous waste (http://www.hercenter.org/hz.cfm) 

 State medical waste locator (http://www.hercenter.org/rmw/rmwlocator.cfm) 

 State universal waste programs (http://www.hercenter.org/uw.cfm) 

Practice Greenhealth (formerly Hospitals for a Healthy Environment): 

http://www.practicegreenhealth.org/ 

Practice Greenhealth’s 10-Step Blueprint (updated August 2008): 

http://www.practicegreenhealth.org/tools/toolkit/guides/
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-1 August 26, 2010 

APPENDIX A: STATE LAWS AND LOCAL ORDINANCES

State regulations on the management of unused pharmaceuticals vary from no regulation, to 

encouragement to “follow all applicable laws,” to specific destruction and recordkeeping 

requirements. Practices are regulated by a variety of state entities including departments of health 

and environment, boards of pharmacy, and licensing agencies. In addition, state rules can vary by 

type of facility. 

State Donation Programs 

Some states have programs in place to allow the reuse of unused pharmaceuticals through state 

repository programs. Typically, these programs allow the reuse of unopened medications (e.g., 

still in tamper-proof packaging or packaged as unit doses) that are non-controlled substances. 

Other common requirements include that the medication is properly maintained (e.g., under 

control by the facility or pharmacy) and expiration date is beyond six months at time of donation. 

Before use, the state requires that the unopened medication be inspected or reviewed, often by a 

pharmacist, to determine if the product is reusable. The type of pharmaceuticals, who can donate, 

and who can accept the donation varies by state as described in Table A-1. The federal 

government does not oversee the state programs; all programs listed in the table are managed at 

the state level. 

Table A-1. Summary of State Donation Programs 

State 

Program 

Type 

Types of 

Pharmaceuticals Who Can Donate? a

Who Can 

Accept? Notes 

Arizona Legislative 

(HB 2382) 

Rx Board will 

issue list of 

unacceptable 

products 

Individuals, 

manufacturers, or 

health care institutions 

Volunteer 

participants: 

pharmacies, 

hospitals, or 

nonprofit 

clinics 

Effective 

6/6/2008; not 

operational as 

of 8/2009 

Arkansas Legislative 

(HB 1031) 

Non-controlled 

substances 

Nursing facilities by 

clinic pharmacies 

Charitable 

clinic 

pharmacies 

Signed 

2/15/2005; 

program is 

currently in 

operation 

California Legislative 

(SB 798) 

Prescription drugs Licensed health care 

facilities, licensed 

pharmacies, and drug 

manufacturers 

Established by 

counties 

Signed 

9/30/2005; not 

operational as 

of 8/2009 

Colorado Legislative 

(SB 07-231) 

Chemotherapeutic 

drugs and medical 

devices 

Cancer patients or 

their families 

Volunteer 

participants: 

pharmacies or 

health care 

facilities 

Effective 

8/8/2007; 

program is 

currently in 

operation 

Connecticut Legislative 

(HB 6002) 

Non-controlled 

substances 

Long-term care 

facilities 

Vendor 

pharmacies or 

Department of 

Social 

Services 

Signed 

6/21/2000; 

program is 

currently in 

operation 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-2 August 26, 2010 

State 

Program 

Type 

Types of 

Pharmaceuticals Who Can Donate? a

Who Can 

Accept? Notes 

Florida Legislative 

(SB 22A and 

HB 371) 

Chemotherapeutic 

drugs and supplies 

Any entity including 

individuals, health care 

facilities, pharmacies, 

manufacturers, or 

wholesalers 

Volunteer 

participants: 

pharmacies or 

health care 

facilities 

Effective 

7/1/2006; 

program is 

currently in 

operation 

Georgia Legislative 

(HB 430) 

Non-controlled, 

prescription drugs 

Any individual or 

entity including a drug 

manufacturers or 

health care facilities 

Volunteer 

participants: 

pharmacies, 

hospitals, or 

nonprofit 

clinics 

Required to be 

implemented 

no later than 

1/1/2007 

Guam Legislative 

(Chapter 5, 

Sections 5103 

and 5104) 

Not limited except 

to meet standards 

established by 

Guam or the U.S. 

Health care facilities, 

pharmacies, 

manufacturers, 

wholesalers, or 

charitable institutions 

Medicine 

Bank, created 

at Community 

Health 

Centers and 

various 

institutional 

facilities that 

are 

government 

owned and 

operated 

Signed in 

2004 

Hawaii Legislative 

(HB 2005 

final) 

Prescription drugs 

previously 

dispensed or 

distributed at an 

institutional 

facility 

Health care facilities 

(initiated by patients or 

facility personnel) 

Institutional 

facilities or 

repositories in 

the state 

Effective 

7/1/2004; not 

operational as 

of 8/2009 

Indiana Legislative 

(HB 1251) 

Unused 

medication 

Health care facilities Pharmacy/ 

pharmacist 

that dispensed 

prescription 

Effective 

7/1/2004; not 

in operation as 

of 8/2009; 

requires the 

office of 

Medicaid 

policy and 

planning to 

review the 

process 

Iowa Legislative 

(HF 724) 

Prescription drugs Patients Volunteer 

participants: 

pharmacies or 

medical 

facilities 

Signed 

5/3/2005; 

program is 

currently in 

operation 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-3 August 26, 2010 

State 

Program 

Type 

Types of 

Pharmaceuticals Who Can Donate? a

Who Can 

Accept? Notes 

Kansas Legislative 

(HB 2578) 

Non-controlled 

substances; 

donated from a 

controlled storage 

unit of the 

donating entity; 

excludes drugs 

purchased under 

Medicaid or State 

Children’s Health 

Insurance Program 

(SCHIP) 

Long-term care 

residents, donating 

entities (e.g., health 

care facilities) 

Qualifying 

medical 

centers or 

clinics in 

consultation 

with 

pharmacists 

Signed 

3/20/2008; 

program is 

currently in 

operation 

Kentucky Legislative 

(SB 23) 

Chemotherapeutic 

(prescription) 

drugs and 

supplies; noncontrolled 

substances 

Health care facilities, 

pharmacies 

Volunteer 

participants: 

pharmacies or 

health care 

facilities 

Effective 

3/18/2005; not 

in operation as 

of 8/2009 

Legislative 

(HB 1402) 

Prescription drugs Any individual or 

entity, including drug 

manufacturers, health 

care facilities, or 

government entities 

Charitable 

pharmacies 

Effective 

8/15/2004 

Louisiana 

Legislative 

(SB 19) 

Prescription drugs Health care facilities 

or government entities 

enrolled in Medicaid 

program 

Charitable 

pharmacies 

Effective 

6/29/2006; 

program is 

currently in 

operation 

Maine Legislative 

(HP 105 and 

HP 327/LD 

411) 

Prescription drugs Health care facilities, 

manufacturers, or 

wholesalers 

Pharmacies 

and certain 

health care 

facilities 

HP 105 

effective 

5/31/2005; HP 

327/ LD 411 

provided 

$300,000 for 

pilot mailback program 

(signed 

6/27/2007) 

Maryland Legislative 

(SB 1059) 

Non-controlled, 

prescription drugs 

Individuals Boardapproved 

drop-off sites 

and 

repositories 

Effective 

7/1/2006; 

program is 

currently in 

operation 

Massachusett

s 

Legislative 

(Chapter 111, 

Section 25l) 

Unused 

medication 

Residents or consultant 

pharmacists in health 

care facilities 

Health care 

facilities 

Signed in 

2004; program 

is currently in 

operation 

Michigan Legislative 

(Public Act 

329 of 2004) 

Unused 

medication from 

the Department of 

Corrections 

Michigan Department of Corrections Effective 2004
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-4 August 26, 2010 

State 

Program 

Type 

Types of 

Pharmaceuticals Who Can Donate? a

Who Can 

Accept? Notes 

Minnesota Legislative 

(Statute 

151.55) 

Chemotherapeutic 

drugs and supplies 

Pharmacies, medical 

facilities, 

manufacturers, or 

wholesalers; 

individuals over 18 

Volunteer 

participants: 

pharmacies or 

medical 

facilities on 

the premises 

Effective 

2007; program 

is currently in 

operation 

Mississippi Legislative 

(State Code 

Section 43-

13-503) 

Prescription drugs Any individual or 

entity, including drug 

manufacturers, health 

care facilities, or 

government entities; 

the State Board of 

Pharmacy; the State 

Department of Health; 

and the Division of 

Medicaid 

Pharmacies, 

hospitals, 

nonprofit 

clinics, or 

health care 

professionals 

Was to be 

implemented 

by 7/1/2005; 

not in 

operation as 

of 8/2009 

Legislative 

(HB 898, SB 

1160) 

Prescription drugs Any individual or 

entity 

Effective 

8/28/2004; 

program is 

currently in 

operation 

Missouri 

Legislative 

(HB 1687) 

Prescription drugs Any individual or 

entity, including but 

not limited to 

manufacturers or 

health care facilities 

Volunteer 

participants: 

hospitals, 

pharmacies, 

nonprofit 

clinics Approved 

7/12/2006; not 

in operation as 

of 4/2009 

Montana Legislative 

(SB 288) 

Non-controlled, 

prescription drugs 

Long-term care 

facilities 

Provisional 

community 

pharmacies 

Effective 

10/1/2001; 

program is 

currently in 

operation 

Nebraska Legislative 

(LB 756 and 

LB 1116) 

Chemotherapeutic 

drugs 

Any individual or 

entity, including but 

not limited to 

manufacturers or 

health care facilities 

Volunteer 

participants: 

physician’s 

offices, 

pharmacies, 

hospitals, or 

health clinics 

Effective 

9/15/2003 and 

clarified in 

2006; program 

is currently in 

operation 

Nevada Legislative 

(SB 327) 

Non-controlled, 

prescription drugs 

(unit dose, sealed 

individual dose, or 

sealed bottle) 

Public or private 

mental health facilities 

Dispensing 

pharmacies 

Effective 

7/1/2003; 

program is 

currently in 

operation 

New 

Hampshire 

Legislative 

(State law, 

NH RSA 

Section 

318.58) 

No details No details No details Authorizes 

reuse 

program; not 

in operation as 

of 12/2009. 

New Jersey Legislative 

(Title 24) 

Prescription drugs Licensed health care 

facilities 

Same licensed 

health care 

facilities 

Not 

operational as 

of 8/2009 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-5 August 26, 2010 

State 

Program 

Type 

Types of 

Pharmaceuticals Who Can Donate? a

Who Can 

Accept? Notes 

New Mexico Legislative 

(SN 82) 

Prescription drugs Corrections facilities 

with a registered or 

licensed nurse 

Pharmacies 

operated by or 

under contract 

with the 

Corrections 

Department 

Signed 

4/7/2009; 

program is 

currently in 

operation 

New York Legislative 

(S 2803-e) 

Unused 

medication 

Residential health care 

facilities (by a 

resident, consultant 

pharmacist, or 

designee) 

Dispensing 

pharmacies 

Referred to 

New York 

Health 

Department 

on 1/9/2008 

North 

Carolina 

Specific guidelines are being developed for a drug repository/return program b

North Dakota Legislative 

(HB 1256) 

Prescription drugs Any individual or 

entity 

Volunteer 

participants: 

practitioners 

or pharmacies 

Signed 

4/2007; 

program is 

currently in 

operation 

Ohio Legislative 

(HB 221) 

Prescription drugs Any individual, 

including 

manufacturers or 

health care facilities 

Volunteer 

participants: 

pharmacies, 

hospitals, or 

nonprofit 

clinics 

Signed 

1/6/2003. 

Program is 

currently in 

operation. 

Oklahoma Legislative 

(HB1297 and 

SB 1640) 

Non-controlled, 

prescription drugs 

Long-term care 

facilities, public 

intermediate care 

facilities for people 

with mental retardation 

(ICF/MR), or 

manufacturers 

Certain 

pharmacies or 

charitable 

clinics 

Effective 

11/1/2006; 

program is 

currently in 

operation 

Oregon Repository/donations not permitted; return and reuse of medications allowed only in long-term 

care pharmacies where drugs have not been dispensed (remain in control of facility staff) b

Pennsylvania Legislative 

(SB 638) 

Chemotherapeutic 

drugs 

Health care facilities 

or pharmacies 

Authorized, 

participant 

pharmacies 

Signed 

5/13/2008; not 

in operation as 

of 8/2009 

Rhode Island Legislative 

(HB 5107 and 

HB 5850) 

Prescription drugs, 

including 

chemotherapeutic 

drugs 

Nursing home, assisted 

living center, and drug 

manufacturer 

Authorized, 

participant 

pharmacy 

Not 

operational as 

of 8/2009 

South 

Carolina 

Repository/donations not permitted; return and reuse of medications allowed based on 

pharmacist’s professional judgment b

South Dakota Legislative 

(HB 1165) 

Unit-dose 

medications 

Patients in hospice 

programs, nursing 

facilities, or assisted 

living facilities 

Hospice 

programs, 

nursing or 

assisted living 

facilities 

Signed 

2/19/2004; not 

in operation as 

of 8/2009 

Tennessee Legislative 

(HB 3560 and 

SB 3660) 

Non-controlled, 

prescription drugs 

Nursing home or 

hospice services 

Charitable 

clinic 

pharmacies 

Effective 

7/1/2006; 

program is 

currently in 

operation 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-6 August 26, 2010 

State 

Program 

Type 

Types of 

Pharmaceuticals Who Can Donate? a

Who Can 

Accept? Notes 

Texas Legislative 

(SB 1896) 

Non-controlled 

substances 

Pharmacists who 

practice in or consult 

with a health care 

facility; licensed health 

care professionals 

responsible for 

administration of drugs 

in a penal institution 

Pharmacies Signed 

6/15/2007; 

program is 

currently in 

operation 

Utah Legislative 

(58-17b-503) 

Non-controlled, 

prescription drugs 

Pharmacists receiving 

return; drug must have 

been prescribed to a 

patient in a nursing 

care facility, ICFMR, 

state prison, county 

jail, or state hospital 

Dispensing 

pharmacy 

Effective 

7/1/2005; not 

in operation as 

of 8/2009 

Vermont Legislative 

(H. 711) 

Prescription drugs 

(unsold or unused) 

Health care facilities 

or wholesale 

distributors 

Volunteer 

participants: 

pharmacies, 

hospitals, or 

nonprofit 

clinics 

No details

Virginia Legislative 

(HB 154, HB 

1854, and HB 

2682) 

Prescription drugs Hospitals (medications 

dispensed to patients 

but not used) 

Pharmacies, 

clinics (2005), 

or hospitals 

(2009) 

Signed 

4/6/2002 and 

3/24/2005; 

program is 

currently in 

operation 

West Virginia Return of unit-dosed, non-controlled substances allowed b

Legislative 

(SB 56) 

Prescription drugs State prison 

pharmacies 

State prison 

pharmacies 

Approved 

8/20/2003 

Wisconsin 

Legislative 

(AB 845 and 

AB 197) 

Chemotherapeutic 

drugs and 

supplies; 

prescription drugs 

for all other 

chronic diseases 

(e.g., diabetes) 

Any individual or 

entity 

Volunteer 

participants: 

medical 

facilities or 

pharmacies 

Enacted 

4/6/2004; 

expanded in 

2005 

Wyoming Legislative 

(HB 194) 

Prescription drugs Any individual or 

entity, including but 

not limited to 

manufacturers, 

physicians, or health 

care facilities 

Volunteer 

participants: 

pharmacies, 

physicians, or 

health care 

facilities 

Signed 

3/2/2005; 

program is 

currently in 

operation 

Source: National Conference of State Legislatures (NCSL), State Prescription Drug Return, Reuse and Recycling 

Laws (website), http://www.ncsl.org/programs/health/rx-reuse.htm. Accessed July 1, 2010. a

 – Health care facility may include hospitals, long-term care facilities, medical clinics, physician offices, et al. 

Check the state program’s definition of health care facility. 

b

 – National Association of Boards of Pharmacy, 2009 Survey of Pharmacy Law 

State Regulations for the Disposal of Unused Pharmaceuticals 

States generally do not specifically regulate the disposal of unused pharmaceuticals, but some 

regulate pharmaceutical management and disposal options, or they provide guidance. Some 

states require unused pharmaceuticals to be destroyed but do not specify the process of 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT A-7 August 26, 2010 

destruction; however, many states have requirements for the types of personnel required to 

conduct and oversee the destruction, especially for controlled substances. States may also have 

more stringent requirements than EPA for the disposal of hazardous waste. Check with the state 

environmental management agency for more details. To identify state requirements, facilities can 

check the state links provided at the following website: 

http://www.epa.gov/osw/nonhaz/industrial/medical/programs.htm or the state program locators 

at http://www.hercenter.org/regsandstandards/stateandlocal.cfm. 
B-1 

Best Management Practices for Unused Pharmaceuticals at Health Care Facilities DRAFT APPENDIX B: SAMPLE UNUSED PHARMACEUTICAL TRACKING SHEET

Location Date 

Pharmaceutical 

Name Form Strength 

Amount 

Wasted Disposal Method Reason Waste

Example: Pharmacy 01/01/2010 Hydrocodone Tablet 5 mg 25 tablets Reverse distribution Expired Example: Room 512 01/01/2010 Hydrocodone Tablet 5 mg 1 tablet Drain Patient refused Example: Med sta 3 01/01/2010 Amoxicillin Liquid 125 mg/5mL 15 mL Trash can Patient discharged 

Location: Nurses station number or pharmacy Form: tablet, capsule, vial, IV, cream, gel, emulsion, inhalant, etc. Amount wasted: number of items or liquid volume 
Best Management Practices for Unused Pharmaceuticals at Health Care Facilities EPA Office of Water 

DRAFT C-1 August 26, 2010 

APPENDIX C: CONSIDERATIONS WHEN CONTRACTING WITH A SPECIALTY WASTE HAULER

Your facility might want to consider the following factors when choosing a specialty waste 

hauler. Remember: you are hiring a company to transport your waste, but the waste is still yours 

and is still your responsibility. 

Confirm that the specialty waste hauler is familiar with all regulations that apply to your 

facility. 

Your specialty waste hauler should be aware of all federal, state, and local pharmaceutical 

disposal, storage, and transport laws. If you are not familiar with the regulations, ask the 

specialty waste hauler for a list of regulations and have them explain to you what laws apply. 

Federal agencies that may regulate waste disposal include the following: 

 U.S. Environmental Protection Agency (EPA): http://www.epa.gov/; 

 Occupational Safety and Health Administration (OSHA): http://www.osha.gov/; 

 U.S. Department of Transportation (DOT): http://www.dot.gov/; 

 Nuclear Regulatory Commission (NRC): http://www.nrc.gov/; 

 Centers for Medicare and Medicaid Services (CMS): http://www.cms.hhs.gov/; 

and 

 Centers for Disease Control and Prevention (CDC): http://www.cdc.gov/. 

Other regulations may be required by state health departments, environmental boards, and 

Medicaid programs and local health departments. 

Confirm that the hauler dedicates resources to keep current with regulations, such as an 

environmental regulations department. Regulations are updated often, and you will want your 

hauler to be familiar with the latest requirements. 

Get to know the hauler staff. 

 Have they been properly trained? Are they familiar with the laws governing waste 

handling, transport, and storage of the types of waste your facility generates? 

 Can they handle emergencies, such as natural disasters and spills? 

Get to know the company. 

Where do they take your waste? How does it get there? 

Does your hauler deliver it directly to a landfill or incinerator? 

Does your hauler operate the landfill or incinerator? Are they licensed to do so? 

Does your hauler transport your waste to another hauler? 

Do they provide you adequate records, such as waste manifests? 

Can they provide proof of training for hauler employees and hauler insurance? 

Request full service. 

Request training for you and your staff on waste management. Make sure proper transport and 

disposal records are provided to you. At a minimum, you should receive a waste manifest 

identifying the types and quantities of waste and their destination21. Will they provide assistance 

with drug inventories?

 

21 RCRA includes manifest requirements for large quantity and small quantity generators (LQGs and SQGs).