Vol. 79 Tuesday, 

No. 174 September 9, 2014 

Part II 

Department of Justice 

Drug Enforcement Administration 

21 CFR Parts 1300, 1301, 1304, et al. 

Disposal of Controlled Substances; Final Rule 


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53520 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1301, 1304, 1305, 

1307, and 1317 

[Docket No. DEA–316] 

RIN 1117–AB18 

Disposal of Controlled Substances 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: This rule governs the secure 

disposal of controlled substances by 

registrants and ultimate users. These 

regulations will implement the Secure 

and Responsible Drug Disposal Act of 

2010 by expanding the options available 

to collect controlled substances from 

ultimate users for the purpose of 

disposal, including: Take-back events, 

mail-back programs, and collection 

receptacle locations. These regulations 

contain specific language allowing law 

enforcement to voluntarily continue to 

conduct take-back events, administer 

mail-back programs, and maintain 

collection receptacles. These regulations 

will allow authorized manufacturers, 

distributors, reverse distributors, 

narcotic treatment programs (NTPs), 

hospitals/clinics with an on-site 

pharmacy, and retail pharmacies to 

voluntarily administer mail-back 

programs and maintain collection 

receptacles. In addition, this rule 

expands the authority of authorized 

hospitals/clinics and retail pharmacies 

to voluntarily maintain collection 

receptacles at long-term care facilities. 

This rule also reorganizes and 

consolidates previously existing 

regulations on disposal, including the 

role of reverse distributors. 

DATES: Effective Date: This rule is 

effective October 9, 2014. 

Compliance Date: All Memoranda of 

Agreement (MOAs) and Memoranda of 

Understanding (MOUs) issued pursuant 

to current 21 CFR 1307.21 will not be 

effective after October 9, 2014. 

Registrants may consult § 1317.05(a)(5) 

for information on requesting new 

MOAs and MOUs for disposal of 

controlled substances. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Outline 

I. Executive Summary 

A. Purpose of the Regulatory Action 

B. Summary of the Major Provisions of the 

Regulatory Action 

C. Summary of Changes in the Final Rule 

II. Background and Legal Authority 

III. Discussion of Comments 

A. Support for the Proposed Rule (1 Issue) 

B. Definitions and Terms (12 Issues) 

C. Types of Entities That May Operate a 

Collection Program (9 Issues) 

D. Locations Where Authorized Collectors 

May Maintain Collection Receptacles or 

Host Take-Back Events (1 Issue) 

E. Registration Requirements for 

Authorized Collectors (5 Issues) 

F. Law Enforcement (7 Issues) 

G. Collection Receptacle Design, Inner 

Liners, Placement, and Security (24 

Issues) 

H. Mail-Back Programs (11 Issues) 

I. Take-Back Events (6 Issues) 

J. Prohibition on Handling, Sorting, and 

Inventorying Inner Liner Contents and 

Mail-Back Package Contents (8 Issues) 

K. Long-Term Care Facilities (LTCFs) (21 

Issues) 

L. Disposing on Behalf of Ultimate Users 

(Other than Residents of LTCFs) (3 

Issues) 

M. Registrant Return, Recall, and Transfer 

(3 Issues) 

N. Destruction (19 Issues) 

O. Economic Concerns (18 Issues) 

P. Recordkeeping and Reporting (8 Issues) 

Q. Hazardous Materials Transportation and 

Hazardous Waste Destruction (3 Issues) 

R. Transporting Collected Substances (3 

Issues) 

S. Miscellaneous Comments (2 Issues) 

IV. Regulatory Analyses 

I. Executive Summary 

A. Purpose of the Regulatory Action 

On October 12, 2010, the Secure and 

Responsible Drug Disposal Act of 2010 

(Disposal Act) was enacted (Pub. L. 

111–273, 124 Stat. 2858). Before the 

Disposal Act, ultimate users who 

wanted to dispose of unused, unwanted, 

or expired pharmaceutical controlled 

substances had limited disposal options. 

The Controlled Substances Act (CSA) 

only permitted ultimate users to destroy 

those substances themselves (e.g., by 

flushing or discarding), surrender them 

to law enforcement, or seek assistance 

from the United States Drug 

Enforcement Administration (DEA). 

These restrictions resulted in the 

accumulation of pharmaceutical 

controlled substances in household 

medicine cabinets that were available 

for abuse, misuse, diversion, and 

accidental ingestion. 

The Disposal Act amended the CSA to 

authorize ultimate users to deliver their 

pharmaceutical controlled substances to 

another person for the purpose of 

disposal in accordance with regulations 

promulgated by the Attorney General. 

21 U.S.C. 822(g), 828(b)(3). This final 

rule implements regulations that expand 

the entities to which ultimate users may 

transfer unused, unwanted, or expired 

pharmaceutical controlled substances 

for the purpose of disposal, as well as 

the methods by which such 

pharmaceutical controlled substances 

may be collected. Specified entities may 

voluntarily administer any of the 

authorized collection methods in 

accordance with these regulations. 

B. Summary of the Major Provisions of 

the Regulatory Action 

The DEA is implementing new 

regulations for the disposal of 

pharmaceutical controlled substances 

by ultimate users in accordance with the 

Disposal Act. In drafting the 

implementing regulations, the DEA 

considered the public health and safety, 

ease and cost of program 

implementation, and participation by 

various communities. To this end, the 

DEA found that in order to properly 

address the disposal of controlled 

substances by ultimate users, it was 

necessary to conduct a comprehensive 

review of DEA policies and regulations 

related to each element of the disposal 

process, including the transfer, delivery, 

collection, destruction, return, and 

recall of controlled substances, by both 

registrants and non-registrants (i.e., 

ultimate users). The reverse distributor 

registration category, which is pertinent 

to the process of registrant disposal, was 

included in this comprehensive review. 

These regulations are incorporated into 

a new part 1317 on disposal. Definitions 

relating to the disposal of controlled 

substances are added to § 1300.05(b), 

including definitions for ‘‘employee,’’ 

‘‘law enforcement officer,’’ ‘‘nonretrievable,’’ and ‘‘on-site’’ and 

definitions relating to controlled 

substances generally are revised or 

added to § 1300.01. 

The goal of this new part on disposal, 

consistent with Congress’s goal in the 

Disposal Act, is to set parameters for 

controlled substance diversion 

prevention that will encourage public 

and private entities to develop a variety 

of methods for collecting and destroying 

pharmaceutical controlled substances in 

a secure, convenient, and responsible 

manner. Also, consistent with the 

Disposal Act’s goal to decrease the 

amount of pharmaceutical controlled 

substances introduced into the 

environment, particularly into the 

water, these regulations provide 

individuals with various additional 

options to dispose of their unwanted or 

unused pharmaceutical controlled 

substances beyond discarding or 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53521 

flushing the substances. As a result of 

these regulations, the DEA hopes that 

the supply of unused pharmaceutical 

controlled substances in the home will 

decrease, thereby reducing the risk of 

diversion or harm. 

Ultimate User Disposal 

An ultimate user is defined by the 

CSA as a ‘‘person who has lawfully 

obtained, and who possesses, a 

controlled substance for his own use or 

for the use of a member of his 

household or for an animal owned by 

him or by a member of his household.’’ 

21 U.S.C. 802(27). This rule provides 

three voluntary options for ultimate user 

disposal: (1) Take-back events, (2) mailback programs, and (3) collection 

receptacles. Individuals lawfully 

entitled to dispose of an ultimate user 

decedent’s property are authorized to 

dispose of the ultimate user’s 

pharmaceutical controlled substances 

by utilizing any of the three disposal 

options. All of the collection methods 

are voluntary and no person is required 

to establish or operate a disposal 

program. The rule also does not require 

ultimate users to utilize any of these 

three methods for disposal of controlled 

substances. Although the three methods 

of disposal allowed by this rule seek to 

help protect the environment and 

prevent controlled substances from 

being diverted to illicit uses, this rule 

does not prohibit ultimate users from 

using existing lawful methods. 

The DEA regulations provide specific 

language that will continue to allow 

Federal, State, tribal, and local law 

enforcement to maintain collection 

receptacles at the law enforcement’s 

physical location; and either 

independently or in partnership with 

private entities or community groups, to 

voluntarily hold take-back events and 

administer mail-back programs. 21 CFR 

1317.35. Thus, ultimate users will 

continue to be able to surrender their 

unwanted pharmaceutical controlled 

substances to law enforcement. 

The DEA is also authorizing certain 

registrants (manufacturers, distributors, 

reverse distributors, narcotic treatment 

programs (NTPs), hospitals/clinics with 

an on-site pharmacy, and retail 

pharmacies) to be ‘‘collectors,’’ with 

authorization to conduct mail-back 

programs. 21 CFR 1317.40 and 1317.70. 

All registrants that choose to establish 

mail-back programs must provide 

specific mail-back packages to the 

public, either at no cost or for a fee, 21 

CFR 1317.70. Collectors that conduct 

mail-back programs must have and 

utilize an on-site method of destruction 

to destroy returned packages, 21 CFR 

1317.05. 

These DEA regulations authorize 

collectors to maintain collection 

receptacles at their registered location. 

21 CFR 1317.40. Thus, ultimate users 

will be able to carry their unwanted 

pharmaceutical controlled substances to 

an authorized retail pharmacy or other 

authorized collector location and 

deposit those controlled substances in a 

secure container for disposal. Hospitals/ 

clinics and retail pharmacies that are 

authorized to be collectors may also 

maintain collection receptacles at longterm care facilities (LTCFs). 21 CFR 

1317.40. LTCFs may dispose of 

pharmaceutical controlled substances 

on behalf of an ultimate user who 

resides, or has resided, at that LTCF, 21 

CFR 1317.80, through a collection 

receptacle that is maintained by an 

authorized hospital/clinic or retail 

pharmacy at that LTCF. 21 CFR 1317.40 

and 1317.80. 

With this rule, the DEA allows all 

pharmaceutical controlled substances 

collected through take-back events, 

mail-back programs, and collection 

receptacles to be comingled with noncontrolled substances, although such 

comingling is not required. 21CFR 

1317.65, 1317.70, and 1317.75. 

Pharmaceutical controlled substances 

collected by collectors may not be 

individually counted or inventoried. 21 

CFR 1317.75. This rule also imposes 

various registration, security, and 

recordkeeping requirements. 

The DEA appreciates there is a cost to 

entities that choose voluntarily to 

provide these methods of collection and 

destruction. The DEA acknowledges 

that some State and local 

pharmaceutical disposal programs 

receive funding and other support from 

numerous sources, including 

conservation groups, local governments, 

State grants, and public and private 

donations. These expanded methods of 

disposal are expected to benefit the 

public by decreasing the supply of 

pharmaceutical controlled substances 

available for misuse, abuse, diversion, 

and accidental ingestion, and protect 

the environment from potentially 

harmful contaminants by providing 

alternate means of disposal for ultimate 

users. However, other advantages may 

accrue directly to those entities that opt 

to maintain a disposal program. For 

example, those authorized registrants 

that choose to maintain collection 

receptacles may be enhanced by the 

increased consumer presence at their 

registered locations and the goodwill 

that develops from providing a valuable 

community service. In addition, mailback program collectors may partner 

with third parties to make mail-back 

packages available to the public. Those 

authorized registrants that choose to 

administer mail-back programs may 

gain from the opportunity to distribute 

to consumers promotional, educational, 

or other informational materials with 

the mail-back packages. 

DEA Registrant Disposal 

The DEA has deleted the existing rule 

related to registrant disposal, 21 CFR 

1307.21, and incorporated similar 

requirements on proper disposal 

procedure and security in a new part 

1317 on disposal. These changes 

provide consistent disposal procedures 

for each registrant category, regardless 

of geographic location. In addition, the 

DEA has modified DEA Form 41 and is 

explicitly requiring that form to be used 

to record the destruction of controlled 

substances that remain in the closed 

system of distribution and also to 

account for registrant destruction of 

pharmaceutical controlled substances 

collected from ultimate users and other 

non-registrants pursuant to the Disposal 

Act. As stated in the NPRM, a controlled 

substance dispensed for immediate 

administration pursuant to an order for 

medication in an institutional setting 

remains under the custody and control 

of that registered institution even if the 

substance is not fully exhausted (e.g., 

some of the substance remains in a vial, 

tube, transdermal patch, or syringe after 

administration but cannot or may not be 

further utilized, commonly referred to 

as ‘‘drug wastage’’ and ‘‘pharmaceutical 

wastage’’). Such remaining substance 

must be properly recorded, stored, and 

destroyed in accordance with DEA 

regulations (e.g., § 1304.22(c)), and all 

applicable Federal, State, tribal, and 

local laws and regulations, although the 

destruction need not be recorded on a 

DEA Form 41. 

Reverse Distributors 

The DEA is providing regulations for 

entities that reverse distribute that are 

clear and consistent. Entities that 

reverse distribute are often the last 

registrant to possess controlled 

substances prior to destruction; 

however, the recordkeeping safeguards 

that exist when controlled substances 

are distributed between registrants are 

not present when these registrants 

destroy controlled substances. Because 

reverse distributors routinely acquire 

controlled substances for destruction 

from other registrants and may also be 

authorized as collectors, reverse 

distributors accumulate greater amounts 

of controlled substances that are 

destined for destruction in comparison 

to other registrants. The DEA is defining 

‘‘reverse distribute;’’ revising the 

definition of ‘‘reverse distributor;’’ (21 


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53522 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

1All of the comments submitted, except two 

comments, are available for public inspection 

online at www.regulations.gov. Two comments are 

not posted (at the commenters’ request) in order to 

protect confidential business information. 

CFR part 1300) outlining security (21 

CFR part 1301), inventory, 

recordkeeping requirements, and other 

procedures that reverse distributors 

must follow to acquire controlled 

substances from registrants and to 

destroy such acquired substances. 21 

CFR part 1304. The DEA also is 

clarifying that these security, inventory, 

and recordkeeping requirements apply 

to certain specified entities that reverse 

distribute but are not registered as 

reverse distributors. See, e.g., 21 CFR 

1304.11(e)(3) (‘‘each person registered or 

authorized to reverse distribute’’). The 

DEA believes that these regulations will 

help all registrants that reverse 

distribute comply with the CSA in a 

manner that decreases the risk of the 

diversion of controlled substances 

during the disposal process. 

Return and Recall 

This rule removes the existing 

regulation on return and recall, 21 CFR 

1307.12, and incorporates separate 

return and recall requirements for 

registrants and non-registrants into new 

§§ 1317.10 and 1317.85. This rule also 

imposes various recordkeeping 

requirements pertaining to controlled 

substances acquired for the purpose of 

return or recall in §§ 1304.22 and 

1305.03. The DEA has simplified the 

requirements of § 1317.10(a) to more 

clearly describe the records that 

registrants must keep. 

Methods of Destruction 

Existing DEA regulations do not 

specify a standard to which controlled 

substances must be destroyed. With this 

final rule, the DEA is implementing a 

standard of destruction—nonretrievable—for registrants that destroy 

controlled substances, and procedures 

for the destruction of controlled 

substances. 21 CFR 1300.05 (‘‘nonretrievable’’), 1317.90, and 1317.95. The 

DEA is not requiring a particular 

method of destruction, so long as the 

desired result is achieved. This standard 

is intended to allow public and private 

entities to develop a variety of 

destruction methods that are secure, 

convenient, and responsible, consistent 

with preventing the diversion of such 

substances. Destruction of controlled 

substances must also meet all other 

applicable Federal, State, tribal, and 

local laws and regulations. Once a 

controlled substance is rendered ‘‘nonretrievable,’’ it is no longer subject to 

the requirements of the DEA 

regulations. 

As explained above under 

‘‘Compliance Date,’’ this final rule 

supersedes all existing MOAs and 

MOUs that registrants may have 

pursuant to § 1307.21, including MOAs 

and MOUs pertinent to storage of 

controlled substances. The DEA retains 

in the new part 1317 the ability for 

practitioners to request assistance from 

the local Special Agent in Charge (SAC) 

regarding the disposal of controlled 

substances. 21 CFR 1317.05. 

Practitioners may request a new MOA or 

MOU pursuant to the new 

§ 1317.05(a)(5). 

C. Summary of the Changes in the Final 

Rule 

The DEA carefully considered the 192 

individually-submitted comments 

received in response to the Notice of 

Proposed Rulemaking (NPRM) on the 

Disposal of Controlled Substances.1 77 

FR 75784, Dec. 21, 2012. The comment 

period closed on February 19, 2013. The 

DEA is making a number of significant 

changes after thorough consideration of 

the issues raised by the comments and 

the potential diversion risks associated 

with these changes. 

In response to concerns regarding 

ultimate users’ ability to have 

convenient disposal options, the DEA is 

vastly expanding those entities that may 

be authorized as collectors, expanding 

the authority of those collectors to 

maintain collection receptacles at 

LCTFs, and relaxing some of the 

proposed security requirements related 

to storage and destruction of controlled 

substances. 

Authorized Collectors 

In addition to manufacturers, 

distributors, reverse distributors, and 

retail pharmacies, the final rule also 

authorizes registered NTPs, as well as 

hospitals/clinics with an on-site 

pharmacy, to operate disposal programs. 

21 CFR 1317.40. By permitting these 

additional registrant categories to be 

collectors, the DEA anticipates that 

ultimate users will now have even more 

locations where they can securely, 

safely, responsibly, and conveniently 

dispose of their unwanted 

pharmaceutical controlled substances. 

In this final rule, the DEA is 

permitting those entities registered as 

NTPs to become authorized collectors to 

manage collection receptacles at their 

registered locations. As stated in the 

Disposal Act, ‘‘the nonmedical use of 

prescription drugs is a growing problem 

in the United States.’’ Multiple 

commenters, including a national 

organization that represents NTPs, 

recommended that the DEA include 

NTPs as authorized collectors. The DEA 

recognizes the valuable role that NTPs 

have in helping those seeking substance 

abuse treatment. After considering the 

importance of providing secure, 

convenient, and responsible disposal 

options for those ultimate users 

currently receiving treatment for 

narcotic substance abuse or entering a 

narcotic treatment program, and the 

benefits of allowing NTPs to provide the 

opportunity to patients to dispose of 

unused controlled substances, the DEA 

is permitting NTPs to be collectors with 

certain enhanced security controls. 21 

CFR 1317.75. 

Due to the nature of the healthcare 

provided, NTPs face unique security 

challenges and heightened diversion 

risks and, as such, the final rule requires 

NTPs to securely place and maintain 

collection receptacles in a room that 

does not contain any other controlled 

substances and is securely locked with 

controlled access. 21 CFR 1317.75. The 

DEA understands that this security 

measure will require employees of the 

NTP to accompany the patient to the 

collection receptacle to facilitate the 

patient’s disposal. See 21 CFR 1317.75. 

Additionally, as the Disposal Act and 

these regulations are intended to 

address the prescription drug abuse 

problem, NTPs and other collectors are 

not authorized to collect schedule I 

controlled substances. E.g., 21 CFR 

1317.75. Collectors must be vigilant in 

ensuring that such illicit substances are 

not collected intentionally or 

inadvertently. E.g., 21 CFR 1317.70 and 

1317.75. 

After extensive review and careful 

deliberation, in this final rule, the DEA 

is also permitting registered hospitals/

clinics with an on-site pharmacy to 

become authorized collectors to 

maintain collection receptacles inside 

their registered locations or at LTCFs, 

and to conduct mail-back programs. 21 

CFR 1317.30, 1317.40, 1317.70, and 

1317.80. In response to the NPRM, 

many commenters stated that collection 

receptacles located inside of hospitals 

would provide ultimate users with an 

opportunity to dispose of medication 

that may no longer be needed or may be 

expired. In determining whether to 

allow hospitals/clinics to become 

authorized collectors, the DEA carefully 

weighed the diversion risks with the 

convenience of authorizing such entities 

to be collectors. The DEA determined 

that the diversion risks require the DEA 

to limit those registered hospitals/

clinics that may become collectors to 

those with on-site pharmacies, and also 

impose separate security conditions on 

the monitoring and location of 

collection receptacles inside hospitals/


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53523 

clinics that become authorized 

collectors. 21 CFR 1317.75. 

The DEA is requiring these additional 

security measures in order to help 

protect against the diversion of collected 

controlled substances because hospitals/ 

clinics are generally much larger and are 

open to a much larger general 

population than the other registrants 

authorized to be collectors; and, as 

discussed in the NPRM, hospitals/

clinics do not operate under the same 

business model or with similar theft and 

loss prevention procedures as the other 

registrants authorized to become 

collectors. For example, the general 

public typically enters retail pharmacies 

for short durations in order to conduct 

retail business and retail pharmacies 

generally have open, clearly observable 

common areas with little opportunity to 

conceal an unlawful purpose. It would 

be unusual and suspicious for a person 

to spend an extended amount of time in 

a retail pharmacy without a known, 

specific purpose, triggering routine theft 

and loss prevention measures. 

In contrast, hospitals are generally 

open 24-hours per day and allow for 

unsupervised public access for extended 

periods of time; they are much larger 

than retail pharmacies and many 

interactions occur behind closed doors 

without routine theft and loss 

prevention measures; and foot traffic 

generally is not routinely monitored for 

unlawful purposes. The DEA believes 

that limiting authorized collection 

activities to hospitals/clinics with an 

on-site pharmacy is necessary to help 

protect against diversion because these 

hospitals/clinics routinely handle a 

large volume of controlled substances 

that are dispensed to in-patients as well 

as to the public, and these entities are 

more experienced with security, theft 

and loss prevention procedures, and 

inventory, recordkeeping and reporting 

requirements than those hospitals/

clinics without an on-site pharmacy. 

For reasons discussed in the NPRM, 

this final rule generally requires that, 

when authorized collectors choose to 

install collection receptacles, those 

collection receptacles must be placed 

inside their registered locations in the 

immediate proximity of a designated 

area where controlled substances are 

stored and at which an employee is 

present. 21 CFR 1317.75; see also 

1317.05. The DEA recognizes that 

hospitals/clinics with an on-site 

pharmacy can be unique in their design 

and it may be more effective to install 

collection receptacles at various 

locations within the hospital/clinic, 

depending on factors such as security, 

convenience, and accessibility. As such, 

it would be challenging for authorized 

hospitals/clinics to adhere to the general 

rule to place collection receptacles in 

the immediate proximity of where 

controlled substances are stored and at 

which an employee is present. 

Accordingly, the DEA is requiring 

hospitals/clinics that are collectors to 

place collection receptacles in locations 

that are regularly monitored by 

employees. 21 CFR 1317.75. In addition, 

the DEA is prohibiting such collectors 

from placing collection receptacles in 

the proximity of any area where 

emergency or urgent care is provided. In 

the DEA’s experience, the risk of 

diversion is particularly high in areas 

where emergency or urgent care is 

provided because of the often chaotic 

environment and the extended amounts 

of time persons spend in such areas. 

This rule also makes clear that DEA 

registrants cannot use the collection 

receptacles to dispose of unused 

controlled substances in their inventory 

or stock. 21 CFR 1317.05 and 1317.75. 

Pharmaceutical controlled substances 

remain under the custody and control of 

the DEA registrant if they are dispensed 

by a practitioner for immediate 

administration at the practitioner’s 

registered location (such as a hospital) 

pursuant to an order for medication. If 

that substance is not fully exhausted 

(e.g., some of the substance remains in 

a vial, tube, or syringe after 

administration but cannot or may not be 

further utilized), then the DEA registrant 

is obligated to destroy the remaining, 

unusable controlled substances, and 

record the destruction in accordance 

with § 1304.22(c). The DEA registrant 

shall not place such remaining, 

unusable controlled substance in a 

collection receptacle as a means of 

disposal. Hospital/clinic staff must also 

not dispose of any controlled substances 

in inventory or stock in a collection 

receptacle. 

The security requirements described 

above are the minimum required in 

order to detect and prevent diversion in 

the unique circumstances of NTPs and 

hospitals/clinics. These registrants 

should be vigilant in the execution of 

their responsibilities as registrants to 

ensure that collected controlled 

substances are not diverted to illicit use, 

and that they do not collect illicit 

substances. Finally, all registrants are 

reminded of the responsibility to report 

theft and significant loss of controlled 

substances within one business day of 

discovery. 

Long-Term Care Facilities (LTCFs) 

Significant changes are made in this 

final rule to help ensure that LTCFs 

have adequate disposal options. In 

addition to allowing retail pharmacies 

to manage and maintain collection 

receptacles at LTCFs, the DEA is also 

allowing hospitals/clinics with an onsite pharmacy to manage and maintain 

collection receptacles at LTCFs. The 

DEA hopes that expanding those 

authorized to collect at LTCFs will 

maximize disposal opportunities for 

LTCF residents. 

In addition, the DEA is alleviating two 

security requirements proposed to apply 

to collection receptacles located at 

LTCFs. First, the DEA is permitting 

authorized hospitals/clinics and retail 

pharmacies to store inner liners that 

have been sealed upon removal from a 

collection receptacle at LTCFs in a 

securely locked, substantially 

constructed cabinet or a securely locked 

room with controlled access for up to 

three business days until the liners can 

be transferred for destruction. The DEA 

encourages collectors to schedule inner 

liner removals and installations to 

coincide with existing LTCF visits when 

possible, for example, arranging a 

routine system in which medication 

deliveries coincide with the removal 

and transfer of sealed inner liners for 

appropriate destruction, thereby making 

storage of sealed inner liners 

unnecessary. Collectors may not transfer 

sealed inner liners from LTCFs to their 

primary registered location (i.e., the 

hospital/clinic or retail pharmacy 

location). As echoed in the comments, 

the DEA remains concerned about the 

security risks of hospital/clinic and 

retail pharmacy employees transporting 

large quantities of collected substances, 

making them potential targets for drug 

seekers. Instead, collectors should 

deliver sealed inner liners to a reverse 

distributor or distributor’s registered 

location by common or contract carrier 

pick-up or by reverse distributor or 

distributor pick-up at the LTCF, 

pursuant to § 1317.05(c)(2)(iv). 

Second, the DEA relaxed the twoemployee integrity requirement for 

inner liner installation, removal, 

storage, and transfer at LTCFs. 

Collectors will retain the option to 

authorize two of their own employees to 

install, remove, store, and transfer inner 

liners; however, the DEA is permitting 

collectors the option to designate a 

supervisor-level employee of the LTCF 

(e.g., a charge nurse, supervisor, or 

similar employee) to install, remove, 

store, or transfer inner liners with only 

one employee of the collector. 

The DEA modified the above security 

requirements (storage and two-person 

integrity) to provide flexibility sufficient 

to encourage authorized hospitals/

clinics and retail pharmacies to collect 

at LTCFs, while ensuring the minimum 

protections required to prevent 


tkelley on DSK3SPTVN1PROD with RULES2
53524 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

diversion at LTCFs. The DEA hopes that 

the inclusion of certain hospitals/clinics 

as authorized to maintain collection 

receptacles at LTCFs, and the 

modifications described above will 

result in expanded safe and secure 

disposal options for LTCF residents. 

The DEA emphasizes that if LTCFs 

dispose of LTCF residents’ controlled 

substances in collection receptacles, 

such activity must be in accordance 

with this regulation and all other 

applicable Federal, State, tribal and 

local laws and regulations, including 

environmental laws and regulations. 

The DEA acknowledges that there 

may be some LTCFs that will not have 

a collection receptacle, and there will be 

instances where LTCF residents are 

incapable of disposing of their own 

unused or unwanted medication. As 

ultimate users, LTCF residents may use 

any of the disposal options afforded 

other ultimate users in this final rule 

(e.g., mail-back programs), in addition to 

the disposal options currently available 

to ultimate users (e.g., flushing or 

otherwise discarding) that will remain 

options even after this final rule is 

implemented. For example, an LTCF 

resident may request that LTCF 

personnel place the resident’s unwanted 

medication in a mail-back package, seal 

the mail-back package, and deposit that 

package into the facility’s outgoing mail 

system. 21 CFR 1317.70. LTCFs should 

be mindful however that the touchstone 

for this disposal method is the 

individual nature of the disposal 

activity; institutional facilities such as 

LTCFs should ensure that the individual 

patient is the disposer, and should be 

wary of establishing any protocols 

whereby the facility itself is engaging in 

collection activities. Simply providing 

the method of disposal (e.g., mail-back 

packages) does not implicate that 

concern. 

Destruction 

After careful and thorough 

consideration of comments received 

regarding the burdens associated with 

the proposed 14-day destruction 

requirement, the DEA is extending the 

time those registrants that reverse 

distribute have to destroy controlled 

substances to 30 days. 21 CFR 

1317.15(d). The DEA anticipates that 

this extension will allow reverse 

distributors and distributors adequate 

time to collect and destroy controlled 

substances in a safe, convenient, and 

secure manner, while also preventing 

diversion and diversion opportunities. 

Practitioner Physical Security 

In this final rule, the DEA is not 

amending § 1301.75(b) pertaining to 

practitioner physical security and is 

instead adding a new paragraph (c) to 

clarify that practitioners shall only store 

sealed mail-back packages and inner 

liners containing collected substances at 

their registered location in a securely 

locked, substantially constructed 

cabinet or a securely locked room with 

controlled access. The DEA has made 

corresponding changes to 

§§ 1317.05(c)(1)(ii) and (c)(2)(ii). Part of 

this requirement was included in the 

proposed rule; however, after careful 

consideration of a number of comments, 

the DEA believes that the proposed 

requirement did not provide sufficient 

controls to protect against diversion and 

was impracticable. Pharmacies and 

institutional practitioners cannot store 

sealed inner liners or returned mailback packages by dispersing them 

throughout the stock of noncontrolled 

substances. 21 CFR 1301.75(b) and (c). 

Other Changes to the Final Rule 

In addition to the changes described 

above, the DEA determined that the 

rule, as proposed, required other 

modifications, as generally described 

below. The DEA is also implementing 

additional technical modifications that 

will not have a substantive effect on this 

rule (e.g., relocating some sections in 

proposed part 1317 to other sections 

within title 21 of the CFR, re-phrasing 

some sections from the proposed rule to 

be simpler, clearer and easier to 

understand, and eliminating 

redundancy). 

In the general definitions section of 

the DEA regulations, the DEA is 

amending § 1300.01(b) to be clear that 

the definitions that generally apply to 

most other parts of chapter II of title 21 

of the CFR also apply to part 1317. In 

response to a number of comments, in 

§ 1300.01(b) the DEA is amending the 

definition of ‘‘reverse distributor’’ to 

clarify that a reverse distributor is a 

person registered with the DEA as a 

reverse distributor. 

Definitions were moved from 

§ 1317.02 to § 1300.05 to provide 

consistency within the CFR pertaining 

to definitions. The DEA adds § 1300.05 

‘‘Definitions relating to the disposal of 

controlled substances,’’ moves the terms 

‘‘authorized employee,’’ ‘‘law 

enforcement officer,’’ and ‘‘nonretrievable’’ from part 1317 to 

§ 1300.05(b), adds a definition of ‘‘onsite’’ to § 1300.05(b), and deletes the 

definitions of ‘‘for cause’’ and ‘‘inner 

liner’’ that were in proposed part 1317. 

The DEA also moves the definition of 

‘‘collection’’ to § 1300.01(b). These 

changes are in response to comments or 

related to the movement of several other 

requirements from part 1317 to other 

parts, as discussed below. 

In addition to moving them to 

§ 1300.05(b), the DEA amends the 

definitions of ‘‘authorized employee’’ 

and ‘‘law enforcement officer.’’ The 

DEA is omitting the word ‘‘authorized’’ 

from the definition of ‘‘authorized 

employee,’’ and codifying the definition 

of ‘‘employee’’ in harmony with the 

general common law of agency. The 

DEA is modifying the definition of ‘‘law 

enforcement officer’’ in part 1317 to 

specifically include officers from law 

enforcement components of Federal 

agencies, and authorized police officers 

of the Veterans Health Administration 

and the Department of Defense. In 

addition, this rule clarifies who may 

qualify as a ‘‘law enforcement officer’’ 

for the purpose of disposal. The DEA is 

changing references to ‘‘law 

enforcement agencies’’ to ‘‘law 

enforcement’’ in order to include law 

enforcement components of Federal 

agencies. 

Although the DEA defined ‘‘inner 

liner’’ in the NPRM, the final rule does 

not amend the CFR to add a definition 

for inner liner. As described below, 

inner liners used in the collection of 

controlled substances must meet the 

specifications outlined in § 1317.60. The 

DEA also is not amending the CFR to 

add a definition of ‘‘for cause,’’ and 

instead is providing an explanation of 

‘‘for cause’’ as it relates to the sections 

to which it applies. 

The DEA added a definition of ‘‘onsite’’ to § 1300.05(b) to clarify that ‘‘onsite’’ means ‘‘located on or at the 

physical premises of the registrant’s 

registered location’’ for purposes of 

destruction and registration as a 

collector. Specifically, a controlled 

substance is destroyed ‘‘on-site’’ when 

destruction occurs on the physical 

premises of the destroying registrant’s 

registered location, and a hospital/clinic 

has an ‘‘on-site’’ pharmacy when it has 

a pharmacy located on the physical 

premises of the registrant’s registered 

location. 

Text was added to the registration 

table in § 1301.13 to reflect that 

distributors, as a coincident activity to 

distribution, may acquire controlled 

substances from collectors for the 

purpose of destruction. The registration 

table was updated so that it would be 

consistent with the regulations in the 

final rule, which authorize distributors 

to destroy controlled substances 

acquired from collectors. 

The DEA received a number of 

comments indicating confusion 

regarding the procedures a registrant 

must follow to modify their DEA 

registration to become a collector. In 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53525 

order to clarify such requirements, the 

DEA is further revising § 1301.51. The 

additional revisions clarify the 

requirements by listing them 

independently of other types of 

registration modifications (e.g., change 

of name or address) and clearly 

indicating that any modifications may 

be made in writing by mail or online. 21 

CFR part 1301. Also, the submission 

method has been modified from ‘‘letter’’ 

to ‘‘written request’’ to accurately 

encompass the various ways the 

modification request may be submitted 

(e.g., online), and the phrase ‘‘to be 

paid’’ was deleted from § 1301.51(c) for 

stylistic reasons. Similarly, the DEA is 

further revising § 1301.52 to clarify that 

any registrant who has been authorized 

as a collector and who desires to 

discontinue their collection of 

pharmaceutical controlled substances 

from ultimate users must notify the 

DEA. 

The DEA is also streamlining certain 

registration and security procedures by 

moving certain requirements from part 

1317, as proposed in the NPRM, to part 

1301. Reverse distributor employee 

security requirements in proposed 

§ 1317.20 were moved to § 1301.74(m) 

for ease of reference and consistency. 

Collector security requirements in 

proposed § 1317.45 were moved to 

§ 1301.71(f) for clarity and consistency. 

The DEA determined that inclusion of 

recordkeeping and reporting 

requirements in part 1317 may lead to 

confusion among registrants. As such, 

the DEA is moving all recordkeeping 

and reporting requirements from part 

1317, as proposed in the NPRM, to part 

1304—Records and Reports of DEA 

Registrants—in order to maintain 

consistency and consolidate all 

recordkeeping and reporting 

requirements into one part. In § 1304.03, 

‘‘each’’ was changed to ‘‘every,’’ and 

‘‘who’’ was changed to ‘‘that’’ for 

stylistic reasons. In § 1304.11(e)(2), the 

first sentence, pertaining to an 

exception for reverse distributors, was 

removed and incorporated into 

§ 1304.11(e)(3) of the final rule to 

accurately reflect the type of registrants 

to which the section applies. 

The DEA is expanding the locations 

where a collector may maintain records 

in § 1304.04(a)(3). The text in 

§ 1304.21(a) was updated to specifically 

include inner liners and mail-back 

packages, which were inadvertently 

overlooked in the NPRM. 21 CFR 

§ 1304.21(c) was updated to include the 

general recordkeeping requirements for 

collection activities as outlined in the 

final rule. The recordkeeping 

requirements for disposal of controlled 

substances in 21 CFR § 1307.21 were 

moved to § 1304.21(e) and amended to 

include recordkeeping procedures for 

destruction. The title and introductory 

text in § 1304.22 were updated to 

accurately reflect their contents. 

Additionally, § 1304.22 was modified to 

include recordkeeping requirements for 

collected controlled substances. The 

second sentence in both § 1304.25(a)(9) 

and § 1304.25(b)(9), which required 

compliance with part 1317 when 

destroying narcotic controlled 

substances, were removed as 

superfluous. All disposal and 

destruction activities are clearly 

delineated in part 1317. Also, various 

Automation of Reports and 

Consolidated Ordering System (ARCOS) 

requirements are removed from part 

1317, as proposed in the NPRM, and are 

consolidated and moved to § 1304.33. In 

addition, the title of § 1304.33 has been 

changed to add clarity, and the acronym 

‘‘ARCOS’’ is clearly spelled out. The 

formatting for § 1304.33(f) was modified 

for ease of understanding, and ‘‘who’’ 

was changed to ‘‘that’’ in two locations 

for consistency. 

The DEA is also amending § 1305.03 

to add a new paragraph (f) to clarify that 

collectors are exempt from order form 

requirements for pharmaceutical 

controlled substances collected through 

mail-back programs and collection 

receptacles for the purpose of disposal. 

The title of § 1307.11 no longer 

references reverse distributors and has 

been changed to ‘‘Distribution by 

dispenser to another practitioner’’ 

because reverse distributor activities 

were moved to part 1317. 

As discussed in the preamble to the 

NPRM and as mentioned in proposed 

§ 1317.100, the DEA clarifies in 

§ 1304.21 of this final rule that, in 

addition to any other recordkeeping 

requirements, all registrants that destroy 

or cause the destruction of a controlled 

substance must maintain a record of that 

destruction on a DEA Form 41. This 

requirement had been discussed in the 

preamble to the proposed rule, and in 

proposed § 1317.100 the DEA stated 

‘‘any registered person that destroys or 

causes the destruction of a controlled 

substance shall maintain a record of 

destruction on a form issued by 

DEA . . ..’’ The DEA has determined 

that this requirement to keep such 

records on DEA Form 41 should be 

explicitly stated in the regulatory text, 

and not just the preamble, for registrants 

to clearly understand the requirements 

to which they are bound. As stated 

above, this requirement to record 

destruction activities on the DEA Form 

41 does not apply to drug wastage or 

pharmaceutical wastage which must be 

properly recorded, stored, and 

destroyed in accordance with DEA 

regulations, and all applicable Federal, 

State, tribal, and local laws and 

regulations. 21 CFR part 1304. 

The DEA is modifying proposed 

§ 1317.70 to address the procedures that 

a collector must follow when ceasing 

operation of a mail-back program. This 

modification requires such collector to 

make reasonable efforts to notify the 

public of their intent to cease mail-back 

collection activities. 21 CFR 1317.70. 

Such collector must also establish an 

agreement with another collector 

authorized to conduct a mail-back 

program to receive all remaining 

packages and arrange for the forwarding 

of such packages to the second 

collector’s registered location. These 

procedures will ensure that another 

authorized entity will be responsible for 

receiving and destroying any mail-back 

packages that were disseminated but not 

received back by the collector prior to 

the time that they ceased operation of 

their mail-back program. 

Finally, the DEA is modifying 

proposed § 1317.75 for two purposes. 

The first modification clarifies that 

collected controlled and non-controlled 

substances can be comingled, but are 

not required to be comingled. 21 CFR 

1317.75. As previously discussed, the 

second modification to this section 

allows certain LTCF employees, as 

designated by the collector authorized 

to maintain a collection receptacle at 

that LTCF, to install, seal, remove, store, 

and transfer for destruction the inner 

liners of the collection receptacle along 

with an employee of the collector. 21 

CFR 1317.80. This modification allows 

greater flexibility for collectors 

authorized to maintain collection 

receptacles at LTCFs. 

II. Background and Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, but are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purpose of this action. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), parts 1300 to 1321. 

The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

providing for a sufficient supply of 

controlled substances and listed 


tkelley on DSK3SPTVN1PROD with RULES2
53526 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

2 21 U.S.C. 822(c)(3) and 957(b)(1)(C) except 

‘‘ultimate users’’ who possess substances for 

purposes referenced in 21 U.S.C. 802(25); however, 

‘‘ultimate user’’ is defined in 21 U.S.C. 802(27). 

3 It is unlawful to knowingly or intentionally 

manufacture, distribute, dispense, or possess with 

the intent to manufacture, distribute, or dispense, 

a controlled substance without the appropriate 

registration. 21 U.S.C. 841(a). 

4The terms ‘‘disposal,’’ ‘‘dispose,’’ or 

‘‘disposition’’ appear several times in the CSA and 

its implementing regulations, but are not defined. 

For example, in the CSA, see 21 U.S.C. 822(g); 

824(f)–(g); 826(c), (e)–(f); 827(a)(3), (d)(1); 842(a)(7); 

853(n); 880(a)(2); 881(e)(1); 958(d)(6); and in the 

CFR, see 21 CFR 1307.21(b) and 1304.22(a)(2)(ix). 

The term ‘‘net disposal,’’ however, is defined at 21 

CFR 1300.01(b). As used, the terms refer to a variety 

of activities that ultimately result in eliminating the 

availability of controlled substances for use. For 

example, within the meaning of the CSA, a 

controlled substance can be ‘‘disposed of’’ by 

destruction, return, recall, sale, or through the 

manufacturing process. The Disposal Act allows an 

ultimate user to deliver a lawfully obtained 

controlled substance to another person ‘‘for the 

purpose of disposal.’’ The DEA believes that the 

ultimate user disposal authorized by the Disposal 

Act includes the transfer or delivery of controlled 

substances for purposes of destruction, return, and 

recall. Such ultimate user activities are consistent 

with the intent to remove unused, unwanted, 

tainted, and expired substances from households 

and out of the reach of children and teenagers 

thereby reducing the risk of diversion and 

protecting the public health and safety. As used in 

this Final Rule, the DEA uses the terms ‘‘disposal’’ 

and ‘‘dispose’’ to generally refer to the wide range 

of activities that result in controlled substances 

being unavailable for further use. When necessary 

to specify a particular activity within the disposal 

process, the particular activity is identified (e.g., 

transfer, deliver, collect/collection, return, recall, 

and destroy/destruction). 

5The Attorney General’s delegation of authority 

to the DEA may be found at 28 CFR 0.100. 

chemicals for legitimate medical, 

scientific, research, and industrial needs 

of the United States. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. To 

this end, controlled substances are 

classified into one of five schedules 

based upon: The potential for abuse, 

currently accepted medical use, and the 

degree of dependence if abused. 21 

U.S.C. 812. Listed chemicals are 

separately classified as list I or list II 

chemicals based on their use and 

importance to the manufacture of 

controlled substances. 21 U.S.C. 

802(33)–(35). 

The CSA establishes a closed system 

of distribution that requires the DEA to 

monitor and control the manufacture, 

distribution, dispensing, import, and 

export of controlled substances and 

listed chemicals until they reach their 

final lawful destination. The secure 

destruction of unused, recalled, tainted, 

expired, or otherwise unwanted 

pharmaceutical controlled substances is 

essential to preventing the diversion of 

these substances into the illicit market. 

In order to maintain this closed 

system of distribution, persons who 

handle (manufacture, distribute, 

dispense, import, export, engage in 

research, or conduct instructional 

activities), or propose to handle, 

controlled substances and listed 

chemicals are required to register with 

the DEA at each principal place of 

business or professional practice. 

Persons registered with the DEA are 

permitted to possess controlled 

substances and listed chemicals as 

authorized by their registration and 

must comply with the applicable 

requirements associated with their 

registration. 21 U.S.C. 822. 

Not all persons who possess 

controlled substances are required to 

register with the DEA. For example, a 

patient who receives a pharmaceutical 

controlled substance pursuant to a 

lawful prescription, i.e., an ultimate 

user, is not required to register with the 

DEA in order to receive and possess that 

substance. 21 U.S.C. 822(c)(3); see also 

21 U.S.C. 957(b)(1)(C).2 The CSA 

defines an ‘‘ultimate user’’ as ‘‘a person 

who has lawfully obtained, and who 

possesses, a controlled substance for his 

own use or for the use of a member of 

his household or for an animal owned 

by him or by a member of his 

household.’’ 21 U.S.C. 802(27). 

While Congress envisioned a closed 

system of distribution that would 

control a substance from its 

manufacture or import through the 

traditional chain of distribution moving 

from registrant to registrant until it 

reached its final lawful use (e.g., 

dispensed to the ultimate user, etc.), it 

did not account for circumstances in 

which pharmaceutical controlled 

substances were lawfully dispensed to, 

and possessed by, an ultimate user but 

not fully used. Although ultimate users 

are exempt from CSA registration 

requirements for the possession of 

pharmaceutical controlled substances, if 

they distribute (e.g., deliver or transfer) 

such substances without the appropriate 

registration, they are in violation of the 

CSA.3 Such unlawful distribution 

includes the transfer of pharmaceutical 

controlled substances for the purpose of 

disposal.4

The Disposal Act, enacted on October 

12, 2010, amended the CSA to allow an 

ultimate user to ‘‘deliver’’ a 

pharmaceutical controlled substance ‘‘to 

another person for the purpose of 

disposal’’ if the person receiving the 

substance is authorized to receive it and 

the disposal takes place in accordance 

with regulations issued by the Attorney 

General to prevent the diversion of 

controlled substances. 21 U.S.C. 

822(g)(1). The Attorney General 

delegated responsibility for 

promulgating the Disposal Act 

implementing regulations to the DEA.5

In addition to authorizing ultimate 

users to deliver their pharmaceutical 

controlled substances to another person 

for the purpose of disposal, the Disposal 

Act also authorizes any person lawfully 

entitled to dispose of an ultimate user 

decedent’s property to deliver the 

ultimate user’s pharmaceutical 

controlled substances to another person 

for the purpose of disposal if the 

ultimate user dies while in lawful 

possession of the substances. The 

Disposal Act also gives the DEA the 

ability, by regulation, to authorize 

LTCFs to dispose of pharmaceutical 

controlled substances on behalf of 

ultimate users who reside, or have 

resided, at the LTCF. Congress directed 

the DEA, in promulgating the Disposal 

Act implementing regulations, to 

consider the public health and safety, 

ease and cost of program 

implementation, and participation by 

various communities. The 

implementing regulations may not 

require any person to establish or 

operate a delivery or disposal program. 

III. Discussion of Comments 

The DEA had received 192 comments 

on the NPRM when the comment period 

closed on February 19, 2013. These 

comments are summarized below, along 

with the DEA’s responses. 

A. Support for the Proposed Rule 

(1 Issue) 

[1] Issue: The DEA received 192 

comments for this rulemaking during 

the 60-day comment period. The vast 

majority of the comments were 

overwhelmingly positive with the 

commenters agreeing that there should 

be more options for secure, convenient, 

and responsible disposal of controlled 

substances. Nineteen commenters 

supported the rule as written in the 

NPRM. Almost every other commenter 

supported the rule to some degree, 

although many commenters had 

concerns with the implementation of 

the specific disposal procedures 

described in the NPRM. 

Response: The DEA appreciates the 

support for this rulemaking and is 

privileged to implement regulations to 

allow for the collection and disposal of 

controlled substances in a secure, 

convenient, and responsible manner. 

The DEA considered all of the 

comments and ramifications of 

implementing proposed changes to the 

rule. In finalizing this rule, the DEA 


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6 Definitions and terms specific to particular 

comment categories, such as ‘‘Law Enforcement’’ 

and ‘‘Long-Term Care Facilities (LTCFs),’’ are 

located in those specific sections. 

considered public health and safety, 

ease and cost of program 

implementation, and participation by 

various communities. 

B. Definitions and Terms 6 (12 Issues) 

[1] Issue: Five commenters asked the 

DEA to define ‘‘ultimate user.’’ 

Response: An ultimate user is defined 

by the CSA as ‘‘a person who has 

lawfully obtained, and who possesses, a 

controlled substance for his own use or 

for the use of a member of his 

household or for an animal owned by 

him or by a member of his household.’’ 

This definition, codified at 21 U.S.C. 

802(27), was not amended or otherwise 

modified by the Disposal Act. 

[2] Issue: Ten commenters asked the 

DEA to clarify the term ‘‘retail 

pharmacy’’ and to specify whether 

‘‘closed-door pharmacies,’’ such as 

those that service LTCFs, ‘‘Federal 

pharmacies,’’ and other pharmacies that 

only provide services to a distinct 

population are considered retail 

pharmacies. 

Response: The intended meaning of 

‘‘retail pharmacy’’ with regard to 

collectors was discussed in the NPRM 

but was not defined in the proposed 

rule itself. The DEA intends ‘‘retail 

pharmacy’’ to include any entity 

registered with the DEA as a retail 

pharmacy as opposed to those entities 

registered as a hospital/clinic. 

Depending on a variety of factors, 

including State authority and 

authorized business practices, some 

entities that dispense controlled 

substances may be registered with the 

DEA as either a retail pharmacy or a 

hospital/clinic. 21 CFR part 1301. In 

other words, pharmacies are not 

registered with the DEA as ‘‘Federal 

pharmacies,’’ ‘‘LTCF pharmacies,’’ or 

even ‘‘closed-door pharmacies.’’ All of 

these pharmacies may be registered as 

retail pharmacies provided they meet 

the requirements of 21 U.S.C. 822 and 

823, and they may be authorized as 

collectors upon proper application. As 

previously discussed, the DEA is also 

allowing entities registered as hospitals/ 

clinics with an on-site pharmacy to be 

collectors. 21 CFR 1317.40. Therefore, 

patients of pharmacies that dispense 

controlled substances pursuant to a 

hospital/clinic registration may benefit 

if the hospital/clinic opts to modify its 

registration to become a collector. 

[3] Issue: Approximately 10 

commenters asked the DEA to expand 

the definition of ‘‘authorized 

employee.’’ These commenters 

expressed concern that the definition of 

‘‘authorized employee’’ in the NPRM 

was too limited in scope, and would 

result in a burden on smaller-staffed 

pharmacies, as well as pharmacies that 

employ contract pharmacists and parttime employees. One commenter asked 

whether or not physician-owners will be 

considered authorized employees. 

Response: The DEA carefully 

considered the commenters’ concerns 

and is modifying the proposed 

definition of ‘‘authorized employee.’’ 21 

CFR § 1300.05(b). In this rule, the DEA 

is omitting the word ‘‘authorized’’ from 

the definition of ‘‘authorized employee’’ 

because the rule already specifies what 

conditions qualify employees to 

conduct certain disposal activities (i.e., 

authorized collectors may not employ, 

as an agent or employee who has access 

to or influence over collected 

substances, any person who has been 

convicted of a felony offense related to 

controlled substances or who has, at any 

time, had an application for registration 

with DEA denied, had a DEA 

registration revoked or suspended, or 

surrendered a DEA registration for 

cause). Also, the DEA is modifying the 

definition of ‘‘employee’’ by adopting 

the general common law of agency’s 

definition of the term and moving the 

definition from proposed part 1317 to 

part 1300. As a result of these changes, 

part-time personnel and physicianowners may be considered ‘‘employees’’ 

for the purpose of disposal if they meet 

the relevant criteria. 

Where Congress does not define 

‘‘employee,’’ the DEA utilizes the 

common law to determine who is an 

‘‘employee.’’ Under U.S. Supreme Court 

precedent, the factors relevant to 

determining whether a person is an 

‘‘employee’’ under the common law 

include, but are not limited to: The 

hiring party’s right to control the 

manner and means by which the 

product is accomplished; the skill 

required; the source of the 

instrumentalities and tools; the location 

of the work; the duration of the 

relationship between the parties; 

whether the hiring party has the right to 

assign additional projects to the hired 

party; the extent of the hired party’s 

discretion over when and how long to 

work; the method of payment; the hired 

party’s role in hiring and paying 

assistants; whether the work is part of 

the regular business of the hiring party; 

whether the hiring party is in business; 

the provision of employee benefits; and 

the tax treatment of the hired party. See 

Nationwide Mut. Ins. Co. v. Darden, 503 

U.S. 318, 323–24 (1992). Other 

applicable factors may be considered 

and no one factor is dispositive. See id. 

at 324. 

After evaluating the relevant factors in 

the context of controlled substance 

security and diversion prevention, in 

the context of disposal, the following 

criteria will determine whether a person 

is an ‘‘employee’’ regardless of the 

number of hours per week the person 

works: Persons who are directly paid by 

the registrant; who are subject to direct 

oversight by the registrant; who are 

required, as a condition of employment, 

to follow the registrant’s procedures and 

guidelines pertaining to the handling of 

controlled substances; who receive a 

performance rating or performance 

evaluation on a regular/routine basis 

from the registrant; who are subject to 

disciplinary action by the registrant; and 

who render services at the registrant’s 

registered location. This definition is 

incorporated in the new § 1300.05, titled 

‘‘Definitions Relating to the Disposal of 

Controlled Substances.’’ These criteria 

focus on the degree of management and 

control that a registrant has over the 

person, and thus, adherence to these 

criteria will directly impact the security 

of controlled substances within the 

registrant’s custody and control. The 

DEA believes that these criteria are the 

minimum required to ensure controlled 

substances are accounted for and not 

diverted to illicit purposes. Under the 

definition, contract personnel who do 

not meet these criteria are not 

‘‘employees’’ for the purposes of 

disposal. 

[4] Issue: One commenter stated that 

the proposed definition of ‘‘authorized 

employee’’ was too expansive, and that 

controlled substances should be 

handled only by individuals who hold 

a professional license. 

Response: The DEA carefully 

considered the diversion risks 

associated with allowing various types 

of persons to handle collected 

substances. The definition of 

‘‘employee,’’ as stated in this final rule, 

will help reduce diversion risks while 

ensuring that authorized collectors have 

sufficient ability to safely and securely 

manage the collection of controlled 

substances. 21 CFR part 1300. 

Individuals who do not hold a 

professional license are considered 

‘‘employees’’ if they meet the criteria as 

explained above. 

[5] Issue: Five commenters asked the 

DEA to define the term ‘‘common or 

contract carrier.’’ 

Response: The DEA declines to define 

this term for the purpose of this rule. 

The DEA’s primary concern regarding 

common or contract carriers is not about 

how these terms are defined, but 

whether there is adequate security to 


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prevent diversion when controlled 

substances are being transported. As 

explained in § 1301.74(e), when 

shipping controlled substances, nonpractitioner registrants are responsible 

for selecting common or contract 

carriers that provide adequate security 

to guard against in-transit losses. In 

addition, non-practitioner registrants are 

responsible for employing precautions 

(e.g., assuring that shipping containers 

do not indicate that contents are 

controlled substances) to guard against 

in-transit losses. Although these specific 

requirements apply to non-practitioners, 

all registrants (practitioners and nonpractitioners) shall provide effective 

controls and procedures to guard against 

theft and diversion of controlled 

substances. 21 CFR part 1301. 

[6] Issue: One commenter suggested 

that the DEA modify the definition of 

‘‘non-retrievable’’ to read: ‘‘means to 

permanently alter any controlled 

substance’s physical and/or chemical 

state through essentially irreversible 

means in order to render that controlled 

substance unavailable and unusable for 

all practical purposes. This definition is 

not intended to require destruction 

beyond the state at which a controlled 

substance becomes unavailable, 

unusable, and, subsequently, no longer 

available for diversion.’’ 

Response: The DEA declines to 

modify the definition as suggested. Such 

a change would significantly weaken 

the non-retrievable standard to a state 

where controlled substances could 

easily be diverted. The permanent and 

irreversible alteration of controlled 

substances is the cornerstone of the nonretrievable standard. 

[7] Issue: Some commenters asked the 

DEA to clarify the meaning of the terms 

‘‘regularly’’ and ‘‘practitioner’’ used in 

the proposed § 1317.05(a)(4). 

Response: ‘‘Practitioner’’ is defined in 

the CSA at 21 U.S.C. 802(21) as ‘‘a 

physician, dentist, veterinarian, 

scientific investigator, pharmacy, 

hospital, or other person licensed, 

registered, or otherwise permitted, by 

the United States or the jurisdiction in 

which he practices or does research, to 

distribute, dispense, conduct research 

with respect to, administer, or use in 

teaching or chemical analysis, a 

controlled substance in the course of 

professional practice or research.’’ The 

term ‘‘regularly’’ has its ordinary 

meaning, with no specific or technical 

implications. The DEA understands the 

ordinary meaning of ‘‘regularly’’ to 

generally be considered as being on a 

routine basis or at routine intervals. 

[8] Issue: One commenter suggested 

that the DEA distinguish reverse 

distributors who only collect controlled 

substances for the purpose of disposal 

from reverse distributors who also 

handle non-controlled substances and 

other waste products. This commenter 

suggested that the DEA lessen the 

requirements for those reverse 

distributors that only collect controlled 

substances for disposal. 

Response: The DEA does not 

distinguish between different ‘‘types’’ of 

reverse distributors. All reverse 

distributors receive controlled 

substances for the purpose of disposal— 

either through return to the 

manufacturer who accepts returns, or 

through destruction. 21 CFR part 1300. 

The regulations impose the minimum 

requirements for reverse distributors 

when handling controlled substances 

regardless of whether they also handle 

other substances. Therefore, there is no 

basis to relax the requirements for 

reverse distributors whose activities are 

limited solely to the collection of 

pharmaceutical controlled substances 

for the purpose of disposal. 

[9] Issue: One commenter asked the 

DEA to clarify the difference between 

‘‘transfer’’ and ‘‘transport’’ as used in 

proposed § 1317.95. 

Response: These terms have their 

ordinary meaning. Generally, the DEA 

uses the term ‘‘transport’’ to refer to the 

physical movement of an item from one 

location to another while ‘‘transfer’’ is 

used to refer to conveying possession or 

control (actual or constructive) from one 

entity to another. 

[10] Issue: One commenter asked the 

DEA to clarify the phrase ‘‘causes the 

destruction’’ as it could be interpreted 

to mean any person involved in the 

process. 

Response: As previously discussed, 

proposed § 1317.100 is relocated in this 

final rule to § 1304.21(e). The DEA 

included the term ‘‘causes the 

destruction’’ to encompass such 

circumstances where a registrant does 

not itself destroy the controlled 

substance but is still responsible for the 

destruction; for example, when a 

registrant or a registrant’s employee 

initiates the destruction process by 

engaging a third-party destruction 

facility that will perform the actual 

destruction pursuant to § 1317.95(c). 

This final rule clarifies this distinction 

in §§ 1317.95(c) and 1304.21(e). 

[11] Issue: One commenter stated that 

the rule should be clarified in use of the 

word ‘‘may’’ with regard to individual 

counting and inventorying of collected 

substances. The commenter indicated 

that the word seems open for 

interpretation. 

Response: The commenter is 

specifically referring to the NPRM 

statement ‘‘[c]ontrolled substances 

collected by collectors may not be 

individually counted or inventoried.’’ 

The DEA understands that this phrase 

may be misinterpreted to mean that 

authorized collectors are not required to 

count or inventory collected substances. 

To clarify, the DEA is modifying 

§§ 1317.60 and 1317.70 to clearly 

indicate that sealed inner liners and 

returned mail-back packages ‘‘shall not 

be opened, x-rayed, analyzed, or 

otherwise penetrated.’’ The DEA also 

modifies § 1317.75(c) to specify that this 

prohibition includes counting or 

inventorying collected substances prior 

to sealing and removing an inner liner 

that contains collected substances, as 

well as after the inner liner is sealed. 

The DEA discusses below the different 

requirements applying to law 

enforcement. 

[12] Issue: One commenter noted that 

the DEA used inconsistent time 

requirements throughout the proposed 

rule, such as ‘‘timely,’’ ‘‘prompt,’’ and 

‘‘as soon as practicable, but no later than 

14 days.’’ Additionally, several 

commenters requested clarification 

regarding the definition of the word 

‘‘prompt’’ in the proposed rule, and 

commenters asked for clarification 

regarding how the DEA would 

determine whether an action is 

‘‘prompt.’’ Commenters asked for 

guidance as to what time range the DEA 

would find reasonably acceptable. 

Response: The DEA’s use of different 

time standards throughout the proposed 

rule was intentional as the different 

circumstances of each requirement 

warrant different standards. The various 

timing requirements are intended to be 

flexible enough to account for 

individual circumstances while also 

ensuring sufficient and adequate 

controls to prevent diversion and 

opportunities for diversion. The DEA 

considered imposing specific timelines 

(e.g., three days, five days); however, the 

wide variety of business models and 

activities made it impossible in most 

circumstances to set a specific deadline 

that would prevent diversion and 

diversion opportunities. Additionally, 

violations of specific timelines would be 

per se violations of the regulations, 

whereas violations of the flexible 

‘‘prompt’’ and ‘‘as soon as practicable’’ 

standards would be considered under 

each registrant’s individual 

circumstances. The DEA’s 

determination will be guided by 

whether the registrant has fulfilled its 

responsibility to provide effective 

controls and procedures to guard against 

theft and diversion. All controlled 

substances destined for destruction 

must be rendered non-retrievable in 

order to be destroyed in a manner 


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consistent with this rule. As such, a 

controlled substance will have been 

promptly destroyed if it is promptly 

rendered non-retrievable. 21 CFR 

1317.95. ‘‘Timely’’ refers to actions that 

have a specific time period for 

compliance, e.g., 30 days. Therefore, in 

each instance in which the rule uses the 

word ‘‘timely’’ to refer to destruction 

requirements for reverse distributors, it 

refers to the specific time period (14 

days in the proposed rule, 30 days in 

the final rule) in which reverse 

distributors are required to destroy 

controlled substances. 21 CFR 1317.15. 

C. Types of Entities That May Operate 

a Collection Program (9 Issues) 

[1] Issue: Several commenters asked 

the DEA to retain the provision in the 

proposed rule to permit retail 

pharmacies to maintain collection 

receptacles. These commenters stated 

that retail pharmacies will provide a 

convenient option for ultimate users 

who desire to safely and securely 

dispose of their unused or unneeded 

controlled substances. Commenters also 

asked the DEA to retain the provision to 

permit retail pharmacies to manage 

collection receptacles at LTCFs. 

Response: The DEA appreciates the 

support for the provisions in the rule 

that permit retail pharmacies to manage 

collection receptacles at not only the 

primary registered location of the retail 

pharmacy, but also LTCFs. 21 CFR 

1317.40 and 1317.80. The DEA believes 

that these two provisions will provide 

ultimate users and others with 

convenient options to safely and 

securely dispose of unused controlled 

substances. The DEA retained these 

provisions in the final rule. 

[2] Issue: Eighteen commenters asked 

the DEA to permit hospitals to become 

authorized collectors so that they may 

maintain collection receptacles. An 

additional two commenters asked the 

DEA to allow specialized hospitals and 

clinics to maintain collection 

receptacles. These commenters stated 

that collection receptacles located 

inside of hospitals would provide 

ultimate users with an opportunity to 

dispose of medication that may no 

longer be needed or may be expired. 

Response: The DEA selected methods 

for disposal that provide opportunities 

for ultimate users to securely, 

conveniently, and responsibly dispose 

of their unused, unwanted, and expired 

pharmaceutical controlled substances 

while also preventing diversion. As 

previously discussed, after extensive 

review and careful deliberation, the 

DEA is permitting certain registered 

hospitals/clinics to become authorized 

collectors. 21 CFR 1317.40. In order to 

counterbalance the diversion risks of 

allowing collection receptacles to be 

located inside hospitals/clinics, the 

DEA is only allowing those hospitals/

clinics with on-site pharmacies to 

become collectors. The DEA is requiring 

these collectors to place collection 

receptacles in locations that are 

regularly monitored by employees, and 

is prohibiting these collectors from 

placing collection receptacles in the 

proximity of any area where emergency 

or urgent care is provided. 21 CFR 

1317.75. 

[3] Issue: One commenter suggested 

that hospitals of a certain size be 

required to become authorized 

collectors. 

Response: The DEA is not requiring, 

nor is the DEA authorized to require, 

any entity to implement a collection 

program or maintain a collection 

receptacle. The Disposal Act explicitly 

states that the ‘‘regulations may not 

require any entity to establish or operate 

a delivery or disposal program.’’ 21 

U.S.C. 822(g)(2). 

[4] Issue: It was requested that the 

DEA allow military treatment facility 

pharmacies (registered with the DEA as 

a hospital/clinic), and the Indian Health 

Service (IHS), including IHS pharmacies 

(IHS, Tribal, and Urban programs) to 

become authorized collectors. One 

commenter also suggested that the DEA 

permit collection receptacles in select 

areas of military installations, such as 

ambulatory care clinics and service 

member barracks. 

Response: As previously discussed, 

any registered hospital/clinic with an 

on-site pharmacy and any retail 

pharmacy may be authorized to be a 

collector. 21 CFR 1317.40. Ambulatory 

care clinics and service member 

barracks are generally not registrants. As 

discussed in the NPRM, the Disposal 

Act did not give the DEA authority to 

create new classes of registration solely 

for the purpose of conducting ultimate 

user disposal activities. The DEA is 

allowing hospitals/clinics with an onsite pharmacy and retail pharmacies to 

be responsible for and manage 

collection receptacles in non-registrant 

LTCFs because the Disposal Act 

acknowledged that LTCFs ‘‘face a 

distinct set of obstacles to the safe 

disposal of controlled substances due to 

the increased volume of controlled 

substances they handle.’’ 21 CFR 

1317.80. LTCF residents generally have 

limited mobility; accordingly, this final 

rule authorizes LTCFs to dispose of 

controlled substances on behalf of 

ultimate users who reside or have 

resided at the LTCF. 21 CFR 1317.30. 

Furthermore, un-registered ambulatory 

care clinics and service member 

barracks generally lack adequate 

safeguards to ensure the security of 

collected pharmaceutical controlled 

substances; thus, allowing collection 

receptacles at such locations poses an 

unacceptable risk of diversion and 

threatens the public health and safety. 

[5] Issue: Eight commenters asked the 

DEA to permit non-registrants to collect 

non-controlled substances for the 

purpose of disposal. 

Response: The DEA’s authority 

regarding drug disposal is specific to 

pharmaceutical controlled substances. 

Non-registrants may collect noncontrolled substances pursuant to all 

applicable Federal, State, tribal, and 

local laws and regulations; however, all 

regulations and laws relevant to 

controlled substances will apply if 

controlled substances are collected, 

even inadvertently. 

[6] Issue: One commenter asked the 

DEA to permit LTCFs to become 

authorized collectors. 

Response: The DEA is without 

authority to permit LTCFs to become 

authorized collectors. As discussed in 

the NPRM, authorized collectors must 

first be registrants in order for the DEA 

to impose and enforce these regulations 

upon them. A majority of LTCFs do not 

have State authority with respect to 

controlled substances—a fundamental 

prerequisite to obtaining a DEA 

registration. The Disposal Act 

authorized the development of 

regulations to permit LTCFs to dispose 

of controlled substances on behalf of 

ultimate users who reside or have 

resided in their facilities. The DEA is 

permitting hospitals/clinics with an onsite pharmacy and retail pharmacies to 

become authorized collectors with 

authority to install and maintain 

collection receptacles at LTCFs, and 

declines to extend this authority to the 

LTCFs themselves. 21 CFR 1317.40. 

[7] Issue: Several commenters urged 

the DEA to create a new status that 

permits non-registrant organizations to 

become authorized collectors for the 

sole purpose of collecting controlled 

substances from ultimate users and 

others authorized to dispose of 

controlled substances on behalf of 

ultimate users. One commenter asked 

that the DEA allow non-profit, nonregistrant organizations to register as 

authorized collectors with a reduced 

fee. 

Response: The DEA is not developing 

a new category of registrant specifically 

for collecting pharmaceutical controlled 

substances from ultimate users. Any 

entity that wishes to collect controlled 

substances from ultimate users must do 

so in accordance with this rule, which 

includes provisions for specified 


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existing registrant categories to modify 

their registration to become authorized 

as collectors. Any person not already 

registered with the DEA, wishing to 

become authorized as a collector must 

first satisfy all of the requirements for 

registration identified in the CSA and its 

implementing regulations. Nonregistrant organizations may partner 

with law enforcement and with 

registrants that are collectors. 21 CFR 

1317.65. 

[8] Issue: One commenter asked the 

DEA to clarify how a local government 

may register with the DEA to become an 

authorized collector. 

Response: As discussed above, the 

DEA is not creating a new registration 

category for the exclusive purpose of 

collecting controlled substances from 

ultimate users. Persons registered with 

the DEA as manufacturers, distributors, 

reverse distributors, NTPs, hospitals/

clinics with an on-site pharmacy, or 

retail pharmacies may apply to modify 

their registration to become an 

authorized collector in the manner 

proscribed by this final rule. 21 CFR 

part 1301. Any person not already 

registered with the DEA, wishing to 

become authorized as a collector must 

first satisfy all of the requirements for 

registration identified in the CSA and its 

implementing regulations. These 

requirements include being authorized 

to handle controlled substances by the 

State in which the applicant is located 

unless exempt by statute or regulation. 

The DEA encourages entities that are 

not registrants to partner with 

authorized collectors or law 

enforcement. 21 CFR 1317.65. For 

example, local governments may partner 

with authorized mail-back collectors to 

provide mail-back packages to the 

public. 

[9] Issue: One commenter asked the 

DEA to clarify that no Federal or State 

government entity may require 

registrants to amend their DEA 

registration to become authorized 

collectors. 

Response: The Disposal Act 

specifically prohibits the DEA from 

requiring any entity to establish or 

operate a delivery or disposal program. 

21 U.S.C. 822(g)(2). The prohibition 

does not extend to every Federal and 

State agency and the DEA does not have 

the authority to institute such a 

prohibition. 

D. Locations Where Authorized 

Collectors May Maintain Collection 

Receptacles or Host Take-Back Events 

(1 Issue) 

[1] Issue: Six commenters asked the 

DEA to permit retail pharmacies to 

manage collection receptacles at 

establishments other than the retail 

pharmacy’s registered location, such as 

community centers. Commenters stated 

other locations may be more convenient 

for ultimate users and would thus 

maximize participation. Two 

commenters asked the DEA to allow 

collection receptacles at unregistered 

locations such as permanent household 

hazardous waste collection sites. 

Response: The DEA acknowledges 

that in some locations, and under 

certain circumstances, alternative 

settings may be more convenient for 

ultimate users, but that is not the only 

consideration. The DEA believes that in 

order to adequately ensure the safety 

and welfare of the public, collection 

receptacles must be located inside the 

DEA-registered location of authorized 

collectors. 21 CFR part 1317.75. 

Authorized collectors, as registrants, are 

readily familiar with the security 

procedures and other requirements to 

handle controlled substances. Most 

publicly-accessible locations where 

controlled substances are not typically 

handled, such as community centers 

and hazardous waste collection sites, 

are not targets for theft in the same 

manner as those locations where 

pharmaceutical controlled substances 

are regularly handled. Thus, those 

locations are unlikely to be familiar 

with, or to have in place, the security 

controls necessary to ensure the security 

of collected substances and prevent 

diversion of controlled substances. 

However, law enforcement may 

continue to conduct take-back events, 

and other persons may partner with law 

enforcement to conduct such take-back 

events at various locations. 21 CFR 

1317.65. 

E. Registration Requirements for 

Authorized Collectors (5 Issues) 

[1] Issue: Several commenters asked 

the DEA to clarify whether or not 

registration modifications for authorized 

collectors may be conducted online. 

Response: Registration modifications 

may be conducted online. For the final 

rule, the DEA is modifying the text of 

§ 1301.51 to clarify that online 

modifications are indeed permitted. 

Registrants may go to 

www.DEAdiversion.usdoj.gov to modify 

their registration when they start or stop 

collection activities. 

[2] Issue: Three commenters stated 

that it is overly burdensome to require 

authorized collectors to modify their 

registration each time they start or stop 

collection activities. These commenters 

asked that the DEA provide additional 

details regarding the registration 

modification process. 

Response: The DEA carefully 

reviewed the registration requirements 

and did not find indications to suggest 

that registration modifications will be 

overly burdensome. The rule requires 

that a registrant must apply to modify 

their DEA registration prior to initiating 

any collection activities. 21 CFR part 

1301. Authorization as a collector is 

subject to renewal in the same manner 

as registration. The DEA will consider 

an authorized collector to be conducting 

collection activities until the 

registration is modified, revoked, 

surrendered, suspended, or otherwise 

terminated. If an authorized collector 

stops collection activities, he/she must 

modify his/her registration to indicate 

such. The requirement to modify a 

registration requires a simple written 

notification to the DEA. This written 

notification can be easily and quickly 

conducted online in a few minutes. 21 

CFR part 1301. The registrant may go 

online and select the option to indicate 

that the registrant has ceased collecting. 

Registrants without ready access to the 

online notification method can easily 

and quickly communicate such 

information to the DEA in writing via 

the mail, which the DEA will process 

promptly upon receipt. 

[3] Issue: One commenter suggested 

that the DEA relax requirements for 

registration modifications regarding 

LTCF collection receptacles. This 

commenter was concerned that 

registration modifications may outpace 

the DEA’s resources. 

Response: The DEA evaluated this 

request and determined that the 

registration requirements regarding 

LTCF collection receptacle management 

are necessary to ensure accountability 

and prevent diversion; the related 

procedures are the minimum necessary 

to ensure that authorized collectors 

maintain the receptacles in a manner 

that is consistent with the applicable 

regulations. 21 CFR part 1301. 

[4] Issue: One commenter asked the 

DEA to clarify whether or not an entity 

may apply for registration as a reverse 

distributor with the sole intent of 

providing destruction services for 

collected substances. 

Response: Any entity may apply for 

registration as a reverse distributor 

pursuant to and in accordance with 21 

U.S.C. 822–823, and 21 CFR part 1301. 

Reverse distributors are not required to 

conduct all activities that they are 

authorized to perform. 

[5] Issue: Two commenters asked the 

DEA to clarify whether a destruction 

facility must be registered with the DEA. 

Response: Pursuant to this rule, a 

destruction facility is not required to 

register with the DEA simply because a 


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registrant utilizes that facility to destroy 

controlled substances in a manner 

consistent with this rule and all other 

applicable Federal, State, tribal, and 

local laws and regulations. At this time, 

the DEA does not believe it is 

appropriate to require these entities to 

be registered because the destroying 

registrant maintains possession and 

control of the substances (and therefore 

retains responsibility and 

accountability) until the substances are 

rendered non-retrievable. 21 CFR part 

1301. All handling, monitoring, 

reporting, recordkeeping, and 

witnessing with regard to the 

destruction of pharmaceutical 

controlled substances must be 

performed by registrants or their 

employees. The DEA has omitted the 

language that was proposed for 

§ 1317.15(c)(4) in order to prevent 

confusion. 

F. Law Enforcement (7 Issues) 

[1] Issue: Several commenters asked 

the DEA to expand the definition of 

‘‘law enforcement officer’’ to include 

law enforcement components of Federal 

agencies and civilian law enforcement 

officers. 

Response: The final rule definition is 

expanded from the proposed rule to 

specifically include officers of the law 

enforcement components of Federal 

agencies, and police officers of the 

Veterans Health Administration and the 

Department of Defense. The NPRM 

proposed a definition of ‘‘law 

enforcement officer’’ to include persons 

who are employees of a ‘‘law 

enforcement agency.’’ The DEA is 

modifying this definition in the final 

rule to specifically include employees of 

law enforcement components of Federal 

agencies. Any person who meets the 

criteria for ‘‘employee’’ and ‘‘law 

enforcement officer’’ outlined in the 

final rule will be a qualified officer for 

the purposes of disposal of 

pharmaceutical controlled substances, 

regardless of whether the person is 

considered a ‘‘civilian’’ law enforcement 

officer. 21 CFR part 1300. 

[2] Issue: Four commenters stated it 

would be overly burdensome to require 

law enforcement to have a collection 

receptacle that fits the specifications in 

the NPRM. These commenters stated 

that the collection receptacle would 

pose logistical issues, and that the 

volume of drugs collected would likely 

exceed the volume that the receptacle 

could contain. Commenters also noted 

that it is unnecessary to mandate that 

law enforcement utilize collection 

receptacles at take-back events. 

Response: Law enforcement are not 

required to have a collection receptacle 

that meets all of the specifications in the 

rule, and the text of the rule is amended 

to clarify that the specifications apply to 

authorized collectors and not law 

enforcement. The only suggested 

requirements for the physical 

construction of collection receptacles 

maintained by law enforcement are that 

they be securely placed and maintained 

at the law enforcement’s physical 

location. 21 CFR 1317.35. Also, law 

enforcement are not required to utilize 

collection receptacles at take-back 

events. The text of the final rule states, 

‘‘[e]ach take-back event should have at 

least one receptacle for the collection of 

permitted substances . . .’’ 21 CFR 

1317.65. Thus, law enforcement should 

have some sort receptacle at take-back 

events. 

[3] Issue: Commenters expressed 

concern that law enforcement may not 

have the facilities to store the collected 

substances until they are shipped to a 

destruction facility. 

Response: The rule suggests that law 

enforcement store collected substances 

in a manner that is consistent with its 

standard procedures for storing illicit 

controlled substances. The language 

used in the text of the rule, ‘‘should,’’ 

is suggestive. Law enforcement are 

encouraged to follow the guidance in 21 

CFR 1317.35; however, they are not 

required to do so. It should be noted 

that the requirements in 21 CFR 1317.65 

pertaining to law enforcement presence 

at take-back events are mandated; 

however, the DEA only suggests 

procedures for the storage and 

transportation of pharmaceutical 

controlled substances collected at takeback events. 

[4] Issue: One commenter asked the 

DEA to permit entities other than law 

enforcement to conduct take-back 

events. 

Response: If an authorized collector 

or other entity wishes to conduct a takeback event, the event must be held in 

partnership with law enforcement, as 

provided in the rule. 21 CFR 1317.65. 

Take-back events are intended to be 

limited-duration events that may take 

place at an unregistered location that is 

easily accessible to the public, such as 

a community center or town center. 

Given the likelihood of publicity and 

low physical security at such locations, 

the DEA believes that it is imperative to 

ensure active law enforcement 

participation for the safety of the event 

participants and the community, as well 

as to help deter theft and diversion of 

pharmaceutical controlled substances. 

[5] Issue: Commenters urged the DEA 

to relax the ‘‘authorized employee’’ 

requirement for civilian law 

enforcement officers. These commenters 

stated that the DEA should treat civilian 

law enforcement officers as ‘‘authorized 

employees’’ for the purposes of this 

rule. They stated that these officers and 

employees currently assist with takeback events, and if they were no longer 

permitted to, there would be a staffing 

shortage to assist with take-back events. 

Additionally, several commenters 

encouraged the DEA to allow civilian 

law enforcement employees to handle 

collected substances if they meet the 

same requirements as an employee or 

handle the substances in a manner 

consistent with law enforcement 

protocols. 

Response: In the NPRM, ‘‘authorized 

employee’’ referred to those registrant 

personnel who would be permitted to 

directly participate in the disposal 

process. ‘‘Authorized employee’’ did not 

pertain to law enforcement officers or to 

take-back events. In the final rule the 

definition is modified, but it still only 

pertains to those persons who may be 

permitted to directly participate in the 

disposal process. 21 CFR part 1300. 

With respect to law enforcement and 

take-back events, as discussed above, 

any person who meets the criteria for 

‘‘employee’’ and ‘‘law enforcement 

officer’’ outlined in the final rule will be 

a qualified officer for the purposes of 

disposal of pharmaceutical controlled 

substances, regardless of whether the 

person is considered a ‘‘civilian’’ law 

enforcement officer. The DEA declines 

to expand the law enforcement 

authority to specifically include civilian 

law enforcement employees. Only 

employed law enforcement officers, as 

defined by this final rule, may handle 

pharmaceutical controlled substances at 

take-back events. As discussed in the 

NPRM and previous responses to this 

issue, the DEA believes that this level of 

security is necessary to prevent theft 

and diversion and to ensure the safety 

of the public due to the highly 

publicized nature of take-back events 

and the fact that such events are likely 

to occur at locations with minimal 

security. The DEA does not believe that 

this requirement will hinder the success 

of take-back events. As previously 

discussed, only one law enforcement 

officer must oversee the take-back event, 

and at the discretion of the law 

enforcement agency or law enforcement 

component of a Federal agency, this 

officer may also be the law enforcement 

officer who maintains control and 

custody of the collected substances. 21 

CFR 1317.65. There are no prohibitions 

against other persons assisting law 

enforcement officers conduct the takeback event. 

[6] Issue: One commenter asked the 

DEA to address what rights Military 


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Provost Marshal Officers have with 

respect to collecting controlled 

substances from ultimate users. 

Response: Under § 1317.35 of the new 

regulation, Federal law enforcement 

may continue to conduct take-back 

events and mail-back programs, and 

operate collection receptacles as further 

detailed in the regulation. If the Office 

of the Provost Marshal is considered 

‘‘Federal law enforcement,’’ it would be 

eligible to conduct such collection 

activities. Federal law enforcement can, 

and in some cases must, appoint a law 

enforcement officer to oversee those 

activities. The appointed officer would 

then have the authority granted by his/ 

her agency. 

[7] Issue: One commenter asked the 

DEA to clarify how law enforcement 

may transport and deliver collected 

substances to a destruction facility (i.e., 

whether they may ship such substances 

using a common carrier) and how law 

enforcement can comply with 

Department of Transportation (DOT) 

requirements when transporting 

substances that may contain hazardous 

materials. 

Response: The DEA has no expertise 

or authority to interpret or apply the 

DOT laws, regulations, or guidelines 

regarding transportation of 

pharmaceutical controlled substances 

that may constitute hazardous materials. 

As such, interested persons are 

encouraged to contact the DOT directly 

with their specific circumstances, and 

such persons can obtain more 

information at www.phmsa.dot.gov/

hazmat. However, the DEA understands 

that the DOT’s Hazardous Materials 

Regulations apply to entities that place 

hazardous materials in commercial 

transportation, and not government 

vehicles operated by government 

personnel solely for non-commercial 

purposes. If more detailed guidance is 

necessary, the DEA encourages law 

enforcement and other entities to 

consult the DOT for guidance on 

transporting collected substances that 

may contain hazardous materials. For 

additional commentary on hazardous 

material disposal please see comment 

section ‘‘Q.’’ entitled ‘‘Hazardous 

Materials Transportation and Hazardous 

Waste Destruction.’’ 

G. Collection Receptacle Design, Inner 

Liners, Placement, and Security (24 

Issues) 

Clarification of Terms 

[1] Issue: One commenter noted that 

the DEA interchangeably used the terms 

‘‘container’’ and ‘‘shell’’ when referring 

to the outer collection receptacle. 

Response: The DEA is modifying the 

final rule to consistently use the term 

‘‘container’’ when referring to the outer 

portion of collection receptacles. This 

change is purely for stylistic consistency 

and makes no substantive change to the 

rule. 

Collection Receptacle Design 

[2] Issue: The DEA specifically 

requested comments regarding the value 

of the use of a uniform symbol to be 

placed on collection receptacles. The 

DEA received 22 comments regarding 

the use of a uniform symbol. Five 

commenters supported the use of a 

uniform symbol, and 17 commenters 

opposed the use of a uniform symbol. 

One commenter suggested that the 

symbol be yellow. Four commenters 

noted that the use of such a symbol is 

unnecessary given the requirement to 

clearly mark and label the receptacles. 

Three commenters expressed concern 

that the use of such symbols would 

result in the receptacles becoming 

targets for diversion. One commenter 

was not opposed to the use of a uniform 

symbol but does not believe it is 

essential. One commenter indicated that 

the use of a uniform symbol should be 

contingent upon the location and 

security of the collection receptacle. 

Response: The DEA appreciates all of 

the comments submitted in response to 

this request. After careful consideration, 

the DEA declines to include a uniform 

symbol requirement in this final rule. 

However, the DEA may consider 

requiring a uniform symbol on 

collection receptacles after a sufficient 

time to observe the effects of the 

existing requirement to clearly mark and 

label collection receptacles. 

[3] Issue: Eleven commenters stated 

that any signage indicating what 

ultimate users may deposit into the 

collection receptacle should be in plain 

language. These commenters noted that 

most ultimate users cannot distinguish 

between controlled substances and noncontrolled substances. Other 

commenters stated that no sign should 

be required at all, and others suggested 

the use of pictograms instead of words. 

Others raised concerns that signage will 

draw attention to the receptacles, thus 

increasing risk for theft and diversion. 

Response: The final rule does not 

require any specific language, design, or 

color choice for the display on the 

collection receptacle as long as the sign 

indicates that only schedules II–V 

controlled substances and noncontrolled substances are acceptable. 21 

CFR 1317.75. As explained above, 

comingling is permitted but not 

required. 21 CFR 1317.75. Plain 

language, pictograms, or a combination 

of the two, may be used, as long as it 

is clear that schedule I controlled 

substances, controlled substances not 

lawfully possessed by the ultimate user, 

and illicit or dangerous substances are 

not permitted to be placed in the 

container. The DEA believes that some 

notice regarding what substances may 

be disposed in collection receptacles is 

necessary in order to provide guidance 

to the public and to discourage the use 

of receptacles for disposing trash or 

other items. While the diversion risks 

presented by the requirement for 

signage is mitigated by physical security 

requirements (e.g., that the receptacle be 

securely fastened to a permanent 

structure), authorized collectors should 

be mindful that the selected signage not 

transform the receptacle into a target for 

theft or diversion. 

[4] Issue: Four commenters suggested 

that the collection receptacle sign 

encourage ultimate users to remove 

medication from its container before 

placing the medication in the collection 

receptacle. Several of the commenters 

who had participated in authorized 

pharmaceutical controlled substance 

take-back programs noted that the 

packaging for medication is 

voluminous, and that including such 

packaging will be burdensome since it 

will necessitate changing inner liners 

more frequently. 

Response: The DEA appreciates these 

commenters’ concerns. Although 

collectors may encourage ultimate users 

to remove substances from their 

containers before depositing them into a 

collection receptacle or mail-back 

package, the DEA declines to require it. 

The DEA has declined to mandate 

whether substances must be disposed 

of, with or without packaging, because 

such requirements would not 

necessarily affect security or increase 

the risks of diversion, and as such, 

should be left to the individual 

collectors and other relevant authorities 

who best know the needs and 

requirements of their programs and 

locations. 

[5] Issue: Other commenters indicated 

that some hazardous waste disposal 

regulations require the disposal of 

medication containers, which may not 

fit into the receptacles. 

Response: As discussed in the 

immediately preceding comment, the 

DEA is neither requiring nor prohibiting 

medication containers to be disposed of 

with pharmaceutical controlled 

substances. Moreover, there is no 

indication that the vast majority of 

medications will not fit into the ‘‘small 

opening’’ that the collection receptacles 

specifications require. For additional 

commentary on hazardous waste 


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disposal please see comment section 

‘‘Q.’’, entitled ‘‘Hazardous Materials 

Transportation and Hazardous Waste 

Destruction.’’ 

[6] Issue: The DEA received 

comments that the inner liner should be 

a large plastic tub or bucket within a 

receptacle that can be easily removed 

and the collected items either dumped 

into smaller containers or sorted before 

being secured into storage for disposal 

or prior to destruction. 

Response: The DEA carefully 

considered the specifications of both the 

inner liner and the outer container of 

the collection receptacle. To prevent 

diversion and protect the public health 

and safety, the DEA drafted this rule 

with the precisely considered objective 

of limiting the number of people who 

handle the collected substances. The 

DEA’s extensive experiences in 

regulating and enforcing the closed 

system of distribution established by the 

CSA have demonstrated that a key factor 

in reducing diversion risk is limiting the 

handling of controlled substances. In 

the context of disposal, this means 

prohibiting the sorting of collected 

substances once they are deposited into 

a collection receptacle. 

[7] Issue: One commenter stated that 

the collection receptacle design 

specifications will require current 

collection programs for non-controlled 

substances to install new collection 

receptacles if those programs wish to 

additionally collect pharmaceutical 

controlled substances. This commenter 

stated that such installations will be 

burdensome and will discourage 

participation for these programs. 

Response: The DEA deeply 

appreciates the concern and activism of 

local communities and other groups 

currently conducting non-controlled 

substance drug take-back programs and 

their wish to expand collection 

activities to pharmaceutical controlled 

substances. Programs such as these are 

an important and vital component of the 

communities they serve. The DEA 

understands that publication of this 

final rule may necessitate the need for 

some programs to implement new 

procedures and install new equipment 

in order to additionally collect 

pharmaceutical controlled substances. 

The DEA has not established the new 

requirements lightly or without 

considerable deliberation as to its 

impacts on existing programs. However, 

the risk of diversion for non-controlled 

substances is relatively low compared to 

the much higher risk of diversion, and 

the corresponding and associated risks 

to public health and safety, for 

pharmaceutical controlled substances. 

The DEA has been charged by Congress 

with the enforcement of the controlled 

substance laws of the United States, and 

must ensure that pharmaceutical 

controlled substances are properly 

secured and not easily susceptible to 

theft or diversion. Accordingly, the 

collection receptacle design 

specifications outlined in § 1317.75 will 

be implemented as proposed. 

[8] Issue: A commenter asked the DEA 

to permit the use of similar receptacles 

that may already exist and were 

designed for the deposit and storage of 

medical waste. 

Response: The DEA is not prohibiting 

the use of collection receptacles that 

currently exist on the market as long as 

such receptacles meet all of the design 

specifications outlined in § 1317.75 of 

this rule. 

[9] Issue: Five commenters stated that 

the requirement for a collection 

receptacle to be fastened to a permanent 

structure is burdensome. Several 

commenters pointed out that many 

pharmacies do not own the property 

that is their DEA-registered location, 

and such fixtures and installments are 

prohibited. One commenter pointed out 

that this requirement would be 

particularly burdensome for small, rural 

pharmacies. Another commenter asked 

if the requirement applies if the 

collection receptacle is located in a 

locked room, inaccessible to the public. 

Response: The DEA appreciates the 

willingness of pharmacies to aid in the 

societal goal of helping to combat 

unauthorized access to and abuse of 

pharmaceutical controlled substances. 

The DEA understands that there may be 

logistical concerns for some retail 

pharmacies that wish to maintain a 

collection receptacle at their registered 

location. However, the DEA believes 

that permanently-secured, fixed 

containers are the minimum required to 

prevent diversion and theft of collected 

substances. The requirement that 

collection receptacles be securely 

fastened to a permanent structure 

applies to all authorized collectors’ 

collection receptacles, no matter the 

location of the registrant. 21 CFR 

1317.75. Although the final rule does 

not expressly prohibit collection 

receptacles from being placed in a 

locked room that is inaccessible to the 

public, the final rule does mandate that 

collection receptacles at authorized 

collectors’ registered locations must be 

accessible to ultimate users, and others 

authorized to dispose of controlled 

substances on behalf of ultimate users, 

as they are the only people who may 

deposit pharmaceutical controlled 

substances into a collection receptacle 

(e.g., ultimate users cannot transfer 

pharmaceutical controlled substances to 

pharmacy staff). 21 CFR 1317.30. The 

DEA encourages retail pharmacies 

leasing their commercial space to work 

with their landlords to allow for the 

installation of collection receptacles 

under the conditions established by this 

rule. 

[10] Issue: Nine commenters stated 

that requiring an outer container with 

an inner liner is unnecessary and 

burdensome. These commenters 

proposed that the collection receptacle 

be designed in such a way that it can be 

returned to the reverse distributor as a 

complete unit. 

Response: The DEA appreciates the 

value in utilizing temporarily secured 

containers that can be sealed and 

shipped for destruction; however, the 

DEA believes that such systems present 

an unreasonable risk of diversion 

because, even when secured, such 

containers can be relatively easily 

removed when compared to a securely 

fastened and locked outer container. 

Relatedly, the DEA is requiring that 

collection receptacles be ‘‘substantially 

constructed,’’ which is intended to 

ensure that the construction is such that 

unauthorized access to the contents of 

the receptacle is not easily obtained. 21 

CFR 1317.75. Accordingly, the DEA is 

requiring that collection receptacles 

have a substantially-constructed outer 

container and removable inner liners. 21 

CFR 1317.60 and 1317.75. 

[11] Issue: Three commenters stated 

that the collection receptacle should not 

be required to have a traditional lock, 

but that its opening be designed so that 

that the contents cannot be removed. 

Response: In implementing the 

Disposal Act to provide secure and 

responsible disposal methods for 

pharmaceutical controlled substances 

by ultimate users, the DEA must ensure 

that collected substances are properly 

secured and not easily susceptible to 

theft or diversion. The requirements 

pertaining to collection receptacles were 

carefully considered and designed to 

limit the handling of the controlled 

substances, from ultimate user to 

destruction. These considerations 

dictated the size of the opening. 

However, the NPRM and the final rule 

allow for flexibility regarding a 

traditional lock, and require that ‘‘the 

small opening in the outer container of 

the collection receptacle shall be locked 

or made otherwise inaccessible to the 

public when an employee is not present 

(e.g., when the pharmacy is closed).’’ 21 

CFR 1317.75(f). 

[12] Issue: One commenter suggested 

that the DEA conduct a national pilot 

program prior to implementation of the 

final rule to ensure that collection 


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receptacle requirements are feasible and 

effective. 

Response: The DEA believes that the 

need to implement this rule in order to 

allow secure convenient options for 

disposal outweighs the delay and 

limited benefit that may be obtained by 

implementing any pilot programs or 

other testing or research. Through 

various outreach efforts, including the 

public meeting the DEA held in January 

2011, comments from industry, and 

information obtained from pilot 

programs, the DEA believes that it has 

effectively researched and analyzed the 

various aspects of this rule. Also, the 

DEA believes that implementation of 

this rule is important to helping reduce 

the amount of unwanted pharmaceutical 

controlled substances available for theft, 

diversion, and accidental ingestion. 

[13] Issue: One commenter asked the 

DEA to allow a Special Agent in Charge 

(SAC) to approve container and inner 

liner designs. 

Response: As discussed in the NPRM, 

the DEA determined that the 

elimination of individual SAC approval 

for various aspects of disposal or 

destruction is necessary in order to 

ensure clear and consistent 

requirements throughout the United 

States, thus reducing the potential for 

confusion regarding requirements for 

ultimate users and authorized 

collectors. Specific approval of 

individual collection receptacles and 

inner liner designs is not required. All 

collection receptacles and inner liner 

designs must meet the specifications 

outlined in this final rule. 21 CFR 

1317.60 and 1317.75. 

[14] Issue: One commenter suggested 

that national pharmacy organizations 

educate the public on proper disposal 

methods and various disposal options. 

This commenter suggested that such 

organizations post information online 

and disseminate leaflets at retail 

establishments. 

Response: With regard to patient 

information regarding disposal, the DEA 

is not requiring any entity to educate the 

public on proper disposal methods and 

their various disposal options. However, 

the DEA anticipates that many entities 

will voluntarily choose to do so. The 

DEA applauds and encourages 

voluntary, educational outreach to the 

public on issues related to the abuse 

potential and proper disposal of 

pharmaceutical controlled substances, 

whether it be through law enforcement, 

community groups, or professional 

organizations. 

Collection Receptacle Inner Liners 

[15] Issue: Several commenters asked 

for clarification regarding inner liner 

tracking requirements. Specifically, 

commenters asked how unique 

identification numbers should be 

assigned, how tracking systems are to be 

implemented, and what entity will be 

responsible for placing identification 

numbers on inner liners. One 

commenter suggested that the DEA 

regulate the manufacture of inner liners 

or require that inner liners be 

sequentially numbered. 

Response: The rule outlines the 

design requirements and the 

recordkeeping requirements for inner 

liners. The purpose of a unique 

identification number is to provide for 

complete and accurate records that can 

be inventoried to ensure that each liner 

is accounted for from receipt, to 

installation, removal, storage, transfer, 

and destruction. 21 CFR part 1304. The 

unique identification numbers therefore 

must be unique to the individual 

collector. 21 CFR 1317.60. The DEA 

does not intend to require any particular 

method for assigning such numbers and 

is modifying the text of proposed 

§ 1317.60(e) by indicating that only 

inner liners must bear a permanent, 

unique identification number. The 

company manufacturing the inner liners 

may assign the numbers. The DEA does 

not have authority to directly regulate 

the manufacturers of the inner liners. 

[16] Issue: One commenter suggested 

that the inner liner be clear so that it can 

be visually inspected for non-compliant 

items. 

Response: Due to associated increased 

risks for diversion, the DEA determined 

that the contents of the inner liners 

must not be viewable once the inner 

liner is sealed. 21 CFR 1317.60. The 

DEA appreciates the concerns regarding 

certain non-compliant items being 

placed in collection receptacles; 

however, for reasons discussed in 

previous comments, no one is permitted 

to handle the contents of inner liners. 21 

CFR 1317.75. The DEA would like to 

point out that the text of the rule does 

not prohibit items from being observed 

prior to being placed in the collection 

receptacle, which could be an effective 

way to ensure that such non-compliant 

items are not placed in the collection 

receptacle. 

[17] Issue: Several commenters 

indicated that the requirement to store 

sealed inner liners in the same manner 

as schedule II controlled substances will 

be overly burdensome and will reduce 

the amount of space available for storing 

schedule II inventory at retail 

pharmacies. These commenters 

suggested that the DEA allow the 

authorized collector to transfer collected 

substances in inner liners to a secure 

warehouse facility for storage until they 

can be picked up or shipped. 

Response: The DEA appreciates these 

concerns but declines to permit 

authorized collectors to transfer 

collected substances to warehouse 

facilities for storage. Filled inner liners 

must be stored only at primary 

registered locations (and at LTCFs in 

accordance with § 1317.80(c)) and may 

not be transported to off-site 

warehouses. The basis for this 

requirement is that the risk of diversion 

increases each time inner liners change 

hands or are transported. However, as 

previously discussed, this final rule 

expands the NPRM requirement and 

authorizes practitioners to store 

collected substances at their registered 

location in either a securely locked, 

substantially constructed cabinet or a 

securely locked room with controlled 

access. 21 CFR 1317.05. 

[18] Issue: Four commenters stated 

that the DEA should permit schedule I 

controlled substances to be disposed of 

via collection receptacles, mail-back 

packages, or take-back events. 

Response: The Disposal Act addresses 

the issue of unused prescription drugs, 

and it allows the DEA to provide 

ultimate users with a secure and 

responsible method to dispose of 

pharmaceutical controlled substances. 

This rule does not address the disposal 

of illicit controlled substances, e.g., 

those substances controlled in schedule 

I of the CSA. Schedule I controlled 

substances, by definition, have no 

accepted medical use in treatment in the 

United States, and may not be lawfully 

prescribed or otherwise distributed to 

any person. In fact, any transfer of a 

schedule I controlled substance by an 

ultimate user is a violation of the CSA, 

unless the ultimate user is participating 

in an investigational use of drugs 

pursuant to 21 U.S.C. 355(i) and 360b(j), 

and the delivery is conducted in 

accordance with 21 CFR 1317.85. 

Collection Receptacle Placement and 

Safety 

[19] Issue: Ten commenters expressed 

concern regarding security in retail 

pharmacies with collection receptacles. 

Several commenters asked the DEA to 

provide guidance for proper security 

measures. One commenter asked for 

clarification on an authorized collector’s 

liability should a receptacle become 

subject to diversion or if improper 

substances are deposited. 

Response: The DEA appreciates the 

concerns of the commenters and has 

carefully considered the risks and 

benefits associated with collection 

receptacles located in authorized retail 

pharmacies. The DEA’s rationale for 


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allowing collection at authorized retail 

pharmacies was described in the NPRM. 

As previously noted, the DEA is not 

requiring any pharmacy to provide a 

collection receptacle. Each registrant is 

free to weigh the risks and benefits in 

determining whether or not to seek 

status as an authorized collector. The 

DEA proposed the rule with the security 

requirement for permanently-secured, 

fixed containers based on a 

determination that this was the 

minimum required to help reduce the 

risk of diversion and theft of 

pharmaceutical controlled substances. 

21 CFR 1317.75. At retail pharmacies, 

the location of collection receptacles 

within the immediate proximity of a 

designated area where controlled 

substances are stored and at which an 

employee is present is anticipated to 

provide an additional layer of security 

due to the increased visibility of the 

receptacles. 21 CFR 1317.75. While 

potential violations of the CSA and its 

implementing regulations are 

investigated and assessed 

independently, this final rule imposes 

the minimum required procedures to 

prevent and detect diversion. Even so, 

each authorized collector’s 

circumstances are unique. All 

registrants should be mindful of their 

responsibility to provide effective 

controls and procedures to guard against 

theft and diversion under 21 CFR 

1301.71(a), and their duty to report 

thefts and significant losses of 

controlled substances under 21 CFR 

1301.74 and 1301.76. 

[20] Issue: One commenter suggested 

that the inner liners be nondescript and 

free of any markings that would indicate 

their contents. This commenter was 

concerned that any markings on the 

inner liners would increase diversion 

risks and make them potential targets 

for drug seekers. 

Response: The DEA appreciates the 

commenter’s concern for potential 

diversion risks that inner liners might 

pose, and made the determination to 

require them only after careful 

consideration of the associated risks and 

benefits of their use, and alternatives to 

their use. The DEA is requiring the size 

of the inner liner to be clearly marked 

on the outside of the liner, and for the 

inner liner to bear a unique 

identification number in order to help 

ensure accountability, and to identify 

and prevent diversion. 21 CFR 1317.60. 

Given the totality of information 

reviewed, the DEA concluded that a 

requirement for the contents to be nonviewable once the inner liner is sealed 

will help reduce diversion risks and 

deter drug seekers. 

[21] Issue: One commenter stated that 

requiring contents of the inner liner to 

be non-viewable could lead to diversion 

as staff could record controlled 

substances as being disposed of without 

actually placing them into the 

receptacle. 

Response: The rule prohibits 

authorized collectors’ staff from 

handling collected substances, even for 

the purpose of depositing them into the 

collection receptacle. Ultimate users, 

and those who are authorized to handle 

controlled substances on behalf of 

ultimate users for the purpose of 

disposal, are the only persons who may 

deposit pharmaceutical controlled 

substances into a collection receptacle. 

21 CFR 1317.30. Therefore, the DEA 

does not envision a circumstance where 

pharmaceutical controlled substances 

might be recorded as having been 

disposed of, but were in actuality 

diverted as a result of pharmacy staff 

never having placed the substances into 

the collection receptacle. 

[22] Issue: One commenter indicated 

that the use of an inner liner that is 

removable and sealable immediately 

upon removal without emptying or 

touching the contents is impractical 

because the contents may spill or fall 

out and then must be handled. 

Response: The DEA carefully 

considered the design and security 

requirements for inner liners and 

determined that the collection 

receptacle option will help to minimize 

the risk of diversion while ensuring 

safety and convenience for ultimate 

users and collectors. As discussed in the 

NPRM, inner liners that allow 

opportunities for collectors to sort or 

otherwise handle the collected 

substances would decrease security and 

increase the risk of diversion. The DEA 

does not believe that overfill or spillage 

from the inner liners will be a concern 

as the requirement that inner liners fit 

within the outer container of the 

collection receptacle is designed to 

prevent such occurrences. However, 

security requirements, such as the 

presence of two employees to remove or 

supervise the removal of an inner liner, 

help reduce the risk of theft and 

diversion if such instances do occur. 21 

CFR 1304.22, 1317.60, and 1317.75. If 

spillage occurs, a registrant’s 

responsibility to provide effective 

controls and procedures to guard against 

theft and diversion of controlled 

substances would require the registrant 

to take corrective action to prevent 

spillage from recurring. 

[23] Issue: Several commenters asked 

the DEA to identify the maximum 

allowable capacity for a receptacle and 

the maximum duration that controlled 

substances may be stored in the 

receptacle. 

Response: There is no maximum or 

minimum capacity for collection 

receptacles at this time. Although there 

is no maximum duration that the 

collected substances may remain in the 

collection receptacle at this time, 

authorized collectors are reminded of 

their responsibility to provide effective 

controls and procedures to guard against 

theft and diversion, 21 CFR 1301.71(a), 

and their duty to report thefts and 

significant losses of controlled 

substances under 21 CFR 1301.74 and 

1301.76. 

[24] Issue: Several commenters asked 

the DEA to allow ‘‘disposal companies,’’ 

distributors, and reverse distributors to 

manage and maintain collection 

receptacles at the registered locations of 

authorized collector retail pharmacies 

and at LTCFs on behalf of the 

authorized collector retail pharmacies. 

These commenters also asked if such 

entities may establish a fee system for 

such services. 

Response: Distributors and reverse 

distributors will not be permitted to 

manage or maintain collection 

receptacles at retail pharmacies or 

LTCFs. 21 CFR 1317.40 and 1317.80. 

The DEA determined that no entities 

other than retail pharmacies and 

hospitals/clinics with an on-site 

pharmacy will be permitted to manage 

collection receptacles at LTCFs. 21 CFR 

1317.40 and 1317.80. As discussed in 

the NPRM, this rule establishes a 

checked system of transfers where each 

registrant who handles collected 

substances serves as a source of 

verification for the other registrants that 

handle the same substances, thus 

ensuring that the collected substances 

reach their intended destination with 

accountability and a reduced risk of 

diversion. In order to maintain this 

system, all collected substances must be 

handled in the manner described in this 

rule, including the requirement that the 

handling of a collection receptacle inner 

liner be restricted to employees of the 

authorized collector as provided, with 

the limited exception for LTCFs. 21 CFR 

1317.80. Such requirements ensure that 

persons handling collected substances 

during the disposal process are 

accountable to their employer, and the 

number of entities handling the 

collected substances is reduced while 

also providing a secure system of checks 

that increases the level of 

accountability. 

H. Mail-Back Programs (11 Issues) 

[1] Issue: Thirteen commenters stated 

that the on-site destruction requirement 

for mail-back programs is severely 


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limiting due to the limited number of 

commercial incinerators. These 

commenters urged the DEA to allow 

collectors to receive mail-back packages 

whether or not they have a means of onsite destruction. Several commenters 

also asked the DEA to allow collectors 

to use a third party to destroy mail-back 

packages. 

Response: As discussed in the NPRM, 

an on-site method of destruction for 

mail-back packages is the minimum 

necessary to prevent diversion of 

controlled substances destined for 

destruction. 21 CFR 1317.05. 

Importantly, an on-site method of 

destruction reduces the accumulation of 

controlled substances in a single 

location, and minimizes the transfer of 

controlled substances between various 

locations. This is intended to help 

minimize the risk of diversion. For each 

of the three methods of ultimate user 

disposal included in this rule, the DEA 

has attempted to minimize the number 

of entities that handle the collected 

substances in order to minimize the risk 

of diversion, which increases each time 

a controlled substance is transferred to 

a new person. It is emphasized that 

authorized collectors may partner with 

reverse distributors and other 

authorized registrants with on-site 

methods of destruction to promote mailback programs, e.g., empty mail-back 

packages may be disseminated at 

hospitals/clinics and retail pharmacies 

and mailed back to a reverse distributor 

with an on-site method of destruction. 

[2] Issue: One commenter strongly 

supports the requirement that 

authorized collectors who conduct a 

mail-back program use an on-site 

method of destruction; however, other 

commenters expressed concern that the 

requirement would discourage 

authorized collectors from conducting 

mail-back programs. Several 

commenters noted that very few 

destruction facilities currently exist and 

there was concern that such facilities do 

not have proper security to handle 

controlled substances. 

Response: As indicated in the 

previous response, mail-back programs 

have the potential to provide a secure 

and responsible means of disposal 

without geographical restriction within 

the United States. As such, the existence 

of a small number of appropriate 

destruction sites should not impact 

ultimate users’ ability to participate or 

the potential for mail-back programs to 

develop. In other words, a single 

destruction site can support many 

different mail-back programs and an 

unlimited number of mail-back 

packages may be provided to ultimate 

users at various locations throughout 

the United States to be mailed back to 

a single destruction site. Also, as 

discussed in the NPRM, the DEA hopes 

that the rule will encourage innovation 

and expansion of destruction methods 

beyond incineration so that additional 

entities may provide destruction 

services for mail-back programs in the 

future. 

[3] Issue: A few commenters 

expressed concern that no entities will 

undertake the implementation of a mailback program because of the related 

expense, noting that the requirement 

that mail-back packages be preaddressed with pre-paid postage will be 

very costly. A commenter also asked the 

DEA to clarify whether unregistered 

retail pharmacies working with a 

registered authorized collector would be 

permitted to make mail-back packages 

available to patients. 

Response: As discussed in the NPRM, 

authorized collectors who conduct mailback programs are encouraged to 

collaborate to operate mail-back 

programs by partnering with other 

entities to assist with the dissemination 

of mail-back packages to ultimate users, 

in order to minimize costs. 

Additionally, pre-paid postage will 

ensure that the package is not returned 

to sender, which will help reduce its 

handling and therefore, the diversion 

risks. Pre-addressed envelopes will help 

ensure that the package is delivered to 

the authorized location. 

[4] Issue: One commenter asked the 

DEA to clarify whether there are specific 

testing requirements in regard to the 

packaging standards (e.g., water/spill 

proof, tear resistant, sealable, etc.). One 

commenter asked the DEA to clarify the 

distinction between packages damaged 

as part of normal transport and packages 

damaged by other means, such as 

tampering. 

Response: The DEA is not requiring 

specific testing requirements to ensure 

packages meet the standards provided 

in § 1317.70 (e.g., water/spill proof, tear 

resistant, sealable, etc.). However, the 

packages must be consistent with these 

standards. Collectors authorized to 

receive mail-back packages must make a 

determination based on the facts and 

circumstances as to whether or not an 

apparently damaged package became so 

through normal transportation or 

through tampering or other intentional 

means. 

[5] Issue: Commenters expressed 

concern that the requirement for mailback collectors to issue mail-back 

packages with unique identification 

numbers is burdensome and does not 

seem to provide any useful information 

since ultimate users are not required to 

notify collectors that they have mailed 

a package, and it is likely that many 

packages will not be used. Five 

commenters asked the DEA to explicitly 

state that authorized collectors who 

conduct mail-back programs will not be 

responsible for reconciling mail-back 

packages that were never returned. 

Response: The DEA believes that 

recording the unique identification 

numbers of mail-back packages in 

accordance with § 1317.70 is a 

reasonable recordkeeping requirement 

designed to help identify and prevent 

diversion; this information can aid 

investigations and is useful for that 

purpose alone. The DEA recognizes that 

disseminated packages may go unused, 

and this alone should not form the basis 

for unreasonable scrutiny of authorized 

collectors. Additionally, at this time, 

authorized collectors are not responsible 

for tracking mail-back packages that 

were disseminated but never returned. 

[6] Issue: One commenter disagreed 

with the DEA’s assessment that mailback programs are more susceptible to 

diversion and therefore require stricter 

controls. 

Response: The DEA carefully 

considered the diversion risks in mailback programs. Based on the DEA’s 

experience, the DEA believes that the 

risks of diversion associated with mailback programs are great because of 

necessary actions including the 

handling of the packages, mail sorting, 

and mail delivery by non-registrants. 

The DEA believes that the security 

measures established by this rule are the 

minimum required to reduce the risk of 

diversion inherent to mail-back 

programs. 

[7] Issue: One commenter expressed 

concern that mail-back packages would 

be subject to greater risks of diversion in 

rural areas. 

Response: The DEA appreciates the 

commenter’s concern. The DEA has 

considered the diversion risks for mailback programs, including packages 

originating in rural areas. It may be true 

that mail-back packages originating in 

some rural areas may be subject to an 

increased risk of diversion due to fewer 

people being able to readily witness 

theft from a mailbox. However, it may 

also be true that risks of diversion from 

mail-back programs might be lower in 

rural areas due to less traffic 

(pedestrian, vehicular, or equine), 

resulting in fewer opportunities for 

tampering with or theft of mail-back 

packages. Regardless, the DEA believes 

that the relative risks of diversion of 

mail-back packages in rural areas are 

mitigated by the required security 

procedures and are outweighed by the 

benefits of providing ultimate users a 

means to dispose of unused, unwanted, 


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or expired pharmaceutical controlled 

substances. 

[8] Issue: The United States Postal 

Service (USPS) has raised a number of 

issues relating specifically to the mailback program, and also to the disposal 

regulations in general. The USPS asked 

the DEA to make several changes to the 

terminology used in the proposed rule, 

so that the DEA regulations will be 

consistent with standard USPS products 

and services. The USPS also requested 

that the DEA clarify that all registrants 

must comply with USPS laws and 

regulations, including applicable USPS 

requirements for packaging and mailing 

pharmaceuticals. 

The USPS asked the DEA to 

consistently refer to ‘‘mail-back 

packages’’ as ‘‘mailing packages’’ rather 

than ‘‘mailers’’ as the USPS refers to 

‘‘mailers’’ as persons or entities entering 

a mailing. The USPS also asked the DEA 

to remove any references to ‘‘business 

reply mail’’ that are inconsistent with 

the USPS’s use of the term. The USPS 

asked that proposed § 1317.85 specify 

that ultimate users may return recalled 

controlled substances to the 

manufacturer or other authorized 

registrant by U.S. Mail. The USPS also 

asked the DEA to clarify that inner 

liners are requirements for collection 

receptacles—not mail-back packages. 

The USPS also requested that the DEA 

state that collectors operating a mailback program must exclusively use the 

United States Postal Service. The USPS 

also asked the DEA to make all 

references to ‘‘mail system’’ in the 

preamble refer exclusively to the United 

States Postal Service. The USPS asked 

that they not be prohibited from 

transporting controlled substances to a 

reverse distributor on behalf of law 

enforcement, especially in light of the 

fact that law enforcement may operate 

mail-back programs. 

Response: The DEA appreciates the 

time taken by the USPS to review the 

proposed rule and submit thoughtful 

comments with their concerns and 

suggestions. In addition, the DEA 

acknowledges that the USPS 

understands these regulations and has 

experience responsibly handling 

controlled substances. The DEA is 

modifying some of the terminology that 

was used in the NPRM, per the USPS’s 

concerns and suggestions. Rather than 

use the term ‘‘mailing packages,’’ all 

references to ‘‘mailers’’ are changed to 

‘‘mail-back packages.’’ The DEA 

believes this will better avoid the 

confusion regarding ‘‘mailers’’ being 

defined as persons or entities that enter 

a ‘‘mailing.’’ The reference to ‘‘business 

reply mail’’ is also removed. The DEA 

declines to specify that ‘‘mail’’ or ‘‘mail 

system’’ refers exclusively to the USPS; 

however, the USPS is a shipping option. 

Additionally, in § 1317.85, ultimate 

users still have the options to return a 

recalled controlled substance as is 

currently allowed under § 1307.12 of the 

existing regulations. The text of the rule 

clearly states that all persons and 

entities must comply with applicable 

Federal laws and regulations, which 

includes USPS laws and regulations. 

Also, inner liners are requirements for 

collection receptacles—not mail-back 

packages. The mail-back package 

specifications are outlined in § 1317.70. 

While the USPS asked that the text of 

the regulation specifically state that 

mail-back packages may be sent via the 

U.S. Postal Service as well as by 

common or contract carrier, the DEA 

declines to make this change. The DEA 

considers the USPS to be a common or 

contract carrier for purposes of the CSA. 

[9] Issue: One commenter asked the 

DEA to clarify whether the regulation 

that requires mail-back programs to 

include only mail-back packages mailed 

from within the United States will 

preclude USPS-serviced mail-back 

programs in any of the areas in which 

it operates (e.g., the Caribbean District, 

other territories such as Guam, and 

United States military installations). 

Response: The term ‘‘import’’ means 

‘‘any bringing in or introduction of’’ a 

controlled substance into any area. 

Pursuant to 21 U.S.C. 952, it is unlawful 

to import controlled substances into the 

customs territory of the United States 

(the 50 States, the District of Columbia, 

and Puerto Rico), except under specific 

circumstances not relevant to ultimate 

user disposal. Thus, an ultimate user 

located outside of the customs territory 

of the United States is not permitted to 

send a mail-back package into the 

customs territory of the United States. 

[10] Issue: One commenter asked the 

DEA to clarify whether authorized 

collectors operating mail-back programs 

may use carrier services that allow 

packages to be held at a carrier facility 

until the packages can be picked up. 

Response: Although some changes to 

business operations may need to occur 

in order for an authorized collector to 

effectively establish and maintain a 

mail-back program, the requirements 

established by this rule are the 

minimum required to detect and 

prevent diversion. As described in this 

rule, mail-back packages must be preaddressed to the authorized mail-back 

location with the on-site destruction 

method, and thus, the packages must be 

delivered to the authorized mail-back 

location rather than picked up by the 

collector. 21 CFR 1317.70. The preaddressed delivery location must be 

capable of receiving such deliveries on 

a regular basis without interruption. 

Otherwise, the opportunities for 

diversion increase as the packages are 

delayed or stored during transit. 

[11] Issue: One commenter suggested 

that the DEA establish a national mailback program. 

Response: This rule authorizes certain 

collectors to conduct mail-back 

programs. 21 CFR 1317.40 and 1317.70. 

There is no limitation regarding the 

geographic coverage of mail-back 

programs within the United States if the 

programs comply with all applicable 

Federal, State, tribal, and local laws and 

regulations. At this time, the DEA does 

not have the resources to operate a 

national mail-back program. 

I. Take-Back Events (6 Issues) 

[1] Issue: One commenter indicated it 

would be difficult for ultimate users to 

participate in take-back events, 

particularly in rural areas. 

Response: The DEA has attempted to 

expand the variety of disposal options 

while also ensuring secure and 

responsible drug disposal, and the DEA 

anticipates that the expansion to 

include certain hospitals/clinics to 

become authorized as collectors will 

provide more disposal options for 

ultimate users, including those in rural 

areas. Additionally, the DEA encourages 

those persons living in rural areas who 

are unable to utilize a collection 

receptacle or attend a take-back event to 

dispose of unwanted pharmaceutical 

controlled substances in the same 

manner in which the pharmaceutical 

controlled substances were received, 

i.e., if the substances were delivered by 

a mail-order pharmacy, the DEA 

encourages the pharmacy to include a 

mail-back package for safe disposal; or, 

if the substances were dispensed at a 

pharmacy, the DEA encourages 

pharmacies to have a collection 

receptacle available for safe disposal. 

Nonetheless, the DEA recognizes that 

some ultimate users may not have 

convenient access to any of the disposal 

options available in this rule. Until the 

availability of these disposal options 

increases, ultimate users who wish to 

dispose of unwanted pharmaceutical 

controlled substances may continue to 

dispose of them in manners consistent 

with all applicable Federal, State, tribal, 

and local laws and regulations. The 

DEA’s Office of Diversion Control Web 

site provides information regarding safe 

disposal of pharmaceutical controlled 

substances, including guidance from the 

FDA and the EPA. Ultimate users can 

find this information at 

www.DEAdiversion.usdoj.gov. 


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53538 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

[2] Issue: Several people asked the 

DEA to clarify the role of law 

enforcement at take-back events. One 

commenter asked the DEA to relax the 

two-employee requirement for law 

enforcement officers handling collected 

substances. Another commenter stated 

that law enforcement officer 

supervision, rather than direct 

participation, should suffice. 

Response: Law enforcement must 

appoint at least one law enforcement 

officer employed by the agency to 

oversee collection at the take-back 

event. 21 CFR 1317.65. ‘‘Oversee’’ has 

its common, everyday meaning: To 

supervise, manage, watch over, and 

direct in an official capacity. The direct 

participation this rule mandates is that 

a law enforcement officer must maintain 

custody and control of the collected 

substances from the time they are 

collected to the point in time that they 

are securely transferred, stored, or 

destroyed. 21 CFR 1317.65. This rule 

does not require two law enforcement 

officers to be present at take-back 

events; however, law enforcement may 

determine that two or more law 

enforcement officers are necessary at a 

particular take-back event due to safety 

and security concerns. In the 

alternative, law enforcement may 

determine that the same law 

enforcement officer may oversee the 

take back event and also maintain 

custody and control of the collected 

substances from the time the substances 

are collected from the ultimate user or 

person authorized to dispose of the 

ultimate user decedent’s property until 

secure transfer, storage, or destruction 

has occurred, as outlined in 

§ 1317.65(b). Although the participation 

of law enforcement is required at takeback events, the DEA is not requiring 

law enforcement to hold or participate 

in take-back events. As discussed in the 

NPRM, law enforcement must 

determine how often available resources 

allow them to hold take-back events. 

[3] Issue: A few commenters 

requested that the DEA allow other 

authorized collectors, such as retail 

pharmacies and reverse distributors, to 

become authorized to hold take-back 

events. One commenter stated that law 

enforcement officers’ presence should 

be optional if there is a collection 

receptacle at the event that meets the 

specifications in the rule. 

Response: If an authorized collector 

or other entity wishes to conduct a takeback event, the event must be held in 

partnership with law enforcement. 21 

CFR 1317.65. Take-back events are 

intended to be limited-duration events 

that may take place at an unsecure 

location that is easily accessible to the 

public, such as a community center or 

town center. Given the likelihood of 

publicity and limited physical security 

at such locations, the DEA believes that 

it is important to ensure active law 

enforcement participation for the safety 

of the event participants and the 

community. The DEA believes that 

active law enforcement participation 

will help deter theft and reduce 

diversion risks. The presence of a 

collection receptacle at a take-back 

event does not preclude the need for 

law enforcement presence at the 

collection site because the publicity for 

the event increases the receptacle’s 

visibility for drug seekers, thus 

increasing diversion risks. 

[4] Issue: A number of entities 

expressed concern that the 

implementation of this rule will result 

in the cessation of DEA-sponsored 

national take-back events. These 

commenters felt that take-back events 

will be too costly for communities and 

law enforcement, and commenters 

suggested that the DEA continue takeback events and provide a transition 

plan from the national take-back events 

until implementation of the rule. 

Response: The DEA-sponsored 

national take-back events were initiated 

as a means of providing safe and 

convenient disposal of pharmaceutical 

controlled substances by ultimate users 

until alternative options could be 

implemented. The DEA is committed to 

continuing national take-back events 

until the effective date of this final rule. 

The DEA believes that implementation 

of disposal methods is best tailored to 

local communities by local 

communities. The DEA encourages 

public and private partnerships to 

optimize the expanded disposal options 

in a cost-efficient manner. 

[5] Issue: One commenter expressed 

concern that existing take-back events 

would likely be unable to continue 

under this rule. This commenter was 

concerned that the prohibition of sorting 

would cause a burden since noncontrolled substances and packaging 

could not be sorted from controlled 

substances. This commenter stated that 

it will be overly burdensome for 

programs to handle all collected 

substances as schedule II controlled 

substances. 

Response: The DEA does not intend 

for this rule to require changes to 

existing non-controlled substance takeback programs. The security measures 

required by this rule are the minimum 

necessary to ensure a safe and secure 

means of disposal of pharmaceutical 

controlled substances. It should be 

noted however, that law enforcement 

are not required to follow the physical 

security requirements for handling, 

sorting, or storing collected controlled 

substances. 21 CFR 1317.35. The 

physical security requirements 

applicable to law enforcement in the 

final rule at §§ 1317.35 and 1317.65 

state that law enforcement ‘‘should’’ 

take certain measures; and that law 

enforcement ‘‘shall’’ appoint a law 

enforcement officer to oversee a takeback event and law enforcement officers 

‘‘shall’’ maintain custody and control of 

the collected substances. Additionally, 

this rule provides a number of 

previously unavailable means of 

ultimate user disposal that are likely to 

decrease the frequency of and need for 

community take-back events. The DEA 

would like to clarify that comingling of 

controlled and non-controlled 

substances is permitted, but not 

required, and co-sponsors of take-back 

events may specify that only controlled 

substances will be accepted. Another 

method to alleviate the burdens would 

be to provide a separate receptacle for 

non-controlled substances at the takeback event. Additionally, as discussed 

in response to previous comments, this 

rule does not require that collected 

substances be in their original 

packaging, and law enforcement may 

discourage or prohibit ultimate users 

from disposing of original packaging 

into the collection receptacle for 

controlled substances at take backevents. 

[6] Issue: One commenter indicated 

that municipalities and other 

organizations should be permitted to 

‘‘take the lead’’ in organizing and 

conducting take-back events in 

conjunction with, and in the presence 

of, law enforcement. Other commenters 

raised concerns that such events 

conducted in partnership with local 

government and community groups 

would no longer be allowed, and that 

the requirements would prevent 

controlled substance take-back events 

from being held concurrently with other 

take-back events, such as for the 

disposal of hazardous waste and noncontrolled substances. 

Response: The rule permits any entity 

to partner with law enforcement to hold 

a pharmaceutical controlled substances 

take-back event. 21 CFR 1317.65(a). 

Municipalities or other organizations 

may partner with law enforcement as 

long as such events are conducted in 

accordance with all applicable laws and 

regulations pertaining to the disposal of 

pharmaceutical controlled substances. 

The DEA emphasizes that take-back 

events are intended to be one-time or 

periodic events held in a community 

center or other convenient and 

accessible location, and that there is no 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53539 

prohibition against holding such events 

in conjunction with events for the 

disposal of other substances, such as 

hazardous waste or non-controlled 

pharmaceuticals. 

J. Prohibition on Handling, Sorting, and 

Inventorying Inner Liner Contents and 

Mail-Back Package Contents (8 Issues) 

[1] Issue: One commenter adamantly 

stated that collected substances should 

not be sorted under any circumstances. 

This commenter expressed concerns 

about diversion risks and the brokering 

of unused controlled substances. 

Response: The DEA agrees that the 

diversion risks of handling, sorting, or 

inventorying collected substances 

outweigh any perceived benefits. The 

DEA has carefully considered all of the 

various commenters’ concerns on the 

prohibition of handling, sorting, and 

inventorying inner liner contents and 

mail-back package contents, and will 

retain these prohibitions. As provided 

in §§ 1317.60(c) and 1317.70(f), inner 

liners shall be sealed immediately upon 

removal from the permanent outer 

container; sealed inner liners and 

returned mail-back packages shall not 

be opened, x-rayed, analyzed, or 

otherwise penetrated. Accordingly, their 

contents shall not be sorted or 

inventoried subsequent to being placed 

into a collection receptacle or mail-back 

package. To clarify this, § 1317.75(c) 

was modified to add the prohibition 

against individually handling 

substances after they have been 

deposited into a collection receptacle. 

These specific security measures are 

designed to help prevent and reduce the 

opportunities for diversion (including 

the re-introduction of tainted 

pharmaceutical controlled substances 

into the stream of commerce). 

[2] Issue: Twenty-four commenters 

stated that pharmacists and other 

volunteers should be permitted to sort 

collected substances, particularly in the 

presence of law enforcement officers at 

take-back events. One commenter stated 

that the DEA should recognize the 

accountability, expertise, and 

experience of healthcare professionals, 

and the DEA should utilize these 

experts in an effort to broaden 

medication disposal efforts. 

Response: The DEA appreciates the 

valuable expertise and experience of 

healthcare professionals, including 

pharmacists. The DEA has carefully 

considered the comments in response to 

the NPRM, and the remarks at the 

January 2011 public meeting. The DEA 

believes that the disposal methods 

outlined in this rule will provide 

ultimate users and their authorized 

representatives with expanded options 

to safely and securely dispose of 

unwanted, unused, and expired 

pharmaceutical controlled substances. 

Pursuant to § 1317.65, law enforcement 

may continue to conduct take-back 

events when a law enforcement officer 

maintains control and custody of 

collected substances at take-back events 

and only the ultimate user transfers 

controlled substances to law 

enforcement control and custody. 

However, non-law enforcement 

personnel may assist the law 

enforcement officer, and the final rule 

does not prohibit healthcare 

professionals from voluntarily polling 

ultimate users about the substances they 

are discarding or from assisting ultimate 

users to separate pharmaceutical 

controlled substances from noncontrolled substances during the 

disposal process, and inventorying the 

non-controlled substances. 

Furthermore, nothing in this rule 

prohibits law enforcement from 

partnering with authorized collectors or 

other entities to inventory or sort 

substances that have been collected by 

law enforcement provided that the 

collected substances remain under the 

control and custody of law enforcement. 

This final rule in § 1317.65(b) requires 

that law enforcement maintain control 

and custody of the collected substances 

from the time the substances are 

collected until secure transfer, storage, 

and destruction has occurred. Therefore, 

if law enforcement opts to inventory or 

sort collected substances within their 

possession, law enforcement should 

provide adequate security to prevent 

diversion or theft of controlled 

substances within their possession and 

control as a result of, or during, 

inventorying or sorting. 

[3] Issue: Thirty-eight commenters 

stated that the DEA should permit 

collectors or certain non-registered 

persons to handle, sort, and inventory 

collected substances for data collection 

and research purposes. Many of these 

commenters urged the DEA to provide 

an exception to allow pharmacists and 

volunteers to inventory and sort 

controlled substances under the 

supervision of law enforcement officers. 

Numerous commenters stated that 

inventorying collected substances is 

crucial to determining a root cause 

analysis of medication waste. Others 

stated that such information could help 

guide prescribing practices and be used 

in educational settings. Several 

commenters stated that inventorying 

collected substances is necessary to 

determine outcome measures for grants 

for disposal programs. Also, several 

commenters stated that the DEA should 

provide an exception for Institutional 

Review Board-approved research 

projects. 

Response: The DEA understands and 

appreciates these comments. As 

discussed in the preceding response, 

law enforcement has the discretion to 

partner with other entities to conduct a 

take-back event pursuant to 

§ 1317.65(a). There are no restrictions 

on how law enforcement handles the 

collected substances so long as they 

maintain control and custody of the 

substance. Accordingly, law 

enforcement may inventory and sort 

substances that law enforcement 

collects. The diversion-related concerns 

present when authorized registrants 

collect controlled substances from 

ultimate users is not present when law 

enforcement collects substances from 

ultimate users. Taking into account the 

totality of the various risks and benefits, 

the DEA believes that this final rule 

imposes the minimum necessary 

controls to allow a secure and 

responsible means by which ultimate 

users can dispose of pharmaceutical 

controlled substances. Relying on its 

experience, and as discussed in the 

NPRM, the DEA finds that any potential 

benefits of allowing authorized 

collectors or unregistered persons to 

independently inventory or sort 

controlled substances after receipt from 

the ultimate user do not outweigh the 

risks of diversion, except when the 

controlled substances remain in the 

control and custody of law enforcement, 

as mentioned in the previous response. 

Data collection is not impossible 

under the rule even though collected 

substances cannot be sorted or 

inventoried after they have been 

deposited into a collection receptacle or 

received by a collector through a mailback package (unless the collection is 

conducted by law enforcement and the 

substances are within the custody and 

control of law enforcement). For 

example, authorized collectors may seek 

information voluntarily from ultimate 

users regarding the substances the 

ultimate user is disposing. And, data 

such as the weight of the inner liners, 

the number of ultimate users attending 

a take-back event, and the number of 

mail-back packages received in relation 

to the number of packages disseminated, 

can be useful measures. The rule only 

prohibits authorized collectors from 

physically handling the substances, 

such as taking the substances from the 

ultimate user, or sorting substances after 

the ultimate user has deposited them 

into a receptacle or mail-back package. 

21 CFR 1317.70 and 1317.75. 

[4] Issue: Twenty-two commenters 

stated that contents should be sorted to 

ensure adequate storage space. Several 


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53540 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

commenters stated that packaging and 

pill bottles should be sorted since they 

are voluminous. Other commenters 

stated that non-controlled substances 

should be sorted from controlled 

substances. 

Response: Pursuant to §§ 1317.70(b) 

and 1317.75(b), comingling of 

controlled and non-controlled 

substances is permitted, but it is not 

required. In addition, this rule does not 

require pharmaceutical controlled 

substances collected from ultimate users 

to be collected and stored in the original 

packaging, and collectors may institute 

procedures to prevent inadvertently 

collecting packaging. Authorized 

collectors may address adequacy of 

space issues by choosing not to collect 

comingled pharmaceutical controlled 

substances and non-controlled 

substances, refusing to accept the 

original controlled substance packaging, 

or by increasing destruction frequencies. 

In addition, the DEA has expanded the 

available storage options for 

practitioners in this final rule by 

allowing practitioners to store sealed 

inner liners and returned mail-back 

packages in a securely locked room with 

controlled access. 21 CFR 1317.05. 

[5] Issue: A commenter noted that 

authorized collectors should have direct 

supervision over the substances that are 

placed into collection receptacles to 

prevent undesirable materials from 

being deposited into collection 

receptacles. 

Response: Each potential authorized 

collector must weigh all of the potential 

risks and benefits in deciding whether 

to implement and manage any ultimate 

user disposal program, including any 

necessary steps to prevent the unwanted 

collection of regulated hazardous waste 

or otherwise undesirable materials, in a 

manner consistent with this rule and all 

other applicable Federal, State, tribal, 

and local laws and regulations. 

Authorized collectors may view what 

ultimate users deposit into collection 

receptacles, and they may ask what 

substances are being deposited. 

Although the actual disposal of a 

pharmaceutical controlled substance 

into a collection receptacle must be 

performed by an ultimate user in 

accordance with § 1317.30, the 

authorized collector maintains ultimate 

control over that receptacle and should 

institute necessary measures to protect 

against the collection of unwanted 

substances so long as such measures are 

consistent with this rule and all other 

applicable Federal, State, tribal, and 

local laws and regulations. 

[6] Issue: Several commenters asked 

that the DEA permit pharmacy staff to 

deposit collected substances into 

collection receptacles. These 

commenters asked the DEA to consider 

situations where the pharmacy is 

completely blocked from the public 

(such as with a bullet-proof barrier). 

Response: For the reasons discussed 

in the NPRM and in previous comment 

responses, the DEA declines to allow 

pharmacy staff to handle 

pharmaceutical controlled substances 

collected from ultimate users. The 

registered location of any retail 

pharmacy that wishes to become an 

authorized collector must satisfy the 

specifications for collection receptacles 

and inner liners. 21 CFR 1317.60 and 

1317.75. If a retail pharmacy desires to 

be an authorized collector, that 

pharmacy shall only allow ultimate 

users (and others authorized to dispose 

of controlled substances on behalf of 

ultimate users) to deposit the 

pharmaceutical controlled substances 

directly into the collection receptacles 

in accordance with § 1317.30. The 

requirements of the collection 

receptacles were carefully considered 

and designed to limit the number of 

hands that handled the pharmaceutical 

controlled substances in order to 

prevent diversion and diversion 

opportunities, as well as to prevent the 

re-introduction of tainted 

pharmaceutical controlled substances 

into the closed system of distribution. 

[7] Issue: Twenty commenters 

suggested that the DEA permit some sort 

of inspection for inner liner and mailback package contents to ensure that 

unacceptable contents are removed, 

such as x-raying and scanning. These 

commenters were particularly 

concerned about mercury-containing 

thermometers, iodine-containing 

medications, medical sharps, 

compressed cylinders, and other 

hazardous waste. Other commenters 

expressed concern that by allowing 

comingling of substances in collection 

receptacles, employees may be 

subjected to hazardous conditions if 

unsafe or hazardous materials are 

deposited. 

Response: The DEA understands and 

appreciates these concerns of the 

commenters; however, the DEA has 

concluded that allowing inspection of 

inner liners and mail-back packages 

presents an unacceptable risk of 

diversion. These issues were closely 

reviewed prior to the NPRM and rereviewed in association with these 

comments. Whether an authorized 

collector comingles ultimate users’ 

pharmaceutical controlled substances 

with non-controlled substances is 

within the discretion of that authorized 

collector. This rule does not mandate 

comingling. 21 CFR 1317.75. Each 

potential authorized collector must 

weigh all of the potential risks and 

benefits in deciding whether to 

implement and manage any ultimate 

user disposal program, including any 

necessary steps to prevent the unwanted 

collection of regulated hazardous waste 

or otherwise undesirable materials, in a 

manner consistent with this rule and all 

other applicable Federal, State, tribal, 

and local laws and regulations. As 

discussed in response to previous 

comments, collectors may control the 

substances collected, and they may view 

substances before they are deposited 

into collection receptacles. For 

additional commentary on hazardous 

waste disposal, please see comment 

section ‘‘Q.’’, entitled ‘‘Hazardous 

Materials Transportation and Hazardous 

Waste Destruction.’’ 

[8] Issue: Some commenters urged 

the DEA to require authorized collectors 

to provide clear instructions on what 

may and may not be placed in mail-back 

packages in order to reduce instances in 

which hazardous materials/waste may 

be inadvertently destroyed in a manner 

that is not consistent with 

environmental or other applicable laws 

or regulations due to the prohibition 

against opening or inspecting the 

contents of mail-back packages. 

Response: The rule includes a 

requirement for the collector to provide 

packages with instructions indicating 

what substances are permitted to be 

included in the package. 21 CFR 

1317.70. The rule does not require 

specific language for such instructions, 

which must ultimately be determined 

by the collector in a manner consistent 

with the rule. 

K. Long-Term Care Facilities (LTCFs) (21 

Issues) 

Definitions and Terms Specific to 

LTCFs 

[1] Issue: Commenters asked the DEA 

to clarify the meaning of ‘‘LTCF’’ with 

regard to assisted living facilities, 

hospice facilities, and residential care in 

private homes, as the meaning of LTCF 

often varies by State. 

Response: LTCF is defined at 

§ 1300.01(b) and ‘‘means a nursing 

home, retirement care, mental care or 

other facility or institution which 

provides extended health care to 

resident patients.’’ 

[2] Issue: Commenters asked the DEA 

to clarify the meaning of ‘‘have resided’’ 

with regard to a LTCF’s ability to 

dispose of controlled substances on 

behalf of residents. 

Response: The phrase ‘‘have resided,’’ 

is utilized in the Disposal Act, but was 

not defined by Congress. The DEA has 


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not determined a need to apply a 

technical definition for this phrase apart 

from its ordinary meaning. The DEA 

understands the ordinary meaning of 

‘‘have resided’’ to be typically 

understood as persons who have died or 

otherwise recently departed a location 

without manifesting intent to return. 

Thus, for example, as discussed in 

response to issue [7] below, when a 

LTCF resident is transferred to another 

facility, the resident ‘‘has resided’’ at the 

LTCF, and the LTCF may dispose of the 

former resident’s pharmaceutical 

controlled substances in an authorized 

collection receptacle. 21 CFR 1317.30. 

Registration of Collection Receptacles at 

LTCFs 

[3] Issue: Commenters asked the DEA 

to clarify whether an authorized LTCF 

location where an authorized collector 

maintains a collection receptacle would 

be considered a ‘‘registered location’’ of 

the retail pharmacy. 

Response: The location of the 

collection receptacle is both a registered 

location and a controlled premise. It is 

a registered location of the authorized 

hospital/clinic or retail pharmacy 

because the authorized collector may 

only install and manage a collection 

receptacle at a LTCF pursuant to the 

authority granted by the DEA, and they 

are limited at that location to 

conducting only those activities that are 

specifically authorized and required 

under this rule as necessary to the 

installation and maintenance of that 

authorized collection receptacle. LTCFs 

with authorized collection receptacles 

are ‘‘controlled premises’’ pursuant to 

21 U.S.C. 880(a) and 21 CFR 1316.02(c); 

accordingly, the DEA may enter LTCFs 

and conduct administrative inspections 

in furtherance of, and in carrying out, 

the responsibilities charged to the DEA 

by the CSA pursuant to 21 U.S.C. 880(b) 

and 21 CFR 1316.03. 

Disposal Methods and Procedures at 

LTCFs 

[4] Issue: A commenter asked the 

DEA if LTCFs may use an on-site 

method of destruction. Three 

commenters specifically asked if LTCFs 

may continue their current drug 

disposal method of ‘‘sewering.’’ Other 

commenters asked the DEA to clarify 

how existing methods of disposal 

utilized by LTCFs will be impacted by 

this rule and to provide for an interim 

method of disposal for LTCFs. 

Response: Although the DEA 

appreciates the commenters’ concerns, 

the DEA cannot comment on each 

potential method of disposal occurring 

at LTCFs prior to these regulations. The 

implementation of authorized disposal 

methods for ultimate users is strictly 

voluntary and, with the exception of 

law enforcement-sponsored programs, 

generally such programs have no lawful 

means of existence prior to the effective 

date of this rule. It is important to note 

that this rule provides additional 

options for disposal and does not 

prohibit any methods currently used by 

LTCFs that are consistent with Federal, 

State, tribal, and local laws and 

regulations. For example, LTCFs are not 

prohibited by this final rule from 

destroying patients’ unwanted 

pharmaceutical controlled substances at 

the LTCF, on behalf of the resident 

patients, in accordance with applicable 

Federal, State, tribal, and local laws and 

regulations, including environmental 

laws and regulations. However, as 

explained further below, the DEA has 

considered the diversion risks and 

determined that the installation and 

maintenance of collection receptacles by 

authorized hospitals/clinics and retail 

pharmacies is the most secure and 

responsible means by which registrants 

may collect and dispose of LTCF 

residents’ pharmaceutical controlled 

substances. 

As stated in § 1317.90(a), the 

requirement to render controlled 

substances ‘‘non-retrievable’’ applies 

only to DEA registrants that destroy 

controlled substances. The ‘‘nonretrievable’’ language does not apply to 

ultimate users. As discussed in the 

NPRM, the DEA does not believe that 

‘‘sewering’’ would render a 

pharmaceutical controlled substance 

‘‘non-retrievable.’’ However, such a 

requirement would not apply to a LTCF 

unless the LTCF is itself a registrant and 

destroying its own pharmaceutical 

controlled substance stock pursuant to 

§ 1317.05(a). 

[5] Issue: Many commenters 

indicated that the DEA should provide 

LTCFs with additional options for 

disposal of controlled substances on 

behalf of residents. Approximately 

fifteen commenters asked the DEA to 

expand which registrants are permitted 

to manage collection receptacles at 

LTCFs. Seven commenters asked the 

DEA to permit LTCFs to use mail-back 

packages. Several commenters stated 

that LTCFs should be allowed to use the 

same disposal options that this rule 

affords ultimate users. 

Response: As previously discussed, 

this rule in § 1317.40 expands the types 

of registrants that may be authorized as 

collectors, and permitted to manage and 

maintain collection receptacles at 

LTCFs. In addition to retail pharmacies 

(including ‘‘closed-door pharmacies’’ 

that service LTCFs), hospitals/clinics 

with an on-site pharmacy may maintain 

collection receptacles at LTCFs. 

Furthermore, the options available to all 

ultimate users to dispose of their 

pharmaceutical controlled substances 

are also available to LTCF residents. As 

ultimate users (defined in 21 U.S.C. 

802(27) as persons who have lawfully 

obtained, and who possess, a controlled 

substance for their own use or for the 

use of a member of their household), 

LTCF residents may avail themselves of 

all disposal methods made available by 

this rule to ultimate users, including 

participation in authorized mail-back 

programs. For example, on behalf of an 

LTCF resident, an LTCF employee may 

place the resident’s unwanted 

pharmaceutical controlled substances in 

a mail-back package, seal it, and deposit 

it into the facility’s outgoing mail 

system. Care should be taken to ensure 

that LTCF residents’ use of mail-back 

programs does not result in the 

accumulation of pharmaceutical 

controlled substances in a single 

location susceptible to internal or 

external diversion threats. 

The DEA has carefully considered the 

risks and benefits of collection activities 

at LTCFs. Among the DEA’s specific 

considerations were that LTCFs 

typically have large volumes of 

controlled substances on-site and that 

they are typically not registered with the 

DEA. The DEA also specifically 

considered the risks and benefits 

associated with LTCF personnel 

disposing of pharmaceutical controlled 

substances on behalf of persons who 

reside or have resided at that LTCF. The 

DEA determined that in order to 

adequately protect the public health and 

safety, and to prevent diversion, the 

collection of such substances must be 

limited to certain registrants that are 

well-equipped to handle the unique 

circumstances surrounding the disposal 

of controlled substances at LTCFs. After 

careful deliberation, the DEA 

determined such registrants should be 

limited to retail pharmacies and 

hospitals/clinics with an on-site 

pharmacy. 21 CFR 1317.40. In making 

its determination, the DEA took 

consideration of the fact that hospitals/ 

clinics with on-site pharmacies, and 

retail pharmacies, routinely dispense 

large volumes of controlled substances 

in a public setting. Additionally, many 

hospitals/clinics with on-site 

pharmacies and retail pharmacies have 

experience working closely with LTCFs 

or have well-established, on-going 

relationships with LTCFs. For example, 

many retail pharmacies and hospitals/

clinics directly deliver pharmaceutical 

controlled substances to LTCF residents, 

some retail pharmacies have developed 


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expertise in dispensing substances at 

LTCFs via an automated dispensing 

system (ADS) (i.e., mechanical systems 

that perform operations or activities 

relative to the dispensing of 

medications), and some LTCFs share 

common management or ownership 

with hospitals/clinics. 

The DEA recognizes that other types 

of registrants also have relationships 

with LTCFs, and considered authorizing 

other types of registrants to install and 

manage collection receptacles at LTCFs. 

However, after careful consideration, 

the DEA determined that the presence of 

certain factors that increase 

opportunities for diversion in the 

specified circumstances weigh against 

further expanding the types of 

registrants that may collect at LTCFs. 

Specifically, the DEA declines to 

allow reverse distributors to install and 

maintain collection receptacles at 

LTCFs because reverse distributors are 

at the end of the supply chain. It would 

be contrary to the public health and 

safety and pose an increased risk of 

diversion to authorize a reverse 

distributor to independently install and 

maintain a collection receptacle at an 

LTCF, remove the inner liner, transport 

collected substances to the final 

destruction location, and ensure they 

are destroyed. One of the principal 

factors considered by the DEA in 

coming to this conclusion is the fact that 

in such a situation, the reverse 

distributor would be the sole registrant 

to maintain the only records of 

installation, removal, and destruction. 

Such an authorization would be 

contrary to the closed system of 

distribution where each registrant who 

handles controlled substances serves as 

a source of verification for the other 

registrants that handle the same 

substances, thus ensuring that 

controlled substances reach their 

intended destination with 

accountability and a reduced risk of 

diversion. The regulations implemented 

by this final rule specifically utilize this 

system of checks for collection activities 

at LTCFs. Retail pharmacies and 

hospitals/clinics with an on-site 

pharmacy are registrants. As established 

in this final rule, when retail 

pharmacies and hospitals/clinics 

maintain collection receptacles at an 

LTCF, they may not transport sealed 

inner liners. Rather, they are expected to 

transfer sealed inner liners to another 

registrant for destruction pursuant to 

§ 1317.05(c)(2)(iv). Two-registrant 

integrity allows the DEA to verify and 

cross-check each registrants’ records. 

Conversely, LTCFs and destruction 

facilities are generally not registrants. 

Therefore, if a reverse distributor were 

authorized to install and maintain 

collection receptacles at LTCFs, and 

also pick-up, transport, and destroy 

sealed inner liners from LTCFs, the DEA 

would be unable to verify the reverse 

distributor’s removal or destruction 

records with another registrant’s 

records. Allowing this would not meet 

the two-registrant integrity requirement 

that is the minimum required to ensure 

accountability, particularly when 

collected substances are destined for 

destruction. 

As discussed in responses to other 

comments, because LTCFs are generally 

not registrants, the DEA is unable to 

allow such facilities to be authorized 

collectors for the purpose of disposing 

ultimate user-collected substances, or 

handle disposed substances on behalf of 

another registrant. We note that 

although LTCFs may not use mail-back 

packages or administer a mail-back 

program, ultimate users who reside in 

LTCFs may use mail-back packages 

under this rule. 21 CFR 1317.30 and 

1317.70. 

[6] Issue: One commenter asked the 

DEA to allow a LTCF resident, or the 

resident’s legal representative, to 

dispose of controlled substances 

through all available means, whether 

the resident is alive or deceased. 

Response: All means of disposing of 

pharmaceutical controlled substances 

are available to ultimate users and 

persons lawfully entitled to dispose of 

an ultimate user decedent’s property, 

including those ultimate users who 

reside, or have resided, in a LTCF. 21 

CFR 1317.30. 

[7] Issue: Commenters also asked the 

DEA to address how LTCFs should 

handle situations in which a resident is 

transferred to a hospital and the resident 

leaves unwanted medication at the 

LTCF. 

Response: Pursuant to the Disposal 

Act, Congress provided the DEA 

authority to authorize LTCFs only to 

‘‘dispose of controlled substances on 

behalf of ultimate users who reside, or 

have resided,’’ at the LTCF. 21 CFR 

1317.30. When a LTCF resident is 

transferred to a hospital or other facility, 

the resident ‘‘has resided’’ at the LTCF, 

and if the medication is intentionally 

left at the LTCF, it is ‘‘unwanted,’’ and 

the resident has discontinued use. 

Accordingly, the LTCF may dispose of 

the former resident’s pharmaceutical 

controlled substances by depositing the 

substances into an authorized collection 

receptacle immediately, but no longer 

than three business days after 

discontinuation of use. 21 CFR 1317.80. 

[8] Issue: Several commenters 

indicated that the three-day disposal 

provision for LTCFs is overly restrictive 

and potentially costly for residents. 

These commenters stated that three days 

is too short a time span and will result 

in residents being forced to purchase 

additional medications when there is a 

short break in use as a result of illness, 

hospitalization, or a trial dosage 

reduction. One commenter stated that 

three days is not a long enough time 

period to determine if the patient may 

need the medication again in the future. 

Response: The DEA declines to 

extend the timeframe for LTCFs to 

dispose of pharmaceutical controlled 

substances on behalf of LTCF residents. 

As previously discussed, LTCFs are 

required to dispose of pharmaceutical 

controlled substances ‘‘immediately, but 

no longer than three business days after 

the discontinuation of use’’ in 

§ 1317.80(a). With respect to 

‘‘discontinuation of use,’’ the final rule 

modifies § 1317.80(a) to include a 

permanent discontinuation as directed 

by the prescriber, as a result of the 

resident’s transfer from the LTCF, or as 

a result of death. The DEA cannot 

readily foresee a circumstance where a 

short break in use as a result of illness, 

short-term hospitalization, or a trial 

dosage reduction would be considered a 

discontinuation of use. Also, if the 

prescriber has not yet determined 

whether or not a medication is needed 

in the future, then it is likely that there 

has not yet been a ‘‘discontinuation of 

use.’’ 

Collection Receptacle Maintenance at 

LTCFs 

[9] Issue: Fifteen commenters 

indicated that the requirement to have 

two employees of the authorized 

collector retail pharmacy remove and 

install inner liners is burdensome, and 

it will discourage retail pharmacies from 

installing and maintaining collection 

receptacles at LTCFs. The commenters 

suggested that the DEA allow LTCF 

personnel to remove, store, and replace 

the inner liners. A commenter suggested 

that LTCF personnel be permitted to 

sort out non-controlled substances to 

reduce the amount of material collected 

in the receptacles. 

Response: As explained above, the 

DEA is amending the final rule to allow 

flexibility in the requirement that two 

employees of the authorized collector be 

present for the installation and removal 

of inner liners at LTCF collection 

receptacles. As amended, the final rule 

in § 1317.80(c) provides that 

installation, storage, and removal may 

also be performed by one employee of 

the authorized collector and one 

supervisor-level employee of the LTCF 

(e.g., a charge nurse, supervisor, or 

similar employee) designated by the 


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hospital/clinic or retail pharmacy 

authorized to collect at that location. 

Hospitals/clinics and retail pharmacies 

that choose the flexibility allowed by 

using a supervisor-level employee from 

the LTCF are reminded that they are 

still ultimately responsible for the 

security of the collected substances, as 

well as keeping complete and accurate 

records and fulfilling reporting 

requirements. The contents of the inner 

liners may not be sorted once deposited 

into a receptacle, pursuant to 

§ 1317.75(c), but, as previously stated, 

§ 1317.75(b) states that comingling of 

controlled and non-controlled 

substances is permitted but not 

required. Therefore, the authorized 

collector or the LTCF may choose to 

limit the collected substances to 

pharmaceutical controlled substances to 

maximize available space in the 

collection receptacle. This can be easily 

accomplished at LTCFs because trained 

medical personnel will be depositing 

substances into collection receptacles 

and should be well-equipped to sort 

controlled substances from noncontrolled substances before depositing 

the substances into a collection 

receptacle. Also, as previously 

discussed, inner liners may be stored at 

LTCFs in accordance with § 1317.80(d). 

Another available option to manage 

volume and the prohibition of on-site 

storage is for an authorized collector to 

maintain more than one collection 

receptacle at an LTCF. 

[10] Issue: Commenters asked the 

DEA to clarify whether reverse 

distributors are permitted to pick up 

collection receptacle inner liners from 

an authorized LTCF location. 

Response: In accordance with 

§ 1317.05(c)(2)(iv), reverse distributors 

may pick up inner liners from collection 

receptacles located at authorized LTCFs, 

and reverse distributors may receive the 

inner liners that are sent to the reverse 

distributor’s registered location from the 

LTCF by common or contract carrier. 

However, the inner liner must be 

removed from the collection receptacle 

under the supervision of either two 

employees from the hospital/clinic or 

retail pharmacy that is managing the 

receptacle, or one employee from the 

managing hospital/clinic or retail 

pharmacy and one supervisor-level 

employee of the LTCF (e.g., a charge 

nurse, supervisor, or similar employee) 

designated by the authorized collector, 

pursuant to § 1317.80(c). 

[11] Issue: Several commenters 

expressed concern regarding the 

transportation and storage of substances 

collected from LTCFs, specifically with 

regard to the safety of employees who 

transport collected substances from 

LTCFs and logistical difficulties (e.g., 

storage space) that may result in fewer 

retail pharmacies willing to install and 

maintain collection receptacles at 

LTCFs. 

Response: As previously discussed, 

hospitals/clinics and retail pharmacies 

may store sealed inner liners at the 

LTCF in a securely locked, substantially 

constructed cabinet, or a securely 

locked room with controlled access for 

up to three business days pursuant to 

§ 1317.80(d). However, the DEA 

encourages LTCFs and authorized 

collectors managing collection 

receptacles at LTCFs to exhaust other, 

more secure, alternatives, including: 

Arranging regularly scheduled pick-ups 

by reverse distributors or common or 

contract carriers to coincide with 

removal of the inner liner or delivery of 

controlled substances to the LTCF; 

operating multiple collection 

receptacles at a LTCF to help minimize 

overflow; and pursuing ultimate user 

disposal options through members of 

the patients household or other persons 

lawfully entitled to dispose of a LTCF 

patient’s property. The DEA believes 

these alternatives are better options than 

storage at LTCFs. LTCFs are generally 

unregistered locations with large 

quantities of highly pilferable controlled 

substances in high doses. The DEA 

carefully weighed the benefits with the 

risks of allowing storage at LTCFs, 

including the potential for creating a 

new avenue of diversion at a location 

over which the DEA has limited 

regulatory oversight. However, in 

consideration of the circumstances 

unique to LTCFs, and to ease the burden 

on LTCFs and authorized collectors, the 

DEA is permitting in this final rule 

sealed inner liners to be stored at LTCFs 

in accordance with § 1317.80(d). 

The DEA has also relaxed the rule, in 

§ 1317.80(c), to allow flexibility in the 

two-person integrity requirement with 

respect to collection at LTCFs by 

allowing authorized hospitals/clinics 

and retail pharmacies to designate a 

supervisory-level employee of the LTCF 

as one of the authorized persons to 

conduct or oversee the installation, 

removal, storage and transfer inner 

liners. However, the authorized 

collector may opt to have two or more 

of its own employees perform or oversee 

these activities. In addition, authorized 

collectors that are practitioners may not 

themselves transport collected 

substances to a destruction location. 21 

CFR 1317.05. Rather, the practitioner 

may destroy the collected substances by 

delivering the sealed inner liners to a 

reverse distributor or distributor’s 

registered location by common or 

contract carrier, or a reverse distributor 

or distributor may pick-up sealed inner 

liners at the LTCF. 21 CFR 1317.05. 

[12] Issue: Commenters indicated 

that the installation and maintenance of 

collection receptacles by retail 

pharmacies at LTCFs will likely result 

in considerable costs, burdens, and 

other liabilities, and, as such, few retail 

pharmacies will be willing to install and 

maintain collection receptacles at 

LTCFs, and few LTCFs will want to bear 

the costs. 

Response: The DEA carefully 

considered the costs associated with all 

aspects of disposal, along with all other 

considerations such as convenience, 

safety, and the risk of diversion, 

including the security and design of 

collection receptacles. As discussed in 

the preamble to this rule, participation 

in any disposal program for ultimate 

users is voluntary and the DEA is not 

authorized to impose the burden of 

costs upon any specific entity. As such, 

each registrant that may become 

authorized as a collector must 

individually weigh the associated 

benefits and burdens in determining 

whether to do so. In order to 

accommodate LTCF residents, the DEA 

has expanded the authorized collectors 

that may maintain collection receptacles 

at LTCFs to include certain hospitals/

clinics and retail pharmacies. 21 CFR 

1317.40. The DEA has also relaxed the 

two-person integrity requirements with 

respect to LTCFs, and is allowing for 

storage of sealed inner liners at the 

LTCF in order to reduce the burdens on 

hospitals/clinics and retail pharmacies. 

21 CFR 1317.80. These are the 

minimum requirements to ensure that 

safety and security of LTCF residents, 

and to deter and detect diversion. 

[13] Issue: Several commenters 

expressed concerns over liability when 

a collection receptacle is installed at a 

LTCF because the collector pharmacy is 

fully responsible for the receptacle but 

does not have constant, direct 

supervision over it. The commenters did 

not specify what type of liability (e.g., 

criminal, civil, administrative, etc.) was 

concerning, however, the commenters 

suggested that the DEA provide the 

authorized collector retail pharmacies a 

release from responsibility when 

installing and maintaining a collection 

receptacle at a LTCF. 

Response: It would be contrary to the 

public health and safety to authorize an 

entity to collect pharmaceutical 

controlled substances from ultimate 

users, and also absolve that entity from 

any responsibility for such collection. In 

any event, the DEA does not have 

authority to provide a general release 

from liability to all hospitals/clinics and 

retail pharmacies that apply for, and are 


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authorized to, install and maintain a 

collection receptacle at a LTCF as part 

of their registered activities. Part of the 

purpose in authorizing only certain 

hospitals/clinics and retail pharmacies 

to install and maintain collection 

receptacles at LTCFs is to ensure that a 

responsible registrant under the 

regulatory authority of the DEA is 

charged with ensuring the secure and 

responsible collection of pharmaceutical 

controlled substances at LTCFs. As 

such, with regard to authorized 

collection receptacles at LTCFs, all 

responsibility for such receptacles, 

including compliance with the CSA and 

DEA regulations, rests with the hospital/ 

clinic or retail pharmacy authorized to 

install and maintain the collection 

receptacle. The DEA designed the 

physical security controls and other 

accountability measures (e.g., 

recordkeeping, two-person integrity, 

regular monitoring by LTCF personnel) 

for collection receptacles at LTCFs in an 

effort to minimize the risk of diversion 

in circumstances where constant, direct 

supervision by the hospital/clinic or 

retail pharmacy is not feasible. In the 

event an authorized collector knows or 

has reason to know diversion from 

collection receptacles is occurring, the 

authorized collector must take steps to 

prevent the diversion, including 

reporting to the appropriate authorities 

pursuant to §§ 1301.74 and 1301.76. 

Such action stems from the 

responsibility to provide effective 

controls and procedures to guard against 

theft and diversion as required by 

§ 1301.71(a). 

Security at LTCFs 

[14] Issue: One commenter asked the 

DEA to clarify the required security 

measures for collection receptacles at 

LTCFs. Two commenters asked the DEA 

to outline what LTCF staff must do to 

monitor the collection receptacle. 

Response: The required security 

measures outlined in §§ 1317.60 and 

1317.75 that apply to all collection 

receptacles also apply to those located 

at LTCFs unless stated otherwise in the 

rule. The rule provides that a collection 

receptacle must be located in an area 

that is regularly monitored by LTCF 

personnel. 21 CFR 1317.75(d)(2)(iii). 

‘‘Regularly monitored’’ has its ordinary 

meaning. The goal of this requirement is 

to prevent diversion; accordingly, 

specific examples would depend on 

individual circumstances. However, a 

sub-basement or other seldom-used 

storage area would not be considered to 

be regularly monitored by LTCF 

personnel because those areas are not 

routinely accessed by LTCF personnel 

in the course of conducting the 

everyday the business of the LTCF. The 

requirement that the receptacle be 

‘‘regularly monitored’’ is designed to 

prevent diversion opportunities, and to 

ensure that diversion would be detected 

as soon as possible. Only authorized 

collectors may install, manage, and 

maintain collection receptacles at 

LTCFs, therefore, only the authorized 

collectors may remove, seal, transfer, 

and store or supervise the removal, 

sealing, transfer, and storage of sealed 

liners. 21 CFR § 1317.80(b). The 

authorized collector is responsible for 

ensuring the regular monitoring of LTCF 

personnel and ensuring the appropriate 

security procedures are in place at 

LTCFs in the event of suspected 

tampering or diversion. If tampering or 

diversion is suspected, LTCF personnel 

should notify law enforcement 

authorities and the authorized collector, 

as the circumstances warrant. 

[15] Issue: Eight commenters 

expressed concern for the safety of 

residents of LTCFs. These commenters 

are concerned that collection 

receptacles in LTCFs may affect resident 

safety due to these locations becoming 

a potential target for drug seekers. Five 

commenters suggested that the DEA 

increase penalties for offenses related to 

collected substances at LTCFs. One 

commenter encouraged the DEA not to 

authorize the installation of collection 

receptacles at LTCFs because their 

presence may compromise the safety of 

staff and residents. 

Response: Congress authorized the 

DEA to implement regulations 

authorizing LTCFs to dispose of 

controlled substances on behalf of 

ultimate users who reside, or have 

resided, at such LTCFs. The DEA has 

considered the risks associated with 

authorizing the installation and 

maintenance of collection receptacles at 

LTCFs, as discussed in the NPRM, and 

determined that the security measures 

described in this rule, in § 1317.75, are 

the minimum required to ensure the 

safe and secure disposal of 

pharmaceutical controlled substances at 

LTCFs. If authorized collectors or LTCFs 

believe the presence of a collection 

receptacle endangers the safety or 

security of the LTCF residents under 

particular circumstances, they should 

take additional measures as appropriate 

to ensure the safety of the residents and 

staff, and to ensure the security of the 

collected substances. And, if those other 

alternatives have failed to abate the 

observed dangers, the authorized 

collector can choose to discontinue 

placing a collection receptacle at a 

particular LTCF. 

The CSA already provides for 

administrative, civil, and criminal 

sanctions for individuals and registrants 

that violate the CSA. The DEA is 

without authority to mandate enhanced 

penalties for violations of the CSA that 

involve LTCFs. 

[16] Issue: Two commenters 

expressed concern about security issues 

due to potential stockpiling of 

unwanted controlled substances at 

LTCFs. These commenters listed the 

following reasons as the bases for their 

concerns: The three business day 

disposal requirement, the lack of 

guidance on the frequency at which 

inner liners must be removed, the two 

employee requirement for installing and 

removing inner liners, and lack of a 

realistic alternative for disposal if no 

retail pharmacy manages a collection 

receptacle at the facility. These 

commenters stated that stockpiling 

would increase diversion risks and 

would be a liability for the LTCF. 

Response: As discussed in the NPRM 

and in response to comments in this 

final rule, these new regulations expand 

the options available to ultimate users 

(including LTCF residents) to dispose of 

excess pharmaceutical controlled 

substances. A resident, a member of the 

resident’s household, and an individual 

lawfully entitled to dispose of the 

decedent resident’s property all may 

dispose of a resident’s pharmaceutical 

controlled substances using any of the 

several methods of disposal mentioned 

here. 21 CFR 1317.30. 

If there is a collection receptacle at 

the LTCF, the collected substances 

should not accumulate under the 

procedures outlined in this rule. One of 

the primary goals of the procedures 

outlined in these new regulations is to 

prevent the accumulation of collected 

substances while awaiting destruction. 

For example, LTCFs are required to 

deposit pharmaceutical controlled 

substances into collection receptacles 

‘‘immediately, but no longer than three 

business days after the discontinuation 

of use,’’ pursuant to § 1317.80(a). 

Although the DEA has not specifically 

proposed regulations regarding the 

frequency at which the inner liners of 

collection receptacles must be replaced, 

an authorized collector that maintains a 

collection receptacle at a LTCF should 

coordinate with that LTCF in order to 

ensure that the inner liners are replaced 

at a frequency suitable to ensure 

continuous safe and secure disposal by 

the LTCF. This type of coordination is 

part of an authorized collector’s 

responsibility to provide effective 

controls and procedures to guard against 

theft and diversion as required by 

§ 1301.71(a). Controls against diversion 

are ineffective when stockpiling of 

unused pharmaceutical controlled 


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substances at a LTCF is the result of an 

authorized collector’s failure to 

adequately maintain a collection 

receptacle. It is emphasized that there is 

no limit on the number of collection 

receptacles that an authorized collector 

may install and maintain at a LTCF. 

Accordingly, the number of receptacles 

may be increased to account for volume 

and/or pick-up schedules. 

As previously discussed, this rule 

allows but does not require authorized 

collectors to store sealed inner liners at 

a LTCF for up to three business days in 

a securely locked, substantially 

constructed cabinet or a securely locked 

room with controlled access, pursuant 

to § 1317.80(d). However, the DEA 

encourages collectors to schedule inner 

liner removals and installations to 

coincide with existing LTCF visits when 

possible, for example, arranging a 

routine system in which medication 

deliveries coincide with the removal 

and transfer of sealed inner liners for 

appropriate destruction, thereby making 

sealed inner liner storage unnecessary. 

Other Concerns Regarding LTCF Drug 

Disposal 

[17] Issue: One commenter expressed 

concern that the DEA’s assumption that 

controlled substances in LTCFs have 

been dispensed to, and are thus the 

property of, a resident may result in the 

reluctance of LTCFs to use automated 

dispensing systems to dispense to an 

ultimate user as needed. 

Response: Congress has defined 

‘‘dispense’’ to mean the delivery of a 

controlled substance to an ultimate user 

by, or pursuant to the lawful order of, 

a practitioner. 21 U.S.C. 802(10). The 

DEA is bound to this definition. 

Accordingly, once a pharmaceutical 

controlled substance has been 

dispensed to a patient, including a 

resident of a LTCF, the substance is the 

property of the patient or ultimate user. 

The use of an automated dispensing 

system (ADS) does not change the 

analysis. An ADS is conceptually 

similar to a vending machine. A 

pharmacy stores bulk drugs in the 

machine in separate bins or containers 

and programs and controls the ADS 

remotely. Only authorized staff at the 

LTCF would have access to its contents, 

which are dispensed on a single-dose 

basis at the time of administration 

pursuant to a prescription. The ADS 

electronically records each dispensing, 

thus maintaining dispensing records for 

the pharmacy. Because the controlled 

substances are not considered dispensed 

until the system provides them, 

substances in the ADS are counted as 

pharmacy stock. Even though ADSs in 

LTCFs are used to dispense medications 

for administration on an as-needed basis 

(i.e., one dose at a time) in accordance 

with a practitioner’s prescription, the 

substance is the property of the LTCF 

resident once dispensed. Even though a 

pharmaceutical controlled substance is 

the property of the ultimate user once 

dispensed from the ADS, the LTCF may 

dispose of the medication on behalf of 

an ultimate user who resides, or has 

resided at an LTCF by depositing the 

medication into an authorized 

collection receptacle located in the 

LTCF. 21 CFR § 1317.80. Controlled 

substances held within the ADS that 

have not been dispensed to a patient are 

considered inventory or stock of the 

registrant and therefore must be 

disposed of by the registrant in 

accordance with 21 CFR § 1317.05. 

[18] Issue: Commenters indicated 

that LTCFs may be serviced by multiple 

pharmacies which could result in 

controlled substances from multiple 

servicing pharmacies being disposed of 

in a single receptacle installed by one 

such pharmacy and asked the DEA to 

clarify how to manage such situations 

(e.g., how other pharmacies would 

contribute to the efforts of collection; 

whether drugs dispensed by other 

pharmacies can be disposed of in the 

receptacle). Commenters also asked the 

DEA to clarify the process and 

requirements for the collection 

receptacle when the LTCF changes 

ownership or pharmacy service. 

Response: This rule allows certain 

hospitals/clinics and retail pharmacies 

to become collectors at LTCFs pursuant 

to § 1317.40, after properly modifying 

their registrations, in accordance with 

part 1301. This rule does not require 

authorized collectors to have any preexisting or other relationships with the 

LTCF. Depending on the circumstances, 

there may be more than one authorized 

collection receptacle at a single LTCF. 

Other than the regulations specific to 

the installation and maintenance of 

collection receptacles and all related 

laws and regulations, the DEA is not, at 

this time, regulating the relationship 

between the authorized collector and 

the LTCF, or between multiple 

authorized collectors that have 

relationships with the LTCF, and the 

DEA is not prohibiting collectors from 

refusing to collect any certain specified 

pharmaceutical controlled substances. 

However, conduct that implements 

exclusionary or anti-competitive actions 

at an LTCF that adversely affects 

competing registrants will be referred to 

the appropriate authorities for action. It 

is important to remind authorized 

collectors with collection receptacles at 

LTCFs that they are solely responsible 

for the security, integrity, and 

maintenance of their own collection 

receptacles and they must be vigilant 

and ensure complete accountability for 

any pharmaceutical controlled 

substances they collect at LTCFs. If a 

LTCF changes ownership and changes 

its name, the authorized collector must 

modify its registration in accordance 

with § 1301.51(b)(2) to reflect the new 

name of the LTCF. 

[19] Issue: One commenter 

specifically suggested that the DEA 

restrict collection receptacles at LTCFs 

to the collection of controlled 

substances and to require signage 

indicating such in order to ensure 

compliance with State Medicaid 

program directives requiring the 

recovering of non-controlled drugs for 

potential credit or restocking. 

Response: The DEA is modifying the 

final rule in §§ 1317.70(b) and 

1317.75(b) to clearly indicate that 

comingling of controlled and noncontrolled substances is permitted but 

not required. The DEA’s authority is 

limited to controlled substances. As 

such, the DEA cannot promulgate 

regulations requiring signage pertaining 

to compliance with State Medicaid 

programs or any other programs outside 

the DEA’s scope of authority, but 

collectors are free to post signage 

pertaining to non-controlled substances. 

Moreover, collectors may post any 

information they deem appropriate for 

the safe and secure disposal of 

controlled substances. All collections 

that may include pharmaceutical 

controlled substances, whether 

comingled or not, must be consistent 

with this rule, and all other applicable 

Federal, State, tribal, and local laws and 

regulations. 

[20] Issue: Two commenters 

referenced prescription labeling 

requirements that prohibit the transfer 

of controlled substances to a person 

other than to whom it was prescribed. 

The commenters asked for clarification 

regarding such transfers and transfers to 

a person lawfully entitled to dispose of 

an ultimate user decedent’s property. 

The commenters indicated that such 

transfers could be considered 

dispensing and therefore outside of the 

authority of the LTCF employee. 

Additional concerns included State 

laws that prohibit LTCFs from giving 

back unused controlled substances to 

the resident or another person and those 

that require such substances to be 

destroyed at the facility. 

Response: Pursuant to 21 U.S.C. 

825(c), FDA regulations require that 

when a schedule II, III, or IV controlled 

substance is dispensed to or for a 

patient, the label include a warning that 

Federal law ‘‘prohibits the transfer of 


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the drug to any person other than the 

patient for whom it was prescribed.’’ 21 

CFR 290.5. This is not a regulation 

within the DEA’s authority; however, 

the regulation does not appear to be 

inconsistent with the Disposal Act. As 

described in detail in the NPRM, the 

CSA expressly provides that it is 

unlawful to distribute a controlled 

substance except as provided. The CSA 

permits an ultimate user who has 

lawfully obtained a pharmaceutical 

controlled substance to deliver the 

controlled substance to another person 

for the purpose of disposal only if that 

person is authorized to receive such 

substance and in accordance with the 

implementing regulations. The CSA 

further provides that if a person dies 

while lawfully in possession of a 

pharmaceutical controlled substance, 

any person lawfully entitled to dispose 

of the decedent’s property may deliver 

the substance to another person for the 

purpose of disposal under the same 

conditions described above. Pursuant to 

the Disposal Act, a LTCF may dispose 

of a resident’s pharmaceutical 

controlled substances in accordance 

with these regulations. When a LTCF 

deposits a pharmaceutical controlled 

substance into a collection receptacle in 

accordance with these regulations, it is 

not ‘‘dispensing.’’ As discussed, 

‘‘dispense’’ means the delivery of a 

controlled substance to an ultimate user 

by, or pursuant to the lawful order of, 

a practitioner. 21 U.S.C. 802(10). 

With regard to State laws, the DEA 

cannot comment on the laws of each 

individual State because these laws are 

outside of the DEA’s purview. The DEA 

is tasked by Congress with 

implementing Federal laws related to 

controlled substances. However, 

nothing contained within the DEA 

regulations should be construed as 

authorizing or permitting any person to 

do any act he/she is not authorized or 

permitted to do under other Federal 

laws or under the law of the State in 

which he/she desires to perform such 

act, nor shall compliance with the 

DEA’s regulations be construed as 

compliance with other Federal or State 

laws. 21 CFR 1307.02. 

[21] Issue: One commenter asked the 

DEA to discuss whether the HHS 

reviewed the rule with regard to their 

‘‘anti-kickback’’ statute. This commenter 

expressed concern over whether or not 

the HHS would permit a retail 

pharmacy that dispenses to a particular 

LTCF to provide collection services to 

the same LTCF free of charge. 

Response: All collection and disposal 

of controlled substances must be 

conducted in accordance with all 

applicable laws and regulations, 

including HHS regulations. This rule 

neither imposes requirements or 

regulations for the funding of disposal 

programs, nor imposes requirements or 

regulations regarding fees that 

registrants may charge to operate 

disposal programs. 

L. Disposing on Behalf of Ultimate Users 

(Other Than Residents of LTCFs) (3 

Issues) 

[1] Issue: Commenters asked the DEA 

to clarify how hospitals, schools, 

summer camps, or other entities may 

dispose of controlled substances that 

unintentionally end up in their 

possession (e.g., when persons abandon 

controlled substances and return is not 

possible). Also, several commenters 

asked the DEA to explain how 

controlled substances may be disposed 

of when the ultimate user or other 

authorized person is unable to dispose 

of them due to death or incapacitation. 

Response: The DEA has limited 

authority regarding who may deliver 

pharmaceutical controlled substances 

for the purpose of disposal. Pursuant to 

the Disposal Act, Congress granted the 

DEA authority to authorize three groups 

of people to deliver controlled 

substances for the purpose of disposal. 

First, an ‘‘ultimate user’’ who has 

lawfully obtained a pharmaceutical 

controlled substance may deliver the 

substance to another person who is 

authorized to accept it for the purpose 

of disposal. The CSA defines ‘‘ultimate 

user’’ as ‘‘a person who has lawfully 

obtained, and who possesses, a 

controlled substance for his own use or 

for the use of a member of his 

household or for an animal owned by 

him or by a member of his household.’’ 

21 U.S.C. 802(27). Second, if a person 

dies while lawfully in possession of a 

pharmaceutical controlled substance, 

any person lawfully entitled to dispose 

of the decedent’s property may deliver 

the substance to another person for the 

purpose of disposal. 21 CFR 1317.30. 

Third, LTCFs may dispose of 

pharmaceutical controlled substances 

on behalf of ultimate users who reside 

or have resided at such facilities. 21 

U.S.C. 822(g). The DEA has no authority 

to expand the types of individuals and 

entities lawfully permitted to deliver 

pharmaceutical controlled substances 

for the purpose of disposal. The DEA 

has carefully considered its statutory 

authority, diversion risks, public safety, 

convenience for ultimate users, and the 

interests of the public. The DEA 

believes that this rule provides safe and 

convenient disposal options for ultimate 

users and other authorized persons. The 

DEA understands that there may be 

circumstances where there is no 

authorized person to dispose of the 

controlled substances, such as when 

controlled substances are abandoned at 

a school or summer camp, and return to 

the ultimate user is not feasible. In such 

instances, the affected entities should 

contact local law enforcement or their 

local DEA office for guidance on proper 

disposal procedures. 

[2] Issue: The DEA received a number 

of comments regarding the lack of 

provisions for hospice and other 

homecare programs to dispose of 

controlled substances on behalf of 

patients. According to the commenters, 

many hospices have written policies 

and procedures in place for the 

management and disposal of controlled 

substances in the patient’s home. Given 

the available options for ultimate user 

disposal, commenters expressed 

concern that hospices may no longer be 

able to assist families in disposing of a 

deceased patient’s drugs. Commenters 

suggested that the DEA allow hospice 

staff to dispose of a decedent’s 

controlled substances by sewering or 

landfill disposal. 

Response: The DEA appreciates the 

difficulties facing home hospice staff 

with regard to the disposal of 

pharmaceutical controlled substances. 

The Disposal Act provides that ‘‘if a 

person dies while lawfully in 

possession of a controlled substance for 

personal use, any person lawfully 

entitled to dispose of the decedent’s 

property may deliver the controlled 

substance to another person for the 

purpose of disposal under the same 

conditions as provided’’ for ultimate 

users. 21 U.S.C. 822(g)(4). Otherwise, 

home hospice and homecare personnel 

are not authorized to receive 

pharmaceutical controlled substances 

from ultimate users for the purpose of 

disposal. In addition, an ultimate user 

includes ‘‘a person who has lawfully 

obtained, and possesses, a controlled 

substance for his own use or for the use 

of a member of his household.’’ 21 

U.S.C. 802(27). Accordingly, a member 

of the hospice patient’s household may 

dispose of the patient’s pharmaceutical 

controlled substances, but the home 

hospice or homecare provider cannot do 

so unless otherwise authorized by law 

(for example, under state law) to dispose 

of the decedent’s personal property. 

This rule provides a number of 

options for ultimate users and persons 

lawfully entitled to dispose of a 

deceased ultimate user’s property to 

safely and securely dispose of 

pharmaceutical controlled substances, 

yet the DEA does not require ultimate 

users to utilize these options. However, 

it is unlawful for ultimate users to 

transfer pharmaceutical controlled 


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substances to unauthorized persons, and 

it is unlawful for unauthorized persons 

to receive such substances. It is also 

unlawful for any person to possess a 

controlled substance unless authorized 

to do so under the CSA (i.e., an ultimate 

user, an entity registered with the DEA, 

or an entity exempt from registration 

with the DEA). 21 U.S.C. 844(a). Home 

hospice and other homecare providers 

are encouraged to assist their patients, 

and their patients’ families, in disposing 

of pharmaceutical controlled substances 

in accordance with the CSA and its 

implementing regulations. While 

education is paramount, home 

healthcare agencies are also encouraged 

to partner with authorized collectors to 

promote or jointly conduct mail-back 

programs. 

[3] Issue: One commenter asked the 

DEA to clarify the authority for a 

hospice employee to utilize a LTCF’s 

collection receptacle for the disposal of 

controlled substances of a LTCF 

resident who is also a patient of the 

hospice. 

Response: This rule does not 

specifically address hospice care or 

hospice employees, who are typically 

not registrants. As discussed, it is 

unlawful to possess a controlled 

substance unless authorized to do so 

under the CSA. 21 U.S.C. 844(a). The 

DEA has, however, provided options for 

the disposal of pharmaceutical 

controlled substances by a LTCF on 

behalf of a person who resides, or has 

resided, at the LTCF, regardless of 

whether or not that person is also 

receiving hospice care. The Disposal Act 

authorized the Attorney General to 

allow LTCFs to dispose of controlled 

substances on behalf of ultimate users 

who reside, or have resided, at the 

LTCF, in a manner determined by the 

Attorney General. 21 U.S.C. 822(g)(3). 

LTCF is defined as ‘‘a nursing home, 

retirement care, mental care, or other 

facility or institution which provides 

extended health care to resident 

patients.’’ 21 CFR part 1300. Congress 

specifically allowed the Attorney 

General to consider permitting LTCFs to 

dispose of pharmaceutical controlled 

substances on behalf of LTCF residents. 

This allowance did not extend to other 

persons who are simply attending to a 

person who is resident of the LTCF. As 

such, a hospice employee is not 

authorized to dispose of pharmaceutical 

controlled substances on behalf of a 

person who resides or has resided at a 

LTCF. 

M. Registrant Return, Recall, and 

Transfer (3 Issues) 

[1] Issue: One commenter urged the 

DEA to retain the existing regulations in 

part 1307. This commenter stated that 

part 1307 adequately addresses 

registrant return, recall, and transfer. 

The commenter stated that part 1307 

functions properly; thus, there is no 

need to change it, and the commenter 

expressed concern that the new 

regulations will disrupt existing 

business practices. The commenter was 

particularly concerned that most 

controlled substances returned to 

distributors are re-salable and ‘‘not 

intended for disposal.’’ Other 

commenters indicated confusion with 

regard to registrants seeking assistance 

from a SAC when disposing of 

controlled substances. 

Response: The DEA first notes that 

the terms ‘‘disposal’’ and ‘‘destruction’’ 

are not interchangeable in the context of 

the rule. As described in the NPRM at 

footnote 4 and in this final rule at 

footnote 4, the terms ‘‘disposal,’’ 

‘‘dispose,’’ and ‘‘disposition’’ appear 

several times in the CSA but are not 

defined. In the NPRM and this final 

rule, the DEA uses the terms ‘‘disposal’’ 

and ‘‘dispose’’ to refer generally to the 

wide range of activities that result in 

controlled substances being unavailable 

for further use or one entity ridding 

themselves of such substances (e.g., 

returns). Within the CSA, a controlled 

substance can be ‘‘disposed of’’ by 

destruction, return, recall, sale, or 

through the manufacturing process. As 

such, the modified regulations regarding 

registrant disposal codify existing 

practice, expand available options, and 

implement consistent procedures among 

registrants in accordance with their 

authorized business activities. This 

required deleting the existing 

regulations at § 1307.21 which 

authorized the SACs to individually 

authorize disposal. The new rule 

eliminates the authority of the SACs to 

individually authorize disposal methods 

for non-practitioners, and retains this 

option for practitioners. 21 CFR 

1317.05. Otherwise, the new regulations 

maintain existing disposal practices for 

registrant inventory and authorize: 

Prompt on-site destruction; prompt 

delivery of controlled substances to a 

reverse distributor; and prompt delivery 

(for the purposes of return and recall) to 

the person from whom the controlled 

substance was obtained, the 

manufacturer, or a registrant authorized 

to accept returns on the manufacturer’s 

behalf. Additionally, non-practitioners 

may promptly transport the controlled 

substances to a reverse distributor, a 

destruction location, or the location of 

any person authorized to receive the 

controlled substances for the purpose of 

return or recall. 21 CFR 1317.05. The 

DEA appreciates that by eliminating the 

option for a SAC to authorize specific 

disposal procedures on a case-by-case 

basis for non-practitioners, some reverse 

distributors may need to alter their 

disposal practices. Although this change 

may impact current business practices, 

as discussed in the NPRM, nationwide 

consistency is necessary in the disposal 

pharmaceutical controlled substances. 

[2] Issue: One commenter asked the 

DEA to clarify what method of return is 

permitted other than via a freight 

forwarding facility pursuant to 

§ 1317.10. 

Response: With regard to the use of 

freight forwarding facilities pursuant to 

21 CFR 1317.10(c), use of the word 

‘‘may’’ indicates that the use of freight 

forwarding facilities is permitted but not 

required. Other authorized methods of 

transferring pharmaceutical controlled 

substances for the purpose of return or 

recall are outlined in § 1317.05(a)(3) and 

(4) for practitioners, and in 21 CFR 

1317.05(b)(3) and (4) for nonpractitioners. 

[3] Issue: One commenter stated that 

it will be difficult for reverse 

distributors to adjust current business 

operations to meet the 14-day 

destruction requirement for recalled 

controlled substances, because product 

returns may be received from thousands 

of customers across the country. 

Additionally, this requirement may not 

be consistent with other agencies’ 

regulations and policies governing 

manufacturers’ voluntary recalls and 

other product recalls. 

Response: As explained further 

below, the 14-day destruction 

requirement (which this final rule 

extends to 30 days) does not apply to 

recalled pharmaceutical controlled 

substances. 21 CFR 1317.15. 

N. Destruction (19 Issues) 

Non-Retrievable Destruction Standard 

[1] Issue: Forty commenters asked the 

DEA to outline performance standards 

and parameters for the ‘‘nonretrievable’’ destruction standard. 

Although many commenters applauded 

the DEA for proposing a standard that 

will permit future innovation, many 

commenters felt that innovation may be 

hindered by the uncertain terms. 

Commenters asked the DEA to list 

currently-approved methods, and to 

outline how the DEA will evaluate new 

technology intended to render 

controlled substances ‘‘non-retrievable.’’ 

Response: In the NPRM, the DEA 

indicated that incineration and 

chemical digestion are some examples 

of current technology that may be 

utilized to achieve the non-retrievable 


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standard. The preamble of the NPRM 

states that sewering (disposal by 

flushing down a toilet or sink) and 

landfill disposal (mixing controlled 

substances with undesirable items such 

as kitty litter or coffee grounds and 

depositing in a garbage collection) are 

examples of current methods of disposal 

that do not meet the non-retrievable 

standard. The term non-retrievable is 

defined in the rule and is resultsoriented because the DEA’s concern is 

that the substance be permanently 

rendered to an unusable state. The 

performance standard is that the method 

renders the substance so that it cannot 

be transformed to a physical or chemical 

condition or state as a controlled 

substance or controlled substance 

analogue. 21 CFR part 1300. The DEA 

will not be routinely engaged in 

evaluating new technologies intended to 

render controlled substances ‘‘nonretrievable.’’ Much like the DEA does 

not evaluate, review, or approve the 

specific processes or methods utilized to 

produce, synthesize or propagate a 

controlled substance, the DEA will not 

evaluate, review, or approve the 

processes or methods utilized to render 

a controlled substance non-retrievable, 

as long as the desired result is achieved. 

[2] Issue: Twenty commenters asked 

the DEA to include the language 

regarding sewering and landfill disposal 

in the text of the regulation. These 

commenters applauded the DEA for 

stating that sewering and landfill 

disposal do not meet the ‘‘nonretrievable’’ standard; however, these 

commenters asked the DEA to include 

this same language in the text of the 

regulation. 

Response: The DEA has determined 

that the most effective way of ensuring 

that the non-retrievable standard of 

destruction remains current with 

continuously changing technology is to 

provide a required end result rather 

than specify what means achieve or fail 

to achieve that result. A substance is 

rendered non-retrievable when its 

physical or chemical state is 

permanently and irreversibly altered 

and it may be unique to a substance’s 

chemical or physical properties; the 

same means of destruction may not 

render every controlled substance nonretrievable. 21 CFR part 1300. Thus, the 

DEA declines to amend the text of the 

regulation to include such a broad 

prohibition. In consideration of the 

Disposal Act’s goal to decrease the 

amount of pharmaceutical controlled 

substances introduced into the 

environment, the DEA emphasizes that 

sewering and landfill alone do not meet 

the non-retrievable standard. Once a 

controlled substance is rendered nonretrievable, it is no longer subject to the 

requirements of the DEA regulations. 

[3] Issue: Several commenters 

requested that the DEA review and 

approve new destruction methods prior 

to allowing their use. 

Response: As discussed in the 

immediately preceding responses, the 

DEA will not be engaged in reviewing 

or approving new destruction methods 

prior to allowing their use. 

[4] Issue: One commenter suggested 

that the DEA provide a transition period 

to allow for additional research into the 

means by which a non-retrievable state 

may be achieved. This commenter 

proposed a timeframe, such as five 

years, to allow appropriate technology 

to develop. This commenter also 

suggested that the DEA permit sewering 

and landfill disposal in the interim. 

Response: The DEA believes that 

technology by which pharmaceutical 

controlled substances may be rendered 

non-retrievable currently exists, thus 

providing existing opportunities for 

compliance with this rule and negating 

the need for a transition period beyond 

the effective date of this rule. 

[5] Issue: Several commenters 

suggested that the DEA collaborate with 

the United States Environmental 

Protection Agency (EPA) to develop best 

practices for achieving a non-retrievable 

state using environmentally responsible 

methods. 

Response: The DEA appreciates the 

environmental concerns surrounding 

the destruction of pharmaceutical 

controlled substances. The DEA has 

worked with, and is continuing to work 

with, the EPA regarding secure and 

responsible drug disposal, particularly 

for pharmaceutical controlled 

substances that may also be considered 

hazardous wastes. Additionally, the 

DEA has clearly stated in the rule that 

all methods of destruction must comply 

with all applicable Federal, State, tribal, 

and local laws and regulations, 

including EPA regulations. 

[6] Issue: A commenter asked the DEA 

to clarify whether or not the nonretrievable standard of destruction 

applies to substances disposed from 

households, and this commenter stated 

that the DEA should develop and 

endorse a practical solution for in-home 

disposal. 

Response: Ultimate users may 

continue to dispose of their own 

pharmaceutical controlled substances in 

the manner recommended by other 

Federal and State agencies, such as the 

FDA, Office of National Drug Control 

Policy (ONDCP), and EPA. The nonretrievable standard is only applicable 

to inventoried controlled substances 

(i.e., a registrant’s stock) and collected 

controlled substances (i.e., substances 

collected from ultimate users by 

authorized collectors) to be disposed of 

by registrants, pursuant to § 1317.90. 

The non-retrievable standard does not 

apply to non-registrants. 

[7] Issue: Several commenters asked 

the DEA to clarify whether or not 

controlled substances that were 

rendered ‘‘non-retrievable’’ will be 

regulated by the DEA. 

Response: As provided in the 

definition, a controlled substance is 

considered non-retrievable when it 

cannot be transformed to a physical or 

chemical condition or state as a 

controlled substance or controlled 

substance analogue. 21 CFR part 1300. 

Once a substance is rendered nonretrievable, it is no longer subject to the 

requirements of the DEA regulations. 

The DEA believes that further 

regulations regarding substances that 

have been rendered non-retrievable are 

currently unnecessary because a nonretrievable substance cannot be abused 

and diversion to illicit use is futile. 

Incineration and Chemical Digestion 

Destruction Methods 

[8] Issue: Several commenters asked 

the DEA to specifically recommend 

incineration as the preferred method to 

achieve a non-retrievable state. 

Response: The DEA believes that any 

actual or perceived endorsement or 

recommendation of a specific 

destruction method, beyond the 

provision of examples of current 

methods in the preamble, could 

suppress exploration and 

implementation of new technologies as 

people may assume that the endorsed or 

recommended methods are required at 

the exclusion of other methods. As 

such, the DEA is specifying a required 

result—non-retrievable—rather than a 

required method for achieving that 

result. 21 CFR 1317.90. 

On-Site Destruction Methods 

[9] Issue: Several commenters asked 

the DEA to clarify what ‘‘on-site 

destruction’’ means. 

Response: As provided in § 1300.05(b) 

of the final rule, on-site destruction 

means that the controlled substances are 

destroyed on the physical premises of 

the destroying registrant’s registered 

location. Collectors that are authorized 

to conduct mail-back programs must 

have and utilize an on-site method of 

destruction, pursuant to 21 CFR 

1317.05(c)(1). The requirement for an 

on-site method of destruction does not 

apply to non-registrants. 

[10] Issue: Commenters also 

expressed concern that distributors are 

unlikely to have an existing on-site 


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method of destruction because they are 

not typically licensed as waste handlers 

and suggested that the DEA provide 

alternatives to on-site destruction for 

hospitals and other medical facilities. 

Response: This rule does not require 

any distributor or other registrant to 

utilize an on-site method of destruction 

except under certain circumstances in 

order to conduct a voluntary activity 

(e.g., receipt of mail-back packages as an 

authorized collector in accordance with 

§ 1317.05(c)(1)). 

[11] Issue: One commenter asked the 

DEA to consider the use of collection 

receptacles with deactivation 

technology. 

Response: This rule does not prohibit 

on-site destruction of pharmaceutical 

controlled substances by authorized 

collectors with ‘‘deactivation’’ 

capability so long as such destruction is 

consistent with the standards set forth 

in the rule and the destruction results in 

a non-retrievable state. 21 CFR 1317.90. 

Other Destruction-Related Concerns 

[12] Issue: Approximately 20 

commenters stated that the 14-day 

destruction requirement is impractical. 

These commenters suggested that the 

DEA allow more time since there are a 

limited number of commercial 

incinerators in the United States. 

Several commenters stated that reverse 

distributors must accumulate large 

amounts of controlled substances in 

order to obtain favorable pricing. Other 

commenters stated that the requirement 

will make it difficult for reverse 

distributors to properly process and 

record all transactions, and it will 

impose substantial financial and 

operational restrictions on reverse 

distributors as most reverse distributors 

do not have on-site destruction and may 

need to travel long distances to reach an 

appropriate destruction facility. 

Response: The DEA has carefully and 

thoroughly considered these concerns, 

and the final rule in § 1317.15(d) 

extends the destruction requirement 

timeframe from 14 calendar days to 30 

calendar days and eliminates the ‘‘as 

soon as practicable’’ standard with 

respect to this destruction requirement. 

The DEA remains concerned about 

increased diversion risks due to 

pharmaceutical controlled substances 

remaining at a single location for 

extended periods of time. As discussed 

in detail in the NPRM, prescription drug 

abuse is an American epidemic, and it 

is America’s fastest growing drug 

problem. When large volumes of 

pharmaceutical controlled substances 

accumulate, they become an attractive 

target for drug seekers and drug abusers. 

Accordingly, regardless of the 

applicable timeframe to destroy 

controlled substances, reverse 

distributors are reminded that they must 

be vigilant and adhere to the 

requirements in the CSA and the 

implementing regulations. Finally, these 

registrants are reminded of their 

responsibility to provide effective 

controls and procedures to guard against 

theft and diversion, and their 

responsibility to notify the DEA of any 

theft or significant loss of any controlled 

substances within one business day of 

discovery. 21 CFR part 1301. The DEA 

continuously monitors compliance with 

the CSA and applicable regulations to 

ensure that controlled substances are 

not diverted to illicit purposes. If 

necessary, the DEA may consider 

revising the requirements applicable to 

reverse distributors’ destruction 

activities, or imposing additional 

security requirements. 

[13] Issue: Several commenters asked 

the DEA to clarify the day the clock 

starts for the 14-day destruction 

requirement. 

Response: As discussed above, the 

final rule extends the timeframe from 14 

days to 30 days. Day 1 is the day the 

substances are physically acquired 

through pick-up or delivery. 21 CFR 

1317.15. 

[14] Issue: One commenter asked the 

DEA to clarify whether or not the 14-day 

destruction requirement applies to law 

enforcement. 

Response: This destruction 

requirement does not apply to law 

enforcement. Law enforcement 

guidelines are outlined in § 1317.35. 

[15] Issue: One commenter suggested 

that the DEA apply the 14-day 

destruction requirement to all 

authorized collectors that destroy or 

cause the destruction of controlled 

substances, not just reverse distributors. 

Response: As previously discussed, 

the final rule extends the destruction 

requirement timeframe from 14 days to 

30 days. 21 CFR 1317.15. This 

requirement applies to reverse 

distributors destroying any controlled 

substance, as well as distributors when 

destroying sealed inner liners acquired 

from authorized collectors for 

destruction. Pursuant to § 1317.05(c), 

authorized collectors that maintain 

mail-back programs or collection 

receptacles must promptly destroy mailback packages and inner liners, without 

adhering to a certain number of days in 

order to provide them some flexibility 

depending upon their particular 

circumstances. 

[16] Issue: Two commenters stated 

that all management and disposal of 

controlled substances should be 

restricted to DEA-registered hazardous 

waste disposal companies. 

Response: The DEA believes that 

restricting the management and disposal 

of controlled substances as suggested 

would severely burden registrants 

without adding benefit. Pursuant to this 

rule, a destruction facility is not 

required to register with the DEA simply 

because a registrant utilizes that facility 

to destroy pharmaceutical controlled 

substances in a manner consistent with 

this rule and all other applicable 

Federal, State, tribal, and local laws and 

regulations. The DEA does not find it 

necessary to register these entities 

because the destroying registrant 

maintains possession and control of the 

substances (and therefore retains 

responsibility and accountability) until 

the substances are rendered nonretrievable. This is because all handling, 

monitoring, security, recordkeeping, 

and witnessing with regard to the 

pharmaceutical controlled substances is 

performed or supervised by registrants. 

[17] Issue: One commenter indicated 

that the DEA should provide for broader 

Federal approval for methods of 

destruction rather than allowing for 

regionally-based guidance through the 

relevant SAC. 

Response: As discussed, this rule 

expands the options available to 

registrants for proper disposal, but does 

not require any particular method of 

destruction, so long as the substances 

are rendered non-retrievable. This rule 

does not authorize SACs to specifically 

authorize any particular method of 

destruction, but it does allow a 

practitioner to seek guidance from the 

relevant SAC regarding the disposal of 

controlled substances. 21 CFR 1317.05. 

[18] Issue: Several commenters asked 

for clarification regarding the means by 

which an authorized collector may 

promptly destroy collected substances, 

and whether chemical treatment of 

controlled substances until such time as 

controlled substances can be retrieved 

for destruction would be considered 

prompt destruction. 

Response: As discussed, the DEA is 

not requiring any particular method or 

means of destruction. All controlled 

substances destined for destruction 

must be rendered non-retrievable in 

order to be destroyed in a manner 

consistent with this rule. 21 CFR 

1317.90. If chemical treatment renders a 

substance non-retrievable, it has been 

properly destroyed and is no longer 

subject to the DEA’s regulations. 

[19] Issue: One commenter suggested 

that the DEA require controlled 

substances to be partially destroyed 

prior to disposal in collection 


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receptacles, such as by grinding them 

up and mixing them with kitty litter. 

Response: With regard to mixing 

pharmaceutical controlled substances 

with other substances prior to 

depositing them in a collection 

receptacle, this rule neither prohibits 

nor requires such activity. Some 

authorized collectors may find it 

desirable to direct ultimate users to mix 

pharmaceutical controlled substances 

with non-hazardous items, such as kitty 

litter, prior to depositing in receptacles; 

however, the DEA declines to mandate 

such a requirement for all authorized 

collectors. The security controls 

required by this rule are the minimum 

required to ensure the safe and secure 

disposal of pharmaceutical controlled 

substances. 

O. Economic Concerns (18 Issues) 

Continuation of Existing Programs 

[1] Issue: Eighteen commenters with 

experience operating a disposal program 

stated that following the new 

regulations will be prohibitively costly, 

and their current program will be forced 

to stop collection activities. These 

commenters stated that they sort 

controlled substances from noncontrolled substances and packaging. 

According to these commenters, 

controlled substances represent a small 

fraction of their total volume of 

collected substances, and the sorting 

prohibition will substantially increase 

costs. 

Response: As explained above, 

comingling of controlled and noncontrolled substances is permitted by 

the rule in § 1317.75, but it is not 

required, and this rule does not require 

pharmaceutical controlled substances 

collected from ultimate users to be 

collected and stored in the original 

packaging. Authorized collectors may 

choose to address adequacy of space 

issues by choosing not to collect 

comingled controlled substances and 

non-controlled substances and by 

excluding packaging materials from 

being deposited into the collection 

receptacle. Also, law enforcement 

continues to have autonomy regarding 

their collection activities, and this rule 

does not prohibit law enforcement from 

handling collected substances. Prior to 

the effective date of this rule, it is 

unlawful for ultimate users to transfer 

controlled substances to any entity 

(excluding law enforcement), except in 

the limited circumstances allowed 

under 21 CFR 1307.21(a)(2). 

[2] Issue: Several commenters stated 

that they would have to hire additional 

help for their program to continue, and 

that they would no longer be able to rely 

on volunteers or other personnel that 

did not meet the NPRM’s ‘‘authorized 

employee’’ definition. 

Response: As discussed, in 

§ 1300.05(b) the final rule modifies the 

proposed definition of ‘‘authorized 

employee’’ to omit the word 

‘‘authorized.’’ In this final rule, the DEA 

is adopting the general common law of 

agency’s definition of the term 

‘‘employee.’’ Any person who meets 

certain criteria may have access to or 

influence over collected substances on 

behalf of an authorized collector. Also, 

under this rule, volunteers may assist 

with disposal programs or take-back 

events as long as they do not have 

access to or influence over the collected 

controlled substances. 

Two Employee Requirement 

[3] Issue: Approximately 30 

commenters felt that it would be 

infeasible for two employees to oversee 

disposal procedures due to limited 

personnel. Commenters suggested 

allowing an ‘‘authorized employee’’ of 

another registrant, such as a reverse 

distributor, to satisfy the second 

‘‘authorized employee’’ requirement. 

One commenter stated that the DEA 

should clarify that under proposed 

§ 1317.75(g), installation and removal of 

inner liners may be performed by a law 

enforcement officer instead of two 

employees. 

Response: The DEA believes that the 

two-employee integrity requirement is a 

necessary security measure to 

effectively guard against diversion and 

to ensure that the controlled substances 

are handled, transferred, and recorded 

in a manner that is consistent with all 

applicable laws and regulations. The 

DEA carefully considered the various 

concerns and took steps to alleviate 

some of these concerns. First, as just 

discussed, the final rule modifies the 

proposed definition of ‘‘authorized 

employee’’ to instead adopt the common 

law of agency’s definition of the term 

‘‘employee,’’ thus including employees 

that were excluded by the definition 

proposed in the NPRM (e.g., part-time 

employees and off-duty law 

enforcement officers). 21 CFR part 1300. 

Second, as previously discussed, the 

final rule relaxes the two employee 

requirement for collection receptacles 

located at LTCFs in § 1317.80(c). The 

DEA is making this exception because of 

the unique circumstances faced by 

LTCFs, as recognized by the Disposal 

Act, and in keeping with the DEA’s 

historically accommodating regulations 

with respect to LTCFs (e.g., 

§§ 1306.11(f) and 1306.13(b) regarding 

faxing schedule II prescriptions and 

dispensing partial prescriptions). The 

DEA believes that the above changes 

will alleviate some of the concerns 

expressed by the commenters while 

maintaining the necessary security to 

reduce diversion risks. 

[4] Issue: Twenty-seven commenters 

stated that the requirement to have two 

employees from the pharmacy present 

to remove and install a collection 

receptacle’s inner liner is excessive and 

too costly. Several commenters noted 

that this requirement alone will 

dissuade retail pharmacies from 

managing collection receptacles. Several 

commenters stated that small 

pharmacies may not have two 

employees working during the same 

shift, or even have two people employed 

full-time by the pharmacy. Two 

commenters suggested requiring a duallock system on collection receptacles, 

where the collector registrant retains 

one key and a reverse distributor retains 

the other. 

Response: The DEA carefully 

considered the commenters’ concerns, 

and amended the text of the rule to 

address this issue. In the context of this 

issue, the two-employee requirement 

only applies to installation and removal 

of the inner liners which does not need 

to be accomplished by two employees 

on the same shift. Also, dual-locks on 

collection receptacles at retail 

pharmacies are not a reasonable 

alternative because collectors are 

authorized only at their own registered 

location or controlled premise. If a retail 

pharmacy employee retained one key in 

a dual-lock system, and a reverse 

distributor retained the other key, then 

the reverse distributor would be 

handling collected substances at the 

retail pharmacy’s registered location or 

controlled premise, an activity that is 

not permitted. Reasonable alternatives 

include installing and removing an 

inner liner during a shift change, or 

other times when there is more than one 

employee present. The final rule also 

modifies the proposed definition of 

‘‘authorized employee,’’ by adopting the 

common law of agency’s definition of 

‘‘employee’’ and correspondingly 

eliminating the requirement that 

employees authorized to conduct 

disposal activities be employed fulltime by the authorized collector. 21 CFR 

part 1300. The DEA believes that the 

two-employee integrity requirement is a 

necessary security measure to 

effectively guard against diversion and 

to ensure that the controlled substances 

are handled, transferred, and recorded 

in a manner that is consistent with all 

applicable laws and regulations. 

[5] Issue: Several commenters stated 

that the requirement that two employees 

from a retail pharmacy be present to 


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install and remove inner liners at LTCFs 

is prohibitively burdensome. Several 

commenters stated that most retail 

pharmacies do not have a vehicle for 

this purpose, and it is a liability to have 

pharmacy employees traveling to LTCFs 

to change inner liners. Two commenters 

suggested that the requirement should 

be one employee from the pharmacy 

and one employee from the LTCF. 

Response: The DEA carefully 

considered alternatives that will provide 

convenient options for the unique 

population of LTCF residents, but will 

also provide safe and secure disposal. 

As amended, the final rule in 

§ 1317.80(c) provides that inner liner 

installations, storage, removals, and 

transfers at LTCFs may be performed 

either by two employees of the 

authorized collector, or by one 

employee of the authorized collector 

and a supervisor-level employee of the 

LTCF designated by the authorized 

collector. The DEA believes that this 

modification is important to encourage 

hospitals/clinics and retail pharmacies 

to maintain collection receptacles for 

LTCF residents, by easing the burdens 

on authorized collectors who maintain 

collection receptacles at LTCFs—the 

only collectors who maintain collection 

receptacles at locations away from their 

primary registered locations. 

Additionally, the DEA recognizes that 

some authorized collectors do not have 

a vehicle specifically for the purpose of 

travelling to LTCFs, or currently allow 

employees to travel. The DEA notes that 

no particular vehicle is required to 

transport employees of the authorized 

collector to the LTCF, and, as discussed 

above, the DEA encourages authorized 

collectors managing a collection 

receptacle at a LTCF to coordinate 

removal of inner liners with the delivery 

of controlled substances dispensed to 

LTCF residents. 

[6] Issue: Fifteen commenters stated 

that it will be economically burdensome 

to have two employees of the reverse 

distributor accompany the collected 

substances to the point of destruction to 

witness the destruction. These 

commenters noted that waste 

management companies often travel 

hundreds of miles to reach a destruction 

facility. The commenters stated that it is 

unreasonable to have two employees of 

the reverse distributor accompany the 

collected substances and witness the 

destruction, and some commenters 

suggested that the DEA permit other 

security mechanisms, such as GPS 

devices and security cameras, to serve 

in lieu of the second employee. 

Response: The DEA believes that the 

two-employee integrity requirement is a 

necessary security measure to 

effectively guard against diversion and 

to ensure that the collected substances 

are handled, transferred, and recorded 

in a manner that is consistent with all 

applicable laws and regulations. 21 CFR 

1317.95. The DEA notes that the DEA 

registrants who expressed concern 

regarding this requirement already 

adhere to it in their current business 

practices. However, the DEA has 

thoroughly and carefully considered the 

commenters’ concerns and considered 

the following alternatives to the twoperson integrity requirement: (1) 

Requiring destruction facilities to 

register with the DEA; (2) requiring the 

transferring registrant (e.g., retail 

pharmacies, hospitals/clinics, etc.) to 

accompany the controlled substances to 

the point of destruction; (3) requiring 

on-site destruction; (4) requiring 

additional recordkeeping and 

witnessing at the point of destruction by 

the non-registrant destruction facility; 

and (5) requiring GPS devices or 

security cameras to serve in lieu of the 

second employee. The DEA did not 

elect these alternatives because the DEA 

is without sufficient authority to impose 

them, or the alternatives were 

impractical, excessive, did not provide 

adequate security, would result in 

voluminous, difficult to maintain and 

verify records, and/or would reduce the 

disposal options available to ultimate 

users. 

The two-person integrity requirement 

is of paramount importance when 

transporting controlled substances to 

the point of destruction because these 

persons are uniquely entrusted with 

ensuring the substances are destroyed 

and not diverted to illicit purposes. 

Registrants that destroy on-site also face 

diversion risks and security concerns 

and must adhere to the two-person 

integrity requirement when destroying 

controlled substances. These diversion 

risks and security concerns increase 

substantially in the case of reverse 

distributors because they routinely 

acquire from other registrants large 

volumes of controlled substances 

destined for destruction, and they 

routinely transport those substances to a 

remote, un-registered location for 

destruction, yet there is no independent 

mechanism to ensure or verify that the 

substances within their possession are 

actually destroyed and not diverted. 

Furthermore, as explained previously, 

in every other transfer of controlled 

substances in the closed system of 

distribution, there are two registrants on 

each side of the transfer to ensure 

accountability and identify and prevent 

diversion. When controlled substances 

are transferred for destruction, there 

may not be a registrant verifying the 

destruction of the controlled substances. 

Adherence to the two-employee 

integrity requirement will provide 

accountability for the controlled 

substances during the destruction 

process, preventing possible loss, 

possible theft, and diversion of the 

controlled substances. 

Similarly, the DEA declines to allow 

GPS devices or security cameras to serve 

in lieu of a second employee. These 

types of security measures can be 

compromised, and do not provide the 

same level of deterrence or risk 

mitigation as the presence of a second 

person because they are strictly afterthe-fact methods of diversion control as 

opposed to providing security 

throughout the transportation and 

destruction process. GPS devices cannot 

provide information as to whether or 

not controlled substances were removed 

from the transporting vehicle, and 

cameras cannot observe transportation 

and destruction from all angles. For 

example, a single driver being 

monitored by GPS and video could 

drive to the destruction facility on the 

approved route, remove the controlled 

substances from the vehicle, move with 

the controlled substances out of the 

view of the camera, and place the 

controlled substances into a separate 

vehicle or hidden spot off camera rather 

than destroying them. In such a 

scenario, neither the GPS, nor the 

camera would indicate any sort of 

diversion, whereas a second person 

would be present throughout 

transportation and destruction to serve 

as a deterrent and ensure that the 

controlled substances were actually 

destroyed. 

For these reasons, the DEA believes 

that the two-person integrity 

requirement is the most reasonable, 

secure, and economic substitute for 

another registrant serving as an 

independent verification method at the 

end of the closed system of distribution. 

Implementation Costs 

[7] Issue: One commenter indicated 

that the enhanced security procedures 

proposed for the disposal process will 

be overly burdensome and costly. This 

commenter recommended that the DEA 

meet with industry stakeholders to 

identify options that will allow 

innovation while maintaining security. 

Response: The security requirements 

in this rule are the minimum needed to 

protect the public health and safety, to 

ensure accountability, and to reduce the 

risk of diversion during the disposal 

process. In addition, there were 

multiple opportunities for industry 

stakeholders (and any other interested 

persons) to participate in the 


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rulemaking process for this rule through 

participation in the public meeting held 

in January 2011, and the submission of 

written comments during the open 

comment period. The DEA carefully 

considered discussion from the meeting, 

as well as the written comments 

submitted in response to the NPRM. 

[8] Issue: Eleven commenters stated 

that the regulations proposed in the 

NPRM are too costly, and the costs will 

discourage potential collectors from 

participating. Several commenters 

expressed concern about the costs 

associated with retail pharmacies 

managing collection receptacles, 

particularly at LTCFs. 

Response: As provided in the 

Disposal Act and discussed in the 

NPRM, the DEA cannot require any 

entity to establish or maintain a disposal 

program. Based on information received 

from the public and industry during the 

public meeting in 2011, as well as 

information received in response to the 

NPRM, the DEA believes that many 

entities are eager to voluntarily establish 

disposal programs. Entities may choose 

to establish disposal programs for 

various reasons, including for profit, to 

build goodwill in the community, to 

attract customers, to advertise 

businesses, and to preserve the 

environment. 

[9] Issue: Several commenters 

provided feedback regarding costs 

related to voluntary implementation and 

maintenance of disposal programs, 

although none provided any actual data 

that could be applied to the cost 

analysis except for a suggestion that the 

DEA review information from a report 

on waste collection, and one commenter 

that provided an estimate without any 

supporting data. Generally, commenters 

indicated that the proposed methods of 

collection would have associated costs 

incurred through recordkeeping, 

purchase of inner liners, changes in 

procedures, increases in destruction 

costs, and development of mail-back 

packages and collection receptacles. 

Commenters encouraged the DEA to 

further explore the potential costs of the 

proposed options as well as additional 

alternatives. 

Response: The DEA appreciates the 

commenters’ concerns regarding 

potential costs associated with the 

implementation and maintenance of 

disposal programs. The DEA has 

updated its economic analysis to 

address, directly, the costs of this rule 

with respect to those registrants that do 

choose to establish a collection program. 

Such implementation, however, is 

strictly voluntary; thus, any entity that 

does not wish to incur the related costs 

may choose not to participate. 

Additionally, as described in the NPRM, 

the DEA anticipates that a variety of 

interest groups, corporations, 

community groups, and other entities 

will work together to provide secure and 

responsible disposal options pursuant to 

this rule. 

[10] Issue: One commenter suggested 

that the DEA provide an exception for 

analytical labs from the requirements of 

proposed § 1317.95(c) (§ 1317.95(d) in 

the final rule), which requires that two 

employees handle the destruction of 

controlled substances, in instances 

where the testing renders a substance 

non-retrievable. 

Response: The DEA declines to 

provide a blanket exception for 

analytical laboratories for the described 

situation. The DEA believes that such 

instances as described by the 

commenter will be incidental to testing. 

If the testing is specifically designed to 

develop new methods of destruction or 

destruction is otherwise not incidental 

to testing, all destruction must be in 

accordance with the provisions in 

subpart C of this rule. 

[11] Issue: One commenter expressed 

concern that this rule will impose 

obligations on authorized collectors that 

are inconsistent with obligations 

imposed by other agencies, particularly 

the FDA, EPA, and DOT. The 

commenter stated that the potential 

liability stemming from such conflicts 

will discourage participation. 

Response: The DEA has worked 

directly with other Federal agencies 

regarding the implementation of this 

rule, including the EPA and DOT. The 

DEA believes that authorized collectors 

may comply with this rule and other 

agency regulations. Authorized 

collectors should contact applicable 

agencies for further guidance if they 

believe that their specific circumstances 

may lead to conflicts. 

Funding and Incentives 

[12] Issue: One commenter asked the 

DEA to allow private/public 

partnerships for collection receptacles, 

mail-back programs, and take-back 

events. 

Response: This rule does not dictate 

what funding sources are permitted or 

prohibited. Entity partnerships are not 

prohibited as long as the authorized 

collector follows all procedures outlined 

in this rule. 

[13] Issue: Ten commenters 

expressed concern that there is no 

mandate, funding, or incentive for 

collectors to participate. Two 

commenters suggested that the DEA 

establish incentives to encourage 

participation, or require all pharmacies 

to install and maintain collection 

receptacles. Several commenters 

indicated that without a clear source of 

funding, cost mitigation, or 

participation incentive, it is unlikely 

that registrants will voluntarily accept 

the financial burdens associated with 

the provision of collection 

opportunities. 

Response: The DEA appreciates the 

suggestions and concerns of the 

commenters regarding funding for 

voluntary controlled substances 

collection programs. The DEA points 

out that the Disposal Act did not 

authorize the DEA to assign 

responsibility of funding to any entity, 

and the Disposal Act specifically 

required the DEA to promulgate the 

implementing regulations in such a way 

that participation would not be 

mandatory. The DEA’s intent in 

soliciting comments regarding this 

rule’s potential economic impact was to 

gain knowledge regarding potential 

costs—not which entities should fund 

disposal programs. The DEA has 

attempted to provide regulations that 

minimize the financial burden while 

retaining a level of security to ensure 

public safety and reduce diversion risks. 

This rule does not address the 

responsibility of costs associated with 

any collection program. The DEA 

recognizes that collection programs will 

have associated costs and each entity 

that chooses to establish and maintain 

such a program must determine how to 

manage such costs. 

Other Economic Concerns 

[14] Issue: A number of commenters 

urged the DEA not to impose additional 

fees on registrants that choose to 

become authorized collectors. These 

commenters asked the DEA to clarify 

whether or not there will be any cost to 

modify a registration to become an 

authorized collector. One commenter 

suggested that the DEA offer a reduced 

fee for non-profit organizations to 

become registered as reverse 

distributors. 

Response: Section 1301.51(c) states 

that no fee will be required to modify 

a registration to become authorized as a 

collector. Pursuant to 21 U.S.C. 886a, 

fees charged by the DEA under its 

diversion control program must be set at 

a level that ensures the recovery of the 

full costs of operating the various 

aspects of the program. The DEA last 

modified the registration fees on April 

16, 2012. 77 FR 15234. If the DEA 

determines in the future that such fees 

should be modified in order to ensure 

the recovery of the full costs of the 

diversion control program, including 

those contained in this rule, the DEA 

will propose a modified fee schedule 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53553 

pursuant to the notice-and-comment 

rulemaking process. The DEA currently 

provides limited exceptions and 

exemptions from registration fees to 

very specific groups and entities as 

identified in part 1301. At this time, the 

DEA does not anticipate expanding such 

exceptions and exemptions as a result of 

or in conjunction with the 

implementation of this rule. 

[15] Issue: A few commenters noted 

that DEA’s Economic Impact Analysis 

estimated the universe of potential 

respondents to include distributors, 

reverse distributors, manufacturers, and 

retail pharmacies, without considering 

hospitals, surgery centers, dental 

clinics, veterinary practices, or 

physicians’ offices. 

Response: The DEA’s analysis 

included a universe of potential 

respondents comprised of only those 

entities that may be affected by the 

rule—those registrants that are eligible 

to become authorized collectors (i.e., 

distributors, reverse distributors, 

manufacturers, NTPs, and hospitals/

clinics with an on-site pharmacy, and 

retail pharmacies). 

[16] Issue: Two commenters stated 

that the DEA did not appropriately 

calculate the costs associated with the 

proposed rule. One commenter stated 

that the DEA should acknowledge the 

costs associated with recordkeeping 

requirements, purchasing inner liners, 

purchasing mail-back packages, 

procedural changes, and increased 

destruction costs. 

Response: As discussed previously, 

the economic analysis of the final rule 

takes into account costs associated with 

voluntary performance of collection 

activities even though the provisions 

that facilitate non-registrant disposal are 

completely voluntary, not mandated. 

Any collector, reverse distributor, 

distributor, or law enforcement that 

chooses to engage in the voluntary 

activities described in this section, does 

so based on its own evaluation of costs 

and benefits (tangible and intangible). 

[17] Issue: One commenter stated that 

the economic impact analysis is 

inadequate because it does not 

acknowledge that parts of this rule are 

an ‘‘indirect’’ mandate for LTCFs. This 

commenter referred to incidents where 

LTCFs will have no other options for 

controlled substance disposal if patients 

are unable to dispose of the medication 

and there is no other person authorized 

to dispose of the controlled substances. 

Response: In response to this 

comment, the final rule modifies the 

language of § 1317.80(a), as proposed, 

which appeared to prohibit LTCFs from 

using any disposal method other than a 

collection receptacle. Under the final 

rule, LTCFs may dispose of controlled 

substances on behalf of an ultimate user 

who resides, or has resided, at such 

LTCF. 21 CFR 1317.30 and 1317.80. The 

DEA notes that the decision to 

implement and manage a collection 

program for ultimate user disposal is 

voluntary. It should be noted that LTCF 

residents are ultimate users themselves 

and they, members of their households, 

and persons lawfully entitled to dispose 

of a decedent’s personal property, may 

avail themselves of all disposal methods 

made available by this rule. 21 CFR 

1317.30. 

[18] Issue: One commenter stated that 

the DEA did not consider veterinary 

practices, prisons, or clinics when 

calculating the economic impact 

analysis. 

Response: In the proposed rule, the 

DEA considered veterinary practices, 

prisons, and clinics in the 

accompanying calculations concerning 

economic impact to the extent that these 

entities would be registered as 

practitioners or non-practitioners. For 

the final rule, the DEA calculated the 

economic impact on these entities to the 

extent that they could become 

collectors. Not all registrants are eligible 

to become authorized collectors. Of this 

specified list of entities inquired about 

by the commenter, only a small 

subsection, specifically hospitals/clinics 

with on-site pharmacies, may become 

authorized as collectors in accordance 

with this final rule. 21 CFR 1317.40 and 

1317.70. 

P. Recordkeeping and Reporting (8 

Issues) 

[1] Issue: One commenter asked the 

DEA to clarify whether or not the 

recordkeeping requirements in the rule 

apply to all registrants or only 

authorized collectors. 

Response: The new recordkeeping 

requirements contained in this rule are 

applicable to all registrants, including 

authorized collectors. To clarify this 

important distinction, the DEA moved 

the recordkeeping provisions in 

proposed part 1317 to part 1304. 

[2] Issue: Several commenters urged 

the DEA to remove the inventory and 

recordkeeping requirements for mailback packages and inner liners. The 

commenters believe that such 

recordkeeping will be challenging and 

provide limited benefits. One 

commenter suggested that the DEA 

instead adopt tracking procedures 

currently used in some non-controlled 

substance collection programs. 

Response: As described in the NPRM, 

inventory and recordkeeping 

requirements for collected substances 

are necessary for a number of reasons, 

including accountability of collected 

substances within the possession and 

control of authorized collectors. The 

inventory and recordkeeping 

requirements included in this rule are 

generally consistent with those 

otherwise required of registrants, thus 

minimizing burden. The DEA believes 

that these inventory and recordkeeping 

requirements are necessary to help 

minimize the risk of diversion and to 

identify diversion of controlled 

substances destined for destruction. 

[3] Issue: One commenter suggested 

that the DEA eliminate ARCOS 

reporting requirements for reverse 

distributors regarding collected 

substances from ultimate users. Another 

commenter asked the DEA to clarify 

what information is required for ARCOS 

reporting. 

Response: In this final rule, 

§ 1304.33(g) (relocated from proposed 

§ 1317.50) exempts reverse distributors 

and distributors that acquire controlled 

substances from collectors or law 

enforcement from reporting to ARCOS 

with respect to pharmaceutical 

controlled substances collected through 

mail-back programs and collection 

receptacles. 

[4] Issue: One commenter asked the 

DEA to clarify what records reverse 

distributors must keep when receiving 

collected substances from law 

enforcement. 

Response: The recordkeeping 

requirements in § 1304.22(e)(4) that 

apply to controlled substances acquired 

by registrants that reverse distribute 

from collectors also apply to those 

acquired from law enforcement. The 

final rule also adds a new paragraph in 

§ 1304.11(e)(3)(iii) specifying the 

information relating to controlled 

substances acquired from collectors and 

law enforcement that a registrant that 

reverse distributes must maintain in its 

inventories. Under the revised 

§ 1304.03(a), these provisions relating to 

reverse distributors apply to any entity 

that reverse distributes, as defined in 

§ 1300.01(b), whether or not it is 

registered with the DEA as a reverse 

distributor. Finally, the requirement in 

§ 1304.21(e) to maintain a DEA Form 41 

applies to the destruction of a sealed 

inner liner or mail-back package by a 

registrant that reverse distributes. 

[5] Issue: Commenters asked the DEA 

to clarify who is responsible for tracking 

the mail-back packages, and how mailback packages that were disseminated 

but not returned to the authorized 

collector will be reconciled with the 

inventory. 

Response: There is currently no 

requirement for the authorized collector 

to reconcile the inventory in order to 


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determine which packages were not 

returned. As discussed in the NPRM, 

the DEA does not believe that requiring 

authorized collectors to institute a 

tracking or notification system for 

ultimate users is necessary at this time, 

although such systems are not 

prohibited so long as the collector does 

not require the ultimate user to provide 

personally identifiable information, as 

specified in § 1317.70(d). 

[6] Issue: Commenters asked the DEA 

to eliminate the following 

recordkeeping requirements for inner 

liners: Tracking unused inner liners on 

hand, recording the acquisition date, 

recording the installation date, and the 

requirement that two employees witness 

the removal and installation of inner 

liners. 

Response: As previously discussed, 

the DEA believes that all of the 

inventory and recordkeeping 

requirements in part 1304 are the 

minimum necessary to ensure 

accountability and identify diversion. 

[7] Issue: Two commenters asked the 

DEA if reporting to the FDA is sufficient 

to satisfy the DEA’s reporting 

requirements for cases of controlled 

substance recalls. 

Response: No. Regardless of any other 

Federal, State, tribal, or local agency 

requirements, each registrant must 

maintain records and make reports to 

the DEA in a manner consistent with the 

requirements of chapter II of title 21 of 

the CFR. 

[8] Issue: One commenter asked the 

DEA to clarify the recordkeeping 

requirements of § 1317.50(b)(2)(iii)— 

specifically, the requirement to record 

the registration number of the collection 

location when the collection occurs at a 

LTCF, which typically does not have a 

registration number. 

Response: The final rule moves the 

referenced requirements to new 

§ 1304.22(f). The record should include 

the approved collection location address 

of the LTCF and the authorized 

collector’s registration number. 

Q. Hazardous Materials Transportation 

and Hazardous Waste Destruction (3 

Issues) 

[1] Issue: Approximately 20 

commenters expressed concern that the 

requirements outlined in this rule for 

the transportation of collected 

substances conflict with current 

regulations under the DOT’s Pipeline 

and Hazardous Materials Safety 

Administration (PHMSA). One concern 

involved the comingling of collected 

substances that the DOT considers 

‘‘hazardous materials’’ with 

nonhazardous materials or hazardous 

materials of a different class. Other 

concerns included how inner liners 

from collection receptacles that contain 

hazardous materials should be labeled 

and packaged for transport, and other 

notice requirements for hazardous waste 

under the DOT’s PHMSA. 

Response: All drug disposal activities 

must be conducted in a manner 

consistent with this rule and all other 

applicable Federal, State, tribal, and 

local laws and regulations. Compliance 

with the destruction requirements 

outlined in subpart C of this rule does 

not exempt any entity from complying 

with other Federal, State, tribal, or local 

laws or regulations. It is not within 

DEA’s expertise or authority to opine 

what pharmaceutical controlled 

substances could be hazardous materials 

subject to DOT regulations. However, 

the DEA consulted with the DOT during 

various stages of this rulemaking. The 

DEA has been informed that if collected 

substances include hazardous materials, 

the transportation of those materials is 

subject to all applicable DOT 

regulations, including the ‘‘Hazardous 

Materials Regulations’’ (HMR). The DEA 

encourages entities to consult 

www.phmsa.dot.gov/hazmat for 

information regarding the HMR. In 

particular, the DEA encourages entities 

to contact the DOT’s PHMSA regarding 

its ‘‘Approvals and Permits Program.’’ 

PHMSA issues approvals and special 

permits to entities that apply for 

authorization to use agency approved 

alternatives to the HMR. Interested 

entities may consult 

www.phmsa.dot.gov/hazmat/regs/sp-a. 

for more information. The DEA has 

worked with the DOT to facilitate this 

process in an effort to ensure maximum 

participation in the collection of 

controlled substances for secure and 

responsible disposal, and the DEA will 

continue to work with the DOT to 

facilitate registrant compliance with all 

applicable laws and regulations. For 

these purposes, it should be noted that 

sealed collection receptacle inner liners 

may be transported inside of a shipping 

container that is labeled and packaged 

for transport with the necessary notice 

requirements applicable to hazardous 

waste under the DOT’s PHMSA. 

[2] Issue: One commenter asked 

whether or not law enforcement must 

comply with the DOT’s PHMSA 

requirements for transporting collected 

substances that may contain hazardous 

materials. 

Response: It is not within the DEA’s 

expertise or authority to opine on the 

applicability of DOT regulations. 

However, the DEA believes that the 

DOT’s Hazardous Materials Regulations 

apply to entities that place hazardous 

materials in commercial transportation, 

and not government vehicles operated 

by government personnel solely for noncommercial purposes. However, State 

and local governments may have 

different regulations that do apply to 

government entities or law enforcement. 

The DEA encourages these entities to 

consult the DOT as well as their State 

and local governments for specific 

guidance on transporting collected 

substances that may contain hazardous 

materials. 

[3] Issue: Commenters asked the DEA 

whether or not collected substances 

must be destroyed as hazardous waste 

under the EPA’s Resource Conversation 

and Recovery Act (RCRA). 

Response: It is not within the DEA’s 

expertise or authority to opine what 

pharmaceutical controlled substances 

could be hazardous waste subject to 

EPA regulations. The DEA does not 

have the authority to regulate hazardous 

waste and thus cannot advise on 

whether or not collected substances 

must be destroyed as hazardous waste 

pursuant to RCRA. However, the DEA 

has worked with the EPA at various 

stages of this rulemaking, and the DEA 

continues to work with the EPA to 

ensure the secure and responsible 

disposal of controlled substances, 

including those that may be considered 

hazardous waste. The DEA believes that 

there is a small portion of 

pharmaceuticals that are regulated as 

hazardous waste, and an even smaller 

portion of pharmaceuticals that are 

regulated as both controlled substances 

and hazardous waste. However, 

pharmaceutical controlled substances 

that are collected directly from ultimate 

users via mail-back programs or 

collection receptacles may fall under 

RCRA’s Household Hazardous Waste 

Exemption; if so, EPA RCRA regulations 

would not apply in those instances. The 

DEA acknowledges that some state and 

local regulations may be more stringent. 

The DEA is working with the EPA to 

ensure that this final rule will enable 

LTCF residents to responsibly, securely, 

and safely dispose of controlled 

substances that may also be considered 

hazardous waste. Collected substances 

from LTCFs may pose a unique 

challenge since the EPA currently uses 

a bifurcated system to determine 

whether pharmaceutical waste from 

LTCFs must be treated as hazardous 

waste under the RCRA. If the waste is 

generated by the resident, it does not 

have to be treated as hazardous waste 

and is exempt under the Household 

Hazardous Waste Exemption. If the 

waste is generated by the LTCF, it must 

be treated as hazardous waste unless it 

is otherwise exempt. Hazardous waste 

generated by LTCFs may be exempt if 


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the LTCF is a ‘‘conditionally-exempt 

small quantity generator.’’ To qualify 

under such exemption, the LTCF must 

generate less than or equal to 100 

kilograms of non-acute hazardous waste, 

and less than or equal to one kilogram 

of acute hazardous waste on a monthly 

basis. The DEA believes that most 

LTCFs may qualify under this 

conditional exemption. Also, the DEA 

acknowledges that many 

pharmaceuticals that are recognized as 

acute hazardous waste (e.g., blood 

thinners) are non-controlled substances. 

The DEA hopes that authorized 

collectors and LTCFs will collaborate to 

minimize the impact that disposing of 

such pharmaceuticals may have on 

collection efforts by separating these 

non-controlled substances from 

controlled substances to be deposited 

into collection receptacles. 

The EPA is aware of the concerns 

regarding collected substances at LTCFs, 

and according to the Fall 2013 

Regulatory Agenda, the EPA is currently 

drafting regulations to address 

hazardous waste pharmaceuticals, 

including the small group of 

pharmaceutical controlled substances 

that the EPA classifies as hazardous 

waste under the RCRA, when discarded. 

According to the Regulatory Agenda, the 

EPA’s proposal, ‘‘Management 

Standards for Hazardous Waste 

Pharmaceuticals,’’ may propose to 

‘‘revise the regulations to improve 

management and disposal of hazardous 

waste pharmaceuticals,’’ and clarify 

regulation of reverse distribution. The 

abstract for the proposal may be viewed 

at www.reginfo.gov. Interested persons 

are encouraged to follow the progress of 

this pending regulatory action. 

The DEA encourages authorized 

collectors and others to seek guidance 

directly from the EPA, and the DEA 

encourages such persons to consult 

www.epa.gov for more information. All 

drug disposal and destruction must be 

conducted in a manner consistent with 

this rule and all other applicable 

Federal, State, tribal, and local laws and 

regulations. 

R. Transporting Collected Substances (3 

Issues) 

[1] Issue: One commenter indicated 

that transporting collected substances 

directly to the destruction location will 

be virtually impossible because drivers 

must stop for rest breaks. 

Response: The DEA recognizes that 

transportation to destruction facilities 

may occur over long distances. The 

requirement to transport collected 

substances directly to the destruction 

facility means that the collected 

substances should be constantly moving 

towards their final destruction 

destination and unnecessary or 

unrelated stops, and stops of an 

extended duration should not occur. 

The final rule in §§ 1317.05(b)(4) and 

1317.95(c)(1) is modified to specify this 

requirement, which is designed to 

reduce the opportunities for diversion. 

[2] Issue: Several commenters were 

concerned that this rule will change 

their existing transport procedures that 

were already approved by their local 

SAC. 

Response: In promulgating this rule, 

the DEA carefully considered the impact 

of these changes to existing procedures 

and is requiring the minimum 

procedures necessary to ensure safe and 

secure means of transporting controlled 

substances. The rule provides a 

nationwide standard, and allows nonpractitioners the flexibility to determine 

the best method of transportation 

considering their own individual 

circumstances while also ensuring 

accountability and reducing theft and 

diversion risks. Any previous waivers, 

Memorandums of Understanding, or 

Memorandums of Agreement issued in 

accordance with § 1307.21 shall be 

superseded by this final rule once it 

becomes effective. However, 

practitioners may seek assistance from 

their local SAC pursuant to 

§ 1317.05(a)(4). 

[3] Issue: Other commenters sought 

guidance on whether or not the DEA 

will limit the quantity of controlled 

substances that may be transported, and 

whether or not there will be additional 

requirements for interstate transport of 

collected substances. 

Response: This final rule does not 

impose any transportation quantity 

limits or any requirements specific to 

interstate transport of controlled 

substances. 

S. Miscellaneous Comments (2 Issues) 

[1] Issue: Approximately eight 

commenters asked the DEA to expand 

the rule to include procedures for 

controlled substances that have been 

‘‘partially administered’’ or ‘‘partially 

dispensed.’’ These commenters referred 

to institutional settings where 

transdermal patches are used, as these 

used patches may contain residual 

amounts of controlled substances. 

Response: As previously discussed, 

destruction of the residual amounts of 

controlled substances administered by a 

practitioner to a patient that remain in 

the delivery apparatus (in this instance, 

the transdermal patch) must continue to 

be recorded in accordance with existing 

§ 1304.22(c). In accordance with the 

revised § 1304.21, these destructions are 

not required to be recorded on DEA 

Form 41. All disposals of inventory 

must be accomplished in accordance 

with § 1317.05(a), and all other 

applicable recordkeeping and inventory 

requirements. 

[2] Issue: One commenter indicated 

that §§ 1317.15 and 1317.95 may 

conflict in that § 1317.15 allows for 

storage by a reverse distributor while 

§ 1317.95 does not. 

Response: The DEA has reviewed the 

relevant portions of this rule and 

determined that §§ 1317.15 and 1317.95 

do not conflict. Section 1317.15 

encompasses the wider topic of reverse 

distributor activities, including the 

acquisition and storage of controlled 

substances from other registrants, 

whereas § 1317.95 deals exclusively 

with the actual destruction process and 

the procedures that are required for 

destruction once substances are in the 

possession and control of the reverse 

distributor (including securely stored 

substances). 

IV. Regulatory Analyses 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act of 

1980 (RFA) (5 U.S.C. 601–612), has 

reviewed this rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. In 

developing this rule, the DEA 

considered numerous alternatives for 

each requirement and method of 

collection and evaluated the impact of 

this rule on small entities. The DEA has 

concluded that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The DEA updated the economic impact 

analysis after considering comments 

made by the public in response to the 

NPRM. The updated economic impact 

analysis of the final rule may be viewed 

in the rulemaking docket at 

www.regulations.gov. 

In developing this rule, the DEA 

considered several options for both 

registrant and non-registrant disposal 

and reverse distributor destruction 

requirements. The DEA analyzed 

alternative methodology approaches 

keeping in mind its obligations under 

the CSA. The DEA considered three 

options for non-registrant disposal: (1) 

‘‘Single Collection,’’ which would 

permit non-registrants to utilize only 

one method of collection to dispose of 

their lawfully possessed controlled 

substances; (2) ‘‘Open Collection,’’ 

which would authorize any person to 

collect controlled substances from 

ultimate users for disposal, regardless of 

their status as a registrant; and (3) 


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‘‘Multiple Collection,’’ which would 

authorize non-registrants to utilize more 

than one method of collection to 

transfer controlled substances for the 

purpose of disposal to law enforcement 

and certain registrants. In addition, the 

DEA considered two options for 

registrant disposal: (1) ‘‘Retain Existing 

Regulations,’’ which would make no 

changes to the existing registrant 

disposal regulations (§§ 1307.12 and 

1307.21); and (2) ‘‘Establish Consistent 

National Standards,’’ which would 

eliminate existing regulations on the 

disposal of controlled substances 

(§§ 1307.12 and 1307.21) and 

promulgate a new part that would 

comprehensively outline the process 

and procedure for the disposal of 

controlled substances by registrants and 

non-registrants. 

Finally, the DEA considered four 

options for reverse distributors: (1) ‘‘Onsite Requirement,’’ which would require 

reverse distributors to have and utilize 

an on-site method of destruction; (2) 

‘‘Prompt Requirement,’’ which would 

require reverse distributors, like all 

other registrants, to promptly destroy 

controlled substances; (3) ‘‘No 

Requirement,’’ which would retain the 

current destruction standard and would 

not put a deadline on when reverse 

distributors must destroy controlled 

substances acquired for destruction; and 

(4) ‘‘No Later Than 30 Calendar Day 

Requirement,’’ which would require 

reverse distributors to destroy 

controlled substances received for the 

purpose of destruction no later than 30 

calendar days from receipt. The DEA 

performed a qualitative analysis of each 

of these alternatives and selected the 

‘‘Multiple Collection’’ option for nonregistrant disposal, the ‘‘Establish 

Consistent National Standards’’ option 

for registrant disposal, and the ‘‘No 

Later than 30 Calendar Day 

Requirement’’ option for reverse 

distributors. 

In accordance with the RFA, the DEA 

evaluated the impact of this rule on 

small entities. While all 1.5 million DEA 

registrants must comply with the rule as 

it relates to the disposal of 

pharmaceutical controlled substances, 

only a small subset of the registrants are 

associated with activities where the rule 

imposes new mandatory requirements 

or provides options for voluntary 

activities. Therefore, the DEA examined 

the impact of two mandatory provisions 

in the rule: The 30-day destruction 

requirement for reverse distributors and 

the two employee transportation 

requirement for manufacturers, 

distributors, and reverse distributors. 

Additionally, the DEA estimated the 

level of voluntary participation in 

collection activities in accordance with 

the rule and the resulting cost impact. 

The mandatory provisions and 

voluntary participation activities are 

estimated to affect 53,533 entities (439 

manufacturers, 585 distributors, 55 

reverse distributors, 656 narcotic 

treatment programs (NTPs), 3,068 

hospitals/clinics, 29,582 pharmacies, 

and 19,148 long term care facilities 

(LTCFs). Of the 53,533 affected entities, 

50,714 (423 manufacturers, 555 

distributors, 38 reverse distributors, 610 

NTPs, 1,346 hospitals/clinics, 29,328 

pharmacies, and 18,414 long term care 

facilities), or 94.7% are estimated to be 

small entities. 

Both the 30-day destruction and the 

two employee transportation 

requirements associated with the 

mandatory portions of the rule will 

apply to the 55 reverse distributors that 

receive controlled substances from other 

registrants for disposal, of which 38 

were estimated to be small entities. The 

potential increase in destruction, 

transport, travel, and labor cost 

associated with these two requirements 

was analyzed for each of the 38 small 

entities. Additionally, reverse 

distributors with on-site destruction 

facilities may receive authorization to 

voluntarily operate a mail-back 

program. The DEA estimates that the 

three small reverse distributors with onsite destruction facilities will each 

operate a mail-back program. The DEA 

does not estimate that any reverse 

distributors will operate collection 

receptacles at their registered locations 

because of the small numbers of 

employees that work at those locations. 

However, reverse distributors will be 

impacted by the destruction of 

controlled substances from collection 

receptacles that are transferred to them 

for destruction. The total estimated cost 

of the mandatory portions and voluntary 

participation aspects of the rule was 

compared to the estimated annual 

revenue for each of the small reverse 

distributors. The economic impact of 

the mandatory portion and voluntary 

participation aspects of this rule is 

estimated to be significant, greater than 

one percent of annual revenue, for two 

(5%) of 38 affected small businesses. 

The two-person transportation 

requirement associated with the 

mandatory portions of the rule also 

affects 423 small manufacturers and 555 

small distributors that transport to 

reverse distributors or to an 

unregistered, off-site location for 

destruction. The potential increase in 

labor cost associated with the twoperson requirement was analyzed for 

manufacturers and distributors. 

Additionally, a small number of 

manufacturers and distributors are 

estimated to volunteer to operate 

collection receptacles at their registered 

locations primarily for use by their 

employees. However, the DEA believes 

that manufacturers and distributors will 

not operate collection receptacles at 

their registered locations unless they 

believe there will be a benefit to them 

for the service. The economic impact of 

the mandatory portion and voluntary 

participation aspects of this rule is 

estimated to be significant for none 

(0.0%) of the 423 small manufacturers 

and none (0.0%) of the 555 small 

distributors. 

The rule also permits certain other 

registrant categories to voluntarily 

conduct collection activities. The DEA 

estimates some retail pharmacies, 

hospitals/clinics with on-site 

pharmacies, and NTPs will voluntarily 

participate as collectors by operating 

collection receptacles at their locations. 

Some retail pharmacies and hospitals/

clinics with an on-site pharmacy are 

also estimated to operate collection 

receptacles at LTCFs. The level of 

participation and operating costs were 

estimated to determine the number of 

small entities with impact greater than 

1% of revenue. 

In summary, the DEA estimates that 

zero (0.0%) of the 423 small 

manufacturers, zero (0.0%) of the 555 

small distributors, two (5.0%) of 38 

small reverse distributors, 62 (10.2%) of 

the small NTPs, zero (0.0%) of the 1,349 

small hospitals/clinics, 810 (2.8%) of 

the 29,328 small pharmacies, and zero 

(0.0%) of the 18,414 small long term 

care facilities may be significantly 

impacted by this rule (that is, where the 

annual cost is estimated to be greater 

than 1% of annual revenue). But DEA 

emphasizes that these estimates are 

entirely dependent on the level of 

voluntary participation by these entities. 

All of the provisions relating to 

collection activities by manufacturers, 

distributors, NTPs, hospitals/clinics, 

pharmacies, and LTCFs are completely 

voluntary and these entities would be 

free to choose whether or not to 

participate based on their own review of 

the cost to them and the anticipated 

benefits in providing collection 

receptacles. 

In total, the DEA estimates that 874 

(1.7%) of the 50,714 affected small 

entities may be significantly affected by 

this rule. The DEA’s assessment of 

economic impact by size category 

indicates that the rule will not have a 

significant effect on a substantial 

number of these small business entities. 

In accordance with the RFA (5 U.S.C. 

605(b)), the Administrator hereby 

certifies that this rulemaking has been 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53557 

7Clin. J. Pain (The Clinical Journal of Pain), 

Volume 22, Number 8, October 2006. 

8Clin. J. Pain (The Clinical Journal of Pain), 

Volume 27, Number 3, March/April 2011. 

drafted consistent with the RFA, that a 

regulatory analysis on the effects or 

impacts of this rulemaking on small 

entities has been done, and that the rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Executive Orders 12866 and 13563 

This rule was developed in 

accordance with the principles of 

Executive Orders 12866 and 13563. 

Based on the completed economic 

analysis, the DEA does not anticipate 

that this rulemaking will have an annual 

effect on the economy of $100 million 

or more or adversely affect, in a material 

way, the economy, a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities. An 

economic analysis of the final rule can 

be found in the rulemaking docket at 

www.regulations.gov. Public comment 

was received in public meetings held on 

January 19–20, 2011, and through a 

solicitation for comment in the NPRM to 

help inform and develop these rules. 

Although not an economically 

significant rule, this rule on the disposal 

of controlled substances has been 

reviewed by the Office of Management 

and Budget (OMB). 

The DEA has determined that reverse 

distributors currently destroy controlled 

substances within the ‘‘No Later than 30 

Calendar Day’’ requirement the majority 

of the time. However, it is recognized 

that there may be instances when 

reverse distributors do not currently 

meet this requirement. Additionally, 

many manufacturers, distributors, and 

reverse distributors currently employ 

two persons to transport controlled 

substances for destruction. However, it 

is recognized that there may be 

instances when manufacturers, 

distributors, and reverse distributors do 

not currently meet this requirement. For 

these instances, the DEA estimated the 

cost to accommodate the requirements 

and has determined the cost is not a 

significant economic impact. 

Moreover, the DEA estimated a range 

of costs of voluntary participation for 

manufacturers, distributors, reverse 

distributors, narcotic treatment 

programs, hospitals/clinics with an onsite pharmacy, and retail pharmacies 

that may participate to collect ultimate 

user pharmaceutical controlled 

substances. 

In summary, the DEA estimates that 

the annual total cost to the economy as 

a result of the rule is $2,719,319 for the 

mandatory provisions of this rule and 

the total annualized cost of the 

mandatory provisions and the voluntary 

participation aspects of the rule ranges 

from $44,896,787 to $73,222,427. The 

DEA estimates the highest cost in any 

given year occurs in the first year, 

ranging from $45,282,242 to 

$99,075,339. Accordingly, the DEA does 

not anticipate that this rulemaking will 

have an annual effect on the economy 

of $100 million or more or adversely 

affect in a material way the economy, a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

or tribal governments or communities. 

Since the aspects of the rule that 

facilitate non-registrant disposal are 

completely voluntary (not mandated), 

manufacturers, distributors, reverse 

distributors, narcotic treatment 

programs, hospitals/clinics with an onsite pharmacy, and retail pharmacies 

may become collectors if they choose to 

engage in the voluntary activities based 

on its own evaluation of costs and 

benefits (tangible and intangible). For 

the purposes of this analysis, the DEA 

assumes that an entity will volunteer to 

perform the activities to facilitate nonregistrant disposal only if there is a net 

zero or positive benefit to the entity. For 

example, a pharmacy may derive 

tangible benefits, such as additional 

revenue from increased retail traffic to 

the pharmacy. Collectors may also 

derive tangible benefits such as public 

safety and good will from their 

collection activities. Any collector that 

chooses to engage in these voluntary 

activities can decide to cease these 

activities at any time. Therefore, for the 

purposes of this analysis, the DEA 

estimates that the cost of the voluntary 

participation aspects of this rule are 

offset by the benefits of the voluntary 

participation aspects of this rule and 

have a net zero economic impact. The 

total cost of the mandatory provisions 

and voluntary participation aspects of 

the rule ($73,222,427 at the highest 

voluntary participation rate) is 

compared to the benefit of this rule. In 

evaluating the costs and benefits of the 

rule, the annual cost of the rule is 

compared with the anticipated 

reduction in the growth rate of costs 

associated with diversion of controlled 

substances into the illicit market. The 

cost-benefit analysis uses the costs 

associated with the nonmedical use of 

prescription opioids, $8.6 billion in 

2001 7 and $53.4 billion in 2006.8 These 

are conservative estimates of the rapidly 

growing total cost associated with 

diversion of controlled substances into 

the illicit market. Although there is a 

lack of evidence to quantify the cost 

savings or public health impacts of the 

rule, the DEA believes that this rule 

reduces the growth in the cost of the 

diversion of controlled substances into 

the illicit market by at least $44.9 to 

$73.2 million annually and, therefore, 

this rule will have positive net 

economic benefits, including benefits 

related to the health and safety of the 

citizens and residents of the United 

States. 

Paperwork Reduction Act 

Pursuant to § 3507(d) of the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501 et seq.), the DEA has 

identified the following collections of 

information related to this rule and has 

submitted these collection requests to 

the OMB for review and approval. This 

rule implements the Disposal Act, in 

addition to reorganizing and 

consolidating existing regulations on 

disposal into a comprehensive 

regulatory framework for the destruction 

of controlled substances. In accordance 

with the CSA, which establishes a 

closed system of distribution for all 

controlled substances, registrants are 

required to make a biennial inventory 

and maintain, on a current basis, a 

complete and accurate record of each 

controlled substance manufactured, 

received, sold, delivered, or otherwise 

disposed of. 21 U.S.C. 827(a) and 958. 

These records must be in accordance 

with and contain such relevant 

information as may be required by 

regulations promulgated by the DEA. 21 

U.S.C. 827(b)(1). 

In this rule, the DEA revises existing, 

and adds a minimum amount of new, 

registrant recordkeeping requirements. 

These requirements are consistent with 

requirements already required by statute 

and regulation. 

Title: Implementation of Registrant 

Recordkeeping Requirements Pursuant 

to the CSA, 21 U.S.C. 827 

The records that registrants are 

required to maintain pursuant to law are 

a vital component of the DEA’s 

enforcement and control 

responsibilities—such records alert the 

DEA to problems of diversion and 

ensure that the system of controlled 

substances distribution is open only to 

legitimate handlers of such substances. 

The DEA is revising the information 

that reverse distributors are currently 

required to record for clarity and 

consistency, and adding a minimum 

amount of new requirements. For all 

controlled substance records, reverse 

distributors will be required to maintain 

their existing business records so that 


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9The universe of potential participants includes 

all registrants that could potentially become 

collectors. It is likely that this estimate will be 

adjusted downward once the DEA obtains more 

information. 

the record of receipt is maintained with 

the corresponding record of return or 

destruction. By maintaining all relevant 

business records together, the DEA will 

be able to trace each substance received 

by a reverse distributor from its 

acquisition to its disposition, whether 

by destruction or return to the 

manufacturer. 

The DEA estimates that there will be 

60 respondents to this information 

collection and that their estimated 

frequency of response will vary because, 

in accordance with 21 U.S.C. 827 and 

958, registrants make an initial and 

biennial inventory and maintain, on a 

current basis, a complete and accurate 

record of each controlled substance 

manufactured, received, sold, delivered, 

or otherwise disposed of. Under existing 

law, reverse distributors are required to 

maintain, for at least two years, 

inventory records and records of 

controlled substances received, 

delivered, destroyed, or returned to the 

manufacturer. The annual hour burden 

for recordkeeping for reverse 

distributors is estimated to increase by 

34 hours due to the requirements in this 

final rule, and the annualized cost to 

respondents is estimated to be $719. 

The DEA is also modifying information 

that registrants are required to record in 

the return and recall process. The DEA 

is eliminating the previous rule on 

return and recall, § 1307.12, and 

implementing separate rules on the 

return and recall of controlled 

substances for registrants and nonregistrants in part 1317. The return and 

recall recordkeeping requirements 

reflect these changes. 

The DEA estimates that the universe 

of potential respondents to this 

information collection will be 1,511,389 

respondents (all registrants may transfer 

controlled substances for return or 

recall). The DEA estimates that the 

frequency of response will vary, 

because, in accordance with 21 U.S.C. 

827(a), registrants must make an initial 

and biennial inventory and maintain, on 

a current basis, a complete and accurate 

record of each controlled substance 

manufactured, received, sold, delivered, 

or otherwise disposed of. Because 

registrants are already required to 

maintain records in accordance with 21 

U.S.C. 827(a)–(b), the DEA anticipates 

that the annual hour burden will not be 

increased by this rule. 

The DEA is implementing new 

recordkeeping requirements for 

registrants that collect controlled 

substances from ultimate users and 

other non-registrants in accordance with 

the new authority provided in the 

Disposal Act. The implementation of the 

Disposal Act regulations will provide 

ultimate users, LTCFs, and other nonregistrants safe and convenient options 

to transfer controlled substances for the 

purpose of disposal: Take-back events, 

mail-back programs, and collection 

receptacles. Registered manufacturers, 

distributors, reverse distributors, 

narcotic treatment programs, hospitals/ 

clinics with an on-site pharmacy, and 

retail pharmacies may obtain 

authorization from the DEA to be a 

collector pursuant to § 1317.40. A 

collector is a registered manufacturer, 

distributor, reverse distributor, narcotic 

treatment program, hospital/clinic with 

an on-site pharmacy, or retail pharmacy 

that is authorized under this rule to 

receive a pharmaceutical controlled 

substance from an ultimate user for the 

purpose of destruction, as defined in 

part 1300. The DEA is requiring 

information that collectors must record 

based on the particular ultimate user 

collection method implemented (i.e., 

mail-back program or collection 

receptacle). 

The DEA estimates that the universe 

of potential participants to this 

information collection will be 87,736 

respondents (Manufacturers—536, 

Distributors—829, Reverse 

Distributors—60, Narcotic Treatment 

Programs—1,332, Hospitals/Clinics— 

15,953, Retail Pharmacies—69,026).9

However, the DEA estimates that the 

participants to this information 

collection will be 54,457 respondents 

(Manufacturers—107, Distributors—166, 

Reverse Distributors—10, Narcotic 

Treatment Programs—999, Hospitals/

Clinics—2862, Retail Pharmacies— 

34,513, and an additional 15,800 

hospitals/clinics and retail pharmacies 

operating collection receptacles at 

LTCFs). The DEA estimates that the 

frequency of response will vary, 

because, in accordance with 21 U.S.C. 

827(a), registrants must make an initial 

and biennial inventory and maintain, on 

a current basis, a complete and accurate 

record of each controlled substance 

manufactured, received, sold, delivered, 

or otherwise disposed of. The DEA 

notes, however, that the option to 

become a collector is voluntary and no 

entity is required to establish or operate 

a disposal program as a collector. While 

the authorization to collect is a new 

activity, the DEA has estimated the level 

of participation. The estimated 54,457 

respondents are estimated to have an 

annualized hour burden of 89,406 with 

an estimated annualized cost of 

$1,670,064. The DEA will continue to 

monitor and analyze the potential 

burden of the new requirements 

imposed by this rule. 

The DEA is authorizing reverse 

distributors to acquire controlled 

substances from law enforcement and 

authorized collectors that have acquired 

controlled substances from ultimate 

users and other non-registrants. The 

DEA is also authorizing distributors to 

acquire controlled substances from 

authorized collectors that collect 

controlled substances from ultimate 

users. The DEA is requiring these 

reverse distributors and distributors to 

maintain complete and accurate records, 

in accordance with part 1304, of 

controlled substances received, 

delivered, or otherwise transferred for 

the purpose of destruction. 

The DEA estimates that the universe 

of potential respondents to this 

information collection will be 889 

respondents (Distributors—829, Reverse 

Distributors—60). The DEA estimates 

that the frequency of response will vary, 

because, in accordance with 21 U.S.C. 

827(a), registrants must make an initial 

and biennial inventory and maintain, on 

a current basis, a complete and accurate 

record of each controlled substance 

manufactured, received, sold, delivered, 

or otherwise disposed of. The 

authorization for reverse distributors to 

acquire controlled substances collected 

by law enforcement and collectors, and 

the authorization for distributors to 

acquire controlled substances from 

collectors, is new. Although the DEA 

has estimated the level of participation, 

the DEA is unable to estimate the 

number of information collection events 

because destruction of multiple 

acquisitions of controlled substances 

can be on a single form. The DEA’s 

initial estimate for the annual hour 

burden is 472 hours (32 minutes per 

event), with an estimated annualized 

cost of $10,037. The DEA will continue 

to analyze the potential burden of the 

new requirements imposed by this rule. 

Title: Registrant Record of Controlled 

Substances Destroyed—DEA Form 41 

OMB Control Number: 1117–0007. 

Form Number: DEA Form 41. 

The records that registrants are 

required to maintain pursuant to law are 

a vital component of the DEA’s 

enforcement and control 

responsibilities—such records alert the 

DEA to diversion and ensure that the 

system of controlled substances 

distribution is open only to legitimate 

handlers of such substances. The DEA is 

requiring registrants involved in the 

destruction of controlled substances to 

record certain information. The record 


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of destruction must include the 

signature of the two employees of the 

registrant that witnessed the 

destruction, in addition to other 

information about the controlled 

substance disposed of and the method 

of destruction utilized. The DEA is 

modifying existing DEA Form 41 to 

record the destruction of controlled 

substances that remain in the closed 

system of distribution and to account for 

registrant destruction of controlled 

substances collected from ultimate users 

and other non-registrants outside the 

closed system pursuant to the Disposal 

Act. DEA Form 41 has previously been 

approved by the OMB and assigned 

OMB control number 1117–0007. In 

accordance with the CSA, registrants 

that destroy controlled substances and 

utilize DEA Form 41 will be required to 

keep and make available the 

information in the specified format, for 

at least two years, for inspection and 

copying by officers or employees of the 

United States authorized by the 

Attorney General. 21 U.S.C. 827(b). 

The DEA estimates that there will be 

87,736 respondents (Manufacturers— 

536, Distributors—829, Reverse 

Distributors—60, Narcotic Treatment 

Programs—1,332, Hospitals/Clinics— 

15,953, Retail Pharmacies—69,026) to 

this information collection. The number 

of respondents (87,736) represents the 

total number of registrants in business 

activities that are most likely to destroy 

controlled substances. The DEA 

estimates that the frequency of response 

will vary, because in accordance with 

21 U.S.C. 827(a), registrants must 

maintain, on a current basis, a complete 

and accurate record of each controlled 

substance manufactured, received, sold, 

delivered, or otherwise disposed of, 

and, as a result, will make a record of 

destruction each time they destroy a 

controlled substance. The DEA 

estimates that the average time per 

response will be 30 minutes and that the 

total annual burden will be 43,868 

hours, with an estimated total annual 

cost burden of $928,247. 

Executive Order 12988 

This rule meets the applicable 

standards set forth in §§ 3(a) and 3(b)(2) 

of Executive Order 12988 to eliminate 

ambiguity, minimize litigation, establish 

clear legal standards, and reduce 

burden. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of State law, 

impose enforcement responsibilities on 

any State or diminish the power of any 

State to enforce its own laws. 

Accordingly, this rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. 

National Environmental Policy Act 

(NEPA) 

This rule provides options for the 

collection of controlled substances by 

registrants and non-registrants 

consistent with DEA regulations and 

Federal, State, tribal, and local laws and 

regulations. Provision of these options is 

intended to result in increased 

collection and destruction of unused 

controlled substances and thereby 

prevent diversion of such unused 

substances to illicit uses and result in 

collection and destruction of larger 

quantities in economical and 

environmentally sound manners. This 

rule establishes legal requirements for 

the handling of controlled substances. 

Destruction of controlled substances 

must be consistent with Federal, State, 

tribal and local laws and regulations. 

The DEA and registrants have 

disposed of controlled substances since 

passage of the CSA. By regulation, the 

U.S. Department of Justice categorically 

excluded the DEA from further NEPA 

analysis with respect to regulations 

relating to the storage and destruction of 

controlled substances. This rule does 

not authorize any new methods of 

storage, transportation, or destruction of 

controlled substances, but is limited to 

the procedures and records pertaining to 

the collection of controlled substances 

for destruction. Accordingly, this 

proposed rule does not significantly 

affect the quality of the human 

environment. The DEA has, therefore, 

determined that this rule does not have 

significant individual or cumulative 

effects on the human environment and 

is excluded from detailed analysis 

pursuant to 28 CFR part 61, Appendix 

B. 

Unfunded Mandates Reform Act 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995 

(2 U.S.C. 1501 et seq.), on the basis of 

information contained in the 

‘‘Regulatory Flexibility Act’’ section 

above, the DEA has determined and 

certifies pursuant to the UMRA that this 

action would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted for inflation) in any one 

year. . . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under provisions of 

the UMRA of 1995. 

Executive Order 13175 

This rule does not have tribal 

implications warranting the application 

of Executive Order 13175. The rule does 

not have substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (5 U.S.C. 804). This rule will not 

result in an annual effect on the 

economy of $100,000,000 or more, a 

major increase in costs or prices, or have 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or the ability 

of United States-based companies to 

compete with foreign based companies 

in domestic and export markets. 

Rule Text 

List of Subjects 

21 CFR Part 1300 

Chemicals, Drug traffic control. 

21 CFR Part 1301 

Administrative practice and 

procedure, Drug traffic control, Security 

measures. 

21 CFR Part 1304 

Drug traffic control, Reporting and 

recordkeeping requirements. 

21 CFR Part 1305 

Drug traffic control. 

21 CFR Part 1307 

Drug traffic control. 

21 CFR Part 1317 

Drug traffic control, Security 

measures. 

For the reasons stated in the 

preamble, the DEA amends 21 CFR 

chapter II as follows: 

PART 1300—DEFINITIONS 

■ 1–2. The authority citation for part 

1300 is revised to read as follows: 

Authority: 21 U.S.C. 802, 821, 822, 829, 

871(b), 951, 958(f). 

■ 3. In § 1300.01, amend paragraph (b) 

as follows: 

■ a. Revise the introductory text; 

■ b. Add a definition of ‘‘Collection’’ in 

alphabetical order; 

■ c. Revise the last sentence in the 

definition of ‘‘Freight forwarding 

facility’’; 

■ d. Add a definition of ‘‘Reverse 

distribute’’ in alphabetical order; and 


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53560 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

■ e. Revise the definition of ‘‘Reverse 

distributor’’. 

The revisions and additions read as 

follows: 

§ 1300.01 Definitions relating to controlled 

substances. 

* * * * * 

(b) As used in parts 1301 through 

1308, 1312, and 1317 of this chapter, the 

following terms shall have the meanings 

specified: 

* * * * * 

Collection means to receive a 

controlled substance for the purpose of 

destruction from an ultimate user, a 

person lawfully entitled to dispose of an 

ultimate user decedent’s property, or a 

long-term care facility on behalf of an 

ultimate user who resides or has resided 

at that facility. The term collector means 

a registered manufacturer, distributor, 

reverse distributor, narcotic treatment 

program, hospital/clinic with an on-site 

pharmacy, or retail pharmacy that is 

authorized under this chapter to so 

receive a controlled substance for the 

purpose of destruction. 

* * * * * 

Freight forwarding facility * * * For 

purposes of this definition, a 

distributing registrant is a person who is 

registered with the Administration as a 

manufacturer, distributor (excluding 

reverse distributor), and/or importer. 

* * * * * 

Reverse distribute means to acquire 

controlled substances from another 

registrant or law enforcement for the 

purpose of: 

(1) Return to the registered 

manufacturer or another registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf; or 

(2) Destruction. 

Reverse distributor is a person 

registered with the Administration as a 

reverse distributor. 

* * * * * 

■ 4. Add § 1300.05 to read as follows: 

§ 1300.05 Definitions relating to the 

disposal of controlled substances. 

(a) Any term not defined in this part 

or elsewhere in this chapter shall have 

the definition set forth in section 102 of 

the Act (21 U.S.C. 802). 

(b) As used in part 1317 of this 

chapter, the following terms shall have 

the meanings specified: 

Employee means an employee as 

defined under the general common law 

of agency. Some of the factors relevant 

to the determination of employee status 

include: The hiring party’s right to 

control the manner and means by which 

the product is accomplished; the skill 

required; the source of the 

instrumentalities and tools; the location 

of the work; the duration of the 

relationship between the parties; 

whether the hiring party has the right to 

assign additional projects to the hired 

party; the extent of the hired party’s 

discretion over when and how long to 

work; the method of payment; the hired 

party’s role in hiring and paying 

assistants; whether the work is part of 

the regular business of the hiring party; 

whether the hiring party is in business; 

the provision of employee benefits; and 

the tax treatment of the hired party. 

Other applicable factors may be 

considered and no one factor is 

dispositive. The following criteria will 

determine whether a person is an 

employee of a registrant for the purpose 

of disposal: The person is directly paid 

by the registrant; subject to direct 

oversight by the registrant; required, as 

a condition of employment, to follow 

the registrant’s procedures and 

guidelines pertaining to the handling of 

controlled substances; subject to receive 

a performance rating or performance 

evaluation on a regular/routine basis 

from the registrant; subject to 

disciplinary action by the registrant; and 

required to render services at the 

registrant’s registered location. 

Law enforcement officer means a 

person who is described in paragraph 

(1), (2) or (3) of this definition: 

(1) Meets all of the following criteria: 

(i) Employee of either a law 

enforcement agency, or law enforcement 

component of a Federal agency; 

(ii) Is under the direction and control 

of a Federal, State, tribal, or local 

government; 

(iii) Acting in the course of his/her 

official duty; and 

(iv) Duly sworn and given the 

authority by a Federal, State, tribal, or 

local government to carry firearms, 

execute and serve warrants, make 

arrests without warrant, and make 

seizures of property; 

(2) Is a Veterans Health 

Administration (VHA) police officer 

authorized by the Department of 

Veterans Affairs to participate in 

collection activities conducted by the 

VHA; or 

(3) Is a Department of Defense (DOD) 

police officer authorized by the DOD to 

participate in collection activities 

conducted by the DOD. 

Non-retrievable means, for the 

purpose of destruction, the condition or 

state to which a controlled substance 

shall be rendered following a process 

that permanently alters that controlled 

substance’s physical or chemical 

condition or state through irreversible 

means and thereby renders the 

controlled substance unavailable and 

unusable for all practical purposes. The 

process to achieve a non-retrievable 

condition or state may be unique to a 

substance’s chemical or physical 

properties. A controlled substance is 

considered ‘‘non-retrievable’’ when it 

cannot be transformed to a physical or 

chemical condition or state as a 

controlled substance or controlled 

substance analogue. The purpose of 

destruction is to render the controlled 

substance(s) to a non-retrievable state 

and thus prevent diversion of any such 

substance to illicit purposes. 

On-site means located on or at the 

physical premises of the registrant’s 

registered location. A controlled 

substance is destroyed on-site when 

destruction occurs on the physical 

premises of the destroying registrant’s 

registered location. A hospital/clinic has 

an on-site pharmacy when it has a 

pharmacy located on the physical 

premises of the registrant’s registered 

location. 

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

■ 5. The authority citation for part 1301 

is revised to read as follows: 

Authority: 21 U.S.C. 821, 822, 823, 824, 

831, 871(b), 875, 877, 886a, 951, 952, 953, 

956, 957, 958, 965. 

■ 6. In § 1301.13, revise paragraphs 

(e)(1)(i) and (ii) to read as follows: 

§ 1301.13 Application for registration; time 

for application; expiration date; registration 

for independent activities; application 

forms, fees, contents and signature; 

coincident activities. 

* * * * * 

(e) * * * 

(1) 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 53561 

Business activity Controlled 

substances 

DEA application 

forms 

Application fee 

($) 

Registration 

period (years) Coincident activities allowed 

(i) Manufacturing .... Schedules I–V ......... New—225 Renewal—225a.3,047 1 Schedules I–V: May distribute that substance or class for which registration 

was issued; may not distribute any 

substance or class for which not registered. 

Schedules II–V: May conduct chemical 

analysis and preclinical research (including quality control analysis) with 

substances listed in those schedules 

for which authorization as a mfr. was 

issued. 

(ii) Distributing ........ Schedules I–V ......... New—225 Renewal—225a.1,523 1 May acquire Schedules II–V controlled 

substances from collectors for the 

purposes of destruction. 

* * * * * * * 

* * * * * 

■ 7. In § 1301.25, revise paragraph (i) to 

read as follows: 

§ 1301.25 Registration regarding ocean 

vessels, aircraft, and other entities. 

* * * * * 

(i) Controlled substances acquired and 

possessed in accordance with this 

section shall be distributed only to 

persons under the general supervision 

of the medical officer employed by the 

owner or operator of the vessel, aircraft, 

or other entity, except in accordance 

with part 1317 of this chapter. 

■ 8. Revise § 1301.51 to read as follows: 

§ 1301.51 Modification in registration. 

(a) Any registrant may apply to 

modify his/her registration to authorize 

the handling of additional controlled 

substances or to change his/her name or 

address by submitting a written request 

to the Registration Unit, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. Additionally, such a 

request may be submitted on-line at 

www.DEAdiversion.usdoj.gov. 

(1) The request shall contain: 

(i) The registrant’s name, address, and 

registration number as printed on the 

certificate of registration; 

(ii) The substances and/or schedules 

to be added to the registration or the 

new name or address; and 

(iii) A signature in accordance with 

§ 1301.13(j). 

(2) If the registrant is seeking to 

handle additional controlled substances 

listed in Schedule I for the purpose of 

research or instructional activities, the 

registrant shall attach three copies of a 

research protocol describing each 

research project involving the additional 

substances, or two copies of a statement 

describing the nature, extent, and 

duration of such instructional activities, 

as appropriate. 

(b) Any manufacturer, distributor, 

reverse distributor, narcotic treatment 

program, hospital/clinic with an on-site 

pharmacy, or retail pharmacy registered 

pursuant to this part, may apply to 

modify its registration to become 

authorized as a collector by submitting 

a written request to the Registration 

Unit, Drug Enforcement Administration. 

See the Table of DEA Mailing Addresses 

in § 1321.01 of this chapter for the 

current mailing address. Additionally, 

such request may be submitted on-line 

at www.DEAdiversion.usdoj.gov. 

(1) The request shall contain: 

(i) The registrant’s name, address, and 

registration number as printed on the 

certificate of registration; 

(ii) The method(s) of collection the 

registrant intends to conduct (collection 

receptacle and/or mail-back program); 

and 

(iii) A signature in accordance with 

§ 1301.13(j). 

(2) If a hospital/clinic with an on-site 

pharmacy or retail pharmacy is applying 

for a modification in registration to 

authorize such registrant to be a 

collector to maintain a collection 

receptacle at a long-term care facility in 

accordance with § 1317.80 of this 

chapter, the request shall also include 

the name and physical location of each 

long-term care facility at which the 

hospital/clinic with an on-site 

pharmacy, or the retail pharmacy, 

intends to operate a collection 

receptacle. 

(c) No fee shall be required for 

modification. The request for 

modification shall be handled in the 

same manner as an application for 

registration. If the modification of 

registration is approved, the 

Administrator shall issue a new 

certificate of registration (DEA Form 

223) to the registrant, who shall 

maintain it with the old certificate of 

registration until expiration. 

■ 9. In § 1301.52, revise the last 

sentence of paragraph (c) and add 

paragraph (f) to read as follows: 

§ 1301.52 Termination of registration; 

transfer of registration; distribution upon 

discontinuance of business. 

* * * * * 

(c) * * * Any controlled substances 

in his/her possession may be disposed 

of in accordance with part 1317 of this 

chapter. 

* * * * * 

(f) Any registrant that has been 

authorized as a collector and desires to 

discontinue its collection of controlled 

substances from ultimate users shall 

notify the Administration of its intent 

by submitting a written notification to 

the Registration Unit, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

Additionally, such notice may be 

submitted on-line at 

www.DEAdiversion.usdoj.gov. When 

ceasing collection activities of an 

authorized mail-back program, the 

registrant shall provide the 

Administration with the name, 

registered address, and registration 

number of the collector that will receive 

the remaining mail-back packages in 

accordance with § 1317.70(e)(3) of this 

chapter. 

■ 10. In § 1301.71, add paragraph (f) to 

read as follows: 

§ 1301.71 Security requirements generally. 

* * * * * 

(f) A collector shall not employ, as an 

agent or employee who has access to or 

influence over controlled substances 

acquired by collection, any person who 

has been convicted of any felony offense 

relating to controlled substances or who, 

at any time, had an application for 

registration with DEA denied, had a 

DEA registration revoked or suspended, 


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53562 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

or has surrendered a DEA registration 

for cause. For purposes of this 

subsection, ‘‘for cause’’ means in lieu of, 

or as a consequence of, any Federal or 

State administrative, civil, or criminal 

action resulting from an investigation of 

the individual’s handling of controlled 

substances. 

■ 11. In § 1301.72, revise paragraph (a) 

introductory text to read as follows: 

§ 1301.72 Physical security controls for 

non-practitioners; narcotic treatment 

programs, and compounders for narcotic 

treatment programs; storage areas. 

(a) Schedules I and II. Raw material, 

bulk materials awaiting further 

processing, finished products which are 

controlled substances listed in Schedule 

I or II (except GHB that is manufactured 

or distributed in accordance with an 

exemption under section 505(i) of the 

Federal Food Drug and Cosmetic Act 

which shall be subject to the 

requirements of paragraph (b) of this 

section), and sealed mail-back packages 

and inner liners acquired in accordance 

with part 1317 of this chapter, shall be 

stored in one of the following secured 

areas: 

* * * * * 

■ 12. In § 1301.74, add paragraph (m) to 

read as follows: 

§ 1301.74 Other security controls for nonpractitioners; narcotic treatment programs 

and compounders for narcotic treatment 

programs. 

* * * * * 

(m) A reverse distributor shall not 

employ, as an agent or employee who 

has access to or influence over 

controlled substances, any person who 

has been convicted of any felony offense 

relating to controlled substances or who, 

at any time, had an application for 

registration with the DEA denied, had a 

DEA registration revoked or suspended, 

or has surrendered a DEA registration 

for cause. For purposes of this 

subsection, ‘‘for cause’’ means in lieu of, 

or as a consequence of, any Federal or 

State administrative, civil, or criminal 

action resulting from an investigation of 

the individual’s handling of controlled 

substances. 

■ 13. In § 1301.75, redesignate 

paragraphs (c) and (d) as paragraphs (d) 

and (e) and add a new paragraph (c) to 

read as follows: 

§ 1301.75 Physical security controls for 

practitioners. 

* * * * * 

(c) Sealed mail-back packages and 

inner liners collected in accordance 

with part 1317 of this chapter shall only 

be stored at the registered location in a 

securely locked, substantially 

constructed cabinet or a securely locked 

room with controlled access, except as 

authorized by § 1317.80(d). 

* * * * * 

■ 14. In § 1301.76, revise paragraph (c) 

to read as follows: 

§ 1301.76 Other security controls for 

practitioners. 

* * * * * 

(c) Whenever the registrant distributes 

a controlled substance (without being 

registered as a distributor as permitted 

in §§ 1301.13(e)(1), 1307.11, 1317.05, 

and/or 1317.10 of this chapter), he/she 

shall comply with the requirements 

imposed on non-practitioners in 

§ 1301.74(a), (b), and (e). 

* * * * * 

PART 1304—RECORDS AND 

REPORTS OF REGISTRANTS 

■ 15. The authority citation for part 

1304 is revised to read as follows: 

Authority: 21 U.S.C. 821, 827, 831, 871(b), 

958(e)–(g), and 965, unless otherwise noted. 

■ 16. Amend § 1304.03 by revising the 

first and second sentences of paragraph 

(a) to read as follows: 

§ 1304.03 Persons required to keep 

records and file reports. 

(a) Every registrant, including 

collectors, shall maintain the records 

and inventories and shall file the reports 

required by this part, except as 

exempted by this section. Any registrant 

that is authorized to conduct other 

activities without being registered to 

conduct those activities, pursuant to 

§§ 1301.22(b), 1307.11, 1307.13, or part 

1317 of this chapter, shall maintain the 

records and inventories and shall file 

the reports required by this part for 

persons registered or authorized to 

conduct such activities. * * * 

* * * * * 

■ 17. In § 1304.04, add paragraph (a)(3) 

to read as follows: 

§ 1304.04 Maintenance of records and 

inventories. 

(a) * * * 

(3) A collector that is authorized to 

maintain a collection receptacle at a 

long-term care facility shall keep all 

records required by this part relating to 

those collection receptacles at the 

registered location, or other approved 

central location. 

* * * * * 

■ 18. In § 1304.11, revise paragraphs (e) 

introductory text and (e)(2) and (3) and 

add paragraphs (e)(6) and (7) to read as 

follows: 

§ 1304.11 Inventory requirements. 

* * * * * 

(e) Inventories of manufacturers, 

distributors, registrants that reverse 

distribute, importers, exporters, 

chemical analysts, dispensers, 

researchers, and collectors. Each person 

registered or authorized (by §§ 1301.13, 

1307.11, 1307.13, or part 1317 of this 

chapter) to manufacture, distribute, 

reverse distribute, dispense, import, 

export, conduct research or chemical 

analysis with controlled substances, or 

collect controlled substances from 

ultimate users, and required to keep 

records pursuant to § 1304.03 shall 

include in the inventory the information 

listed below. 

* * * * * 

(2) Inventories of distributors. Each 

person registered or authorized to 

distribute controlled substances shall 

include in the inventory the same 

information required of manufacturers 

pursuant to paragraphs (e)(1)(iii) and 

(iv) of this section. 

(3) Inventories of registrants that 

reverse distribute. Each person 

registered or authorized to reverse 

distribute controlled substances shall 

include in the inventory, the following 

information: 

(i) The name of the substance, and 

(ii) The total quantity of the 

substance: 

(A) For controlled substances in bulk 

form, to the nearest metric unit weight 

consistent with unit size; 

(B) For each controlled substance in 

finished form: Each finished form of the 

substance (e.g., 10-milligram tablet or 

10-milligram concentration per fluid 

ounce or milliliter); the number of units 

or volume of each finished form in each 

commercial container (e.g., 100-tablet 

bottle or 3-milliliter vial); and the 

number of commercial containers of 

each such finished form (e.g., four 100- 

tablet bottles or six 3-milliliter vials); 

and 

(C) For controlled substances in a 

commercial container, carton, crate, 

drum, or other receptacle that has been 

opened: If the substance is listed in 

Schedule I or II, make an exact count or 

measure of the contents; or if the 

substance is listed in Schedule III, IV, or 

V, make an estimated count or measure 

of the contents, unless the container 

holds more than 1,000 tablets or 

capsules in which case an exact count 

of the contents shall be made; or 

(iii) For controlled substances 

acquired from collectors and law 

enforcement: The number and size (e.g., 

five 10-gallon liners, etc.) of sealed 

inner liners on hand, or 

(iv) For controlled substances 

acquired from law enforcement: the 


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number of sealed mail-back packages on 

hand. 

* * * * * 

(6) Inventories of dispensers and 

researchers. Each person registered or 

authorized to dispense or conduct 

research with controlled substances 

shall include in the inventory the same 

information required of manufacturers 

pursuant to paragraphs (e)(1)(iii) and 

(iv) of this section. In determining the 

number of units of each finished form 

of a controlled substance in a 

commercial container that has been 

opened, the dispenser or researcher 

shall do as follows: 

(i) If the substance is listed in 

Schedules I or II, make an exact count 

or measure of the contents; or 

(ii) If the substance is listed in 

Schedule III, IV, or V, make an 

estimated count or measure of the 

contents, unless the container holds 

more than 1,000 tablets or capsules in 

which case he/she must make an exact 

count of the contents. 

(7) Inventories of collectors. Each 

registrant authorized to collect 

controlled substances from ultimate 

users shall include in the inventory the 

following information: 

(i) For registrants authorized to collect 

through a mail-back program, the record 

shall include the following information 

about each unused mail-back package 

and each returned mail-back package on 

hand awaiting destruction: 

(A) The date of the inventory; 

(B) The number of mail-back 

packages; and 

(C) The unique identification number 

of each package on hand, whether 

unused or awaiting destruction. 

(ii) For registrants authorized to 

collect through a collection receptacle, 

the record shall include the following 

information about each unused inner 

liner on hand and each sealed inner 

liner on hand awaiting destruction: 

(A) The date of the inventory; 

(B) The number and size of inner 

liners (e.g., five 10-gallon liners, etc.); 

(C) The unique identification number 

of each inner liner. 

■ 19. In § 1304.21, revise paragraphs (a), 

(c), and (d) and add paragraph (e) to 

read as follows: 

§ 1304.21 General requirements for 

continuing records. 

(a) Every registrant required to keep 

records pursuant to § 1304.03 shall 

maintain, on a current basis, a complete 

and accurate record of each substance 

manufactured, imported, received, sold, 

delivered, exported, or otherwise 

disposed of by him/her, and each inner 

liner, sealed inner liner, and unused 

and returned mail-back package, except 

that no registrant shall be required to 

maintain a perpetual inventory. 

* * * * * 

(c) Separate records shall be 

maintained by a registrant for each 

independent activity and collection 

activity for which he/she is registered or 

authorized, except as provided in 

§ 1304.22(d). 

(d) In recording dates of receipt, 

importation, distribution, exportation, 

other transfers, or destruction, the date 

on which the controlled substances are 

actually received, imported, distributed, 

exported, otherwise transferred, or 

destroyed shall be used as the date of 

receipt, importation, distribution, 

exportation, transfer, or destruction 

(e.g., invoices, packing slips, or DEA 

Form 41). 

(e) Record of destruction. In addition 

to any other recordkeeping 

requirements, any registered person that 

destroys a controlled substance 

pursuant to § 1317.95(d), or causes the 

destruction of a controlled substance 

pursuant to § 1317.95(c), shall maintain 

a record of destruction on a DEA Form 

41. The records shall be complete and 

accurate, and include the name and 

signature of the two employees who 

witnessed the destruction. Except, 

destruction of a controlled substance 

dispensed by a practitioner for 

immediate administration at the 

practitioner’s registered location, when 

the substance is not fully exhausted 

(e.g., some of the substance remains in 

a vial, tube, or syringe after 

administration but cannot or may not be 

further utilized), shall be properly 

recorded in accordance with 

§ 1304.22(c), and such record need not 

be maintained on a DEA Form 41. 

■ 20. In § 1304.22, revise the section 

heading, introductory text, and 

paragraph (e) and add paragraph (f) to 

read as follows: 

§ 1304.22 Records for manufacturers, 

distributors, dispensers, researchers, 

importers, exporters, registrants that 

reverse distribute, and collectors. 

Each person registered or authorized 

(by §§ 1301.13(e), 1307.11, 1307.13, or 

part 1317 of this chapter) to 

manufacture, distribute, dispense, 

import, export, reverse distribute, 

destroy, conduct research with 

controlled substances, or collect 

controlled substances from ultimate 

users, shall maintain records with the 

information listed in paragraphs (a) 

through (f) of this section. 

* * * * * 

(e) Records for registrants that reverse 

distribute. Each person registered or 

authorized to reverse distribute 

controlled substances shall maintain 

records with the following information 

for each controlled substance: 

(1) For controlled substances acquired 

for the purpose of return or recall to the 

manufacturer or another registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf pursuant to part 1317 of this 

chapter: 

(i) The date of receipt; the name and 

quantity of each controlled substance 

received; the name, address, and 

registration number of the person from 

whom the substance was received; and 

the reason for return (e.g., recall or 

return); and 

(ii) The date of return to the 

manufacturer or other registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf; the name and quantity of each 

controlled substance returned; the 

name, address, and registration number 

of the person from whom the substance 

was received; the name, address, and 

registration number of the registrant to 

whom the substance was returned; and 

the method of return (e.g., common or 

contract carrier). 

(2) For controlled substances acquired 

from registrant inventory for destruction 

pursuant to § 1317.05(a)(2), (b)(2), and 

(b)(4) of this chapter: 

(i) The date of receipt; the name and 

quantity of each controlled substance 

received; and the name, address, and 

registration number of the person from 

whom the substance was received; and 

(ii) The date, place, and method of 

destruction; the name and quantity of 

each controlled substance destroyed; the 

name, address, and registration number 

of the person from whom the substance 

was received; and the name and 

signatures of the two employees of the 

registrant that witnessed the 

destruction. 

(3) The total quantity of each 

controlled substance shall be recorded 

in accordance with the following: 

(i) For controlled substances in bulk 

form: To the nearest metric unit weight 

or volume consistent with unit size; 

(ii) For controlled substances in 

finished form: Each finished form (e.g., 

10-milligram tablet or 10-milligram 

concentration per fluid ounce or 

milliliter); the number of units or 

volume of finished form in each 

commercial container (e.g., 100-tablet 

bottle or 3-milliliter vial); and the 

number of commercial containers of 

each such finished form (e.g., four 100- 

tablet bottles or six 3-milliliter vials); 

and 

(iii) For controlled substances in a 

commercial container, carton, crate, 

drum, or other receptacle that has been 

opened: If the substance is listed in 


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53564 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Rules and Regulations 

Schedule I or II make an exact count or 

measure of the contents; or if the 

substance is listed in Schedule III, IV, or 

V, make an estimated count or measure 

of the contents, unless the container 

holds more than 1,000 tablets or 

capsules in which case an exact count 

of the contents shall be made. 

(4) For each sealed inner liner 

acquired from collectors or law 

enforcement and each sealed mail-back 

package acquired from law enforcement 

pursuant to § 1317.55 of this chapter: 

(i) The number of sealed inner liners 

acquired from other persons, including 

the date of acquisition, the number and, 

for sealed inner liners the size (e.g., five 

10-gallon liners, etc.), of all sealed inner 

liners and mail-back packages acquired 

to inventory, the unique identification 

number of each sealed inner liner and 

mail-back package, and the name, 

address, and, for registrants, the 

registration number of the person from 

whom the sealed inner liners and mailback packages were received, and 

(ii) The date, place, and method of 

destruction; the number of sealed inner 

liners and mail-back packages 

destroyed; the name, address, and, for 

registrants, the registration number of 

the person from whom the sealed inner 

liners and mail-back packages were 

received; the number and, for sealed 

inner liners the size (e.g., five 10-gallon 

liners, etc.), of all sealed inner liners 

and mail-back packages destroyed; the 

unique identification number of each 

sealed inner liner and sealed mail-back 

package destroyed; and the name and 

signatures of the two employees of the 

registrant that witnessed the 

destruction. 

(5) For all records, the record of 

receipt shall be maintained together 

with the corresponding record of return 

or destruction (DEA Form 41). 

(f) Records for collectors. Each person 

registered or authorized to collect 

controlled substances from ultimate 

users shall maintain the following 

records: 

(1) Mail-Back Packages: 

(i) For unused packages that the 

collector makes available to ultimate 

users and other authorized nonregistrants at the collector’s registered 

address: The date made available, the 

number of packages, and the unique 

identification number of each package; 

(ii) For unused packages provided to 

a third party to make available to 

ultimate users and other authorized 

non-registrants: The name of the third 

party and physical address of the 

location receiving the unused packages, 

date sent, and the number of unused 

packages sent with the corresponding 

unique identification numbers; 

(iii) For sealed mail-back packages 

received by the collector: Date of receipt 

and the unique identification number 

on the individual package; and 

(iv) For sealed mail-back packages 

destroyed on-site by the collector: 

Number of sealed mail-back packages 

destroyed, the date and method of 

destruction, the unique identification 

number of each mail-back package 

destroyed, and the names and signatures 

of the two employees of the registrant 

who witnessed the destruction. 

(2) Collection receptacle inner liners: 

(i) Date each unused inner liner 

acquired, unique identification number 

and size (e.g., 5-gallon, 10-gallon, etc.) 

of each unused inner liner acquired; 

(ii) Date each inner liner is installed, 

the address of the location where each 

inner liner is installed, the unique 

identification number and size (e.g., 5- 

gallon, 10-gallon, etc.) of each installed 

inner liner, the registration number of 

the collector, and the names and 

signatures of the two employees that 

witnessed each installation; 

(iii) Date each inner liner is removed 

and sealed, the address of the location 

from which each inner liner is removed, 

the unique identification number and 

size (e.g., 5-gallon, 10-gallon, etc.) of 

each inner liner removed, the 

registration number of the collector, and 

the names and signatures of the two 

employees that witnessed each removal; 

(iv) Date each sealed inner liner is 

transferred to storage, the unique 

identification number and size (e.g., 5- 

gallon, 10-gallon, etc.) of each sealed 

inner liner stored, and the names and 

signatures of the two employees that 

transferred each sealed inner liner to 

storage; 

(v) Date each sealed inner liner is 

transferred for destruction, the address 

and registration number of the reverse 

distributor or distributor to whom each 

sealed inner liner was transferred, the 

unique identification number and the 

size (e.g., 5-gallon, 10-gallon, etc.) of 

each sealed inner liner transferred, and 

the names and signatures of the two 

employees that transferred each sealed 

inner liner to the reverse distributor or 

distributor; and 

(vi) For sealed inner liners destroyed 

on-site by the collector: The same 

information required of reverse 

distributors in paragraph (e)(4)(ii) of this 

section. 

■ 21. In § 1304.25, revise the section 

heading and paragraphs (a)(9) and (b)(9) 

to read as follows: 

§ 1304.25 Records for treatment programs 

that compound narcotics for treatment 

programs and other locations. 

* * * * * 

(a) * * * 

(9) The quantity disposed of by 

destruction, including the reason, date, 

and manner of destruction. 

(b) * * * 

(9) The number of units of finished 

forms and/or commercial containers 

destroyed in any manner by the 

registrant, including the reason, date, 

and manner of destruction. 

■ 22. Amend § 1304.33 by revising the 

section heading and paragraph (f) and 

adding paragraph (g) to read as follows: 

§ 1304.33 Reports to Automation of 

Reports and Consolidated Orders System 

(ARCOS). 

* * * * * 

(f) Exceptions. (1) A registered 

institutional practitioner that repackages 

or relabels exclusively for distribution 

or that distributes exclusively to (for 

dispensing by) agents, employees, or 

affiliated institutional practitioners of 

the registrant may be exempted from 

filing reports under this section by 

applying to the ARCOS Unit of the 

Administration. 

(2) Registrants that acquire recalled 

controlled substances from ultimate 

users pursuant to § 1317.85 of this 

chapter may report as a single 

transaction all recalled controlled 

substances of the same name and 

finished form (e.g., all 10-milligram 

tablets or all 5-milligram concentration 

per fluid ounce or milliliter) received 

from ultimate users for the purpose of 

reporting acquisition transactions. 

(g) Exemptions. (1) Collectors that 

acquire controlled substances from 

ultimate users are exempt from the 

ARCOS reporting requirements only 

with respect to controlled substances 

collected through mail-back programs 

and collection receptacles for the 

purpose of disposal. 

(2) Reverse distributors and 

distributors that acquire controlled 

substances pursuant to § 1317.55(a) or 

(b) of this chapter are exempt from the 

ARCOS reporting requirements in this 

section with regard to any controlled 

substances acquired pursuant to 

§ 1317.55(a) or (b) of this chapter. 

* * * * * 

PART 1305—ORDERS FOR SCHEDULE 

I AND II CONTROLLED SUBSTANCES 

■ 23. The authority citation for part 

1305 continues to read as follows: 

Authority: 21 U.S.C. 821, 828, 871(b), 

unless otherwise noted. 

■ 24. In § 1305.03, add paragraphs (e), 

(f), and (g) to read as follows: 

§ 1305.03 Distributions requiring a Form 

222 or a digitally signed electronic order. 

* * * * * 


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(e) Deliveries to an authorized DEA 

registrant by an ultimate user, a longterm care facility on behalf of an 

ultimate user who resides or has resided 

at that facility, or a person authorized to 

dispose of the ultimate user decedent’s 

property. 

(f) Distributions to reverse distributors 

and distributors by collectors and law 

enforcement pursuant to § 1317.55 of 

this chapter. 

(g) Deliveries of controlled substances 

from ultimate users for the purpose of 

recalls pursuant to § 1317.85 of this 

chapter. 

PART 1307—MISCELLANEOUS 

■ 25. The authority citation for part 

1307 continues to read as follows: 

Authority: 21 U.S.C. 821, 822(d), 871(b), 

unless otherwise noted. 

■ 26. In § 1307.11, revise section 

heading and remove and reserve 

paragraph (a)(2). 

The revision reads as follows: 

§ 1307.11 Distribution by dispenser to 

another practitioner. 

* * * * * 

§ 1307.12 [Removed] 

■ 27. Remove § 1307.12. 

■ 28. Revise § 1307.13 to read as 

follows: 

§ 1307.13 Incidental manufacture of 

controlled substances. 

Any registered manufacturer who, 

incidentally but necessarily, 

manufactures a controlled substance as 

a result of the manufacture of a 

controlled substance or basic class of 

controlled substance for which he is 

registered and has been issued an 

individual manufacturing quota 

pursuant to part 1303 of this chapter (if 

such substance or class is listed in 

Schedule I or II) shall be exempt from 

the requirement of registration pursuant 

to part 1301 of this chapter and, if such 

incidentally manufactured substance is 

listed in Schedule I or II, shall be 

exempt from the requirement of an 

individual manufacturing quota 

pursuant to part 1303 of this chapter, if 

such substances are disposed of in 

accordance with part 1317 of this 

chapter. 

§ 1307.21 [Removed] 

■ 29. Remove § 1307.21. 

■ 30. In § 1307.22, revise the section 

heading and the first sentence to read as 

follows: 

§ 1307.22 Delivery of surrendered and 

forfeited controlled substances. 

Any controlled substance surrendered 

by delivery to the Administration under 

part 1317 of this chapter or forfeited 

pursuant to section 511 of the Act (21 

U.S.C. 881) may be delivered to any 

department, bureau, or other agency of 

the United States or of any State upon 

proper application addressed to the 

Office of Diversion Control, Drug 

Enforcement Administration. 

* * * * * 

■ 31. Add part 1317 to read as follows: 

PART 1317—DISPOSAL 

Sec. 

1317.01 Scope. 

Subpart A—Disposal of Controlled 

Substances by Registrants 

1317.05 Registrant disposal. 

1317.10 Registrant return or recall. 

1317.15 Reverse distributor registration 

requirements and authorized activities. 

Subpart B—Disposal of Controlled 

Substances Collected From Ultimate Users 

and Other Non-Registrants 

1317.30 Authorization to collect from nonregistrants. 

1317.35 Collection by law enforcement. 

1317.40 Registrants authorized to collect 

and authorized collection activities. 

1317.55 Reverse distributor and distributor 

acquisition of controlled substances from 

collectors or law enforcement. 

1317.60 Inner liner requirements. 

1317.65 Take-back events. 

1317.70 Mail-back programs. 

1317.75 Collection receptacles. 

1317.80 Collection receptacles at long-term 

care facilities. 

1317.85 Ultimate user delivery for the 

purpose of recall or investigational use of 

drugs. 

Subpart C—Destruction of Controlled 

Substances 

1317.90 Methods of destruction. 

1317.95 Destruction procedures. 

Authority: 21 U.S.C. 821, 822, 823, 827, 

828, 871(b), and 958. 

§ 1317.01 Scope. 

This part sets forth the rules for the 

delivery, collection, and destruction of 

damaged, expired, returned, recalled, 

unused, or otherwise unwanted 

controlled substances that are lawfully 

possessed by registrants (subpart A) and 

non-registrants (subpart B). The purpose 

of such rules is to provide prompt, safe, 

and effective disposal methods while 

providing effective controls against the 

diversion of controlled substances. 

Subpart A—Disposal of Controlled 

Substances by Registrants 

§ 1317.05 Registrant disposal. 

(a) Practitioner inventory. Any 

registered practitioner in lawful 

possession of a controlled substance in 

its inventory that desires to dispose of 

that substance shall do so in one of the 

following ways: 

(1) Promptly destroy that controlled 

substance in accordance with subpart C 

of this part using an on-site method of 

destruction; 

(2) Promptly deliver that controlled 

substance to a reverse distributor’s 

registered location by common or 

contract carrier pick-up or by reverse 

distributor pick-up at the registrant’s 

registered location; 

(3) For the purpose of return or recall, 

promptly deliver that controlled 

substance by common or contract carrier 

pick-up or pick-up by other registrants 

at the registrant’s registered location to: 

The registered person from whom it was 

obtained, the registered manufacturer of 

the substance, or another registrant 

authorized by the manufacturer to 

accept returns or recalls on the 

manufacturer’s behalf; or 

(4) Request assistance from the 

Special Agent in Charge of the 

Administration in the area in which the 

practitioner is located. 

(i) The request shall be made by 

submitting one copy of the DEA Form 

41 to the Special Agent in Charge in the 

practitioner’s area. The DEA Form 41 

shall list the controlled substance or 

substances which the registrant desires 

to dispose. 

(ii) The Special Agent in Charge shall 

instruct the registrant to dispose of the 

controlled substance in one of the 

following manners: 

(A) By transfer to a registrant 

authorized to transport or destroy the 

substance; 

(B) By delivery to an agent of the 

Administration or to the nearest office 

of the Administration; or 

(C) By destruction in the presence of 

an agent of the Administration or other 

authorized person. 

(5) In the event that a practitioner is 

required regularly to dispose of 

controlled substances, the Special Agent 

in Charge may authorize the practitioner 

to dispose of such substances, in 

accordance with subparagraph (a)(4) of 

this section, without prior application 

in each instance, on the condition that 

the practitioner keep records of such 

disposals and file periodic reports with 

the Special Agent in Charge 

summarizing the disposals. The Special 

Agent in Charge may place such 

conditions as he/she deems proper on 

practitioner procedures regarding the 

disposal of controlled substances. 

(b) Non-practitioner inventory. Any 

registrant that is a non-practitioner in 

lawful possession of a controlled 

substance in its inventory that desires to 

dispose of that substance shall do so in 

one of the following ways: 


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(1) Promptly destroy that controlled 

substance in accordance with subpart C 

of this part using an on-site method of 

destruction; 

(2) Promptly deliver that controlled 

substance to a reverse distributor’s 

registered location by common or 

contract carrier or by reverse distributor 

pick-up at the registrant’s registered 

location; 

(3) For the purpose of return or recall, 

promptly deliver that controlled 

substance by common or contract carrier 

or pick-up at the registrant’s registered 

location to: The registered person from 

whom it was obtained, the registered 

manufacturer of the substance, or 

another registrant authorized by the 

manufacturer to accept returns or recalls 

on the manufacturer’s behalf; or 

(4) Promptly transport that controlled 

substance by its own means to the 

registered location of a reverse 

distributor, the location of destruction, 

or the registered location of any person 

authorized to receive that controlled 

substance for the purpose of return or 

recall as described in paragraph (b)(3) of 

this section. 

(i) If a non-practitioner transports 

controlled substances by its own means 

to an unregistered location for 

destruction, the non-practitioner shall 

do so in accordance with the procedures 

set forth at § 1317.95(c). 

(ii) If a non-practitioner transports 

controlled substances by its own means 

to a registered location for any 

authorized purpose, transportation shall 

be directly to the authorized registered 

location and two employees of the 

transporting non-practitioner shall 

accompany the controlled substances to 

the registered destination location. 

Directly transported means the 

substances shall be constantly moving 

towards their final location and 

unnecessary or unrelated stops and 

stops of an extended duration shall not 

occur. 

(c) Collected controlled substances. 

Any collector in lawful possession of a 

controlled substance acquired by 

collection from an ultimate user or other 

authorized non-registrant person shall 

dispose of that substance in the 

following ways: 

(1) Mail-back program. Upon receipt 

of a sealed mail-back package, the 

collector shall promptly: 

(i) Destroy the package in accordance 

with subpart C of this part using an onsite method of destruction; or 

(ii) Securely store the package and its 

contents at the collector’s registered 

location in a manner consistent with 

§ 1301.75(c) of this chapter (for 

practitioners), or in a manner consistent 

with the security requirements for 

Schedule II controlled substances (for 

non-practitioners) until prompt on-site 

destruction can occur. 

(2) Collection receptacles. Upon 

removal from the permanent outer 

container, the collector shall seal it and 

promptly: 

(i) Destroy the sealed inner liner and 

its contents; 

(ii) Securely store the sealed inner 

liner and its contents at the collector’s 

registered location in a manner 

consistent with § 1301.75(c) of this 

chapter (for practitioners), or in a 

manner consistent with § 1301.72(a) of 

this chapter (for non-practitioners) until 

prompt destruction can occur; or 

(iii) Securely store the sealed inner 

liner and its contents at a long-term care 

facility in accordance with § 1317.80(d). 

(iv) Practitioner methods of 

destruction. Collectors that are 

practitioners (i.e., retail pharmacies and 

hospitals/clinics) shall dispose of sealed 

inner liners and their contents by 

utilizing any method in paragraph (a)(1), 

(a)(2), or (a)(4) of this section, or by 

delivering sealed inner liners and their 

contents to a distributor’s registered 

location by common or contract carrier 

pick-up or by distributor pick-up at the 

collector’s authorized collection 

location. 

(v) Non-practitioner methods of 

destruction. Collectors that are nonpractitioners (i.e., manufacturers, 

distributors, narcotic treatment 

programs, and reverse distributors) shall 

dispose of sealed inner liners and their 

contents by utilizing any method in 

paragraph (b)(1), (b)(2), or (b)(4) of this 

section, or by delivering sealed inner 

liners and their contents to a 

distributor’s registered location by 

common or contract carrier or by 

distributor pick-up at the collector’s 

authorized collection location for 

destruction. Freight forwarding facilities 

may not be utilized to transfer sealed 

inner liners and their contents. 

§ 1317.10 Registrant return or recall. 

(a) Each registrant shall maintain a 

record of each return or recall 

transaction in accordance with the 

information required of manufacturers 

in § 1304.22(a)(2)(iv) of this chapter. 

(b) Each registrant that delivers a 

controlled substance in Schedule I or II 

for the purpose of return or recall shall 

use an order form in the manner 

described in part 1305 of this chapter. 

(c) Deliveries for the purpose of return 

or recall may be made through a freight 

forwarding facility operated by the 

person to whom the controlled 

substance is being returned provided 

that advance notice of the return is 

provided and delivery is directly to an 

agent or employee of the person to 

whom the controlled substance is being 

returned. 

§ 1317.15 Reverse distributor registration 

requirements and authorized activities. 

(a) Any person that reverse distributes 

a controlled substance shall be 

registered with the Administration as a 

reverse distributor, unless exempted by 

law or otherwise authorized pursuant to 

this chapter. 

(b) A reverse distributor shall acquire 

controlled substances from a registrant 

pursuant to §§ 1317.05 and 1317.55(a) 

and (c) in the following manner: 

(1) Pick-up controlled substances 

from a registrant at the registrant’s 

registered location or authorized 

collection site; or 

(2) Receive controlled substances 

delivered by common or contract carrier 

or delivered directly by a nonpractitioner registrant. 

(i) Delivery to the reverse distributor 

by an authorized registrant directly or 

by common or contract carrier may only 

be made to the reverse distributor at the 

reverse distributor’s registered location. 

Once en route, such deliveries may not 

be re-routed to any other location or 

person, regardless of registration status. 

(ii) All controlled substance deliveries 

to a reverse distributor shall be 

personally received by an employee of 

the reverse distributor at the registered 

location. 

(c) Upon acquisition of a controlled 

substance by delivery or pick-up, a 

reverse distributor shall: 

(1) Immediately store the controlled 

substance, in accordance with the 

security controls in parts 1301 and 1317 

of this chapter, at the reverse 

distributor’s registered location or 

immediately transfer the controlled 

substance to the reverse distributor’s 

registered location for secure storage, in 

accordance with the security controls in 

parts 1301 and 1317 of this chapter, 

until timely destruction or prompt 

return of the controlled substance to the 

registered manufacturer or other 

registrant authorized by the 

manufacturer to accept returns or recalls 

on the manufacturer’s behalf; 

(2) Promptly deliver the controlled 

substance to the manufacturer or 

another registrant authorized by the 

manufacturer to accept returns or recalls 

on the manufacturer’s behalf; or 

(3) Timely destroy the controlled 

substance in a manner authorized in 

subpart C of this part. 

(d) A reverse distributor shall destroy 

or cause the destruction of any 

controlled substance received for the 

purpose of destruction no later than 30 

calendar days after receipt. 


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Subpart B—Disposal of Controlled 

Substances Collected From Ultimate 

Users and Other Non-Registrants 

§ 1317.30 Authorization to collect from 

non-registrants. 

(a) The following persons are 

authorized to collect controlled 

substances from ultimate users and 

other non-registrants for destruction in 

compliance with this chapter: 

(1) Any registrant authorized by the 

Administration to be a collector 

pursuant to § 1317.40; and 

(2) Federal, State, tribal, or local law 

enforcement when in the course of 

official duties and pursuant to 

§ 1317.35. 

(b) The following non-registrant 

persons in lawful possession of a 

controlled substance in Schedules II, III, 

IV, or V may transfer that substance to 

the authorized persons listed in 

paragraph (a) of this section, and in a 

manner authorized by this part, for the 

purpose of disposal: 

(1) An ultimate user in lawful 

possession of a controlled substance; 

(2) Any person lawfully entitled to 

dispose of a decedent’s property if that 

decedent was an ultimate user who died 

while in lawful possession of a 

controlled substance; and 

(3) A long-term care facility on behalf 

of an ultimate user who resides or 

resided at such long-term care facility 

and is/was in lawful possession of a 

controlled substance, in accordance 

with § 1317.80 only. 

§ 1317.35 Collection by law enforcement. 

(a) Federal, State, tribal, or local law 

enforcement may collect controlled 

substances from ultimate users and 

persons lawfully entitled to dispose of 

an ultimate user decedent’s property 

using the following collection methods: 

(1) Take-back events in accordance 

with § 1317.65; 

(2) Mail-back programs in accordance 

with § 1317.70; or 

(3) Collection receptacles located 

inside law enforcement’s physical 

address. 

(b) Law enforcement that conducts a 

take-back event or a mail-back program 

or maintains a collection receptacle 

should maintain any records of removal, 

storage, or destruction of the controlled 

substances collected in a manner that is 

consistent with that agency’s 

recordkeeping requirements for illicit 

controlled substances evidence. 

(c) Any controlled substances 

collected by law enforcement through a 

take-back event, mail-back program, or 

collection receptacle should be stored in 

a manner that prevents the diversion of 

controlled substances and is consistent 

with that agency’s standard procedures 

for storing illicit controlled substances. 

(d) Any controlled substances 

collected by law enforcement through a 

take-back event, mail-back program, or 

collection receptacle should be 

transferred to a destruction location in 

a manner that prevents the diversion of 

controlled substances and is consistent 

with that agency’s standard procedures 

for transferring illicit controlled 

substances. 

(e) Law enforcement that transfers 

controlled substances collected from 

ultimate users pursuant to this part to a 

reverse distributor for destruction 

should maintain a record that contains 

the following information: If a sealed 

inner liner as described in § 1317.60 is 

used, the unique identification number 

of the sealed inner liner transferred, and 

the size of the sealed inner liner 

transferred (e.g., 5-gallon, 10-gallon, 

etc.); if a mail-back package as described 

in § 1317.70 is used, the unique 

identification number of each package; 

the date of the transfer; and the name, 

address, and registration number of the 

reverse distributor to whom the 

controlled substances were transferred. 

§ 1317.40 Registrants authorized to collect 

and authorized collection activities. 

(a) Manufacturers, distributors, 

reverse distributors, narcotic treatment 

programs, hospitals/clinics with an onsite pharmacy, and retail pharmacies 

that desire to be collectors shall modify 

their registration to obtain authorization 

to be a collector in accordance with 

§ 1301.51 of this chapter. Authorization 

to be a collector is subject to renewal. 

If a registrant that is authorized to 

collect ceases activities as a collector, 

such registrant shall notify the 

Administration in accordance with 

§ 1301.52(f) of this chapter. 

(b) Collection by registrants shall 

occur only at the following locations: 

(1) Those registered locations of 

manufacturers, distributors, reverse 

distributors, narcotic treatment 

programs, hospitals/clinics with an onsite pharmacy, and retail pharmacies 

that are authorized for collection; and 

(2) Long-term care facilities at which 

registered hospitals/clinics or retail 

pharmacies are authorized to maintain 

collection receptacles. 

(c) Collectors may conduct the 

following activities: 

(1) Receive and destroy mail-back 

packages pursuant to § 1317.70 at an 

authorized registered location that has 

an on-site method of destruction; 

(2) Install, manage, and maintain 

collection receptacles located at their 

authorized collection location(s) 

pursuant to §§ 1317.75 and 1317.80; and 

(3) Promptly dispose of sealed inner 

liners and their contents as provided for 

in § 1317.05(c)(2). 

§ 1317.55 Reverse distributor and 

distributor acquisition of controlled 

substances from collectors or law 

enforcement. 

(a) A reverse distributor is authorized 

to acquire controlled substances from 

law enforcement that collected the 

substances from ultimate users. A 

reverse distributor is authorized to 

acquire controlled substances collected 

through a collection receptacle in 

accordance with §§ 1317.75 and 

1317.80. 

(b) A distributor is authorized to 

acquire controlled substances collected 

through a collection receptacle in 

accordance with §§ 1317.75 and 

1317.80. 

(c) A reverse distributor or a 

distributor that acquires controlled 

substances in accordance with 

paragraph (a) or (b) of this section shall: 

(1) Acquire the controlled substances 

in the manner authorized for reverse 

distributors in § 1317.15(b)(1) and (2); 

(2) Dispose of the controlled 

substances in the manner authorized for 

reverse distributors § 1317.15(c) and (d); 

and 

(3) Securely store the controlled 

substances in a manner consistent with 

the security requirements for Schedule 

II controlled substances until timely 

destruction can occur. 

§ 1317.60 Inner liner requirements. 

(a) An inner liner shall meet the 

following requirements: 

(1) The inner liner shall be 

waterproof, tamper-evident, and tearresistant; 

(2) The inner liner shall be removable 

and sealable immediately upon removal 

without emptying or touching the 

contents; 

(3) The contents of the inner liner 

shall not be viewable from the outside 

when sealed; 

(4) The size of the inner liner shall be 

clearly marked on the outside of the 

liner (e.g., 5-gallon, 10-gallon, etc.); and 

(5) The inner liner shall bear a 

permanent, unique identification 

number that enables the inner liner to 

be tracked. 

(b) Access to the inner liner shall be 

restricted to employees of the collector. 

(c) The inner liner shall be sealed by 

two employees immediately upon 

removal from the permanent outer 

container and the sealed inner liner 

shall not be opened, x-rayed, analyzed, 

or otherwise penetrated. 


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§ 1317.65 Take-back events. 

(a) Federal, State, tribal, or local law 

enforcement may conduct a take-back 

event and collect controlled substances 

from ultimate users and persons 

lawfully entitled to dispose of an 

ultimate user decedent’s property in 

accordance with this section. Any 

person may partner with law 

enforcement to hold a collection takeback event in accordance with this 

section. 

(b) Law enforcement shall appoint a 

law enforcement officer employed by 

the agency to oversee the collection. 

Law enforcement officers employed and 

authorized by the law enforcement 

agency or law enforcement component 

of a Federal agency conducting a takeback event shall maintain control and 

custody of the collected substances from 

the time the substances are collected 

from the ultimate user or person 

authorized to dispose of the ultimate 

user decedent’s property until secure 

transfer, storage, or destruction of the 

controlled substances has occurred. 

(c) Each take-back event should have 

at least one receptacle for the collection 

of controlled substances. The collection 

receptacle should be a securely locked, 

substantially constructed container with 

an outer container and a removable 

inner liner as specified in § 1317.60 of 

this chapter. The outer container should 

include a small opening that allows 

contents to be added to the inner liner, 

but that does not allow removal of the 

inner liner’s contents. 

(d) Only those controlled substances 

listed in Schedule II, III, IV, or V that 

are lawfully possessed by an ultimate 

user or person entitled to dispose of an 

ultimate user decedent’s property may 

be collected. Controlled and noncontrolled substances may be collected 

together and be comingled, although 

comingling is not required. 

(e) Only ultimate users and persons 

entitled to dispose of an ultimate user 

decedent’s property in lawful 

possession of a controlled substance in 

Schedule II, III, IV, or V may transfer 

such substances to law enforcement 

during the take-back event. No other 

person may handle the controlled 

substances at any time. 

§ 1317.70 Mail-back programs. 

(a) A mail-back program may be 

conducted by Federal, State, tribal, or 

local law enforcement or any collector. 

A collector conducting a mail-back 

program shall have and utilize at their 

registered location a method of 

destruction consistent with § 1317.90 of 

this chapter. 

(b) Only those controlled substances 

listed in Schedule II, III, IV, or V that 

are lawfully possessed by an ultimate 

user or person lawfully entitled to 

dispose of an ultimate user decedent’s 

property may be collected. Controlled 

and non-controlled substances may be 

collected together and be comingled, 

although comingling is not required. 

(c) Collectors or law enforcement that 

conduct a mail-back program shall make 

packages available (for sale or for free) 

as specified in this paragraph to 

ultimate users and persons lawfully 

entitled to dispose of an ultimate user 

decedent’s property, for the collection of 

controlled substances by common or 

contract carrier. Any person may 

partner with a collector or law 

enforcement to make such packages 

available in accordance with this 

section. The packages made available 

shall meet the following specifications: 

(1) The package shall be nondescript 

and shall not include any markings or 

other information that might indicate 

that the package contains controlled 

substances; 

(2) The package shall be water- and 

spill-proof; tamper-evident; tearresistant; and sealable; 

(3) The package shall be preaddressed 

with and delivered to the collector’s 

registered address or the participating 

law enforcement’s physical address; 

(4) The cost of shipping the package 

shall be postage paid; 

(5) The package shall have a unique 

identification number that enables the 

package to be tracked; and 

(6) The package shall include 

instructions for the user that indicate 

the process for mailing back the 

package, the substances that can be sent, 

notice that packages may only be mailed 

from within the customs territory of the 

United States (the 50 States, the District 

of Columbia, and Puerto Rico), and 

notice that only packages provided by 

the collector will be accepted for 

destruction. 

(d) Ultimate users and persons 

lawfully entitled to dispose of an 

ultimate user decedent’s property shall 

not be required to provide any 

personally identifiable information 

when mailing back controlled 

substances to a collector. The collector 

or law enforcement may implement a 

system that allows ultimate users or 

persons lawfully entitled to dispose of 

an ultimate user decedent’s property to 

notify the collector or law enforcement 

that they are sending one of the 

designated packages by giving the 

unique identification number on the 

package. 

(e) A collector that conducts a mailback program pursuant to paragraph (a) 

shall: 

(1) Accept only those controlled 

substances contained within packages 

that the collector made available for the 

collection of controlled substances by 

mail and packages that are lawfully 

forwarded to the collector pursuant to 

paragraph (e)(3) of this section. 

(2) Within three business days of 

receipt, notify the Field Division Office 

of the Administration in their area of the 

receipt of a package that likely contains 

controlled substances that the collector 

did not make available or did not agree 

to receive pursuant to subparagraph 

(e)(3) of this section. 

(3) When discontinuing activities as a 

collector or ceasing an authorized mailback program: 

(i) Make a reasonable effort to notify 

the public prior to discontinuing such 

activities or ceasing the authorized mailback program; and 

(ii) Obtain the written agreement of 

another collector that has and utilizes at 

its registered location a method of 

destruction consistent with § 1317.90 of 

this chapter to receive all remaining 

mail-back packages that were 

disseminated but not returned and 

arrange for the forwarding of only such 

packages to that location. 

(f) Only law enforcement officers 

employed by the law enforcement 

agency or law enforcement component 

of a Federal agency and employees of 

the collector shall handle packages 

received through an authorized mailback program. Upon receipt of a mailback package by a collector conducting 

a mail-back program, the package shall 

not be opened, x-rayed, analyzed, or 

otherwise penetrated. 

§ 1317.75 Collection receptacles. 

(a) Collectors or Federal, State, tribal, 

or local law enforcement may manage 

and maintain collection receptacles for 

disposal. 

(b) Only those controlled substances 

listed in Schedule II, III, IV, or V that 

are lawfully possessed by an ultimate 

user or other authorized non-registrant 

person may be collected. Controlled and 

non-controlled substances may be 

collected together and be comingled, 

although comingling is not required. 

(c) Collectors shall only allow 

ultimate users and other authorized 

non-registrant persons in lawful 

possession of a controlled substance in 

Schedule II, III, IV, or V to deposit such 

substances in a collection receptacle at 

a registered location. Collectors shall 

not permit an ultimate user to transfer 

such substance to any person for any 

reason. Once a substance has been 

deposited into a collection receptacle, 

the substance shall not be counted, 


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sorted, inventoried, or otherwise 

individually handled. 

(d) Collection receptacles shall be 

securely placed and maintained: 

(1) Inside a collector’s registered 

location, inside law enforcement’s 

physical location, or at an authorized 

long-term care facility; 

(2) At a registered location, be located 

in the immediate proximity of a 

designated area where controlled 

substances are stored and at which an 

employee is present (e.g., can be seen 

from the pharmacy counter). Except as 

follows: 

(i) At a hospital/clinic: A collection 

receptacle shall be located in an area 

regularly monitored by employees, and 

shall not be located in the proximity of 

any area where emergency or urgent 

care is provided; 

(ii) At a narcotic treatment program: A 

collection receptacle shall be located in 

a room: That does not contain any other 

controlled substances and is securely 

locked with controlled access; 

(iii) At a long-term care facility: A 

collection receptacle shall be located in 

a secured area regularly monitored by 

long-term care facility employees. 

(e) A controlled substance collection 

receptacle shall meet the following 

design specifications: 

(1) Be securely fastened to a 

permanent structure so that it cannot be 

removed; 

(2) Be a securely locked, substantially 

constructed container with a permanent 

outer container and a removable inner 

liner as specified in § 1317.60 of this 

chapter; 

(3) The outer container shall include 

a small opening that allows contents to 

be added to the inner liner, but does not 

allow removal of the inner liner’s 

contents; 

(4) The outer container shall 

prominently display a sign indicating 

that only Schedule II–V controlled and 

non-controlled substances, if a collector 

chooses to comingle substances, are 

acceptable substances (Schedule I 

controlled substances, controlled 

substances that are not lawfully 

possessed by the ultimate user, and 

other illicit or dangerous substances are 

not permitted); and 

(f) Except at a narcotic treatment 

program, the small opening in the outer 

container of the collection receptacle 

shall be locked or made otherwise 

inaccessible to the public when an 

employee is not present (e.g., when the 

pharmacy is closed), or when the 

collection receptacle is not being 

regularly monitored by long-term care 

facility employees. 

(g) The installation and removal of the 

inner liner of the collection receptacle 

shall be performed by or under the 

supervision of at least two employees of 

the authorized collector. 

§ 1317.80 Collection receptacles at longterm care facilities. 

(a) A long-term care facility may 

dispose of controlled substances in 

Schedules II, III, IV, and V on behalf of 

an ultimate user who resides, or has 

resided, at such long-term care facility 

by transferring those controlled 

substances into an authorized collection 

receptacle located at that long-term care 

facility. When disposing of such 

controlled substances by transferring 

those substances into a collection 

receptacle, such disposal shall occur 

immediately, but no longer than three 

business days after the discontinuation 

of use by the ultimate user. 

Discontinuation of use includes a 

permanent discontinuation of use as 

directed by the prescriber, as a result of 

the resident’s transfer from the longterm care facility, or as a result of death. 

(b) Only authorized retail pharmacies 

and hospitals/clinics with an on-site 

pharmacy may install, manage, and 

maintain collection receptacles at longterm care facilities and remove, seal, 

transfer, and store, or supervise the 

removal, sealing, transfer, and storage of 

sealed inner liners at long-term care 

facilities. Collectors authorized to 

install, manage, and maintain collection 

receptacles at long-term care facilities 

shall comply with all requirements of 

this chapter, including §§ 1317.60, 

1317.75, and 1317.80. 

(c) The installation, removal, transfer, 

and storage of inner liners shall be 

performed either: By or under the 

supervision of one employee of the 

authorized collector and one supervisorlevel employee of the long-term care 

facility (e.g., a charge nurse or 

supervisor) designated by the 

authorized collector; or, by or under the 

supervision of two employees of the 

authorized collector. 

(d) Upon removal, sealed inner liners 

may only be stored at the long-term care 

facility for up to three business days in 

a securely locked, substantially 

constructed cabinet or a securely locked 

room with controlled access until 

transfer in accordance with 

§ 1317.05(c)(2)(iv). 

(e) Neither a hospital/clinic with an 

on-site pharmacy nor a retail pharmacy 

shall operate a collection receptacle at a 

long-term care facility until its 

registration has been modified in 

accordance with § 1301.51 of this 

chapter. 

§ 1317.85 Ultimate user delivery for the 

purpose of recall or investigational use of 

drugs. 

(a) In the event of a product recall, an 

ultimate user in lawful possession of a 

controlled substance listed in Schedule 

II, III, IV, or V may deliver the recalled 

substance to the manufacturer of the 

substance or another registrant 

authorized by the manufacturer to 

accept recalled controlled substances on 

the manufacturer’s behalf. 

(b) An ultimate user who is 

participating in an investigational use of 

drugs pursuant to 21 U.S.C. 355(i) and 

360b(j) and wishes to deliver any 

unused controlled substances received 

as part of that research to the registered 

dispenser from which the ultimate user 

obtained those substances may do so in 

accordance with regulations 

promulgated by the Secretary of Health 

and Human Services pursuant to 21 

U.S.C. 355(i) and 360b(j). 

Subpart C—Destruction of Controlled 

Substances 

§ 1317.90 Methods of destruction. 

(a) All controlled substances to be 

destroyed by a registrant, or caused to 

be destroyed by a registrant pursuant to 

§ 1317.95(c), shall be destroyed in 

compliance with applicable Federal, 

State, tribal, and local laws and 

regulations and shall be rendered nonretrievable. 

(b) Where multiple controlled 

substances are comingled, the method of 

destruction shall be sufficient to render 

all such controlled substances nonretrievable. When the actual substances 

collected for destruction are unknown 

but may reasonably include controlled 

substances, the method of destruction 

shall be sufficient to render nonretrievable any controlled substance 

likely to be present. 

(c) The method of destruction shall be 

consistent with the purpose of rendering 

all controlled substances to a nonretrievable state in order to prevent 

diversion of any such substance to illicit 

purposes and to protect the public 

health and safety. 

§ 1317.95 Destruction procedures. 

The destruction of any controlled 

substance shall be in accordance with 

the following requirements: 

(a) Transfer to a person registered or 

authorized to accept controlled 

substances for the purpose of 

destruction. If the controlled substances 

are transferred to a person registered or 

authorized to accept the controlled 

substances for the purpose of 

destruction, two employees of the 

transferring registrant shall load and 


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unload or observe the loading and 

unloading of any controlled substances 

until transfer is complete. 

(b) Transport to a registered location. 

If the controlled substances are 

transported by a registrant to a 

registered location for subsequent 

destruction, the following procedures 

shall be followed: 

(1) Transportation shall be directly to 

the registered location (the substances 

shall be constantly moving towards 

their final location and unnecessary or 

unrelated stops and stops of an 

extended duration shall not occur); 

(2) Two employees of the transporting 

registrant shall accompany the 

controlled substances to the registered 

location; 

(3) Two employees of the transporting 

registrant shall load and unload or 

observe the loading and unloading of 

the controlled substances until transfer 

is complete; 

(c) Transport to a non-registered 

location. If the controlled substances are 

transported by a registrant to a 

destruction location that is not a 

registered location, the following 

procedures shall be followed: 

(1) Transportation shall be directly to 

the destruction location (the substances 

shall be constantly moving towards 

their final destruction location and 

unnecessary or unrelated stops and 

stops of an extended duration shall not 

occur); 

(2) Two employees of the transporting 

registrant shall accompany the 

controlled substances to the destruction 

location; 

(3) Two employees of the transporting 

registrant shall load and unload or 

observe the loading and unloading of 

the controlled substances; 

(4) Two employees of the transporting 

registrant shall handle or observe the 

handling of any controlled substance 

until the substance is rendered nonretrievable; and 

(5) Two employees of the transporting 

registrant shall personally witness the 

destruction of the controlled substance 

until it is rendered non-retrievable. 

(d) On-site destruction. If the 

controlled substances are destroyed at a 

registrant’s registered location utilizing 

an on-site method of destruction, the 

following procedures shall be followed: 

(1) Two employees of the registrant 

shall handle or observe the handling of 

any controlled substance until the 

substance is rendered non-retrievable; 

and 

(2) Two employees of the registrant 

shall personally witness the destruction 

of the controlled substance until it is 

rendered non-retrievable. 

Dated: August 25, 2014. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2014–20926 Filed 9–8–14; 8:45 am] 

BILLING CODE 4410–09–P 


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