Vol. 77 Friday, 

No. 246 December 21, 2012 

Part V 

Department of Justice 

Drug Enforcement Administration 

21 CFR Parts 1300, 1301, 1304 et al. 

Disposal of Controlled Substances; Proposed Rule 

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75784 Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1301, 1304, 1305, 

1307, 1317, and 1321 

[Docket No. DEA–316] 

RIN 1117–AB18 

Disposal of Controlled Substances 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This rule proposes 

requirements to govern the secure 

disposal of controlled substances by 

both DEA registrants and ultimate users. 

These regulations would implement the 

Secure and Responsible Drug Disposal 

Act of 2010 (Pub. L. 111–273) by 

expanding the options available to 

collect controlled substances from 

ultimate users for purposes of disposal 

to include: Take-back events, mail-back 

programs, and collection receptacle 

locations. These proposed regulations 

contain specific language to continue to 

allow law enforcement agencies to 

voluntarily conduct take-back events, 

administer mail-back programs, and 

maintain collection receptacles. These 

regulations propose to allow authorized 

manufacturers, distributors, reverse 

distributors, and retail pharmacies to 

voluntarily administer mail-back 

programs and maintain collection 

receptacles. In addition, this proposed 

rule expands the authority of authorized 

retail pharmacies to voluntarily 

maintain collection receptacles at long 

term care facilities. This proposed rule 

also reorganizes and consolidates 

existing regulations on disposal, 

including the role of reverse 

distributors. 

DATES: Electronic comments must be 

submitted and written comments must 

be postmarked on or before February 19, 

2013. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after midnight Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–316’’ on all electronic and 

written correspondence. DEA 

encourages all comments be submitted 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the http:// 

www.regulations.gov Web site for easy 

reference. Paper comments that 

duplicate the electronic submission are 

not necessary as all comments 

submitted to http://www.regulations.gov 

will be posted for public review and are 

part of the official docket record. Should 

you, however, wish to submit written 

comments via regular or express mail, 

they should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Office of Diversion Control (OD/ 

DX), 8701 Morrissette Drive, 

Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: John 

W. Partridge, Executive Assistant, Office 

of Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 307–4654. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and are made available for 

public inspection online at http:// 

www.regulations.gov and in the DEA’s 

public docket. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

If you would like to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you would like to submit 

confidential business information as 

part of your comment, but do not want 

it to be posted online or made available 

in the public docket, you must include 

the phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted, and the comment, in 

redacted form, will be posted online and 

placed in the DEA’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION paragraph. 

Outline 

I. Executive Summary 

A. Purpose of the Regulatory Action 

B. Summary of the Major Provisions of the 

Regulatory Action 

II. Background 

A. Legal Authority 

B. History of Disposal of Controlled 

Substances 

C. Existing DEA Regulations 

III. Prescription Drug Abuse Epidemic 

IV. Scope of Proposed Rule 

V. Proposed Disposal Act Implementing 

Regulations 

A. Disposal of Controlled Substance by 

Ultimate Users—Authorized Persons 

B. Disposal of Controlled Substances by 

Ultimate Users—Authorized Methods 

C. Disposal of Controlled Substances by 

Registrants 

D. Return and Recall 

E. Methods of Destruction 

VI. Miscellaneous Changes 

VII. Regulatory Analyses 

Executive Summary 

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 controlled substance 

pharmaceuticals had limited disposal 

options. The Controlled Substances Act 

(CSA) only permitted ultimate users to 

destroy those substances themselves, for 

example by flushing or discarding, or to 

dispose of such substances by 

surrendering them to law enforcement 

or by seeking assistance from the U.S. 

Drug Enforcement Administration 

(DEA). These restrictions resulted in the 

accumulation of controlled substances 

in household medicine cabinets that 

were available for abuse, misuse, and 

accidental ingestion. The Disposal Act 

amended the CSA to authorize ultimate 

users to deliver their 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) and 828(b)(3). 

The Attorney General delegated 

responsibility for promulgating the 

Disposal Act implementing regulations 

to DEA. These proposed regulations 

expand the entities to which ultimate 

users may transfer unused, unwanted, 

or expired controlled substances for the 

purpose of disposal, as well as the 

methods by which such controlled 

substances may be collected. Specified 

entities may voluntarily administer any 

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of the authorized collection methods in 

accordance with these proposed 

regulations. 

Summary of the Major Provisions of the 

Regulatory Action 

DEA is proposing new regulations for 

the disposal of controlled substances by 

ultimate users in accordance with the 

Disposal Act. In drafting the 

implementing regulations, DEA 

considered the public health and safety, 

ease and cost of program 

implementation, and participation by 

various communities. To this end, 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 (e.g., 

ultimate users). The reverse distributor 

registration category, which is pertinent 

to the process of registrant disposal, was 

included in this comprehensive review. 

These regulations will be incorporated 

into a new part 1317 on disposal. 

The goal of this proposed new part on 

disposal, consistent with Congress’s 

goal in passing the Disposal Act, is to 

set controlled substance diversion 

prevention parameters that will 

encourage public and private entities to 

develop a variety of methods for 

collecting and destroying controlled 

substances in a secure, convenient, and 

responsible manner. Also consistent 

with Congress’s goal in passing the 

Disposal Act to decrease the amount of 

controlled substances introduced into 

the environment, particularly into the 

water, these regulations provide 

individuals various additional options 

to dispose of their unwanted or unused 

controlled substances beyond 

discarding or flushing the substances. 

As a result of these regulations, the 

supply of unused controlled substances 

in the home should decrease, thereby 

reducing the risk of unintentional 

diversion or harm. 

Ultimate User Disposal 

This rule proposes three voluntary 

options for ultimate user disposal: (1) 

Take-back events, (2) mail-back 

programs, and (3) collection receptacles. 

In addition to ultimate users, 

individuals lawfully entitled to dispose 

of ultimate user decedent’s property are 

authorized to dispose of the ultimate 

user’s substances by utilizing any of the 

three options for disposal. All of the 

proposed collection methods are 

voluntary and no person is required to 

establish or operate a disposal program. 

DEA proposes specific language that 

will continue to authorize federal, state, 

tribal, and local law enforcement 

agencies, either independently or in 

partnership with private entities or 

community groups, to voluntarily hold 

take-back events and administer mailback programs. DEA also proposes to 

authorize certain registrants 

(manufacturers, distributors, reverse 

distributors, and retail pharmacies) to be 

‘‘collectors,’’ with authorization to 

conduct mail-back programs. All mailback programs must provide specific 

mail-back packages to the public, either 

at no cost or for a fee, and collectors that 

conduct mail-back programs must have 

and utilize an on-site method of 

destruction. 

Finally, DEA proposes that law 

enforcement agencies voluntarily 

maintain collection receptacles at that 

agency’s physical location and to 

authorize collectors to maintain 

collection receptacles at their registered 

location. Retail pharmacies that are 

authorized to be collectors may 

maintain collection receptacles at long 

term care facilities (LTCFs). LTCFs are 

permitted to dispose of controlled 

substances on behalf of an ultimate user 

that resides or has resided at that LTCF 

only through a collection receptacle that 

is maintained by a retail pharmacy at 

that LTCF. 

DEA proposes to allow all controlled 

substances collected through take-back 

events, mail-back programs, and 

collection receptacles to be comingled 

with non-controlled substances. 

Controlled substances collected by 

collectors may not be individually 

counted or inventoried. In addition, 

DEA proposes various collection 

security and recordkeeping 

requirements. 

DEA appreciates that there is a cost to 

voluntarily providing these methods of 

collection and destruction. DEA notes 

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 benefit the public by 

decreasing the supply of controlled 

substances available for misuse, abuse, 

and accidental ingestion, and protect 

the environment from potentially 

harmful contaminants. 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, the proposed regulation 

specifies that mail-back program 

collectors may partner with third parties 

to make mailers 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 mailers. 

Registrant Disposal 

DEA proposes to delete the existing 

rule related to registrant disposal, 21 

CFR 1307.21, and incorporate similar 

requirements on proper disposal 

procedure, security, and recordkeeping 

in a new part 1317 on disposal. DEA 

proposes these changes in order to 

provide consistent disposal procedures 

for each registrant category, regardless 

of geographic location. In addition, DEA 

proposes to modify 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. 

Reverse Distributors 

DEA proposes revised regulations for 

reverse distributors that are clear, 

consistent, and consolidated into one 

part. Reverse distributors are often the 

last registrant to possess controlled 

substances prior to destruction because 

they are at the end of the closed system 

and the same recordkeeping safeguards 

that exist when controlled substances 

are distributed between registrants are 

not present. 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. DEA believes that the 

proposed regulations will help reverse 

distributors comply with the Controlled 

Substances Act in a manner that 

effectively decreases the risk of the 

diversion of controlled substances 

during the disposal process. DEA 

proposes to revise the definition of 

reverse distributor in addition to 

proposing new procedures that reverse 

distributors must follow to acquire 

controlled substances from registrants 

and other security and recordkeeping 

requirements. 

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1The Attorney General’s delegation of authority 

to DEA may be found at 28 CFR 0.100. 

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 these terms are 

not defined. For example, in the CSA, see 21 U.S.C. 

822(g); 824(f) and (g); 826(c), (e), and (f); 827(a)(3) 

and (d)(1); 842(a)(7); 853(n); 880(a)(2); 881(e)(1); 

and 958(d)(6); and in the CFR, see 21 CFR 

1307.21(b). 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.’’ 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 Notice of Proposed Rulemaking, 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. When necessary to specify a particular activity 

within the disposal process, the particular activity 

is identified, e.g., transfer, deliver, collect/ 

collection, return, recall, destroy/destruction. 

Return and Recall 

DEA proposes to delete the existing 

rule on return and recall, 21 CFR 

1307.12, and incorporate into a new part 

1317 clarified and separate return and 

recall requirements for registrants and 

non-registrants. 

Methods of Destruction 

DEA proposes a standard of 

destruction—non-retrievable—for 

persons that intend to destroy 

controlled substances. In particular, 

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. 

Background 

Legal Authority 

The Drug Enforcement 

Administration (DEA) implements and 

enforces Titles II and III of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970 and the 

Controlled Substances Import and 

Export Act (21 U.S.C. 801–971), as 

amended, and referred to as the 

Controlled Substances Act (CSA).1 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 

chemicals for legitimate medical, 

scientific, research, and industrial 

purposes. 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 based on their use and 

importance to the manufacture of 

controlled substances (List I or List II 

chemicals). 21 U.S.C. 802(33)–(35). 

The CSA establishes a closed system 

of distribution that requires 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 

controlled substances is essential to 

preventing the diversion of controlled 

substances into the illicit market. 

In order to maintain this closed 

system of distribution, persons that 

manufacture, distribute, dispense, 

import, export, or conduct research or 

chemical analysis with controlled 

substances and listed chemicals are 

required to register with DEA at each 

principal place of business or 

professional practice. Persons registered 

with 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 that possess 

controlled substances are required to 

register with DEA. For example, a 

patient who receives a controlled 

substance pursuant to a lawful 

prescription, also known as an ultimate 

user, is not required to register with 

DEA in order to receive and possess that 

controlled 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 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 controlled substances, 

if they distribute (i.e., deliver or 

transfer) such controlled substances 

without the appropriate registration, 

they are in violation of the CSA.3 Such 

unlawful distribution includes the 

transfer of controlled substances for the 

purpose of disposal.4

On October 12, 2010, the Secure and 

Responsible Drug Disposal Act of 2010 

(Disposal Act) was enacted (Pub. L. 

111–273, 124 Stat. 2858). The Disposal 

Act amended the CSA to allow an 

ultimate user to ‘‘deliver’’ a controlled 

substance ‘‘to another person for the 

purpose of disposal’’ if the person 

receiving the controlled substance is 

authorized to receive that substance 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 DEA. 

In addition to authorizing ultimate 

users to deliver their controlled 

substances to another person for the 

purpose of disposal, the Disposal Act 

also authorized any person lawfully 

entitled to dispose of an ultimate user 

decedent’s property to deliver the 

ultimate user’s controlled substance to 

another person for the purpose of 

disposal if the ultimate user dies while 

in lawful possession of the controlled 

substance. The Disposal Act also gave 

DEA the ability, by regulation, to 

authorize long term care facilities 

(LTCFs) to dispose of controlled 

substances on behalf of ultimate users 

who reside or have resided at the LTCF. 

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5H.R. Rep. No. 91–1444 (1970), reprinted in 1970 

U.S.C.C.A.N. 4566, 4571–4572. 

6 In 1973, the BNDD was abolished and all BNDD 

functions were transferred to DEA. Reorganization 

Plan No. 2 of 1973, 38 FR 18380 (July 2, 1973). 

7The procedures are found today in 21 CFR 

1307.21. 

Congress directed 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. 

History of Disposal of Controlled 

Substances 

In 1970, Congress created the CSA 

after consolidating more than 50 laws 

related to the control of narcotics and 

dangerous drugs. The statute was 

‘‘designed to improve the 

administration and regulation of the 

manufacturing, distribution, and 

dispensing [and import/export] of 

controlled substances by providing for a 

‘closed’ system of drug distribution for 

legitimate handlers of such drugs’’ with 

criminal penalties for transactions 

outside the legitimate chain.5 With the 

enactment of the CSA, the Attorney 

General delegated the responsibility for 

promulgating the CSA’s implementing 

regulations to DEA’s predecessor, the 

Bureau of Narcotics and Dangerous 

Drugs (BNDD).6

BNDD recognized that to maintain the 

closed system of distribution, secure 

avenues for the destruction of controlled 

substances were essential. The 

implementing regulations specifically 

addressed the issue of the disposal of 

controlled substances (36 FR 7776, 

April 24, 1971). In particular, the 

implementing regulations outlined a 

process under which any person 

lawfully in possession of a controlled 

substance could distribute such 

substance to the person from whom he/ 

she obtained it or return it to the 

manufacturer or the manufacturer’s 

registered agent, and created procedures 

for any person in possession of a 

controlled substance, with instruction 

from DEA, to either deliver or transfer 

the substance to another for destruction, 

or to destroy that substance themselves. 

21 CFR 1307.12 and 1307.21. These 

procedures have changed little since 

1971. 

DEA Registrant Disposal—Reverse 

Distributors 

Through the mid-1990s, DEA 

accepted controlled substances from 

registrants for destruction or authorized 

registrants to destroy controlled 

substances pursuant to 21 CFR 1307.21. 

Manufacturers also accepted returns of 

controlled substances from their 

customers as an additional service. 

Eventually, a group of brokers emerged 

with the sole purpose to collect 

controlled substances from registrants 

for destruction pursuant to the 

procedures outlined in DEA’s 

regulations.7 Initially, this group 

registered with DEA as distributors and 

called the services that they provided 

‘‘reverse distribution.’’ At about the 

same time, another group emerged 

called ‘‘inventory control processors/ 

auditors’’ whose primary purpose was 

to identify expired substances in a 

registrant’s inventory and prepare them 

for disposal by the registrant pursuant to 

21 CFR 1307.21, or return to the person 

from whom it was obtained or to the 

manufacturer. This group was not 

required to register with DEA in order 

to conduct their activities because they 

did not take possession of the 

substances. Any inventory control 

processors/auditors that wanted to take 

possession of controlled substances 

were required to register with DEA as 

distributors. To reduce the risk of 

diversion from these activities, and 

ensure accountability during the 

disposal process, DEA and the 

registered distributors entered into 

memorandums of understanding 

(MOUs) that outlined acceptable 

disposal procedures until permanent 

regulations were finalized. 

Initially, DEA proposed to codify 

these MOUs by issuing a Notice of 

Proposed Rulemaking to define and 

register a new category of manufacturer 

registration called ‘‘disposers’’ that 

would authorize those registrants to 

receive controlled substances for the 

primary purpose of destruction (60 FR 

43732, August 23, 1995). This rule was 

never finalized. In 2003, DEA 

readdressed the issue of registrant 

disposal in an Interim Final Rule (IFR) 

to define and register ‘‘reverse 

distributors’’ (68 FR 41222, July 11, 

2003). In 2005, DEA published a final 

rule, thereby finalizing a new category 

of distributor registration called 

‘‘reverse distributors’’ (70 FR 22591, 

May 2, 2005). The final rule authorized 

reverse distributors to acquire 

controlled substances from DEA 

registrants for the purpose of return to 

the manufacturer or manufacturer’s 

agent or for processing those substances 

for disposal in accordance with 21 CFR 

1307.21. The final rule also codified 

security, recordkeeping, reporting, and 

order form requirements applicable to 

reverse distributors. 

Non-Registrant Disposal 

As discussed above, prior to passage 

of the Disposal Act, the CSA did not 

address the disposal of controlled 

substances by ultimate users. 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.). The CSA did not, however, 

account for circumstances in which 

controlled substances were lawfully 

dispensed to and possessed by an 

ultimate user, but not fully used. To this 

end, the CSA did not authorize the 

ultimate user to transfer unwanted and 

unused controlled substances to another 

person for the purpose of disposal. 

Moreover, the CSA did not address 

the disposal of controlled substances by 

long term care facilities (LTCFs). DEA 

defines a LTCF as ‘‘a nursing home, 

retirement care, mental care or other 

facility or institution which provides 

extended health care to resident 

patients.’’ 21 CFR 1300.01(b). Generally, 

controlled substances are prescribed by 

a LTCF resident’s physician and 

dispensed by the resident’s pharmacist; 

such controlled substances are owned 

by the resident. This is in contrast with 

patients in a hospital where controlled 

substances are dispensed dose by dose 

and remain under the possession and 

control of the registered dispenser, the 

hospital. Accordingly, a LTCF may 

secure its residents’ controlled 

substances for custodial purposes only. 

The controlled substances remain in the 

lawful possession of the resident, the 

ultimate user. As with any other 

ultimate user, prior to the enactment of 

the Disposal Act, a LTCF resident in 

lawful possession of dispensed 

controlled substances could not 

distribute those substances to another 

person, even for the purpose of disposal. 

In anticipation of the growing need of 

ultimate users and LTCFs to dispose of 

unused and unwanted controlled 

substances, DEA published an Advance 

Notice of Proposed Rulemaking to 

solicit information on the disposal of 

controlled substances by ultimate users 

and LTCFs (74 FR 3480, January 21, 

2009). Subsequently, as discussed 

above, on October 12, 2010, the Secure 

and Responsible Drug Disposal Act of 

2010 was enacted. 

Existing DEA Regulations 

Existing DEA regulations on the 

disposal of controlled substances are 

codified at 21 CFR 1307.12 and 1307.21. 

The process for returns is outlined in 21 

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8The National Take-Back Days were held on 

September 25, 2010, April 30, 2011, October 29, 

2011, April 28, 2012, and September 29, 2012. 

9 DEA registrants are not authorized to dispose of 

controlled substances at these events; DEA 

registrants must comply with the current DEA 

regulations regarding disposal of controlled 

substance stock/inventory. 

10Centers for Disease Control and Prevention, 

‘‘Morbidity and Mortality Weekly Report,’’ Vol. 61, 

No. 1, at 10 (January 13, 2012). 

11Partnership for a Drug-Free America and 

MetLife Foundation, ‘‘2009 Parents and Teens 

Attitude Tracking Study Report,’’ March 2, 2010. 

12Partnership for a Drug-Free America and 

MetLife Foundation, ‘‘2010 Partnership Attitude 

Tracking Study,’’ April 6, 2011. 

13The National Survey on Drug Use and Health 

(NSDUH) is an annual survey of the civilian, noninstitutionalized, population of the United States 

aged twelve or older. The survey is conducted by 

the Department of Health and Human Services 

Office of Applied Studies, Substance Abuse and 

Mental Health Services Administration (SAMHSA). 

14Substance Abuse and Mental Health Services 

Administration, ‘‘Results from the 2010 National 

Survey on Drug Use and Health: Volume I, 

Summary of National Findings,’’ Office of Applied 

Studies, 2011 (NSDUH Series H–41, HHS 

Publication No. SMA 11–4658), http://www.oas.

samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf. 

15Partnership for a Drug-Free America and 

MetLife Foundation, ‘‘2010 Partnership Attitude 

Tracking Study,’’ April 6, 2011. 

16Lloyd D. Johnson, Ph.D., et al, ‘‘Monitoring the 

Future National Results on Adolescent Drug Use: 

Overview of Key Findings, 2011,’’ Institute for 

CFR 1307.12 and permits any person in 

lawful possession of a controlled 

substance to distribute that substance, 

without being registered to distribute, to 

the person from whom the substance 

was obtained or to the manufacturer or 

manufacturer’s registered agent. 

The procedure governing the transfer 

of controlled substances for disposal is 

outlined in 21 CFR 1307.21. In the 

existing regulations, any person in 

possession of any controlled substance 

that desires or is required to dispose of 

such substance may request authority 

and instructions for disposal from the 

DEA Special Agent in Charge (SAC) in 

the region in which they are located. 

The SAC must authorize and instruct 

applicants to dispose in one of four 

ways, by: (1) Transfer to a DEA 

registrant authorized to possess the 

substance; (2) delivery to an agent of 

DEA or to the nearest DEA office; (3) 

destruction in the presence of an agent 

of DEA or other authorized person; or 

(4) such other means that the SAC 

determines to assure that the substance 

does not become available to 

unauthorized persons. 21 CFR 

1307.21(b). 

Registrants requesting authority and 

instructions from the SAC to dispose of 

controlled substances must submit to 

the SAC three copies of DEA Form 41 

listing the controlled substances that the 

registrant would like to dispose. 21 CFR 

1307.21(a). Registrants required to 

regularly dispose of controlled 

substances may ask the SAC for 

authorization to dispose of those 

substances without prior approval from 

DEA in each instance if the registrant 

agrees to keep records of disposal. 

Further, the SAC may place additional 

conditions upon the ongoing approval 

to dispose. 21 CFR 1307.21(c). 

Reverse Distributors 

DEA currently defines a reverse 

distributor as ‘‘a registrant who receives 

controlled substances acquired from 

another DEA registrant for the purpose 

of—(1) Returning unwanted, unusable, 

or outdated controlled substances to the 

manufacturer or the manufacturer’s 

agent; or (2) Where necessary, 

processing such substances or arranging 

for processing such substances for 

disposal.’’ 21 CFR 1300.01(b). Reverse 

distributors are required to meet general 

security requirements, the security 

requirements applicable to nonpractitioners, and specific inventory, 

recordkeeping, and reporting 

requirements. DEA registrants are 

authorized to distribute their lawfully 

possessed controlled substances to a 

registered reverse distributor to the 

extent authorized by their registration 

and in conformity with the CSA and its 

implementing regulations. 21 U.S.C. 

822(b) and 958(g); See, e.g., 21 CFR 

1301.13(e) and 1307.11. Manufacturers, 

distributors, importers, and 

practitioners are currently authorized to 

distribute their lawfully possessed 

controlled substances to a reverse 

distributor without prior authorization 

from the SAC in the region they are 

located. 21 CFR 1301.13(e)(i), (ii), (viii) 

and 1307.11(a)(2). 

Law Enforcement Agencies and 

Ultimate User Take-Back Events 

Until DEA finalizes the implementing 

regulations for the Disposal Act and 

expanded options for disposal are 

available, ultimate users may not deliver 

their lawfully obtained controlled 

substances to any other person for the 

purpose of disposal other than by 

surrender to law enforcement or under 

the direction of the DEA Special Agent 

in Charge in the area in which the 

person is located. In the interim, DEA 

has established National Take-Back 

Days.8 DEA organized these nationwide 

one day events as a collaborative effort 

with state and local law enforcement 

agencies. The National Take-Back Days 

provide the public with a convenient 

and secure way to surrender 

pharmaceutical controlled substances to 

law enforcement for destruction.9

Prescription Drug Abuse Epidemic 

Before the Disposal Act, the CSA did 

not address the disposal of controlled 

substances by ultimate users. To dispose 

of their controlled substances, ultimate 

users were permitted to destroy the 

substances themselves (e.g., mix the 

substances with coffee grounds, place in 

a plastic bag, and throw into the garbage 

or flush) or surrender the substances to 

law enforcement or DEA. There is 

concern, however, that throwing 

controlled substances into the garbage 

or flushing them can contribute to 

harming the environment. Because the 

public has limited options for disposal, 

outdated and unwanted controlled 

substances often accumulate in 

medicine cabinets, easily within reach 

of children and teenagers. In passing the 

Disposal Act, Congress recognized that 

the secure disposal of controlled 

substances is important because of the 

significant prescription drug abuse 

problem in the United States. The 

Centers for Disease Control and 

Prevention declared prescription drug 

overdoses an epidemic.10 Studies show 

the adverse consequences associated 

with the substantially high levels of 

abuse and misuse (non-medical use) of 

prescription drugs. 

The availability of outdated or 

unwanted prescription drugs is 

problematic because there is a concern 

that young people may perceive 

prescription and/or over-the-counter 

drugs as ‘‘safer’’ than illegal drugs 

because of their intended, legitimate 

medical use.11 This misperception may 

be shared by parents. Over 20 percent of 

parents believe that it is acceptable to 

give a teen a prescription drug that was 

not prescribed to them.12 The 2010 

National Survey on Drug Use and 

Health (NSDUH)13 indicates that over 70 

percent of Americans twelve and older 

who used pain relievers non-medically 

in the previous year obtained the drugs 

from a friend or relative.14 Another 

study found that more than 50 percent 

of teens obtained prescription drugs 

from their own family’s medicine 

cabinet.15

The prevalence of controlled 

substance prescription drug abuse 

among teenagers is right behind their 

abuse of marijuana (to include organic 

marijuana and synthetic cannabinoids). 

The 2011 ‘‘Monitoring the Future’’ 

survey of teenagers found that 8.1 

percent of high school seniors reported 

non-medical use of Vicodin (a brand 

name for Schedule III hydrocodone 

combination products) in the past year, 

and 4.9 percent reported non-medical 

use of OxyContin (a brand name for 

Schedule II oxycodone sustained release 

products) in the past year.16 This is 

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Social Research, The University of Michigan, 

22012. 

17Lloyd D. Johnston, Ph.D., et al, ‘‘Monitoring the 

Future National Results on Adolescent Drug Use: 

Overview of Key Findings, 2009,’’ National Institute 

of Drug Abuse, 2010 (NIH Publication No. 10– 

7583). 

18Substance Abuse and Mental Health Services 

Administration, ‘‘Results from the 2010 National 

Survey on Drug Use and Health: Volume I, 

Summary of National Findings,’’ Office of Applied 

Studies, 2011 (NSDUH Series H–41, HHS 

Publication No. SMA 11–4658), http://www.oas.

samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf. 

19These estimates were similar to those from the 

2009 survey but 13 percent higher than those from 

the 2008 survey. 

20 Id. 

21Substance Abuse and Mental Health Services 

Administration, 2010 National Survey on Drug Use 

and Health. 

22U.S. Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Center for Injury Prevention 

and Control, ‘‘Drug Poisoning Deaths in the United 

States, 1980–2008,’’ December 2011. 

23Behavioral Health Statistics and Quality, 

‘‘Highlights of the 2009 Drug Abuse Warning 

Network (DAWN) Findings on Drug-Related 

Emergency Department Visits,’’ The DAWN Report, 

December 28, 2010. 

24 Id. at 4. 

25 Id. at 3. 

26 DEA does not address the proper disposal of 

listed chemicals by DEA registrants in this 

rulemaking. 

27Any previous waivers, MOUs, and MOAs 

issued in accordance with 21 CFR 1307.21 shall be 

superseded by this rulemaking on the ‘‘Disposal of 

Controlled Substances’’ if and when it is finalized. 

28 DEA proposes in 21 CFR 1301.76 to delete 

reference to 1307.12 and replace it with reference 

to 21 CFR part 1317; in 21 CFR 1304.11(e) and the 

introductory paragraph of 1304.22 to delete 

reference to 21 CFR 1307.12; in 21 CFR 1301.25(i), 

1301.52(c), and 1307.13 to delete reference to 21 

CFR 1307.21 and replace it with reference to 21 

CFR part 1317; in 21 CFR 1304.25(a)(9) and 

1304.25(b)(9) to delete reference to 21 CFR 1307.22 

and replace it with reference to 21 CFR part 1317; 

and in 21 CFR 1304.04(a) to add reference to 21 

CFR part 1317. DEA also proposes in 21 CFR 

1307.22 to delete reference to 21 CFR 1307.21, and 

replace it with reference to 21 CFR part 1317. DEA 

proposes to revise the title of 21 CFR 1307.22 to 

‘‘Delivery of surrendered and forfeited controlled 

substances’’ for clarity. 

consistent with reports by high school 

students of increased non-medical use 

of painkillers in the past five years.17

According to a 2009 survey by the 

Partnership at Drugfree.org, more than 

50 percent of teenagers (grades 9–12) 

believe that prescription drugs are easier 

to obtain than illegal drugs. 

Prescription drug abuse is the fastest 

growing drug problem in the United 

States. Findings from the 2010 NSDUH 

estimate that 7.0 million persons aged 

twelve or older used prescription-type 

psychotherapeutic drugs—pain 

relievers, anti-anxiety medications, 

stimulants, and sedatives—nonmedically in the previous month.18 This 

represents 2.7 percent of the U.S. 

population.19 In 2010, 2 million persons 

aged twelve or older used pain relievers 

non-medically for the first time.20 On 

average, every day 2,046 12 to 17-yearolds abuse a prescription pain reliever 

for the first time.21

Non-medical prescription drug use, 

particularly among young adults, is 

having a devastating effect on the 

United States. According to the Centers 

for Disease Control and Prevention, 

poisoning deaths, which include drug 

overdoses such as those from 

prescription drugs, are the leading cause 

of injury death in the United States; 

nearly nine out of ten poisoning deaths 

are caused by drugs and more than 40% 

of those involve opioid analgesics.22

According to SAMHSA’s latest Drug 

Abuse Warning Network (DAWN) data, 

of the 4.6 million emergency 

department visits in 2009 associated 

with drug use, about 1.2 million visits 

involved the non-medical use of 

pharmaceuticals.23 Emergency 

department visits involving nonmedical use of pharmaceuticals (misuse 

or abuse) almost doubled between 2004 

and 2009 from 627,291 in 2004 to 

1,244,679 visits in 2009 (a 98.4 percent 

increase).24 About half of the 2009 

emergency department visits related to 

misuse or abuse of pharmaceuticals 

involved painkillers and more than onethird involved drugs to treat insomnia 

and anxiety.25

Scope of Proposed Rule 

In response to this growing problem, 

DEA is proposing new, expanded 

regulations for the disposal of controlled 

substances by ultimate users in 

accordance with the Disposal Act. These 

regulations will provide ultimate users 

with more options for disposal of their 

controlled substances so that the 

controlled substances will not 

accumulate and be available for misuse, 

abuse, and accidental ingestion by 

children and the elderly. In drafting the 

implementing regulations, DEA 

considered the public health and safety, 

ease and cost of program 

implementation, and participation by 

various communities. To this end, 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 (e.g., 

ultimate users).26 The reverse 

distributor registration category, which 

is pertinent to the process of registrant 

disposal, was included in this 

comprehensive review. 

As discussed above, DEA currently 

regulates the disposal of controlled 

substances by registrants and other 

persons in accordance with 21 CFR 

1307.21 and regulates the returns 

process through 21 CFR 1307.12. The 

existing disposal regulation gives DEA 

Special Agents in Charge (SACs) the 

discretion to authorize disposal in a 

manner that reduces the risk of 

diversion from this activity on a caseby-case basis. These regulations have 

changed little since the CSA was 

enacted. While this approach is 

effective, with the enactment of the 

Disposal Act and the increasing need for 

the responsible disposal of controlled 

substances by registrants and nonregistrants alike, DEA believes that in 

order to securely and effectively dispose 

of unwanted or unused controlled 

substances, consistent nationwide 

standards on disposal are necessary. As 

a result, DEA proposes to delete 21 CFR 

1307.12 on ‘‘Distribution to supplier or 

manufacturer’’ and 21 CFR 1307.21 on 

‘‘Disposal of controlled substances’’ and 

promulgate a new part 1317 that will 

expand available disposal options, 

establish nationwide standards for the 

disposal of controlled substances, and 

comprehensively outline the process 

and procedure for the disposal of 

controlled substances by registrants, 

ultimate users, and other non-registrants 

such as long term care facilities.27

The goal of this proposed new part on 

disposal, consistent with Congress’s 

goal in passing the Disposal Act, is to 

set controlled substance diversion 

prevention parameters that will allow 

public and private entities to develop a 

variety of methods for collecting and 

destroying controlled substances in a 

secure, convenient, and responsible 

manner. DEA believes that the new part 

on disposal will provide registrants and 

non-registrants alike clear and 

consistent requirements for the disposal 

of controlled substances. It is intended 

to maximize cost efficiency, voluntary 

participation, and public accessibility 

while simultaneously promoting the 

secure and responsible disposal of 

controlled substances in order to 

prevent diversion. 

In accordance with the changes 

described above, DEA proposes to delete 

any reference to 21 CFR 1307.12 and 

1307.21 and replace it with a reference 

to the new 21 CFR part 1317, where 

appropriate.28 DEA also proposes to 

revise 21 CFR 1301.13(e)(1)(i) to delete 

reference to a disposer category of 

registration in the coincident activity 

column for manufacturers. A disposer 

category of registration was proposed by 

DEA in 1995, but was never finalized 

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(60 FR 43732, August 23, 1995). 

Reference to a disposer category was 

inadvertently included in a previous 

rulemaking (68 FR 58587, October 10, 

2003). 

January 19–20, 2011 Public Meeting 

On January 19 and 20, 2011, DEA 

held a well-attended public meeting to 

receive information from interested 

parties and the public and gather ideas 

for drafting regulations for the newly 

enacted Disposal Act. (The Notice of 

Meeting was published in the Federal 

Register on December 22, 2010, 75 FR 

80536.) This meeting provided an 

opportunity for all interested persons 

—the general public, including ultimate 

users, parents, pharmacies, waste 

management companies, long term care 

and pharmaceutical related industries, 

as well as federal, state, and local 

agencies, including law enforcement 

personnel, and others—to express their 

views regarding safe and effective 

methods of disposal of controlled 

substances consistent with the CSA. 

Representatives of various industries 

and organizations as well as federal, 

state, and local agencies made 

presentations at the meeting and many 

submitted written comments prior to the 

meeting. 

In drafting the Disposal Act 

implementing regulations, DEA 

gathered information about disposal 

from the more than 70 written 

comments and 44 oral presentations that 

were submitted and transcribed from 

the two day public meeting. Information 

and experience resulting from pilot 

projects around the United States 

involving mail-back programs, take-back 

events, and collection receptacles for 

pharmaceuticals were shared and 

helped inform this proposed rule. 

Representatives of law enforcement 

agencies provided information on their 

experience, existing procedures, and 

perspective, particularly with respect to 

take-back events as a method of 

collection. Representatives from DEA 

registrant and other affected groups, 

such as pharmacies, reverse distributors, 

and the waste management industry, 

provided insights on technology and 

existing destruction procedures. 

Presentations by the Environmental 

Protection Agency, the Food and Drug 

Administration, the U.S. Postal Service, 

the U.S. Army, and state and local 

agencies provided information on 

relevant federal, state, and local laws 

and procedures pertaining to the 

disposal and transportation of 

controlled substances, particularly 

pharmaceuticals. DEA appreciated and 

considered all information provided at 

or submitted in response to the Notice 

of Meeting in drafting this NPRM. 

Proposed Disposal Act Implementing 

Regulations 

Disposal of Controlled Substances by 

Ultimate Users—Authorized Persons 

In accordance with the Disposal Act, 

DEA proposes new regulations for the 

disposal of controlled substances by 

ultimate users and other nonregistrants—in particular: (1) Persons 

lawfully entitled to dispose of ultimate 

user decedent’s property and (2) LTCFs 

on behalf of ultimate users that reside or 

have resided at that LTCF. In drafting 

these proposed implementing 

regulations, DEA considered the public 

health and safety, ease and cost of 

program implementation, and 

participation by various communities. 

To this end, DEA proposes three options 

for ultimate users to dispose of 

controlled substances: (1) Take-back 

events; (2) mail-back programs; and (3) 

collection receptacle locations. These 

proposed options are voluntary and no 

person is required to establish or 

operate a disposal program, although 

any person who chooses to do so and is 

authorized by DEA to do so must adhere 

to the final regulations. 

DEA proposes to authorize ultimate 

users and persons lawfully entitled to 

dispose of an ultimate user decedent’s 

property to deliver lawfully possessed 

controlled substances in Schedules II, 

III, IV, and V to law enforcement 

agencies through take-back events, mailback programs, and collection 

receptacles, and to authorized collectors 

through mail-back programs and 

collection receptacles. DEA is also 

proposing to authorize LTCFs, on behalf 

of an ultimate user that resides or has 

resided at that LTCF, to deliver a 

resident’s lawfully possessed controlled 

substances in Schedule II, III, IV, or V 

to certain on-site collection receptacles 

operated by a registered retail pharmacy 

that is an authorized collector. The 

collection of Schedule I controlled 

substances is not permitted because, 

generally, ultimate users cannot 

lawfully possess Schedule I substances 

unless they are participating in an 

investigational use of drugs pursuant to 

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

ultimate users in lawful possession of 

Schedule I substances for 

investigational use, DEA proposes that 

they follow the disposal procedures in 

21 CFR 1317.85(b). Furthermore, the 

proposed collection methods are 

intended for the collection and 

destruction of lawfully possessed 

controlled substances, not as an avenue 

for the disposal of substances that were 

illegally obtained. 

DEA proposes in sections 1317.65— 

1317.80 that controlled substances 

collected from ultimate users and other 

authorized non-registrant persons may 

be comingled with non-controlled 

substances—both controlled and noncontrolled substances may be collected 

together so long as the requirements 

outlined for controlled substances are 

followed. Comingling reduces the risk of 

diversion and is practical, efficient, and 

economical. Members of the public 

cannot easily identify the difference 

between controlled and non-controlled 

substances. As collection pilot programs 

demonstrate, the requirement that 

controlled and non-controlled 

substances be collected separately is 

expensive, time-consuming, and 

hampers the collection process. In 

addition, comingling controlled 

substances is another way to minimize 

the risk of diversion of collected 

controlled substances. For example, 

many pharmacies and institutional 

practitioners disperse controlled 

substances throughout the stock of noncontrolled substances in order to deter 

the theft or diversion of the controlled 

substances. See 21 CFR 1301.75(b). 

DEA proposes in section 1317.30 that 

federal, state, tribal, and local law 

enforcement agencies continue with 

authority to collect ultimate user 

controlled substances, and that certain 

registrants authorized by DEA to be a 

‘‘collector’’ be authorized to collect 

controlled substances from ultimate 

users, persons lawfully entitled to 

dispose of ultimate user decedent’s 

property, and, in some circumstances, 

long term care facilities. DEA is 

authorizing certain registrant categories 

to be ‘‘collectors’’ so that DEA can 

ensure sufficient physical security 

controls are in place, thereby 

minimizing the risk of diversion. 

Registrants are subject to controls 

related to their DEA registration. These 

pre-existing controls will protect against 

the diversion of controlled substances in 

the process of ultimate user collection. 

Possession for Disposal 

Once a controlled substance is 

lawfully dispensed to an ultimate user, 

the ultimate user is in possession of that 

substance. Only the ultimate user or 

other authorized persons (i.e., persons 

lawfully entitled to dispose of an 

ultimate user decedent’s property and, 

in some cases, the LTCF where the 

ultimate user resides or has resided) 

may dispose of such controlled 

substances in accordance with DEA’s 

proposed ultimate user disposal 

regulations. In contrast, a controlled 

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substance dispensed for immediate 

administration pursuant to an order for 

medication in an institutional setting 

remains in the possession of that 

registered institution, even if 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). 

Such remaining substance must be 

properly recorded, stored, and 

destroyed in accordance with DEA 

regulations, and all applicable federal, 

state, tribal, and local laws and 

regulations. These same principles 

would apply to hospice settings, which 

may be registered by DEA as an 

institutional practitioner or may be 

unregistered like many LTCFs. 

Law Enforcement Agencies 

DEA proposes specific language in 

section 1317.35 to continue to authorize 

law enforcement agencies, on a 

voluntary basis, to collect controlled 

substances from ultimate users and 

persons lawfully entitled to dispose of 

an ultimate user decedent’s property 

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

receptacles located at the law 

enforcement agency’s physical address. 

DEA recommends that law 

enforcement agencies electing to 

participate in ultimate user disposal 

maintain any records of receipt or 

collection in a manner that is consistent 

with that agency’s recordkeeping 

requirements for illicit controlled 

substance evidence handling and store 

any controlled substances collected in a 

manner that reasonably prevents the 

diversion of controlled substances and 

is consistent with that agency’s standard 

procedures for storing illicit controlled 

substances. Destruction of controlled 

substances must be in accordance with 

applicable federal, state, tribal, and local 

laws and regulations. DEA recommends 

that law enforcement agencies also keep 

a record of any transfer of controlled 

substances to reverse distributors for 

destruction; such records may assist 

DEA in ensuring that reverse 

distributors are keeping proper records 

of those controlled substances they 

acquire from law enforcement agencies 

that conduct ultimate user disposal 

activities. DEA recognizes that law 

enforcement agencies have existing 

procedures regarding the handling, 

storage, or transfer for destruction of 

controlled substances. These proposed 

rules do not require changes to those 

procedures. DEA anticipates that those 

existing procedures will provide the 

necessary security to prevent the 

diversion of controlled substances. 

DEA proposes that law enforcement 

agencies that choose to conduct mailback programs within their jurisdiction 

must make available to ultimate users 

packages described in proposed section 

1317.70. Such packages may, however, 

be made available pursuant to a 

partnership or other agreement between 

the law enforcement agency and another 

person for the purpose of funding, 

dissemination, production, or other 

non-collection activity meant to 

facilitate the law enforcement agency’s 

mail-back program. Such standards will 

help to alleviate the primary security 

concerns related to mail-back programs. 

As explained below, many such 

concerns exist regardless of the 

destination of the mail-back packages; 

thus, security standards related to the 

mail-back packages must be maintained 

even if the program is conducted by a 

law enforcement agency. DEA 

emphasizes, however, that the authority 

of law enforcement agencies to conduct 

ultimate user disposal programs is not a 

mechanism by which registrants may 

circumvent these proposed regulations 

or any other applicable laws or 

regulations. Any person, group, or entity 

that partners with a law enforcement 

agency to implement an ultimate user 

disposal program must comply with all 

applicable laws and regulations. In 

specific terms, any authorized collector 

that partners with a law enforcement 

agency to jointly conduct a collection 

program must adhere to these proposed 

regulations and any other applicable 

laws and regulations. 

DEA appreciates that implementing 

some of the proposed disposal methods 

may present challenges to some state, 

tribal, and local law enforcement 

agencies. When implementing any new 

community service, all government 

agencies must balance available 

resources against established priorities. 

DEA hopes that these regulations will 

provide flexibility and opportunities for 

communities, interest groups, 

registrants, and law enforcement 

agencies to partner together to provide 

cost effective, safe, and convenient 

methods of ultimate user disposal. DEA 

looks forward to receiving suggestions 

from state, tribal, and local law 

enforcement agencies concerning its 

proposed regulations for the disposal of 

controlled substances by law 

enforcement agencies. 

Collectors 

DEA proposes in section 1300.01(b) to 

define a ‘‘collector’’ as a registered 

manufacturer, distributor, reverse 

distributor, or retail pharmacy that is 

authorized to receive a controlled 

substance for the purpose of destruction 

from an ultimate user, person lawfully 

entitled to dispose of an ultimate user 

decedent’s property, or a long term care 

facility on behalf of an ultimate user 

that resides or has resided at that 

facility. In section 1317.40(a), DEA 

proposes that registered manufacturers, 

distributors, reverse distributors, and 

retail pharmacies may obtain 

authorization from DEA to be a 

collector. No manufacturer, distributor, 

reverse distributor, or retail pharmacy is 

required to be a collector. 

In proposing which DEA registrants 

could become authorized collectors, 

DEA considered public health and 

safety, diversion control, and 

convenience and accessibility. In 

particular, DEA is proposing to 

authorize registered retail pharmacies to 

become collectors because such 

registrants are open to the public and 

have theft and loss prevention measures 

within the pharmacy processing area as 

well as outside the confines of the 

prescription processing and pick-up 

area, which easily lends itself to secure 

collection receptacle placement. Retail 

pharmacy personnel also routinely 

handle controlled substances intended 

for the ultimate user in a public setting 

while keeping such substances secure, 

and they have experience comingling 

controlled and non-controlled 

substances in the receipt and storage 

process. As public retail establishments, 

retail pharmacies generally have 

experience with the general public as 

customers and routinely implement 

theft and loss prevention measures. 

For the foregoing reasons, retail 

pharmacies co-located with hospitals 

may be authorized to maintain 

collection receptacles in accordance 

with these regulations. Registered 

hospitals themselves, however, may not 

be authorized as collectors. This should 

have limited adverse impact on the 

ability of hospital patients to participate 

in ultimate user disposal because DEA 

believes many hospitals are co-located 

with registered retail pharmacies as a 

convenient service for outpatients. DEA 

proposes to restrict hospitals from being 

authorized collectors because they do 

not generally operate under the same 

business model or with similar theft and 

loss prevention procedures as retail 

pharmacies. For example, the general 

public is expected to enter retail 

pharmacies for short durations in order 

to conduct retail business. The physical 

layout of retail pharmacies is designed 

for open, clearly observable common 

areas and practically no areas 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, 

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29 In accordance with the Disposal Act, which 

permitted DEA to, by regulation, authorize LTCFs 

to dispose of controlled substances on behalf of 

ultimate users that reside or have resided at the 

LTCF (see 21 U.S.C. 822(g)(3)), DEA is also 

proposing to authorize the collection of controlled 

substances at those LTCFs for which a registered 

retail pharmacy is authorized to maintain a 

collection receptacle (see discussion of LTCFs 

below). 

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; they are 

much larger than retail pharmacies and 

many interactions occur behind closed 

doors without routine theft and loss 

prevention measures; and foot traffic is 

not routinely monitored for unlawful 

purposes. These differences reduce the 

effectiveness of the proposed 

regulation’s diversion control 

mechanisms and substantially increase 

the risk of diversion at hospitals if 

hospitals were authorized as collectors. 

The above discussed risks in allowing 

hospitals as collectors are not necessary 

in light of the many other options 

available to ultimate users to dispose of 

unwanted or unused controlled 

substances. 

In addition to the increased risk of 

diversion at hospitals, there is a risk of 

inadequate recordkeeping if hospitals 

are permitted as collectors. Unlike retail 

pharmacies, registered hospitals do not 

dispense controlled substances to 

ultimate users pursuant to legitimate 

prescriptions. Rather, registered 

hospitals administer controlled 

substances to inpatients dose by dose, 

and the controlled substances remain 

within the possession and control of the 

registered dispenser, the hospital. As 

such, registered hospitals may not 

dispose of controlled substances in 

collection receptacles, but must follow 

the revised regulations for registrant 

destruction, and keep records of such 

destruction. 

DEA is also proposing to allow retail 

pharmacies to operate collection 

receptacles in LTCFs under certain 

circumstances, as discussed below, 

because—unlike hospitals—LTCFs ‘‘face 

a distinct set of obstacles to the safe 

disposal of [ultimate user] controlled 

substances due to the increased volume 

of controlled substances they handle.’’ 

Pub. L. 111–273, 2, 124 Stat. 2858. DEA 

is further proposing to authorize 

registered manufacturers, distributors, 

and reverse distributors to become 

collectors because, although such 

registrants have registered locations that 

generally are not open to the public, 

they do have heightened security 

requirements and are accustomed to 

receiving, securing, and distributing 

large amounts of controlled substances 

on a daily basis. DEA believes that 

expanding collector authorization to 

these registrants will provide the 

necessary convenience and accessibility 

to the public while ensuring the public 

health and safety and minimizing 

potential diversion. 

To obtain authorization to be a 

collector, a manufacturer, distributor, 

reverse distributor, or retail pharmacy 

must apply for a modification to their 

registration in accordance with 21 CFR 

1301.51, which DEA is proposing to 

revise in order to reflect these changes. 

Upon DEA approval of this modification 

in registration, each authorized 

registrant’s DEA Certificate of 

Registration will specify that registrant’s 

status as a ‘‘collector’’ and the 

location(s) approved for collection. 

Once approved to be a collector, the 

option for renewal will be available to 

authorized registrants when they renew 

their registration. 

DEA proposes in section 1317.40(a) 

that if the registrant that is authorized 

to collect ceases activities as a collector, 

such registrant must modify their 

registration in accordance with 21 CFR 

1301.51 to indicate that they no longer 

collect. In accordance with 21 CFR 

1301.52, the registration of any person 

and any modifications, including 

authorization to be a collector, 

terminates if and when such person 

dies, ceases legal existence, 

discontinues business or professional 

practice, or surrenders a registration. 

Any registrant that ceases legal 

existence or discontinues business or 

professional practice must notify the 

Administrator promptly of such fact. 21 

CFR 1301.52(a). Additionally, a 

registrant’s authorization to collect is 

dependent upon the registration status 

of the manufacturer, distributor, reverse 

distributor, or retail pharmacy. 

Accordingly, the expiration, revocation, 

suspension, or surrender of a DEA 

registration will also result in the loss of 

the registrant’s authorization to be a 

collector. 

DEA proposes in section 1317.40(c) 

that authorized collectors may conduct 

the following activities: (1) Receive 

mail-back packages from ultimate users 

and persons lawfully entitled to dispose 

of an ultimate user decedent’s property 

if the collector has and utilizes an onsite method of destruction; (2) install, 

manage, and maintain collection 

receptacles at locations for which the 

registrant is authorized to collect; and 

(3) promptly dispose of sealed inner 

liners and their contents as provided for 

in § 1317.05(c)(2). DEA proposes in 

section 1317.40(b) that collection may 

occur only at the registered locations of 

manufacturers, distributors, reverse 

distributors, and retail pharmacies that 

are authorized to collect at those 

locations and at long term care facilities 

(LTCFs) at which registered retail 

pharmacies are authorized to maintain a 

collection receptacle (see discussion on 

LTCFs below). 

DEA proposes to authorize as 

collectors those persons already 

registered as manufacturers, 

distributors, reverse distributors, and 

retail pharmacies because, as registrants, 

these persons are accountable, have 

experience handling large volumes of 

controlled substances on a routine basis, 

and they are subject to controls related 

to their DEA registration. These preexisting controls also protect against the 

diversion of controlled substances in the 

process of ultimate user collection. 

Further, DEA believes that ultimate user 

collection should occur at DEA 

registered locations because these 

premises are subject to DEA inspection, 

security, and other controls.29 Such 

requirements ensure that proper 

security and other controls are in place 

to minimize the risk of diversion from 

the collection of controlled substances. 

Finally, with the passage of the Disposal 

Act, Congress did not provide DEA the 

authority to register persons specifically 

for the purpose of collecting and 

disposing of controlled substances from 

ultimate users. DEA is therefore 

restricted to operating within its 

previously existing statutory authority 

with regard to registration. 

In section 1317.45, DEA proposes that 

authorized collectors employ as an 

agent or employee with access to or 

influence over controlled substances 

acquired pursuant to their status as a 

collector, only those persons that have 

never been convicted of any felony 

offense related to controlled substances 

and have never, 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. DEA is proposing 

security requirements for collectors in 

order to strengthen the accountability of 

the ultimate user collection process, 

which occurs outside the closed system 

of distribution, by ensuring that only 

those employees that have met certain 

employee screening requirements have 

access to or influence over controlled 

substances collected from ultimate 

users. This requirement is similar to the 

employee screening requirements for 

registered practitioners in 21 CFR 

1301.76, where there is also a high risk 

of diversion. 

The information that collectors must 

maintain in their records is proposed in 

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30The recordkeeping requirements differ 

depending on whether the records pertain to the 

registrant’s inventory or stock, or the registrant’s 

activities as an authorized collector. The 

requirements contained in the current regulations 

are those imposed on registrants with regard to their 

stock on hand (i.e., their inventory of controlled 

substances). Controlled substances collected from 

ultimate users are not part of a registrant’s 

inventory and would not be counted as such. 

31Reverse distributors or distributors may acquire 

controlled substances that have been collected by 

collection receptacle at either an authorized 

collector’s registered location or, pursuant to 

sections 1317.75(g) and 1317.80(d), at a long term 

care facility for which a registered retail pharmacy 

is authorized to collect. See subsequent discussion 

for more detail on reverse distributors. 

32For clarity, DEA proposes in 21 CFR 

1304.11(e)(2) and 1304.22(b) to cross reference 

these reverse distributor and distributor 

recordkeeping requirements covered by 21 CFR 

1317.55. 

section 1317.50. In accordance with the 

CSA, every DEA registrant must 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).30 These records must be 

maintained separately from all other 

records of the registrant or, 

alternatively, in the case of non-narcotic 

controlled substances, be in such a form 

that required information is readily 

retrievable from the ordinary business 

records of the registrant. 21 U.S.C. 

827(b)(2). The records must be kept and 

be available for at least two years for 

inspection and copying by officers or 

employees of the Attorney General. 21 

U.S.C. 827(b)(3). DEA may promulgate 

regulations that specify the information 

that registrants are required to maintain 

in their records. 21 U.S.C. 827(b). 

To this end, DEA is proposing 

information that collectors must record 

based on the particular ultimate user 

collection method utilized (i.e., mailback program or collection receptacle). 

The inner liners and mail-back packages 

that DEA proposes to be utilized in the 

collection of ultimate user controlled 

substances are intended for the disposal 

of controlled substances. As a result, 

DEA is requiring that collectors make an 

inventory of all inner liners and mailback packages and maintain records on 

the use and destruction of such liners 

and packages in order to properly 

account for the disposal of controlled 

substances in accordance with the CSA. 

Once sealed, inner liners and mail-back 

packages shall not be opened, x-rayed, 

or otherwise penetrated and the 

substances contained in the inner liners 

and mail-back packages may not be 

individually handled, counted, 

inventoried, or otherwise discerned. 

DEA is also proposing in section 

1317.50 that collectors be exempt from 

the ARCOS requirements in 21 CFR 

1304.33 and the order form 

requirements in 21 CFR part 1305 only 

when they collect controlled substances 

from ultimate users or other authorized 

non-registrant persons. Such substances 

are outside the closed system of 

distribution, and these tracking and 

accountability mechanisms are designed 

for substances within the closed system 

of distribution. 

Registered Reverse Distributors and 

Distributors 

DEA appreciates that law enforcement 

agencies and authorized collectors may 

not have the resources to destroy 

controlled substances received from 

ultimate users. Such persons may use 

the services of a registered reverse 

distributor for this purpose. DEA 

proposes in section 1317.55(a) to 

authorize registered reverse distributors 

to acquire for purposes of destruction 

controlled substances that have been 

collected by: (1) Law enforcement 

agencies; and (2) authorized collectors 

through collection receptacles. DEA also 

proposes in section 1317.55(b) to 

authorize registered distributors, in 

addition to registered reverse 

distributors, to acquire for purposes of 

destruction controlled substances 

collected by authorized collectors 

through collection receptacles.31 DEA is 

proposing in section 1317.55(c) that 

registered reverse distributors and 

registered distributors that choose to 

acquire such collected controlled 

substances from authorized collectors 

do so in the manner prescribed for 

acquiring registrants’ controlled 

substance inventory for purposes of 

disposal. This consistent procedure will 

help provide certainty in the disposal 

process, and help prevent errors during 

the acquisition process. Such 

acquisitions may be made pursuant to 

pick-up by the reverse distributor or 

distributor at the registrant’s registered 

or authorized collection location, by 

delivery by common or contract carrier 

to the reverse distributor’s or 

distributor’s registered location, or by 

direct delivery from a non-practitioner 

to the reverse distributor’s or 

distributor’s registered location. 

DEA proposes that authorized 

collectors that conduct mail-back 

programs must have and use an on-site 

method of destruction, and, as a result, 

these collectors will not be authorized 

to deliver or transfer those substances to 

a registered reverse distributor or 

distributor. The requirement to destroy 

on-site would not apply to law 

enforcement agencies that conduct mailback programs; law enforcement 

agencies may continue to transfer any 

collected substance to an authorized 

reverse distributor. 

Registered reverse distributors and 

distributors do not have to be 

authorized collectors to acquire 

collected controlled substances from 

law enforcement agencies or authorized 

collectors. In such circumstances, the 

substances being acquired have already 

been collected by law enforcement 

agencies and authorized collectors and 

should already be securely sealed in an 

inner liner or mail-back package in 

accordance with sections 1317.65– 

1317.80. 

DEA also proposes in section 

1317.55(c) that those registered reverse 

distributors and distributors that acquire 

controlled substances from law 

enforcement agencies and authorized 

collectors must destroy such controlled 

substances or securely transfer and store 

the controlled substances utilizing 

applicable procedures described in 

section 1317.15(c) until timely 

destruction can occur. In addition, 

reverse distributors and distributors 

must destroy the controlled substances 

as soon as practicable but no later than 

fourteen calendar days of pick-up or 

delivery, pursuant to proposed section 

1317.15(d). Consistent procedures for 

the acquisition and disposal of 

registrant inventory and ultimate user 

collected controlled substances will 

streamline practices and help prevent 

confusion and error in the transfer, 

storage, and destruction processes. Any 

storage of such substances at the 

registered location of the reverse 

distributor or distributor must be in a 

manner consistent with the security 

requirements for Schedule II controlled 

substances. This is to minimize the risk 

of diversion because inner liners and 

mail-back packages shall not be opened 

once they are sealed and their contents 

will not be known, and, as a result, such 

liners and packages should be stored as 

though each contains a Schedule II 

controlled substance. 

DEA also proposes in sections 

1317.55(d) and 1317.100 to require that 

these reverse distributors and 

distributors keep records regarding the 

receipt, storage, transfer, and 

destruction of those controlled 

substances acquired from law 

enforcement agencies and authorized 

collectors.32 Such records will help to 

ensure that the collected substances are 

accounted for and properly destroyed. 

Finally, DEA proposes in section 

1317.55(e) and (f) to exempt reverse 

distributors and distributors that acquire 

collected controlled substances from 

law enforcement agencies or authorized 

collectors from the ARCOS 

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33 DEA proposes in section 1317.02 to define ‘‘law 

enforcement officer’’ for the purpose of 21 CFR part 

1317. In order to prevent the appearance that a third 

party has access to or influence over controlled 

substances, for example by directly or indirectly 

funding law enforcement disposal activities, DEA is 

requiring the law enforcement officer to be directly 

employed full time by a law enforcement agency, 

be under the direction and control of the federal, 

state, tribal, or local government, be acting in the 

course of their official duty, and be duly sworn and 

given the authority by the federal, state, tribal, or 

local government to: (1) Carry firearms; (2) execute 

and serve warrants; (3) make arrests without 

warrant; and (4) make seizures of property. 

requirements in 21 CFR 1304.33 and the 

order form requirements in 21 CFR part 

1305, only when they acquire controlled 

substances that have been collected 

from ultimate users by law enforcement 

agencies or authorized collectors. Such 

substances are outside the closed system 

of distribution, and these tracking and 

accountability mechanisms are designed 

for substances within the closed system 

of distribution. 

Disposal of Controlled Substances by 

Ultimate Users—Authorized Methods 

Take-Back Events 

The first method of collection that 

DEA proposes, in section 1317.65, is 

take-back events. Ultimate users and 

persons lawfully entitled to dispose of 

an ultimate user decedent’s property 

would be authorized to utilize a takeback event in accordance with 1317.65 

to dispose of their controlled substances 

in Schedules II, III, IV, and V. As 

mentioned above, DEA is proposing 

specific language that will continue to 

authorize law enforcement agencies to 

conduct take-back events. DEA believes 

that take-back events should be 

conducted only by law enforcement 

agencies because such events are highly 

publicized, are often held at easily 

accessible locations within a 

community, and do not have the same 

security controls as permanent 

collection locations. As such, take-back 

events are more vulnerable to diversion. 

Although only law enforcement 

agencies would continue to be 

authorized to conduct take-back events, 

DEA proposes in section 1317.65(a) that 

private entities or community groups 

may continue to partner with law 

enforcement to hold community takeback events, thereby allowing for greater 

community involvement, education, 

and outreach, while minimizing the risk 

of diversion. 

Many of the provisions that DEA 

proposes in section 1317.65, with 

respect to take-back events, are 

recommendations (‘‘should’’ instead of 

‘‘shall’’) because DEA has no intent to 

change existing law enforcement 

procedures regarding the handling, 

storage, transfer, or destruction of 

controlled substances. DEA is, however, 

proposing some requirements that law 

enforcement agencies must follow in 

order to hold a take-back event. For 

example, in section 1317.65(b), DEA 

proposes that any law enforcement 

agency that conducts a take-back event 

shall appoint a law enforcement officer, 

who must be employed full time by the 

agency, to oversee the collection. 

Further, law enforcement officers 

employed 33 and authorized by the law 

enforcement agency conducting the 

take-back event must 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 or destruction has 

occurred. DEA believes that designated 

law enforcement officers should be 

required to maintain control and 

custody of the controlled substances at 

all times in order to protect against theft 

and diversion. 

Take-back events provide ultimate 

users the opportunity to dispose of 

Schedule II, III, IV, and V controlled 

substances, which they legally possess, 

at a designated place and time. DEA 

proposes in section 1317.65(c) that each 

take-back event should have at least one 

receptacle for the collection of 

permitted substances. Although this is 

only a recommendation for law 

enforcement agencies that conduct takeback events, DEA believes that optimal 

security and protection of public health 

and safety can be achieved if controlled 

and non-controlled substances are 

collected in a collection receptacle that 

is securely locked and substantially 

constructed with an outer shell and 

removable inner liner. 

DEA also proposes in section 

1317.65(e) that only an ultimate user or 

person lawfully entitled to dispose of an 

ultimate user decedent’s property may 

transfer controlled substances to the law 

enforcement agency during the takeback event. No other person, such as a 

take-back event volunteer, may handle 

or touch the controlled substances at 

any time. DEA is proposing this 

requirement to limit the number of 

hands through which the substances 

pass because the risk of diversion 

increases each time a controlled 

substance is transferred to a new person. 

Mail-Back Programs 

The second method of collection that 

DEA proposes, in section 1317.70, is 

mail-back programs. Ultimate users and 

persons lawfully entitled to dispose of 

an ultimate user decedent’s property are 

authorized to utilize a mail-back 

program in accordance with 1317.70 to 

dispose of their controlled substances in 

Schedules II, III, IV, and V. DEA 

proposes in section 1317.70(a) specific 

language to continue to authorize law 

enforcement agencies to voluntarily 

conduct mail-back programs; and mailback programs may be conducted by 

registered manufacturers, distributors, 

reverse distributors, or retail pharmacies 

that: (1) Are authorized as collectors; 

and (2) have and utilize an on-site 

method of destruction at their registered 

location. The security requirements 

proposed with respect to the other 

proposed collection methods (take-back 

events and collection receptacles) are 

adequate to ensure that controlled 

substances are collected and maintained 

in a manner that prevents diversion 

until transfer and destruction can occur. 

Designing regulations that ensure the 

security of controlled substances in the 

context of mail-back programs is 

challenging because, unlike take-back 

events and collection receptacle 

locations, there is a third party who 

handles the controlled substances as 

they are transferred from the ultimate 

user to the authorized collector in mailback programs—the mail system. This 

unique circumstance provides 

opportunities for diversion that do not 

exist with the other collection methods, 

thus requiring more stringent controls 

than the other methods. As a result, 

DEA proposes to allow mail-back 

programs to be voluntarily conducted by 

DEA registrants that are authorized 

collectors that have and utilize an onsite method of destruction and by law 

enforcement agencies in order to 

minimize the transfer of controlled 

substances between various locations. 

This is intended to minimize the risk of 

diversion. 

DEA also proposes in section 

1317.70(c) that any authorized collector 

or law enforcement agency that 

conducts a mail-back program must 

produce and provide specified 

packages, either at no cost or for a fee, 

to ultimate users for the collection of 

controlled substances through the mail, 

and may do so in partnership with third 

parties for convenience, funding, or any 

other lawful purpose. One example of 

such a partnership would be when an 

authorized collector with an on-site 

method of destruction (e.g., a DEAregistered reverse distributor) produces 

appropriate mail-back packages, and 

allows a third party business partner 

that is frequently accessed by the public 

(e.g., a retail pharmacy) to provide these 

packages to patronizing customers. In 

this circumstance, the registered reverse 

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distributor would be responsible for 

operating the mail-back program, 

including recordkeeping and security, 

and it must receive the mail-back 

packages directly at its registered 

location for on-site destruction. DEA 

proposes that packages used for 

collection by mail-back must meet 

certain specifications. The proposed 

package requirements include only 

those specifications necessary to ensure 

that controlled substances sent through 

the mail, outside of the closed system of 

distribution, can be tracked with a high 

degree of confidence in their security. 

These requirements are intended to 

protect public health and safety and 

prevent the diversion of controlled 

substances. 

In particular, the packages are 

proposed to be postage paid (e.g., 

business reply), preaddressed to the 

authorized mail-back location, 

nondescript, tamper-evident and tearresistant, among other things. This is to 

ensure that the mailers are not delayed 

or diverted through address changes, 

theft, or because the package has 

inadequate postage. Such mailers must 

be addressed to the authorized 

collector’s registered location with the 

on-site method of destruction or to the 

law enforcement agency’s physical 

address and cannot be addressed to any 

other location, such as a post office box. 

DEA is also proposing to require that 

each package must have a unique 

identification number so that each 

package can be tracked. In an effort to 

increase the ease of program 

implementation and to enhance the 

security of the mail-back option, DEA is 

also proposing that each package 

include instructions for the user that 

indicate the process for mailing back the 

package, the permitted substances that 

can be sent, and notice that only 

packages provided by the authorized 

collector will be accepted for 

destruction. 

DEA considered requiring registrants 

to establish a system that would allow 

ultimate users to notify the collector 

when the ultimate user mailed back a 

package containing controlled 

substances, similar to pilot projects 

described in the public hearing. 

However, the burden of requiring a 

notification system outweighed the 

benefits of such a system, particularly 

when other security-enhancing 

measures are proposed. DEA believes 

that the collector inventory and 

recordkeeping requirements—that a 

collector conducting a mail-back 

program must keep inventory of mailers 

created and record the unique 

identification number of each mail-back 

package received—coupled with the 

stringent package specifications—for 

example the package must be postage 

paid and preaddressed—are sufficient 

controls to help protect against 

diversion while minimizing the burden 

on ultimate users. However, while DEA 

is not proposing to require collectors to 

create and maintain a notification 

system, such a system is not prohibited 

by the proposed regulations. To ensure 

privacy, the proposed language of 

section 1317.70(d) specifies that the 

public cannot be required to provide 

any personally identifiable information 

when mailing back controlled 

substances to an authorized collector. 

DEA proposes in section 1317.70(e) 

that the authorized collector shall 

accept for the purpose of on-site 

destruction only those packages that 

they made available, directly or in 

partnership with a third party, for the 

collection of controlled substances. This 

requirement is designed so that 

authorized collectors, who control the 

production of uniform mail-back 

packages that are both nondescript and 

not readily identified as containing 

controlled substances, can easily 

identify authorized packages and 

thereby increase the likelihood that they 

accept only those packages that they are 

authorized to accept. 

If the authorized collector 

inadvertently and unknowingly accepts 

controlled substances from an ultimate 

user in a package that they did not make 

available for the collection of controlled 

substances, the authorized collector 

shall notify the DEA office in their area 

of the receipt of the package within 

three business days of receipt and store 

the package, in a manner consistent 

with the routine mail-back package 

storage requirements discussed below, 

until the collector receives further 

instructions from DEA. 

The ‘‘three business day’’ requirement 

allows the registrant enough time to 

process the packages received while still 

ensuring that DEA is notified of the 

incident in a timely manner thus 

allowing further investigation if 

necessary. The requirements for postage 

paid and preaddressed packages are 

designed to reduce the likelihood that 

authorized collectors will receive 

unauthorized controlled substances via 

mail-back programs because the sender 

would have to address such package 

and pay for postage. Ultimate users will 

likely not engage in such 

inconveniences when postage paid and 

preaddressed mailers are available. 

DEA proposes in section 1317.70(f) 

that law enforcement officers employed 

by the law enforcement agency and 

‘‘authorized employees’’ of a collector 

be the only individuals permitted to 

handle packages collected through a 

mail-back program. Under the proposed 

definition in 1317.02(a), an ‘‘authorized 

employee’’ is a person directly 

employed by the registrant full time 

(i.e., not employed as a contractor or 

agent of a third party) and must not 

have been convicted of any felony 

offense related to controlled substances 

and not have had at any time an 

application for registration with DEA 

denied, had a DEA registration revoked 

or suspended, or surrendered a DEA 

registration for cause. These enhanced 

security requirements are proposed 

consistent with existing security 

screening procedures for employees of 

certain registrants and will strengthen 

the integrity of the mail-back process by 

ensuring that only trusted employees 

have access to or influence over 

controlled substances. 

DEA proposes in section 1317.70(f) 

that upon receipt of a package through 

a mail-back program, an authorized 

collector shall not open the package, xray, analyze, or otherwise penetrate the 

package. DEA proposes in section 

1317.05(c)(1) that the authorized 

collector must promptly destroy the 

package on-site or securely store the 

package until prompt on-site 

destruction or timely notification to 

DEA of receipt of an unauthorized 

package in accordance with 1317.70(e) 

can occur. DEA is proposing the flexible 

‘‘prompt’’ destruction and secure 

storage standard for collectors rather 

than a specific time frame to ensure that 

controlled substances do not 

accumulate while pending destruction 

or secure storage and are destroyed in a 

prompt manner, thus reducing the 

opportunities for diversion, while still 

accounting for the individual 

circumstances of registrants that destroy 

controlled substances. If the authorized 

collector is a reverse distributor, 

however, such destruction must occur 

as soon as practicable but no later than 

fourteen calendar days of receipt in 

accordance with proposed section 

1317.15(d), which is discussed below. 

Mail-back programs provide a 

convenient means of disposal for 

ultimate users who may not otherwise 

have access to a safe method of disposal. 

Mail-back programs are valuable 

because they may be made available to 

a large number of ultimate users 

regardless of geographic location. 

Because this method of ultimate user 

disposal presents high risks of 

diversion, DEA has carefully weighed 

many options and proposes the outlined 

requirements. The proposed 

requirements may limit the number of 

persons authorized to conduct a mailback program; however, a single 

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34Mail-back programs are restricted to the receipt 

of mailers initiated within the U.S. in order to be 

consistent with the import requirements of the CSA 

as provided in Subchapter II of Chapter 13 of Title 

21 of the U.S. Code (21 U.S.C. 951 et. seq.). 

35The basis for distinguishing between 

practitioners and non-practitioners when specifying 

disposal procedures is explained in detail below 

under the discussion of controlled substance 

inventory disposal, beginning on page 61. 

36The basis for distinguishing between 

practitioners and non-practitioners when specifying 

disposal procedures is explained in detail below 

under the discussion of controlled substance 

inventory disposal, beginning on page 61. 

authorized mail-back program is capable 

of receiving packages from any location 

within the U.S.34 The mail-back method 

of disposal for ultimate users is a 

valuable and convenient option, 

however, the high risk of diversion 

inherent to this method requires 

stringent controls, including postcollection tracking and accountability 

mechanisms, as well as on-site 

destruction by authorized collectors. 

Collection Receptacles 

The third voluntary method of 

collection that DEA proposes, in section 

1317.75, is collection receptacles. DEA 

proposes specific language in section 

1317.75(a) to continue authorization for 

any federal, state, tribal, or local law 

enforcement agency to maintain a 

collection receptacle at the law 

enforcement agency’s physical location 

as well as to authorize any DEA 

registered manufacturer, distributor, 

reverse distributor, or retail pharmacy 

authorized as a collector to maintain a 

collection receptacle at their DEA 

registered location. Collection 

receptacles may be located at a 

collector’s registered location (and 

certain authorized LTCFs, as discussed 

below) or at a law enforcement agency’s 

physical location—they may not be 

placed at non-registered locations such 

as libraries or community centers. DEA 

is proposing collection receptacles be 

placed at registered locations to ensure 

that controlled substances are collected 

at those locations that have existing 

security controls in place, with the 

exception of LTCFs, thereby reducing 

the risk of diversion while still 

providing for a convenient option for 

ultimate user disposal. 

Like take-back events and mail-back 

programs, DEA proposes in sections 

1317.75(b) and (c) and 1317.80(a) that 

the only persons that may transfer 

controlled substances to the authorized 

collector’s collection receptacle are the 

ultimate user, persons lawfully entitled 

to dispose of an ultimate user 

decedent’s property, and, as discussed 

below, a LTCF on behalf of an ultimate 

user that resides or has resided at that 

LTCF when a collection receptacle is 

located at that LTCF. This requirement 

is proposed in order to limit the number 

of hands through which the substance 

passes because the risk of diversion 

increases each time a controlled 

substance is transferred to a new person. 

The proposed collection receptacle 

requirements in section 1317.75(d) and 

(e) are intended to protect against 

diversion. In particular, DEA is 

proposing the minimum collection 

receptacle requirements necessary to 

protect against diversion while allowing 

flexibility. The collection receptacles 

used by authorized collectors must have 

a permanent outer container with a 

removable inner liner. The outer 

container must have an opening big 

enough to allow contents to be added to 

the inner liner, but small enough to 

prevent removal of the inner liner 

contents. The opening must be capable 

of being locked at times when an 

authorized employee is not present, 

unless the collection receptacle is 

located in a secured area of a long term 

care facility which is regularly 

monitored by LTCF personnel. 

DEA defines an inner liner in section 

1317.02 and proposes requirements for 

inner liners in section 1317.60. In 

particular, like the mail-back packages, 

the inner liner must be waterproof, 

tamper-evident, and tear-resistant. The 

inner liner must be removable and 

sealable immediately upon removal 

without emptying or touching the 

contents and the contents of the inner 

liner shall not be viewable from the 

outside when sealed. The size of the 

inner liner must be clearly marked on 

the outside of the liner, for example, be 

clearly marked ‘‘5 gallon’’ or ‘‘10 

gallon.’’ Finally, the inner liner must 

bear a permanent, unique identification 

number that enables the liner to be 

tracked. DEA is proposing these inner 

liner requirements to ensure that 

controlled substances are collected and 

destroyed in an accountable, secure, and 

convenient way in order to both prevent 

the diversion of controlled substances 

and to protect public health and safety. 

In an effort to increase the ease of 

program implementation, to increase the 

security of collection by collection 

receptacle and to remind the public that 

illicit substances shall not be collected, 

DEA is also proposing that the outer 

container prominently display a sign 

indicating that only non-controlled 

drugs and Schedule II, III, IV, or V 

controlled substances are acceptable for 

collection. DEA seeks comment on the 

value and utility of requiring that a 

specific, uniform symbol be placed on 

each collection receptacle. 

DEA is also proposing other security 

measures, including the requirement 

that collection receptacles be securely 

fastened to a permanent structure such 

as a wall, floor, or immovable 

countertop so that they cannot be 

removed. At a registered location, the 

collection receptacle must be located 

within the immediate proximity of a 

designated area where controlled 

substances are stored and where an 

authorized employee is present. At a 

long term care facility, the collection 

receptacle must be located in a secured 

area monitored by personnel of that long 

term care facility. In addition, access to 

the inner liner is restricted to authorized 

employees. Containers secured in 

compliance with the proposed 

requirements are intended to deter and 

prevent theft and pilferage. 

DEA proposes in section 1317.75(g) 

that the removal of the inner liner of the 

collection receptacle shall be performed 

by or under the supervision of at least 

two authorized employees of the 

authorized collector. To this end, a 

registered reverse distributor or 

distributor is permitted to remove and 

take the inner liner of the collection 

receptacle for destruction so long as the 

removal is performed under the 

supervision of at least two authorized 

employees of the authorized collector. 

In accordance with section 

1317.05(c)(2), upon removal of the inner 

liner of the collection receptacle, the 

authorized collector shall promptly: (1) 

Destroy the inner liner and its contents; 

or (2) store the inner liner and its 

contents at the collector’s registered 

location in a manner consistent with the 

security requirements for Schedule II 

controlled substances until prompt 

destruction can occur. 

Authorized collectors who are 

registered practitioners 35 shall dispose 

of the sealed inner liners and their 

contents in one of the following ways: 

(1) Promptly destroy the sealed inner 

liners and their contents, using an onsite method of destruction in 

accordance with Subpart C of part 1317 

of this chapter; (2) promptly deliver the 

sealed inner liners and their contents by 

common or contract carrier to the 

registered location of a reverse 

distributor or distributor for destruction, 

or by reverse distributor pick-up at the 

collector’s registered or authorized 

location; or (3) request assistance from 

the Special Agent in Charge of the 

Administration in the area in which the 

practitioner is located by submitting one 

copy of DEA Form 41 identifying what 

is to be disposed. 

Authorized collectors who are not 

registered practitioners 36 shall dispose 

of the sealed inner liners and their 

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Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 75797 

37For the purposes of 21 U.S.C. 880(a), collection 

receptacles at long term care facilities maintained 

by a registered retail pharmacy authorized as a 

collector is a ‘‘controlled premise’’ of that registered 

retail pharmacy. 

contents in one of the following ways: 

(1) Promptly destroy the sealed inner 

liners and their contents, using an onsite method of destruction in 

accordance with Subpart C of part 1317 

of this chapter; (2) promptly deliver the 

sealed inner liners and their contents by 

common or contract carrier to the 

registered location of a reverse 

distributor or distributor, or by reverse 

distributor pick-up at the collector’s 

registered or authorized location; or (3) 

promptly transport the sealed inner 

liners and their contents by the 

collector’s own means to the registered 

location of a reverse distributor or 

distributor, or to the location of 

destruction. DEA is proposing the 

flexible ‘‘prompt’’ destruction, transfer, 

and storage standard for collectors 

rather than a specific time frame to 

ensure that controlled substances do not 

accumulate while pending destruction, 

transfer, or storage, while still 

accounting for the individual 

circumstances of registrants that operate 

and maintain collection receptacles. If 

the authorized collector is a reverse 

distributor, however, such destruction 

must occur as soon as practicable but no 

later than fourteen calendar days of 

receipt in accordance with proposed 

section 1317.15(d), which is discussed 

below. 

Long Term Care Facilities 

The Disposal Act authorized the 

Attorney General to develop regulations 

to permit long term care facilities to 

dispose of controlled substances on 

behalf of ultimate users who reside or 

have resided at such facilities in a 

manner that provides effective controls 

against diversion and is consistent with 

public health and safety. As such, DEA 

proposes in section 1317.80 to allow 

collection receptacles to be placed at 

long term care facilities for the disposal 

of controlled substances in accordance 

with outlined requirements. 

DEA is proposing that only a 

registered retail pharmacy that receives 

authorization to collect at a specific long 

term care facility may manage and 

maintain collection receptacles at that 

long term care facility and remove or 

supervise the removal of the inner liner 

of the collection receptacles at that long 

term care facility. Such registered retail 

pharmacies that desire to operate a 

collection receptacle at a long term care 

facility must apply to modify their 

registration in accordance with 21 CFR 

1301.51 and include in their application 

for modification in registration the 

physical location of each long term care 

facility at which the registered 

pharmacy intends to operate a 

collection receptacle. If the retail 

pharmacy that is authorized to collect 

ceases activities as a collector, such 

registrant must modify their registration 

in accordance with 21 CFR 1301.51 to 

indicate that they no longer collect or 

have ceased collection at a particular 

physical location.37 The requirements in 

21 CFR 1301.52(a) related to the 

termination of registration also apply. 

A registered retail pharmacy 

authorized to maintain a collection 

receptacle at a long term care facility 

shall comply with the proposed 

requirements in 21 CFR 1317.75 that 

govern collection receptacles. At a long 

term care facility, the collection 

receptacle must be located in a secured 

area monitored by personnel of that long 

term care facility. In addition, access to 

the inner liner is restricted to authorized 

employees of the registered retail 

pharmacy. Because an authorized 

employee must be employed full time 

by the registrant, employees of the long 

term care facility will not have access to 

the inner liner of the collection 

receptacle, unless they are also a full 

time employee of the registered retail 

pharmacy that maintains that collection 

receptacle. In addition, DEA is 

proposing that two authorized 

employees of the retail pharmacy must 

remove or supervise the removal of the 

inner liner from the collection 

receptacle. In an effort to increase 

security and control of controlled 

substances collected, no employee of 

the long term care facility will have 

access to or influence over the contents 

of the collection receptacle, except to 

deposit controlled substances into it. 

DEA is proposing that long term care 

facilities be permitted to dispose of 

controlled substances in Schedules II 

through V on behalf of an ultimate user 

who resides or has resided at such long 

term care facility. As with all other 

collection methods, controlled and noncontrolled substances may be comingled 

in the collection receptacle. DEA 

proposes that the long term care facility 

be required to transfer controlled 

substances into collection receptacles 

(on behalf of ultimate users who reside 

or have resided at the long term care 

facility) immediately, but no longer than 

three business days after it is 

determined that the ultimate user no 

longer needs or wants, or should 

discontinue use of the controlled 

substance. DEA proposes this 

requirement on the transfer of 

controlled substances at a long term care 

facility in an effort to prevent the 

accumulation of ultimate user 

controlled substances at long term care 

facilities. DEA believes that this 

requirement balances security concerns 

with the ease of long term care facility 

participation by allowing these facilities 

to determine whether it is appropriate 

for them to dispose on behalf of an 

ultimate user. 

Pursuant to 21 U.S.C. 822(g)(3), DEA 

is proposing that a long term care 

facility must dispose of those controlled 

substances only by depositing the 

substances into an authorized collection 

receptacle at the long term care facility. 

The long term care facility is not 

permitted to deliver or transfer the 

controlled substances off-site. If the long 

term care facility does not have access 

to an on-site collection receptacle, they 

are not otherwise permitted to dispose 

of a controlled substance on behalf of an 

ultimate user. Rather, the ultimate user 

or persons lawfully entitled to dispose 

of ultimate user decedent’s property 

should dispose of those controlled 

substances. See 21 U.S.C. 822(g)(1) and 

822(g)(4). 

Because ultimate user medications are 

concentrated in and often administered 

by long term care facilities, DEA 

considered proposing to authorize long 

term care facilities to dispose of 

controlled substances on behalf of an 

ultimate user through mail-back 

programs and through take-back events. 

However, the majority of such facilities 

are not registered by DEA to handle 

controlled substances, and, therefore, do 

not have in place physical security 

controls and other requirements that 

minimize the risk of diversion such as 

the obligation to maintain effective 

controls against diversion, report thefts 

and losses, and screen certain 

employees for controlled substancerelated felony convictions. DEA believes 

that only authorized DEA registrants 

and law enforcement agencies should be 

authorized to collect controlled 

substances from ultimate users because 

they have in place the proper security 

and other controls to help guard against 

diversion. Because long term care 

facilities are typically not registered 

with DEA and face the unique challenge 

of disposing of controlled substances on 

behalf of an ultimate user, DEA is 

proposing an option for LTCFs that 

balances convenience with security. 

The on-site collection receptacles will 

reduce the risk that controlled 

substances may be removed from the 

facilities by employees (e.g., to transport 

substances to a take-back event for 

disposal) who will not be subject to the 

same screening procedures as 

employees of authorized collectors, 

such as the requirement that authorized 

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75798 Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 

38Although reverse distributors and other 

collectors conducting mail-back programs will 

likewise receive a large number of mailers, DEA 

does not anticipate that the same risk exists. 

Collectors authorized to conduct mail-back 

programs will be DEA registrants that already 

routinely receive controlled substances and have in 

place security controls. A long term care facility, 

however, is likely not a DEA registrant, does not 

already routinely send out controlled substances, 

and will not have in place the same types of 

security controls. 

employees who have access to or 

influence over controlled substances 

have no felony convictions related to 

controlled substances. Additionally, 

DEA believes that the mail-back option 

is not suitable because of the likelihood 

that long term care facilities may need 

to dispose of large quantities of 

controlled substances or dispose of 

controlled substances on a frequent 

basis. One security aspect of the mailback method of disposal is the 

requirement that mailers be nondescript, so as not to be readily 

identifiable as containing controlled 

substances. If a large number of such 

mailers are consistently sent from an 

unregistered facility whose residents are 

likely to possess controlled substances, 

such as a long term care facility, that 

security measure loses much of its 

efficacy, thereby increasing the risk of 

diversion, and may even have the 

unintended effect of making a long term 

care facility’s mailing system a target for 

diversion.38 DEA is, therefore, 

proposing to only permit long term care 

facilities to use an on-site collection 

receptacle that is under the control of an 

authorized retail pharmacy registrant to 

dispose of controlled substances on 

behalf of an ultimate user. DEA believes 

that a secure on-site collection 

receptacle is the best method to protect 

against diversion and is consistent with 

public health and safety. 

Although LTCFs may only dispose of 

their residents’ controlled substances 

through collection receptacles at the 

LTCF, LTCF residents themselves may 

utilize any other disposal method 

available to ultimate users, including 

mail-back programs and take-back 

events. Care should be taken to ensure 

that LTCF residents’ use of mail-back 

programs and take-back events does not 

result in the accumulation of controlled 

substances in a single location 

susceptible to internal or external 

diversion threats, as discussed above. 

Additional Security Controls for the 

Collection of Controlled Substances 

Through Mail-Back Programs and 

Collection Receptacles 

As discussed above, sealed mail-back 

packages and inner liners acquired by 

collectors and registered reverse 

distributors and distributors must be 

stored in a manner consistent with the 

physical security requirements for 

Schedule II controlled substances. 

Registered reverse distributors, 

distributors, and manufacturers 

authorized as collectors and that store 

mail-back packages and inner liners 

acquired from an ultimate user must 

follow the physical security controls for 

storing Schedule II controlled 

substances in accordance with 21 CFR 

1301.72, which DEA proposes to revise. 

An authorized collector that is a retail 

pharmacy must follow the physical 

security controls for storing Schedule II 

controlled substances in accordance 

with 21 CFR 1301.75; however, such 

sealed mail-back packages and inner 

liners may not be dispersed through the 

practitioner’s stock of non-controlled 

substances as described in 21 CFR 

1301.75(b), which DEA proposes to 

revise. DEA understands that storing 

sealed mail-back packages and inner 

liners as though they are Schedule II 

controlled substances is a stringent 

requirement; however the majority of 

authorized collectors, as registrants, are 

likely to already have these storage 

capabilities in place. DEA is proposing 

these physical security requirements 

because Schedule II is the highest 

schedule of controlled substances that is 

lawfully permitted to be included in the 

mail-back packages and inner liners. 

Because mail-back packages and inner 

liners may not be opened and their 

contents will not be known, such 

packages and liners should be stored as 

though each package and liner contains 

a Schedule II controlled substance. 

In the event of theft, pilferage, or loss, 

registrants must notify DEA, in 

accordance with 21 CFR 1301.76(b) and 

1301.74(c). DEA considers any theft or 

loss from a collection receptacle or mailback program to be a ‘‘significant loss’’ 

within the meaning of the regulation 

because such losses would be 

attributable to the unique activities 

involving the disposal of controlled 

substances. 21 CFR 1301.74(c)(3). Also, 

because the controlled substances 

collected cannot be individually 

handled or sorted, it must be assumed 

that the loss includes Schedule II 

controlled substances. 21 CFR 

1301.74(c)(2) and 1301.76(b). Finally, 

collection receptacles and mail-back 

packages are likely candidates for 

diversion because these collection 

methods are highly publicized and 

accessible to the public, and, as a result, 

any theft or loss from these collection 

methods is considered significant. 21 

CFR 1301.74(c)(5) and 1301.76(b)(5). 

Tracking Controlled Substances 

Collected From Ultimate Users and 

Other Authorized Non-Registrants From 

Collection to Destruction 

In accordance with the closed system 

and the statutory framework of the CSA, 

DEA must ensure that all controlled 

substances collected from ultimate users 

are properly and promptly secured, 

stored, and destroyed. DEA considered 

allowing authorized persons to count or 

otherwise inventory controlled 

substances collected from ultimate 

users. Any effort to count, identify, or 

otherwise inventory the contents of 

sealed packages or inner liners, 

however, would require individualized 

identification of the contents, increase 

the number of hands through which 

controlled substances pass, and require 

that the packages and inner liners 

remain opened and exposed for 

extended periods of time. These factors 

greatly increase the risk of diversion 

and, when combined with the increased 

costs associated with such efforts, 

outweigh the potential benefit. 

As a result of these security and 

diversion prevention considerations, 

DEA is proposing a system of collection 

that requires the ultimate user or other 

authorized non-registrant person in 

lawful possession of a controlled 

substance to personally handle such 

substance at all times until it is safely 

and securely placed in an authorized 

mail-back package or in an appropriate 

collection receptacle at an authorized 

location or at a take-back event. 

Additionally, an authorized collector 

would be required to collect items only 

in a collection receptacle with an inner 

liner or in a mail-back package, both of 

which must be uniquely identifiable, 

sealable, waterproof, tamper-evident, 

and tear-resistant. No person may open 

or otherwise access any secured mailback package or inner liner. 

DEA is proposing that each inner liner 

and mail-back package provided by an 

authorized collector must have a unique 

identification number that enables the 

liner and package to be tracked. The 

authorized collector must record the 

unique identification number located on 

the inner liner or mail-back package so 

that it can be properly tracked from 

collection to destruction. Law 

enforcement agencies are encouraged, 

but not required, to implement similar 

recordkeeping and tracking procedures. 

DEA believes that the proposed 

recordkeeping and tracking system is 

the most effective and efficient way to 

ensure that those controlled substances 

collected from ultimate users and other 

authorized non-registrants are secure 

until destruction, and are actually 

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Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 75799 

39 ‘‘Inventory’’ means ‘‘all factory and branch 

stocks in finished form of a basic class of controlled 

substance manufactured or otherwise acquired by a 

registrant, whether in bulk, commercial containers, 

or contained in pharmaceutical preparations in the 

possession of the registrant (including stocks held 

by the registrant under separate registration as a 

manufacturer, importer, exporter, or distributor).’’ 

21 CFR 1300.01(b). 

40 Defined by the CSA 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.’’ 21 

U.S.C. 802(21). Under the CSA, ‘‘[t]he Attorney 

General shall register practitioners * * * to 

dispense, or conduct research with, controlled 

substances * * * .’’ 21 U.S.C. 823(f). 

destroyed. DEA has proposed a rule that 

allows authorized collectors the 

flexibility to create a tracking system 

that is proportionate to the scope and 

method of their desired disposal 

program while also meeting the 

applicable security and control 

requirements proposed by DEA. 

Disposal of Controlled Substances by 

Registrants 

The procedures for the disposal of 

controlled substances by registrants are 

often determined on a case-by-case basis 

by the DEA Special Agent in Charge 

(SAC) in the area where the registrant is 

located. In many circumstances, the 

SAC has the discretion to determine 

how to authorize and instruct registrants 

to dispose of controlled substances, 

including how the substances may be 

destroyed. 21 CFR 1307.21(a) and (b). 

DEA proposes to expand the 

inventory 39 disposal options available 

to registrants, delete the existing rule 

related to registrant disposal (21 CFR 

1307.21), and incorporate similar 

requirements on proper disposal 

procedure, security, and recordkeeping 

into a new part 1317 on disposal. DEA 

is proposing these changes to ensure 

consistency in disposal procedures 

among registrant categories, regardless 

of geographic location. Such regulations 

will reduce the burden on registrants by 

eliminating the existing requirement for 

every registrant to contact the SAC in 

their area when they wish to destroy 

controlled substances. Also, the 

procedures and security and 

recordkeeping requirements that DEA 

proposes are intended to codify existing 

practice and to set singular and 

consistent procedures for DEA 

registrants in accordance with their 

authorized business activities while 

protecting the public health and safety 

and minimizing the risk of diversion. 

Registration requirements and 

authorized activities vary depending on 

the type of controlled substance 

business activity in which a person is 

engaged. Accordingly, if a registrant 

desires to deliver controlled substances 

for any lawful purpose, the registrant 

must be authorized by his registration to 

conduct the delivery—the registrant 

must be authorized to engage in such 

conduct either as a business activity or 

coincident activity. This general rule 

also applies if a registrant desires to 

deliver controlled substances to an 

authorized person by transporting the 

substances itself and maintaining 

custody and control of the substances 

during transportation. 

Pursuant to the Controlled Substances 

Act, registration to distribute conveys 

broad authority to deliver controlled 

substances for a lawful purpose. 

‘‘Distribute’’ means to ‘‘deliver (other 

than by administering or dispensing) a 

controlled substance or a listed 

chemical. The term ‘distributor’ means 

a person who so delivers a controlled 

substance or listed chemical.’’ 21 U.S.C. 

802(11). Accordingly, registrants 

authorized to distribute controlled 

substances (e.g., non-practitioners such 

as manufacturers, distributors, and 

reverse distributors) may themselves 

deliver such substances to authorized 

persons for the purpose of disposal in 

accordance with applicable security and 

recordkeeping procedures. In contrast, 

the Controlled Substances Act narrows 

the authorization of practitioners 40 (e.g., 

physicians, pharmacies, and hospitals) 

to ‘‘dispense,’’ which means ‘‘to deliver 

a controlled substance to an ultimate 

user or research subject by, or pursuant 

to the lawful order of, a practitioner, 

including the prescribing and 

administering of a substance * * *’’ 21 

U.S.C. 802(10) (emphasis added). 

Authorization to dispense does not 

include authorization to distribute and 

vice versa. See 21 U.S.C. 802(11) 

(specifically excluding ‘‘dispense’’ from 

the definition of ‘‘distribute’’). As such, 

registration to dispense specifically 

conveys narrow authority to deliver a 

controlled substance to an ultimate user 

pursuant to the lawful order of a 

practitioner. Registrants who are only 

authorized to dispense controlled 

substances (e.g., practitioners) are 

therefore not authorized to deliver these 

substances themselves to any entity 

other than an ultimate user, even for the 

purpose of disposal. Instead, 

practitioners may only deliver these 

substances to authorized persons by 

common or contract carrier or by pickup at the practitioner’s registered 

location. 

As discussed, non-practitioners (e.g., 

manufacturers, distributors, and reverse 

distributors) are not similarly limited in 

their authority to lawfully deliver 

controlled substances. DEA therefore 

proposes in section 1317.05(b) to allow 

non-practitioners to deliver (i.e., 

transfer) controlled substances 

themselves for the purpose of disposal 

provided that such substances are 

transported directly to the destruction 

location and accompanied by two 

authorized employees. This proposed 

requirement is consistent with existing 

practices by registered manufacturers, 

distributors, and reverse distributors 

when transporting and disposing of 

controlled substances. These nonpractitioners generally follow these 

procedures (in addition to various other 

procedures) as a counter-measure 

against theft and diversion. DEA 

proposes these procedures, along with 

the procedures set forth at section 

1317.95, as the minimum required to 

help ensure the physical security of 

highly pilferable controlled substances 

and as a deterrent to theft and diversion. 

Consistent with the requirements of 

the Controlled Substances Act, DEA 

proposes in section 1317.05(b) to 

authorize non-practitioners to dispose of 

their controlled substance inventory in 

one of four ways: (1) Promptly destroy 

the substance using an on-site method 

of destruction in accordance with 

applicable federal, state, tribal, and local 

laws and regulations (as required by 

section 1317.90); (2) promptly deliver 

the substance to a registered reverse 

distributor at its registered location by 

common or contract carrier, or by 

reverse distributor pick-up; (3) for the 

purpose of return or recall, promptly 

deliver the substance by common or 

contract carrier or pick-up at the 

registrant’s registered location to the 

person from whom it was obtained, the 

registered manufacturer of the 

substance, or another registrant 

authorized by the manufacturer to 

accept returns or recalls; or (4) promptly 

transport the 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 the 

substance for the purpose of return or 

recall. 

As discussed, a practitioner’s 

registration does not convey authority to 

distribute, deliver, or otherwise transfer 

controlled substances to any entity other 

than an ultimate user. Accordingly, DEA 

proposes in section 1317.05(a) to 

authorize practitioner registrants to 

dispose of their controlled substance 

inventory in one of four ways: (1) 

Promptly destroy the substance using an 

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75800 Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 

41Current DEA regulations at 21 CFR 

1307.11(a)(2) discuss practitioner distribution of 

controlled substances to a reverse distributor. DEA 

proposes to clarify that provision at the proposed 

section 1317.05. As such, DEA proposes to delete 

21 CFR 1307.11(a)(2) to eliminate redundancy. 

on-site method of destruction in 

accordance with applicable federal, 

state, tribal, and local laws and 

regulations (as required by section 

1317.90); (2) promptly deliver the 

substance to a reverse distributor at its 

registered location by common or 

contract carrier, or by reverse distributor 

pick-up; 41; (3) for the purpose of return 

or recall, promptly deliver the substance 

to the registered person from whom the 

substance was obtained, the registered 

manufacturer of the substance, or 

another registrant authorized to accept 

returns or recalls by common or contract 

carrier or by pick-up at the registrant’s 

registered location; or (4) request 

assistance from the Special Agent in 

Charge of the Administration in the area 

in which the practitioner is located. 

DEA proposes to allow practitioner 

registrants to retain the existing ability 

to request assistance from the SAC in 

the area in which the practitioner is 

located to dispose of their controlled 

substances, similar to the existing 

provisions of section 1307.21, in order 

to expand the options available for 

practitioners to destroy controlled 

substances or cause controlled 

substances to be destroyed. DEA 

proposes that the SAC in the 

practitioner’s area may authorize the 

practitioner to: Transfer the controlled 

substances to a person registered under 

the Act and authorized to transport and 

destroy the substance; deliver the 

substances to an agent of the DEA or the 

nearest DEA office; or destroy the 

substances in the presence of an agent 

of the DEA or other authorized person. 

In circumstances in which a practitioner 

regularly destroys controlled 

substances, the practitioner may do so 

on a regular basis upon instructions 

from the relevant SAC. 

Registrants that destroy controlled 

substances must do so promptly, unless 

otherwise specified. DEA is proposing 

the flexible ‘‘prompt’’ destruction 

standard rather than a specific time 

frame for destruction to ensure that 

controlled substances do not 

accumulate while pending destruction 

and are destroyed in a timely manner, 

while still accounting for the individual 

circumstances of registrants that destroy 

controlled substances. 

For all registrants that destroy 

controlled substances or cause 

controlled substances to be destroyed 

(e.g., by transferring the substance to an 

authorized reverse distributor or 

transporting the substance to an off-site, 

unregistered location for destruction), 

DEA proposes in section 1317.95 that 

such registrants be required to follow 

certain security procedures related to 

employees, transportation, loading and 

unloading, handling, and destruction. 

DEA is proposing enhanced security 

requirements in order to strengthen the 

integrity of the disposal process, which 

has been expanded to include more 

disposal options and eliminates the 

requirement of prior notice of 

destruction to DEA, by filing DEA Form 

41 prior to destruction, in every 

instance except when practitioners seek 

disposal assistance pursuant to 

proposed section 1317.05(a)(4). When a 

DEA registrant that destroys or causes 

the destruction of controlled substances 

is the last registered person to possess 

such substances, the registrant must 

follow increased security measures at 

the point of destruction to ensure 

accountability and effectively minimize 

the risk of diversion. 

For registrants that destroy controlled 

substances on-site, that maintain 

possession of controlled substances 

until they are rendered non-retrievable 

(e.g., when transporting substances to an 

unregistered location for destruction), or 

that transfer custody to an authorized 

person for disposal, DEA is proposing 

employee security requirements in 

section 1317.95 to ensure that only 

employees that have satisfied certain 

employee screening requirements are 

authorized to oversee the handling of 

controlled substances during the 

destruction process. Under the proposed 

definition in 1317.02(a), an ‘‘authorized 

employee’’ is a person directly 

employed by the registrant full time 

(i.e., not employed as a contractor or 

agent of a third party) who must not 

have been convicted of any felony 

offense related to controlled substances 

and not have had at any time an 

application for registration with DEA 

denied, had a DEA registration revoked 

or suspended, or surrendered a DEA 

registration for cause. 

The proposed security measures 

include the requirement that two 

authorized employees load and unload 

(or observe the loading and unloading 

of) controlled substances during transfer 

of the substances to another registrant; 

and, if the substances are destroyed on 

a registrant’s registered premises, two 

authorized employees shall personally 

witness the destruction and shall handle 

(or observe the handling of) the 

substance until it is rendered nonretrievable. This two-person integrity 

requirement is necessary because the 

destroying registrant is the last person 

authorized to handle the substance 

before destruction and this requirement 

will reduce the opportunity for 

diversion and help to ensure that the 

controlled substances are actually 

destroyed and not diverted to illicit use. 

Additionally, DEA proposes in 

section 1317.100 that a registrant that 

destroys controlled substances or causes 

the destruction of controlled substances 

is required to maintain a record of the 

destruction in a form to be issued by 

DEA. This form will be DEA Form 41. 

At present, DEA Form 41 is used as a 

record of destruction by registrants. 

DEA is proposing to modify DEA Form 

41 to act as the record of destruction, 

including the signature of the two 

authorized employees witnessing the 

destruction. In an effort to minimize the 

burden on registrants, and in 

accordance with the proposed 

comprehensive new part on disposal, 

registrants that destroy or cause the 

destruction of controlled substances and 

utilize DEA Form 41 will no longer be 

required to submit three copies of DEA 

Form 41 to the SAC in their area, except 

one copy shall be submitted by 

practitioners seeking assistance 

pursuant to section 1317.05(a). Rather, 

in accordance with the CSA, such 

registrants will be required to keep and 

make available that record, 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. Furthermore, all 

methods of destruction must be 

conducted in accordance with all 

applicable federal, state, local, and tribal 

laws and regulations. 

Reverse Distributors 

Reverse distributors are a unique 

group of registrants whose primary 

function is to possess controlled 

substances for the purpose of 

destruction or return. In this regard, 

reverse distributors provide a valuable 

service to other registrants in the 

disposal process. In the distribution of 

controlled substances between 

registrants, each registrant serves as a 

check on the other and verifies whether 

the controlled substance has reached its 

lawful destination. This is 

accomplished through existing 

reporting, recordkeeping, and order 

form requirements. 21 U.S.C. 827–828; 

21 CFR part 1304 and 21 CFR part 1305. 

However, a reverse distributor that 

acquires controlled substances from 

another registrant for destruction is the 

last person to possess such substance 

before destruction so there is no 

recipient to verify that the substance has 

been destroyed. Furthermore, reverse 

distributors accumulate greater amounts 

of controlled substances that are 

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42While reverse distributor-specific regulations 

are consolidated into proposed new 21 CFR part 

1317, registered reverse distributors will still be 

required to follow all other applicable regulations 

that fall outside 21 CFR part 1317. 

destined for destruction in comparison 

to other registrants. This is because 

reverse distributors routinely acquire 

controlled substances for destruction 

from other registrants and may also be 

authorized as collectors. As a result, 

DEA is proposing security and 

recordkeeping requirements that apply 

specifically to a reverse distributor’s 

unique function. 

The existing regulations pertaining to 

reverse distributors are located in 

different parts of the CFR. DEA is 

proposing revised regulations for 

reverse distributors that are clear, 

consistent, and consolidated into one 

part.42 DEA believes that these proposed 

regulations will help reverse 

distributors comply with the Controlled 

Substances Act in a manner that 

effectively decreases the risk of 

diversion of controlled substances 

during the disposal process. 

DEA proposes to revise the definition 

of reverse distributor in section 

1300.01(b). In the existing regulations, a 

reverse distributor is permitted to 

acquire controlled substances from 

other registrants for the purpose of 

return to the manufacturer or 

manufacturer’s agent, or ‘‘to process for 

or arrange the processing for’’ disposal. 

DEA proposes to revise the definition of 

‘‘reverse distributor’’ by first defining 

‘‘reverse distribute’’ to mean ‘‘to acquire 

controlled substances from another DEA 

registrant or a law enforcement agency 

for the purpose of: (1) Return to the 

manufacturer or another registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf, or (2) destruction.’’ A ‘‘reverse 

distributor’’ is a person who reverse 

distributes a controlled substance. 

In the existing definition of reverse 

distributor, a reverse distributor is 

permitted to acquire controlled 

substances from other registrants for the 

purpose of return to the manufacturer or 

manufacturer’s agent. DEA proposes 

revising the definition to authorize a 

reverse distributor to acquire controlled 

substances from another DEA registrant 

for the purpose of return to the 

manufacturer or another registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf. This revision is proposed so that 

the reverse distribute definition is 

consistent with the proposed revisions 

to return and recall in sections 1317.05 

and 1317.85 (discussed below). DEA 

believes that this new definition clearly 

and accurately reflects the proper role of 

a reverse distributor. 

DEA proposes in section 1317.15(b) to 

authorize registered reverse distributors 

to acquire controlled substances from 

other registrants in one of two ways: (1) 

Pick-up the controlled substance from a 

registrant at the registrant’s registered 

location (‘‘pick-up’’), or (2) receive the 

controlled substance from a registrant at 

the reverse distributor’s registered 

location, delivered directly by a nonpractitioner or by common or contract 

carrier (‘‘delivery’’). Once en route from 

a registrant’s registered location to a 

reverse distributor’s registered location, 

shipments or packages of controlled 

substances may not be re-routed to 

another person or location, even if that 

person or location is registered with 

DEA. DEA believes that re-routing 

shipments or packages destined for one 

registrant to another registrant 

substantially increases the likelihood of 

diversion. 

DEA proposes in section 1317.15(c) 

that upon acquisition of a controlled 

substance from a registrant, a reverse 

distributor must either: (1) Immediately 

store the controlled substance at, or 

transfer the controlled substance to, the 

reverse distributor’s registered location 

for secure storage until timely 

destruction or timely return to the 

registered manufacturer of the substance 

can occur, (2) immediately deliver the 

controlled substance to the 

manufacturer or manufacturer’s agent, 

(3) timely destroy the controlled 

substance, or (4) immediately deliver 

the controlled substance to the place of 

destruction for timely destruction. The 

requirement for ‘‘immediate’’ transfer or 

delivery is intended to ensure that 

shipments or packages are continuously 

moving towards their ultimate, secure 

destination. Such continuous movement 

reduces the risk of diversion by limiting 

the opportunity for theft or loss. 

Consistent with 21 CFR 1301.12(b)(4) 

and the existing definition of ‘‘freight 

forwarding facility’’ in 21 CFR 

1300.01(b), a reverse distributor may not 

operate freight forwarding facilities for 

purposes of transporting controlled 

substances. DEA proposes to clarify this 

by specifically excluding reverse 

distributors from the definition of 

‘‘freight forwarding facility’’ in section 

1300.01(b). 

DEA is also proposing in section 

1317.15(d) to require reverse 

distributors to destroy or cause the 

destruction of any controlled substances 

received for the purpose of destruction 

as soon as practicable but no later than 

within fourteen calendar days of pickup or delivery. A reverse distributor that 

acquires a controlled substance for 

destruction is the last person to possess 

such substance before destruction and, 

therefore, must follow increased 

security measures. The ‘‘as soon as 

practicable but no later than fourteen 

calendar day’’ requirement is unique to 

reverse distributors—other registrants 

that destroy must do so promptly and 

do not have to follow a specific time 

limit—because the primary business 

activity of reverse distributors, unlike 

other registrants, is to acquire controlled 

substances for the purpose of 

destruction or return. As a result, 

reverse distributors generally 

accumulate greater amounts of 

controlled substances that are destined 

for destruction in comparison to other 

registrants. They are typically the last 

registrant to handle the controlled 

substance with no other registrant 

reporting and recording receipt of the 

substance as a check against diversion. 

The ‘‘as soon as practicable but no later 

than fourteen calendar day’’ 

requirement will ensure that reverse 

distributors destroy or cause the 

destruction of controlled substances in 

a timely manner while also enabling 

them sufficient time to prepare the 

necessary records required for 

destruction. In addition, the ‘‘as soon as 

practicable but no later than fourteen 

calendar day’’ requirement will reduce 

the risk of diversion by limiting the 

opportunity for theft or loss. This is 

necessary because, just as there is a 

greater risk of diversion when 

controlled substances are being 

transported for the purposes of 

destruction, there is a greater risk of 

diversion the longer a substance 

destined for destruction remains in 

storage awaiting destruction. 

DEA is proposing to specify a 

maximum time limit for reverse 

distributors to destroy or cause the 

destruction of any controlled substance 

received for the purpose of 

destruction—as soon as practicable but 

no later than fourteen calendar days of 

receipt (pick-up or delivery). While DEA 

believes that the majority of reverse 

distributors already destroy or cause the 

destruction of controlled substances 

received for the purpose of destruction 

‘as soon as practicable’ but no later than 

fourteen calendar days of receipt, DEA 

recognizes that some may not. For the 

reverse distributors that do not currently 

meet this standard, this requirement 

may cause these reverse distributors to 

incur additional costs through more 

frequent transportation of controlled 

substances to the point of destruction 

and destruction of partial loads. For 

purposes of this proposal, DEA assumes 

that some reverse distributors may have 

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to adjust current business operations in 

order to comply with this new 

requirement, such as by restricting the 

receipt of deliveries to their registered 

location to specific days and/or 

amounts, or by changing pick-up routes 

to accommodate the requirement that 

any controlled substance received for 

the purpose of destruction be destroyed 

as soon as practicable but no later than 

fourteen calendar days of receipt. 

DEA believes that the proposed ‘‘as 

soon as practicable but no later than 

fourteen calendar day’’ requirement is 

reasonable and will reduce the risks of 

diversion. However, DEA also 

acknowledges that there are assorted 

federal, state, and local transportation 

and environmental laws and regulations 

that reverse distributors must comply 

with in addition to those under the CSA 

and these proposed regulations. DEA 

also acknowledges that these proposed 

regulations may result in reverse 

distributors choosing to be responsible 

for much more controlled substances 

than they are currently responsible. 

Accordingly, DEA invites comments on 

the practicability of implementing the 

‘‘as soon as practicable but no later than 

fourteen calendar day’’ requirement 

while also maintaining effective 

controls against diversion. Considering 

there are currently a limited number of 

registered reverse distributors with 

significant variations in current 

business practices across the United 

States, DEA seeks information regarding 

how the ‘‘as soon as practicable but no 

later than fourteen calendar day’’ 

destruction requirement would impact 

business practices, if at all, with specific 

focus on the potential long-term and 

short-term costs of implementing this 

requirement, and whether such costs 

would be offset by other measures. DEA 

also invites comment regarding the 

effects that shorter and longer time 

limits for destruction—specifically, as 

soon as practicable but no later than 

seven calendar days or thirty calendar 

days for destruction—would have on 

current business practices, including the 

physical security controls and operating 

procedures that would be implemented 

or modified in order to guard against 

theft and diversion, and the potential 

costs that may be incurred as a result of 

alternative time limits. 

DEA is also proposing in section 

1317.20 enhanced employee security 

requirements for reverse distributors. 

DEA proposes that reverse distributors 

be prohibited from employing, as an 

agent or employee who has access to or 

influence over controlled substances, 

any person that has ever been convicted 

of any felony offense related to 

controlled substances or has ever had an 

application for registration with DEA 

denied, had a DEA registration revoked 

or suspended, or surrendered a DEA 

registration for cause. DEA is proposing 

these enhanced security requirements 

for reverse distributors in order to 

strengthen the integrity of the disposal 

process by ensuring that only certain 

employees are authorized to have access 

to or influence over controlled 

substances. This requirement is similar 

to existing employee security 

requirements for registered practitioners 

in 21 CFR 1301.76(a), where there is a 

high risk of diversion and limited 

physical security requirements. 

DEA is also proposing in 1317.25 to 

streamline and clarify recordkeeping 

requirements for registered reverse 

distributors that acquire controlled 

substances from other registrants so that 

they are consistent and accurately 

reflect reverse distributor authorized 

activities in compliance with the 

Controlled Substances Act. These 

requirements are separate from the 

recordkeeping requirements for reverse 

distributors that acquire controlled 

substances from law enforcement 

agencies and authorized collectors, as 

discussed above, in proposed section 

1317.55. 

First, the existing regulations require 

registered reverse distributors to record 

in an inventory, information regarding 

specific quantities of controlled 

substances that is different from the 

information required in continuing 

records. 21 CFR 1304.11(e)(3) and 

1304.22(e). To reconcile this 

discrepancy, DEA proposes in sections 

1317.25(b) and (c) that in both inventory 

and continuing records, a reverse 

distributor must record the quantity of 

a controlled substance in both finished 

and bulk form, and the quantity 

contained in a commercial container, 

carton, crate, drum, or other receptacle 

that has been opened. 

Second, in accordance with the CSA, 

every DEA registrant must 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). These records must be 

maintained separately from all other 

records of the registrant or, 

alternatively, in the case of non-narcotic 

controlled substances, be in such a form 

that required information is readily 

retrievable from the ordinary business 

records of the registrant. 21 U.S.C. 

827(b)(2). The records must be kept and 

be available for at least two years for 

inspection and copying by officers or 

employees of the Attorney General. 21 

U.S.C. 827(b)(3). Under its statutory 

authority, DEA may promulgate 

regulations that specify the information 

that registrants are required to maintain 

in their records. 21 U.S.C. 827(b). 

To this end, DEA proposes in section 

1317.25(c) to require registered reverse 

distributors to: (1) Keep records 

regarding each controlled substance 

received from another registrant for the 

purpose of return to a manufacturer or, 

if designated, to another registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf, and (2) keep records regarding 

each controlled substance destroyed, 

including information pertaining to the 

receipt and destruction of the controlled 

substance. These records, similar to the 

current requirements in 21 CFR 

1304.22(e) that DEA proposes to delete, 

are necessary for inspection to maintain 

the integrity of the closed system and to 

assist in the detection and prevention of 

diversion. 

DEA proposes in section 1317.25(c)(4) 

that for all controlled substance records, 

reverse distributors will be required to 

maintain the record of receipt with the 

corresponding record of return or 

destruction. By maintaining all relevant 

records together, DEA will be able to 

account for each substance received by 

a reverse distributor from its acquisition 

to its disposition, whether by 

destruction or return to the 

manufacturer. DEA also emphasizes that 

each registrant must prepare and 

maintain separate and independent 

records in order to ensure accountability 

of each registrant, and the integrity of 

the closed system of distribution. 

Return and Recall 

DEA is proposing to delete the 

existing rule on return and recall, 21 

CFR 1307.12, and to clarify and separate 

the role of registrants and nonregistrants in the return and recall of 

controlled substances. This is because of 

the different circumstances surrounding 

registrant and ultimate user return and 

recall. 

Return and Recall by Registrants 

DEA proposes procedures for the 

return and recall of controlled 

substances by DEA registrants in 

sections 1317.05(a)(3), 1317.05(b)(3), 

and 1317.05(b)(4), and recordkeeping 

and order form requirements in a new 

section 1317.10, which are similar to the 

existing rule on return and recall in 21 

CFR 1307.12. The proposed new 

sections, however, clarify which 

registrants are authorized to distribute 

and receive returns and recalls and 

clarifies the recordkeeping and order 

form requirements. DEA proposes in 

sections 1317.05(a)(3), 1317.05(b)(3), 

and 1317.05(b)(4) that registrants in 

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lawful possession of a controlled 

substance may return that substance for 

the purpose of return or recall to: (1) 

The registered person from whom it was 

obtained; (2) the registered 

manufacturer of the substance; or (3) 

another registrant authorized by the 

manufacturer to accept returns or recalls 

on the manufacturer’s behalf. The 

procedures governing return of the 

substance are determined by the 

returning registrant’s authorization as a 

practitioner or non-practitioner, as 

discussed above. This is consistent with 

the intent of the Controlled Substances 

Act to prevent opportunities for 

diversion because the substances are 

being transferred within the closed 

system of distribution for the purpose of 

disposal (i.e., return or recall) without 

having left the closed system of 

distribution, and accountability is 

ensured by pertinent recordkeeping 

requirements. 

DEA proposes in section 1317.10(a) 

information that must be maintained in 

the records of registrants returning 

controlled substances and registrants 

receiving returns. In addition, pursuant 

to proposed section 1317.10(b), DEA 

Form 222 must be used by each 

registrant that distributes a controlled 

substance in Schedule I or II for the 

purpose of return and recall in 

accordance with 21 CFR part 1305. The 

freight forwarding provision of the 

existing rule is also retained in section 

1317.10(c). 

Ultimate User Product Recall 

DEA proposes in section 1317.85 

procedures for the recall or return of 

controlled substances by ultimate users. 

Currently, DEA authorizes ultimate user 

distribution for the purpose of recall 

under existing 21 CFR 1307.12, but the 

language in this section is overly broad. 

The proposed section 1317.85(a) 

reduces ambiguity that exists under 

current regulations by specifying to 

whom an ultimate user is permitted to 

deliver their recalled controlled 

substance and by outlining consistent 

and clear requirements for registrants 

authorized to receive those recalled 

substances from ultimate users. 

In particular, DEA proposes in section 

1317.85(a) to authorize an ultimate user 

in lawful possession of a controlled 

substance in Schedules II, III, IV, or V 

to deliver the recalled controlled 

substance to the manufacturer of the 

substance or another registrant 

authorized by the manufacturer to 

accept returns or recalls on the 

manufacturer’s behalf. In the event of a 

product recall, the manufacturer of the 

recalled controlled substance or another 

registrant authorized by the 

manufacturer to accept returns or recalls 

on the manufacturer’s behalf is 

authorized to receive recalled controlled 

substances from an ultimate user and 

does not need to be an authorized 

collector to do so. This is because the 

necessary security and experience in 

handling controlled substances is 

already in place. Recalled controlled 

substances received by authorized 

registrants from ultimate users are reentering the closed system of 

distribution and must be handled 

(stored, destroyed, etc.), unless 

otherwise specified, in accordance with 

procedures that the registrant is 

otherwise required to follow. 

DEA proposes in 1317.85(a)(1) that 

registrants authorized to receive recalled 

controlled substances from ultimate 

users maintain a record of recalled 

controlled substances received from 

ultimate users. Those registrants, 

however, are exempted under section 

1317.85(a)(2) from the requirements in 

21 CFR part 1305 pertaining to DEA 

Form 222 for substances received from 

non-registrants. In accordance with the 

Disposal Act, the delivery of a Schedule 

II controlled substance for the purpose 

of disposal by an ultimate user, longterm care facility, or other person acting 

in accordance with the Disposal Act is 

exempt from order form requirements 

(i.e., an ultimate user or long-term care 

facility may transfer a Schedule II 

controlled substance to another person 

for the purpose of disposal without a 

written order of the person to whom 

such substance is transferred). 21 U.S.C. 

828(b)(3). In other words, when an 

ultimate user delivers a recalled 

controlled substance to an authorized 

registrant for the purpose of disposal, in 

this case recall, such transactions are 

exempt from the requirements found in 

21 CFR part 1305. 

DEA is also proposing in section 

1317.85(a)(3) that the authorized 

registrant report all recalled controlled 

substance acquisition transactions 

pursuant to 21 CFR 1304.33. Such 

registrants may report either each 

individual receipt or a single transaction 

that includes 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. 

Finally, DEA proposes in 1317.85(b) 

that an ultimate user that 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 substance received as 

part of that research to the registered 

dispenser from which it was obtained, 

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). 

Methods of Destruction 

DEA is proposing a standard of 

destruction—non-retrievable—for 

persons that destroy or cause the 

destruction of controlled substances. 

Some examples of current technology 

that may achieve the non-retrievable 

standard are incineration and chemical 

digestion. Flushing and mixing 

controlled substances with coffee 

grounds or kitty litter are examples of 

existing methods of destruction that do 

not meet the non-retrievable standard. 

These examples are not exhaustive and 

DEA is not requiring, endorsing, 

authorizing, or recommending any 

particular method of destruction so long 

as the desired result is achieved and the 

method is compliant with all applicable 

federal, state, tribal, and local laws and 

regulations. 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. DEA is proposing a standard 

of destruction that provides 

communities the flexibility to tailor 

disposal options to meet their resources 

and needs and allows for advances in 

technology. 

Non-Retrievable 

Each controlled substance has its own 

inherent chemical and/or physical 

properties. Accordingly, the objective of 

‘‘destruction’’ is to render the substance 

no longer susceptible to diversion for an 

illicit or non-medical use. DEA intends 

to provide maximum flexibility to allow 

for technological innovation and 

development in controlled substance 

destruction processes. As such, DEA 

solicits comments on the proposed 

requirement that all destruction 

processes be applied in such a manner 

that the controlled substances are 

rendered ‘‘non-retrievable.’’ 

Any destruction method applied to a 

controlled substance must render it 

‘‘non-retrievable.’’ The proposed 

definition of ‘‘non-retrievable’’ means to 

permanently alter any controlled 

substance’s physical and/or chemical 

state through 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. 

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43See Findings, Sec. 2, Secure and Responsible 

Drug Disposal Act of 2010. 

44 DEA proposes in 21 CFR 1301.76 to delete 

reference to 1307.12 and replace it with reference 

to 21 CFR part 1317; in 21 CFR 1304.11(e) and the 

introductory paragraph of 1304.22 to delete 

reference to 21 CFR 1307.12; in 21 CFR 1301.25(i), 

1301.52(c), and 1307.13 to delete reference to 21 

CFR 1307.21 and replace it with reference to 21 

CFR part 1317; in 21 CFR 1304.25(a)(9) and 

1304.25(b)(9) to delete reference to 21 CFR 1307.22 

and replace it with reference to 21 CFR part 1317; 

and in 21 CFR 1304.04(a) to add reference to 21 

CFR part 1317. DEA also proposes in 21 CFR 

1307.22 to delete reference to 21 CFR 1307.21, but 

not replace it with reference to 21 CFR part 1317. 

This revision to 21 CFR 1307.22 will allow existing 

practices for seizure and forfeiture to continue. DEA 

proposes to revise the title of 21 CFR 1307.22 to 

‘‘Delivery of forfeited controlled substances’’ for 

clarity. 

In the case of ultimate user disposal 

where most people are unable to 

differentiate between controlled and 

non-controlled substances and because 

cataloging or taking inventory of 

substances may be detrimental to efforts 

to prevent diversion, all of the proposed 

collection methods allow comingling of 

pharmaceuticals. As a result, this 

proposed rule would require a method 

of destruction sufficient to render all 

included controlled substances nonretrievable. Likewise, where the actual 

substances collected are unknown, but 

may reasonably include controlled 

substances, the proposed rule would 

require selection of a method of 

destruction sufficient to render nonretrievable any controlled substance 

likely to be present. Information 

received at the January 2011 public 

meeting held by DEA indicated that 

incineration in accordance with federal, 

state, and local law may be the currently 

most-used method of destruction to 

achieve this result. Even so, DEA is 

proposing a standard that allows 

flexibility so long as the desired result 

is achieved, thus allowing for 

technological innovation and 

development. Regardless of the 

destruction method, the destruction 

must be conducted in accordance with 

all federal, state, tribal, and local laws 

and regulations. 

Environmental Considerations 

In passing the Disposal Act to provide 

those individuals seeking to dispose of 

unwanted or unused controlled 

substances in their household with 

more disposal options beyond 

discarding or flushing the substances, 

Congress expected that there would be 

fewer such substances introduced into 

the environment, particularly into the 

water.43 DEA also recognizes that the 

establishment of alternative, lawful 

means for disposing of unused or 

expired pharmaceutical controlled 

substances may alleviate some existing 

environmental concerns. For example, 

recent studies have reported on the 

presence of pharmaceutical chemicals 

in varying concentrations in water 

supplies. DEA is hopeful that the 

increased availability of methods for 

citizens to safely and securely dispose 

of unwanted prescription drugs will 

have a positive impact on reducing the 

introduction of chemical contaminants 

into the water supply. However, 

collection and destruction of unwanted 

and unused pharmaceuticals cannot and 

will not address water contamination 

that occurs from other means such as 

bodily elimination or excretion of such 

substances. 

The requirements of this proposed 

rule only govern compliance with the 

Controlled Substances Act. Any selected 

method of destruction of controlled 

substances meeting the requirements of 

this proposed rule must also comply 

with all applicable federal, state, and 

local laws and regulations applicable at 

the time of the destruction. Because of 

the broad range of such environmental 

and other laws and regulations, this 

proposed rule does not purport to 

address what laws may or may not be 

applicable in a particular circumstance 

now or at some future date. 

As DEA and public and private 

entities introduce proposed options for 

disposal of controlled substances to the 

general public and in specific 

communities, it is anticipated that the 

environmental benefits of proper 

collection and destruction will be 

emphasized in the public education and 

publicity surrounding the disposal of 

unwanted or unused controlled 

substances. Public health and safety is 

protected and improved both in 

preventing diversion of controlled 

substances during a national epidemic 

of pharmaceutical drug abuse and in 

providing options for collection that 

result in secure and environmentally 

sound destruction consistent with 

federal, state, tribal, and local laws and 

regulations. 

Miscellaneous Changes 

In accordance with the changes 

described above, DEA proposes to delete 

any reference to 21 CFR 1307.12 and 

1307.21 and replace it with a reference 

to the new 21 CFR part 1317, where 

appropriate.44 DEA also proposes to 

revise 21 CFR 1301.13(e)(1)(i) to delete 

reference to a disposer category of 

registration in the coincident activity 

column for manufacturers. A disposer 

category of registration was proposed by 

DEA in 1995, but was never finalized 

(60 FR 43732, August 23, 1995). 

Reference to a disposer category was 

inadvertently included in a previous 

rulemaking (68 FR 58587, October 10, 

2003). 

Regulatory Analyses 

Regulatory Flexibility Act 

Under the Regulatory Flexibility Act 

of 1980 (RFA) (5 U.S.C. 601–612), 

federal agencies must evaluate the 

impact of rules on small entities and 

consider less burdensome alternatives. 

As discussed in the preceding sections 

of the regulatory preamble, DEA has 

considered numerous alternatives for 

each proposed requirement and method 

of collection and evaluated the impact 

of this proposed rule on small entities. 

DEA has concluded that the rule will 

not, if promulgated, have a significant 

economic impact on a substantial 

number of small entities. An economic 

analysis of the Proposed Rule can be 

found in the rulemaking docket at 

http://www.regulations.gov. 

In developing this proposed rule, DEA 

considered several options for both 

registrant and non-registrant disposal 

and reverse distributor destruction 

requirements. DEA analyzed alternative 

methodology approaches keeping in 

mind its statutory obligations under the 

CSA. DEA considered three options for 

non-registrant disposal: (1) Single 

Collection, which would authorize nonregistrants 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 DEA registrant; and (3) 

Multiple Collection, which would 

authorize non-registrants to utilize more 

than one method of collection to 

transfer controlled substances for 

purposes of disposal to law enforcement 

agencies and certain DEA registrants. In 

addition, DEA considered two options 

for registrant disposal: (1) Retain 

Existing Regulations, which would 

make no changes to the existing 

registrant disposal regulations (21 CFR 

1307.12 and 1307.21); and (2) Establish 

Consistent National Standards, which 

would delete existing regulations on the 

disposal of controlled substances (21 

CFR 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, DEA considered four options 

for reverse distributors: (1) On-site 

Requirement, which would require 

reverse distributors to have and utilize 

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Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 75805 

45Clin J Pain (The Clinical Journal of Pain), 

Volume 22, Number 8, October 2006. 

46Clin J Pain (The Clinical Journal of Pain), 

Volume 27, Number 3, March/April 2011. 

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 timeline on when reverse 

distributors must destroy controlled 

substances acquired for destruction; and 

(4) As Soon As Practicable But No Later 

Than Fourteen Calendar Day 

Requirement, which would require 

reverse distributors to destroy 

controlled substances received for the 

purpose of destruction as soon as 

practicable but no later than fourteen 

calendar days of receipt. DEA performed 

a qualitative analysis of each of these 

alternatives and selected the ‘‘Multiple 

Collection’’ option for non-registrant 

disposal, the ‘‘Establish Consistent 

National Standard’’ option for registrant 

disposal, and the ‘‘As Soon As 

Practicable But No Later Than Fourteen 

Calendar Day Requirement’’ option for 

reverse distributors. 

In accordance with the RFA, DEA 

evaluated the impact of this rule on 

small entities and anticipates that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. If 

promulgated, this proposed rule would 

affect all 1.4 million controlled 

substance registrants, which 

corresponds to approximately 381,386 

businesses affected by the proposed 

rule. DEA estimates that 370,133 (97 

percent) of the affected businesses are 

considered ‘‘small entities’’ in 

accordance with the RFA and Small 

Business Administration (SBA) 

standards. 5 U.S.C. 601(6) and 15 U.S.C. 

632. DEA estimates that there should be 

minimal to no economic impact as a 

result of this proposed rule. 

In accordance with the Regulatory 

Flexibility Act (5 U.S.C. 605(b)), the 

Administrator hereby certifies that this 

proposed rulemaking has been drafted 

consistent with the Act and that a 

regulatory analysis on the effects or 

impacts of this proposed rulemaking on 

small entities has been done and that 

the proposed rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Executive Orders 12866 and 13563 

This proposed rule was developed in 

accordance with the principles of 

Executive Orders 12866 and 13563. 

Based on an economic analysis, 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 Proposed Rule can be found in the 

rulemaking docket at http:// 

www.regulations.gov. Public comment 

was received in public meetings held on 

January 19–20, 2011, to help inform and 

develop these proposed rules. Public 

comment is encouraged on this 

proposed rule through the internet with 

easy access to supporting information 

found at http://www.regulations.gov. 

Although not an economically 

significant rule, this proposed rule on 

the disposal of controlled substances 

has been reviewed by the Office of 

Management and Budget. 

For DEA registrants that destroy 

controlled substances as described 

above, DEA anticipates that this 

rulemaking will have minimal or no 

economic impact and that modified 

DEA Form 41 could result in some level 

of cost savings. In addition, for 

registered reverse distributors, DEA 

anticipates that the security and 

recordkeeping requirements contained 

in the proposed rule will result in 

minimal or no costs. 

DEA has determined that reverse 

distributors currently destroy controlled 

substances within the proposed ‘‘as 

soon as practicable but no later than 

fourteen 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 proposed 

requirement. For these instances, DEA 

believes reverse distributors will be able 

to make modifications to their pick-up/ 

receipt and destruction schedule to 

accommodate the proposed 

requirements with minimal to no 

economic impact. Moreover, DEA 

conservatively estimates that the 

voluntary provisions for collectors, 

reverse distributors, distributors, and 

law enforcement agencies will have a 

net economic impact of nearly zero, and 

invites comment on this estimate. The 

proposed provisions that facilitate NonRegistrant Disposal are completely 

voluntary, not mandated. Any collector, 

reverse distributor, distributor, or law 

enforcement agency may 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, 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 its collection 

activities. Any collector, reverse 

distributor, distributor, or law 

enforcement agency that chooses to 

engage in these voluntary activities can 

decide to cease these activities at any 

time. Therefore, for the purposes of this 

analysis, DEA estimates that the 

voluntary provisions in this section 

have net zero economic impact on the 

regulated entities. 

In summary, DEA estimates that there 

should be minimal to no annual total 

cost to the economy as a result of the 

proposed rule. Accordingly, 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. 

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 and listed chemicals into the 

illicit market. The cost-benefit analysis 

uses the costs associated with the 

nonmedical use of prescription opioids, 

$8.6 billion in 2001 45 and $53.4 billion 

in 2006.46 These are conservative 

estimates of the rapidly growing total 

cost associated with diversion of 

controlled substances and listed 

chemicals into the illicit market. As 

DEA has determined this rule poses 

minimal to no economic impact, DEA 

concludes that this rule reduces the 

growth in the cost of the diversion of 

controlled substances and listed 

chemicals into the illicit market, 

therefore, this rule will have a positive 

benefit for the health and safety of the 

citizens and residents of the United 

States. 

Paperwork Reduction Act 

Pursuant to Section 3507(d) of the 

Paperwork Reduction Act of 1995 (PRA) 

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

identified the following collections of 

information related to this proposed 

rule on the disposal of controlled 

substances and has submitted these 

collection requests to the Office of 

Management and Budget (OMB) for 

review and approval. This proposed 

rule implements the Secure and 

Responsible Drug Disposal Act of 2010 

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47The universe of potential participants includes 

all registrants that could potentially become 

authorized collectors. It is likely that this estimate 

will be adjusted downward once DEA obtains more 

information. 

(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 

Controlled Substances Act (CSA), which 

establishes a closed system of 

distribution for all controlled 

substances, DEA 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). These records must be in 

accordance with and contain such 

relevant information as may be required 

by regulations promulgated by DEA. 21 

U.S.C. 827(b)(1). In this rule, DEA 

proposes to revise existing and add a 

minimum amount of new registrant 

recordkeeping requirements, which are 

consistent with those requirements that 

are already required by statute and the 

proposed new part on disposal that 

creates a comprehensive regulatory 

framework for the destruction of 

controlled substances. 

Title: Implementation of Registrant 

Recordkeeping Requirements Pursuant 

to the Controlled Substances Act, 21 

U.S.C. 827 

The recordkeeping requirements that 

DEA registrants are required to maintain 

pursuant to law are a vital component 

of DEA’s enforcement and control 

responsibilities—such records alert DEA 

to problems of diversion and ensure that 

the system of controlled substances 

distribution is open only to legitimate 

handlers of such substances. 

As discussed in the section on reverse 

distributors above, DEA is proposing to 

revise the information that registered 

reverse distributors are currently 

required to record consistent with 

previous requirements as well as a 

minimum amount of requirements 

under the proposed new comprehensive 

regulatory framework for the destruction 

of controlled substances. As discussed 

in more detail above, DEA proposes to 

modify the existing information that 

reverse distributors are required to 

record for clarity and consistency. In 

addition, DEA proposes that for all 

controlled substance records, reverse 

distributors will be required to maintain 

their existing business records so that 

the record of receipt is maintained with 

the corresponding record of return or 

destruction. By maintaining all relevant 

business records together, 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. 

DEA estimates that there will be 60 

respondents to this information 

collection and that their estimated 

frequency of response will vary. DEA 

estimates that the frequency of response 

will vary, because in accordance with 

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

Because DEA is proposing 

recordkeeping requirements that 

registered reverse distributors are 

already required to maintain in 

accordance with 21 U.S.C. 827(a) and 

(b), DEA anticipates that the annual 

hour burden will not be increased by 

the proposed rule. 

DEA is also proposing revised 

information that registrants are required 

to record in the return and recall 

process. DEA proposes to delete the 

existing rule on return and recall, 21 

CFR 1307.12, and to implement separate 

rules on the return and recall of 

controlled substances for registrants and 

non-registrants. The return and recall 

recordkeeping requirements have been 

revised to reflect these changes. 

DEA estimates that the universe of 

potential respondents to this 

information collection will be 68,344 

respondents (Distributors—828, Reverse 

Distributors—60, Manufacturers—522, 

Retail Pharmacies—66,934). DEA 

estimates that the frequency of response 

will vary, because in accordance with 

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

Because DEA is proposing 

recordkeeping requirements that 

registrants are already required to 

maintain in accordance with 21 U.S.C. 

827(a) and (b), DEA anticipates that the 

annual hour burden will not be 

increased by the proposed rule. 

DEA is proposing 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. To 

implement the Disposal Act, DEA is 

proposing to provide ultimate users, 

long term care facilities, and other nonregistrants safe and convenient options 

to transfer controlled substances for 

purposes of disposal: Take-back events, 

mail-back programs, and collection 

receptacle locations. In the proposed 

rule, registered manufacturers, 

distributors, reverse distributors, and 

retail pharmacies may obtain 

authorization from DEA to be a 

collector. A collector is a registered 

person authorized to receive a 

controlled substance for the purpose of 

disposal from non-registrants in lawful 

possession of controlled substances. 

DEA is proposing information that 

collectors must record based on the 

particular ultimate user collection 

method utilized (i.e., mail-back program 

or collection receptacle). 

DEA estimates that the universe of 

potential participants to this 

information collection will be 68,344 

respondents (Distributors—828, Reverse 

Distributors—60, Manufacturers—522, 

Retail Pharmacies—66,934).47 DEA 

estimates that the frequency of response 

will vary, because in accordance with 

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

DEA notes, however, that the option to 

become an authorized collector is 

voluntary and no entity is required to 

establish or operate a disposal program 

as an authorized collector. The 

authorization to collect is a new activity 

and DEA has no criterion to determine 

the level of participation. As a result, 

the number of respondents is based on 

the current number of registrants which 

may request authorization to become a 

collector and the annual hour burden 

cannot be determined at this time. DEA 

will continue to monitor and analyze 

the potential burden of the new 

requirements imposed by this proposed 

rule and will review all comments 

submitted in response to this proposed 

rule and information collection request. 

DEA is also proposing to authorize 

registered reverse distributors and 

distributors to acquire controlled 

substances from authorized law 

enforcement agencies and certain 

collectors that have acquired controlled 

substances from ultimate users and 

other non-registrants. DEA proposes to 

require these registered reverse 

distributors and distributors to maintain 

complete and accurate records of 

controlled substances received, 

delivered, or otherwise transferred for 

the purpose of destruction. 

DEA estimates that the universe of 

potential respondents to this 

information collection will be 888 

respondents (Distributors—828, Reverse 

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Distributors—60). DEA estimates that 

the frequency of response will vary, 

because in accordance with 21 U.S.C. 

827(a), 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. The 

authorization for reverse distributors 

and distributors to acquire controlled 

substances collected by law 

enforcement agencies and authorized 

collectors is new. As a result, DEA 

presently has no criterion to determine 

the level of participation and the annual 

hour burden cannot be determined at 

this time. DEA will continue to analyze 

the potential burden of the new 

requirements imposed by this proposed 

rule and review all comments submitted 

in response to this proposed rule and 

information collection request. 

Title: Registrant Record of Controlled 

Substances Destroyed—DEA Form 41 

OMB Control Number: 1117–0007. 

Form Number: DEA Form 41. 

The recordkeeping requirements that 

DEA registrants are required to maintain 

pursuant to law are a vital component 

of DEA’s enforcement and control 

responsibilities—such records alert DEA 

to problems of diversion and ensure that 

the system of controlled substances 

distribution is open only to legitimate 

handlers of such substances. DEA is 

proposing information that registrants 

involved in the destruction of controlled 

substances must record. The record of 

destruction must include the signature 

of the two authorized 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. DEA proposes to 

modify existing DEA Form 41 to reflect 

the proposed record of destruction for 

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 OMB and 

assigned OMB control number 1117– 

0007. 

In accordance with the current 21 

CFR 1307.21, a DEA registrant that 

desires to dispose of a controlled 

substance must submit three copies of 

DEA Form 41 to the Special Agent in 

Charge (SAC) in their area. DEA is 

proposing to delete 21 CFR 1307.21 and 

replace it with a comprehensive part 

1317 on disposal. In an effort to 

minimize the burden on registrants and 

in accordance with the proposed 

comprehensive regulatory framework 

for disposal, registrants that destroy 

controlled substances and utilize DEA 

Form 41 will no longer be required to 

submit three copies of DEA Form 41 to 

the SAC in their area. Rather, in 

accordance with the CSA, such 

registrants 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). 

DEA estimates that there will be 

68,344 respondents (Distributors—828, 

Reverse Distributors—60, 

Manufacturers—522, Retail 

Pharmacies—66,934) to this information 

collection. The number of respondents 

(68,344) represents the total number of 

registrants in business activities that are 

most likely to destroy controlled 

substances. DEA estimates that the 

frequency of response will vary, because 

in accordance with 21 U.S.C. 827(a), 

registrants 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. DEA 

estimates that the average time per 

response will be 30 minutes and that the 

total annual burden will be 34,172 

hours. 

Request for Comments Regarding the 

Proposed Information Collection 

All estimates include the time for 

reviewing instructions; searching 

existing data sources; gathering or 

maintaining the needed data; and 

reviewing the information. DEA solicits 

comments concerning: Whether these 

information collection requirements are 

necessary for the proper performance of 

the functions of DEA, including whether 

the information has practical utility; the 

accuracy of DEA’s estimates of the 

burden of the information collection 

requirements; the quality, utility, and 

clarity of the information to be 

collected; and whether the burden of 

collection of information on those who 

are to respond, including through the 

use of automated collection techniques 

or other forms of information 

technology, may be minimized. For 

information or a copy of the paperwork 

package submitted to OMB, contact John 

W. Partridge, Executive Assistant, Office 

of Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 307–4654. 

Organizations and individuals 

desiring to submit comments on the 

collection of information requirements 

should direct them to Drug Enforcement 

Administration, Attention: Office of 

Diversion Control (OD/DX), 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

OMB is required to make a decision 

concerning the collection of information 

requirements contained in this proposed 

rule between 30 and 60 days after its 

publication in the Federal Register. 

Therefore, a comment to OMB is best 

assured of having its full effect if OMB 

receives it within 30 days of 

publication. The final rule will respond 

to any OMB or public comments on the 

information collection requirements 

contained in this proposal. 

DEA is not authorized to impose a 

penalty on persons for violating 

information collection requirements 

which do not display a current OMB 

control number, if required. DEA 

intends to obtain current OMB control 

numbers for any new information 

collection requirements resulting from 

this rulemaking action prior to the 

effective date of the final rule. The OMB 

control number, when assigned, will be 

announced by separate notice in the 

Federal Register. 

Executive Order 12988 

This proposed regulation meets the 

applicable standards set forth in 

Sections 3(a) and 3(b)(2) of Executive 

Order 12988 Civil Justice Reform 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 proposed rule provides options 

for the collection of controlled 

substances by registrants and nonregistrants 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 

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75808 Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Proposed Rules 

environmentally sound manners. This 

proposed rule establishes the legal 

requirements for the handling of 

controlled substances. Destruction of 

controlled substances must be 

consistent with federal, state, tribal and 

local laws and regulations. 

DEA and the regulated community 

have disposed of controlled substances 

since passage of the CSA. DEA has 

published a categorical exclusion from 

further NEPA analysis for the storage 

and destruction of controlled 

substances. This proposed rule would 

not authorize any new methods of 

storage, transportation, or destruction of 

controlled substances, but is limited to 

the logistics and documentation of the 

collection of controlled substances for 

destruction. Accordingly, this proposed 

rule does not significantly affect the 

quality of the human environment. DEA 

has, therefore, determined that this 

proposed 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 

This proposed rule will not result in 

the expenditure by state, local, and 

tribal governments, in the aggregate, or 

by the private sector, of $136,000,000 or 

more (adjusted for inflation) in any one 

year, and will not significantly or 

uniquely affect small governments. 

Therefore, no actions were deemed 

necessary under the provisions of the 

Unfunded Mandates Reform Act of 

1995, 2 U.S.C. 1532. 

Executive Order 13175 

This proposed rule is required by 

statute, will not have tribal implications 

and will not impose substantial direct 

compliance costs on Indian tribal 

governments. 

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, Reporting and 

recordkeeping requirements, Security 

measures. 

For the reasons set forth above, DEA 

proposes to amend 21 CFR parts 1300, 

1301, 1304, 1305, 1307, and 1317 as 

follows: 

PART 1300—DEFINITIONS 

1. 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). 

2. Amend § 1300.01, in paragraph (b) 

by: 

a. Alphabetically adding a definition 

of ‘‘collection’’; 

b. Revising the third sentence of the 

definition of ‘‘freight forwarding 

facility’’; 

c. Alphabetically adding definitions 

of ‘‘non-retrievable’’ and ‘‘reverse 

distribute’’; and 

d. Revising the definition of ‘‘reverse 

distributor’’. 

The additions and revisions read as 

follows: 

§ 1300.01 Definitions relating to controlled 

substances. 

* * * * * 

(b) * * * 

Collection means to receive a 

controlled substance for the purpose of 

destruction from an ultimate user, a 

person lawfully entitled to dispose of 

ultimate user decedent’s property, or a 

long term care facility on behalf of an 

ultimate user that resides or has resided 

at that facility. The term collector means 

a registered manufacturer, distributor, 

reverse distributor, 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. 

* * * * * 

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 and/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 and/or physical 

properties. A controlled substance is 

considered ‘‘non-retrievable’’ when it 

cannot be transformed to a physical 

and/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. 

* * * * * 

Reverse distribute means to acquire 

controlled substances from another DEA 

registrant or a law enforcement agency 

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 means a person 

who reverse distributes a controlled 

substance. 

* * * 

* * * * * 

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

3. The authority citation for part 1301 

continues 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. 

4. Amend § 1301.13 by revising 

paragraph (e)(1)(i) 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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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 

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 mfg. was 

issued. 

* * * * * * * 

* * * * * 

5. Amend § 1301.25 by revising 

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. 

6. 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, to change his/her name or 

address, or in the case of retail 

pharmacies, manufacturers, distributors, 

and reverse distributors, to authorize 

such registrant to be a collector, by 

submitting a letter of 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. 

(1) The letter 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, a request 

for authorization to collect and the 

type(s) of collection the registrant 

intends to conduct (collection 

receptacle or mail-back program), or the 

new name or address; and 

(iii) A signature in accordance with 

§ 1301.13(j) of this part. 

(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. 

(3) If a registered retail pharmacy is 

applying for a modification in 

registration to authorize such registrant 

to be a collector and maintain a 

collection receptacle at a long term care 

facility in accordance with § 1317.80 of 

this chapter, the registrant shall include 

the physical location of each long term 

care facility at which the registered 

pharmacy intends to operate a 

collection receptacle. 

(b) No fee shall be required to be paid 

for modifications. The request for 

modification shall be handled in the 

same manner as an application for 

registration. If the modification in 

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. 

7. Amend § 1301.52 by revising 

paragraph (c) to read as follows: 

§ 1301.52 Termination of registration; 

transfer of registration; distribution upon 

discontinuance of business. 

* * * * * 

(c) Any registrant desiring to 

discontinue business activities 

altogether or with respect to controlled 

substances (without transferring such 

business activities to another person) 

shall return for cancellation his/her 

certificate of registration, and any 

unexecuted order forms in his/her 

possession, to the Registration Unit, 

Drug Enforcement Administration. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for current 

mailing address. Any controlled 

substances in his/her possession may be 

disposed of in accordance with part 

1317 of this chapter. 

* * * * * 

8. Amend 1301.72 by revising 

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, and 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 FFDCA which shall 

be subject to the requirements of 

paragraph (b) of this section), in 

addition to sealed mail-back packages 

and inner liners collected in accordance 

with part 1317 of this chapter, shall be 

stored in one of the following secured 

areas: 

* * * * * 

9. Amend § 1301.75 by revising 

paragraph (b) to read as follows: 

§ 1301.75 Physical security controls for 

practitioners. 

* * * * * 

(b) Controlled substances listed in 

Schedules II, III, IV, and V, in addition 

to sealed mail-back packages and inner 

liners collected in accordance with part 

1317 of this chapter, shall be stored in 

a securely locked, substantially 

constructed cabinet. However, 

pharmacies and institutional 

practitioners may disperse such 

substances, excluding sealed mail-back 

packages and collection receptacle inner 

liners, throughout the stock of noncontrolled substances in such a manner 

as to obstruct the theft or diversion of 

the controlled substances. 

* * * * * 

10. Amend § 1301.76 by revising 

paragraph (c) to read as follows: 

§ 1301.76 Other security controls for 

practitioners. 

* * * * * 

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(c) Whenever the registrant distributes 

a controlled substance (as permitted in 

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

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 

11. The authority citation for part 

1304 is revised to read as follows: 

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

958(f) and (g), and 965, unless otherwise 

noted. 

12. Amend § 1304.03 by revising the 

first two sentences of paragraph (a) to 

read as follows: 

§ 1304.03 Persons required to keep 

records and file reports. 

(a) Each registrant shall maintain the 

records and inventories and shall file 

the reports required by this part and 

part 1317 of this chapter, except as 

exempted by this section. Any registrant 

who is authorized to conduct other 

activities without being registered to 

conduct those activities, pursuant to 

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

this chapter, shall maintain the records 

and inventories and shall file the reports 

required by this part for persons 

registered to conduct such activities. 

* * * 

* * * * * 

13. Amend § 1304.04 by revising 

paragraph (a) introductory text to read 

as follows: 

§ 1304.04 Maintenance of records and 

inventories. 

(a) Except as provided in paragraphs 

(a)(1) and (2) of this section, every 

inventory and other records required to 

be kept under this part and part 1317 of 

this chapter must be kept by the 

registrant and be available, for at least 

2 years from the date of such inventory 

or records, for inspection and copying 

by authorized employees of the 

Administration. 

* * * * * 

14. Amend § 1304.11 by revising 

paragraph (e) introductory text, 

paragraph (e)(2), and paragraph (e)(3) 

introductory text to read as follows: 

§ 1304.11 Inventory requirements. 

* * * * * 

(e) Inventories of manufacturers, 

distributors, dispensers, researchers, 

importers, exporters and chemical 

analysts. Each person registered or 

authorized (by §§ 1301.13, 1307.11, or 

1307.13 of this chapter) to manufacture, 

distribute, dispense, import, export, 

conduct research or chemical analysis 

with controlled substances and required 

to keep records pursuant to § 1304.03 

shall include in the inventory the 

information listed below. 

* * * * * 

(2) Inventories of distributors. Except 

for reverse distributors covered by 

§ 1317.25 of this chapter, 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 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: 

* * * * * 

15. Amend § 1304.22 by revising the 

introductory text, paragraph (b), and 

removing paragraph (e). 

The revisions read as follows: 

§ 1304.22 Records for manufacturers, 

distributors, dispensers, researchers, 

importers and exporters. 

Each person registered or authorized 

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

this chapter) to manufacture, distribute, 

dispense, import, export, or conduct 

research with controlled substances 

shall maintain records with the 

information listed below. 

* * * * * 

(b) Records for distributors. Except for 

reverse distributors covered by 

§§ 1317.25 and 1317.55 of this chapter, 

each person registered or authorized to 

distribute controlled substances shall 

maintain records with the same 

information required of manufacturers 

pursuant to paragraphs (a)(2)(i), (ii), (iv), 

(v), (vii), (viii), and (ix) of this section 

or, when applicable, § 1317.55 of this 

chapter. 

* * * * * 

16. Amend § 1304.25 by revising 

paragraphs (a)(9) and (b)(9) to read as 

follows: 

§ 1304.25 Records for treatment programs 

which compound narcotics for treatment 

programs and other locations. 

* * * * * 

(a) * * * 

(9) The quantity disposed of by 

destruction, including the reason, date 

and manner of destruction. All other 

destruction of narcotic controlled 

substances shall comply with part 1317 

of this chapter. 

(b) * * * 

(9) The number of units of finished 

forms and/or commercial containers 

destroyed in any manner by the 

registrant, including the reason, the date 

and manner of destruction. All other 

destruction of narcotic controlled 

substances shall comply with part 1317 

of this chapter. 

PART 1305—ORDERS FOR SCHEDULE 

I AND II CONTROLLED SUBSTANCES 

17. The authority citation for part 

1305 continues to read as follows: 

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

unless otherwise noted. 

18. Amend § 1305.03 by adding 

paragraph (e) to read as follows: 

§ 1305.03 Distributions requiring a Form 

222 or a digitally signed electronic order. 

* * * * * 

(e) Deliveries to an authorized DEA 

registrant pursuant to part 1317 of this 

chapter by an ultimate user, a long-term 

care facility on behalf of an ultimate 

user that resides or has resided at that 

facility, or a person authorized to 

dispose of the ultimate user decedent’s 

property. 

PART 1307—MISCELLANEOUS 

19. The authority citation for part 

1307 continues to read as follows: 

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

unless otherwise noted. 

§ 1307.11 [Amended] 

20. In § 1307.11, remove and reserve 

paragraph (a)(2). 

§ 1307.12 [Removed] 

21. Remove § 1307.12. 

22. 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 

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pursuant to part 1303 of this chapter, if 

such substances are disposed of in 

accordance with part 1317 of this 

chapter. 

§ 1307.21 [Removed] 

23. Remove § 1307.21 

24. Revise § 1307.22 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. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. The application shall 

show the name, address, and official 

title of the person or agency to whom 

the controlled drugs are to be delivered, 

including the name and quantity of the 

substances desired and the purpose for 

which intended. The delivery of such 

controlled drugs shall be ordered by the 

Administrator, if, in his opinion, there 

exists a medical or scientific need 

therefor. 

25. Add part 1317 to read as follows: 

PART 1317—DISPOSAL 

Sec. 

1317.01 Scope. 

1317.02 Definitions. 

Subpart A—Disposal of Controlled 

Substances by Registrants 

1317.05 Registrant disposal. 

1317.10 Registrant return or recall 

recordkeeping and order form 

requirements. 

1317.15 Reverse distributor registration 

requirements and authorized activities. 

1317.20 Reverse distributor employee 

security requirement. 

1317.25 Reverse distributor inventory, 

recordkeeping, reporting, and order form 

requirements. 

Subpart B—Disposal of Controlled 

Substances by Ultimate Users and Other 

Non-Registrants 

1317.30 Authorization to collect from nonregistrants. 

1317.35 Collection by law enforcement 

agencies. 

1317.40 Registrants authorized to collect 

and authorized collection activities. 

1317.45 Collector security requirements. 

1317.50 Collector inventory, recordkeeping, 

reporting, and order form requirements. 

1317.55 Registered reverse distributor and 

distributor acquisition of controlled 

substances from law enforcement 

agencies or authorized collectors. 

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. 

1317.100 Recordkeeping requirements. 

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

828; 871(b); and 958. 

§ 1317.01 Scope. 

This part prescribes the process and 

procedures for the delivery, collection, 

and destruction of damaged, expired, 

recalled, unused, or otherwise 

unwanted controlled substances that are 

lawfully possessed by DEA registrants 

(Subpart A) and non-registrants 

(Subpart B). The purpose of such 

procedures is to provide prompt, safe, 

and effective disposal methods while 

providing effective controls against the 

diversion of controlled substances. 

§ 1317.02 Definitions. 

(a) As used in this part, the following 

terms shall have the meaning specified: 

Authorized Employee means an 

individual employed full time by the 

registrant, who has not been convicted 

of a felony offense related to controlled 

substances and has not, 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. 

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. 

Inner liner means a liner that meets 

the specifications listed in § 1317.60 of 

this chapter and is used in the 

collection of controlled substances. 

Law enforcement officer means a 

person that is: 

(i) Employed full time by a law 

enforcement agency; 

(ii) Under the direction and control of 

a federal, state, tribal, or local 

government; 

(iii) Acting in the course of their 

official duty; and 

(iv) Duly sworn and given the 

authority by any federal, state, tribal, or 

local government to carry firearms, 

execute and serve warrants, make 

arrests without warrant, and make 

seizures of property. 

(b) Any other term contained in this 

part and not defined in paragraph (a) of 

this section shall have the definition set 

forth in section 102 of the Act (21 U.S.C. 

802) or part 1300 of this chapter. 

Subpart A—Disposal of Controlled 

Substances by Registrants 

§ 1317.05 Registrant disposal. 

(a) Practitioner Inventory. Any DEA 

registered practitioner in lawful 

possession of a controlled substance in 

its inventory who 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 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) 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 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 applicant to dispose of the 

controlled substance in one of the 

following manners: 

(A) By transfer to a person registered 

under the Act and 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. 

(iii) 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)(2) 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 

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summarizing the disposals. The Special 

Agent in Charge may place such 

conditions as she/he deems proper on 

practitioner procedures regarding the 

disposal of controlled substances. 

(b) Non-practitioner inventory. Any 

DEA registrant who is a non-practitioner 

in lawful possession of a controlled 

substance in its inventory who 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 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 the location of destruction, the nonpractitioner shall follow the procedures 

set forth at § 1317.95(b). 

(ii) If a non-practitioner transports 

controlled substances by its own means 

to a registered location for any other 

authorized purpose described in this 

paragraph (b)(4), transportation shall be 

directly to the authorized registered 

location and two authorized employees 

of the transporting non-practitioner 

shall accompany the controlled 

substances to the destination registered 

location. 

(c) Collected Controlled Substances. 

Any authorized 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 

authorized 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 in a 

manner consistent with the security 

requirements for Schedule II controlled 

substances until prompt on-site 

destruction can occur or, with regard to 

the receipt of unauthorized packages, 

until instructions from the 

Administration are received. 

(2) Collection Receptacles. Upon 

removal from the permanent outer shell, 

the authorized collector shall promptly: 

(i) Destroy the inner liner and its 

contents; or 

(ii) Store the inner liner and its 

contents at the collector’s registered 

location in a manner consistent with the 

security requirements for Schedule II 

controlled substances until prompt 

destruction can occur. 

(iii) Practitioner Methods of 

Destruction. Authorized collectors who 

are registered practitioners shall dispose 

of sealed inner liners and their contents 

by utilizing any method in 

§ 1317.05(a)(1), (a)(2), or (a)(4), 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. 

(iv) Non-Practitioner Methods of 

Destruction. Authorized collectors who 

are non-practitioners shall dispose of 

sealed inner liners and their contents 

utilizing any method in § 1317.05(b)(1), 

(b)(2), or (b)(4), 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. Except distributing 

registrants shall not utilize freight 

forwarding facilities to transfer sealed 

inner liners and their contents. 

§ 1317.10 Registrant return or recall 

recordkeeping and order form 

requirements. 

(a) Each registrant shall maintain a 

record of each return or recall 

transaction in accordance with part 

1304 of this chapter. 

(1) Each registrant that delivers a 

controlled substance to another 

registrant for the purpose of return or 

recall shall maintain a record pursuant 

to § 1304.22(b). 

(2) Each registrant that receives a 

controlled substance for the purpose of 

return or recall shall maintain a record 

that includes the following information: 

the date of the transaction; the name, 

form, and quantity of each controlled 

substance received; and the name, 

address, and registration number of the 

delivering registrant from whom the 

substance was received. 

(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 

prescribed 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 DEA as a reverse 

distributor, unless exempted by law or 

otherwise authorized pursuant to this 

chapter. 

(b) A registered reverse distributor 

shall acquire controlled substances from 

a DEA registrant pursuant to §§ 1317.05 

and 1317.55(a) in the following manner: 

(1) The registered reverse distributor 

may pick-up controlled substances from 

a DEA registrant at the DEA registrant’s 

registered location; or 

(2) The registered reverse distributor 

may receive controlled substances 

delivered by common or contract carrier 

or delivered directly by a registrant who 

is a non-practitioner. 

(i) Delivery to the registered reverse 

distributor by an authorized DEA 

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 rerouted to any other location or person, 

regardless of registration status. 

(ii) All controlled substance deliveries 

to a registered reverse distributor shall 

be personally received by an authorized 

employee of the reverse distributor at 

the registered location. 

(c) Upon acquisition of a controlled 

substance by pick-up or delivery, a 

registered reverse distributor shall: 

(1) Immediately and securely store the 

controlled substance at the reverse 

distributor’s registered location, or 

immediately transfer the controlled 

substance to the reverse distributor’s 

registered location for secure storage 

until timely destruction or timely return 

of the substance to the registered 

manufacturer or other registrant 

authorized by the manufacturer to 

accept returns or recalls on the 

manufacturer’s behalf; 

(2) Immediately deliver the controlled 

substance to the registered manufacturer 

or another registrant authorized by the 

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manufacturer to accept returns or recalls 

on the manufacturer’s behalf; 

(3) Timely destroy the controlled 

substance in a manner prescribed in 

Subpart C of this part; or 

(4) Immediately deliver the controlled 

substance to the location of destruction 

for timely destruction pursuant to 

paragraph (d) of this section. 

(d) A registered reverse distributor 

shall destroy or cause the destruction of 

any controlled substance received for 

the purpose of destruction as soon as 

practicable but no later than fourteen 

calendar days of receipt. 

§ 1317.20 Reverse distributor employee 

security requirement. 

A registered 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 DEA denied, had a 

DEA registration revoked or suspended, 

or has surrendered a DEA registration 

for cause. 

§ 1317.25 Reverse distributor inventory, 

recordkeeping, reporting, and order form 

requirements. 

(a) A registered reverse distributor 

that acquires controlled substances from 

a registrant shall maintain the records, 

reports, and order forms described in 

this section and part 1304 of this 

chapter, except that a reverse distributor 

that acquires controlled substances from 

law enforcement agencies or authorized 

collectors pursuant to subpart B of this 

part shall follow § 1317.55(d) through (f) 

of this chapter. 

(b) Inventory requirements. Each 

person registered as a reverse distributor 

shall include the following information 

in the inventory records required by 

§ 1304.11 of this chapter: 

(1) The name of the substance; and 

(2) The total quantity of the substance: 

(i) For controlled substances in bulk 

form, to the nearest metric unit weight 

consistent with unit size; 

(ii) 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 

(iii) 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. 

(c) Record requirements. Each person 

registered as a reverse distributor shall 

maintain records with the following 

information required by § 1304.21 of 

this chapter: 

(1) For return or recall to 

manufacturers: 

(i) The date of receipt; the name and 

quantity of each controlled substance 

received; the name, address, and DEA 

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 DEA number of the 

person from whom the substance was 

received; the name, address, and DEA 

number of the registrant to whom the 

substance was returned; and the method 

of return (e.g., common or contract 

carrier). 

(2) For destruction: 

(i) The date of receipt; the name and 

quantity of each controlled substance 

received; and the name, address, and 

DEA number of the person from whom 

the substance was received; and 

(ii) The date of destruction; the 

method of destruction; the name and 

quantity of each controlled substance 

destroyed; the name, address, and DEA 

number of the person from whom the 

substance was received; the place of 

destruction; and the name and signature 

of the two authorized employees of the 

registered reverse distributor 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 

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 all records, the record of 

receipt shall be maintained together 

with the corresponding record of return 

or destruction. 

(d) Reports to ARCOS. Registered 

reverse distributors shall report 

acquisition/distribution transactions 

pursuant to § 1304.33 of this chapter. 

(e) Order forms. Each person 

registered to reverse distribute 

controlled substances in Schedules I or 

II shall comply with the requirements in 

part 1305 of this chapter. 

Subpart B—Disposal of Controlled 

Substances by 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 DEA 

to be a collector pursuant to § 1317.40 

of this chapter; and 

(2) Any federal, state, tribal, or local 

law enforcement agency or any law 

enforcement officer employed thereby 

acting in the course of that person’s 

official duties and pursuant to § 1317.35 

of this chapter. 

(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 that 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 of this chapter only. 

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§ 1317.35 Collection by law enforcement 

agencies. 

(a) A Federal, state, tribal, or local law 

enforcement agency 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 of this chapter; 

(2) Mail-back programs in accordance 

with § 1317.70 of this chapter; or 

(3) Collection receptacles located at 

the law enforcement agency’s physical 

address and in accordance with 

§ 1317.75 of this chapter. 

(b) A law enforcement agency that 

conducts a take-back event or a mailback 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 a law enforcement agency 

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 a law enforcement agency 

through a take-back event, mail-back 

program, or collection receptacle should 

be transferred to a destruction location 

in a manner that prevents diversion. 

(e) A law enforcement agency 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 an inner 

liner as described in § 1317.60 of this 

chapter is used, the unique 

identification number of the inner liner 

transferred, the size of the 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 DEA 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, and retail 

pharmacies may apply to 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 who is authorized to collect 

ceases activities as a collector, such 

registrant shall apply to modify its 

registration in accordance with 

§ 1301.51 of this chapter to indicate that 

the registrant no longer collects. 

(b) Collection by registrants shall 

occur only at the following locations: 

(1) Those registered locations of 

manufacturers, distributors, reverse 

distributors, and retail pharmacies that 

are authorized for collection; and 

(2) Long term care facilities at which 

registered retail pharmacies are 

authorized to maintain collection 

receptacles. 

(c) Authorized collectors may conduct 

the following activities: 

(1) Receive mail-back packages at a 

registered location that has an on-site 

method of destruction pursuant to 

§ 1317.70 of this chapter; 

(2) Install, manage, and maintain 

collection receptacles located at their 

authorized collection location(s); and 

(3) Promptly dispose of sealed inner 

liners and their contents as provided for 

in § 1317.05(c)(2). 

§ 1317.45 Collector security requirements. 

An authorized 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, or 

has surrendered a DEA registration for 

cause. 

§ 1317.50 Collector inventory, 

recordkeeping, reporting, and order form 

requirements. 

(a) Inventory record requirements. 

Each authorized collector shall maintain 

the following information in the 

inventory: 

(1) For registrants authorized to 

collect through a mail-back program, the 

record shall include the following 

information about each unused mailback package and each returned mailback package on hand awaiting 

destruction: 

(i) The date of the inventory; 

(ii) The number of mail-back 

packages; and 

(iii) The unique identification number 

of each package on hand, whether 

unused or awaiting destruction. 

(2) 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 inner liner on 

hand awaiting destruction: 

(i) The date of the inventory; 

(ii) The number of inner liners; 

(iii) The unique identification number 

of each inner liner; and 

(iv) The size (e.g., 5 gallon, 10 gallon, 

etc.) of each inner liner. 

(b) Continuing record requirements. 

Each authorized collector shall maintain 

the following records: 

(1) For registrants authorized to 

collect through a mail-back program, the 

record shall include the following: 

(i) For those unused packages that the 

collector makes available to ultimate 

users and other authorized nonregistrants at the authorized collector’s 

registered address: The date made 

available, the number of packages, and 

the unique identification number of 

each package; 

(ii) For those unused packages 

provided to a third party to make 

available to ultimate users and other 

authorized non-registrants (e.g., a 

pharmacy, grocery store, etc.): 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) Upon receipt of a sealed package: 

The date of receipt and the unique 

identification number on the individual 

package; and 

(iv) Upon destruction of a sealed 

package pursuant to Subpart C of this 

chapter: In accordance with the 

recordkeeping requirements in 

§ 1317.100 of this chapter. 

(2) For registrants authorized to 

collect through a collection receptacle, 

the record shall include the following: 

(i) Upon acquisition of each inner 

liner: The date the inner liner is 

acquired, the corresponding unique 

identification number of each inner 

liner, and the size (e.g., 5 gallon, 10 

gallon, etc.) of each inner liner. 

(ii) Upon installation of each inner 

liner in a collection receptacle: The date 

of installation, the address and DEA 

registration number of the location of 

the collection receptacle where the 

inner liner is installed, the unique 

identification number of the inner liner, 

the size of the inner liner (e.g., 5 gallon, 

10 gallon, etc.), and the name of two 

authorized employees who witnessed 

the installation; 

(iii) Upon removal of the inner liner: 

The date of removal, the address and 

DEA registration number of the 

collection location, the unique 

identification number of the inner liner, 

the size of the inner liner (e.g., 5 gallon, 

10 gallon, etc.), and the name of two 

authorized employees who witnessed 

the removal; 

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(iv) Upon secure storage of a sealed 

inner liner: The date of the transfer to 

storage, the unique identification 

number of the inner liner stored, the 

size of the inner liner stored (e.g., 5 

gallon, 10 gallon, etc.), and the name of 

two authorized employees who 

transferred the inner liner to secure 

storage; 

(v) Upon transfer of a sealed inner 

liner to a reverse distributor or 

distributor: The date of the transfer, the 

address and DEA registration number of 

the reverse distributor or distributor to 

whom the inner liner was transferred, 

the unique identification number of the 

inner liner transferred, the size of the 

inner liner transferred (e.g., 5 gallon, 10 

gallon, etc.), and the name of the two 

authorized employees who transferred 

the inner liner to the reverse distributor 

or distributor; and 

(vi) Upon destruction pursuant to 

subpart C of this chapter: In accordance 

with the recordkeeping requirements in 

§ 1317.100 of this chapter. 

(c) Reports to ARCOS. Authorized 

collectors are exempt from the ARCOS 

reporting requirements in § 1304.33 of 

this chapter for controlled substances 

collected through mail-back programs 

and collection receptacles for the 

purpose of disposal. 

(d) Order forms. Authorized collectors 

are exempt from the requirements in 

part 1305 of this chapter for controlled 

substances collected through mail-back 

programs and collection receptacles for 

the purpose of disposal. 

§ 1317.55 Registered reverse distributor 

and distributor acquisition of controlled 

substances from law enforcement agencies 

or authorized collectors. 

(a) A registered reverse distributor is 

authorized to acquire controlled 

substances from law enforcement 

agencies that collect controlled 

substances from ultimate users. A 

registered reverse distributor is 

authorized to acquire controlled 

substances from authorized collectors 

that collect controlled substances 

through a collection receptacle in 

accordance with §§ 1317.75 and 1317.80 

of this chapter. 

(b) A registered distributor is 

authorized to acquire controlled 

substances from authorized collectors 

that collect controlled substances 

through a collection receptacle pursuant 

to §§ 1317.75 and 1317.80 of this 

chapter. 

(c) A registered reverse distributor or 

a registered distributor that acquires 

controlled substances in accordance 

with paragraphs (a) or (b) of this section 

shall: 

(1) Acquire the controlled substances 

in the manner prescribed in § 1317.15(b) 

of this part; 

(2) Dispose of the controlled 

substances in the following manner: 

(i) Immediately and securely store the 

controlled substance at the reverse 

distributor’s registered location, or 

immediately transfer the controlled 

substances to the reverse distributor’s 

registered location for secure storage, 

until timely destruction; or 

(ii) Immediately deliver the controlled 

substance to the location of destruction 

for timely destruction. 

(iii) Destroy, or cause the controlled 

substances to be destroyed, as soon as 

practicable but no later than fourteen 

calendar days of receipt. 

(iv) Destruction shall be in accordance 

with Subpart C of this part. 

(3) Secure storage of the controlled 

substances shall be in a manner 

consistent with the security 

requirements for Schedule II controlled 

substances until timely destruction can 

occur. 

(d) Record requirements. A registered 

reverse distributor or a registered 

distributor that acquires controlled 

substances pursuant to paragraphs (a) or 

(b) of this section shall maintain the 

following records: 

(1) Upon receipt: The date of receipt; 

the name and address of the law 

enforcement agency or the name, 

address, and DEA registration number of 

the authorized collector from whom the 

inner liner (or mail-back package if from 

a law enforcement agency) was 

received; the unique identification 

number of the inner liner (or mail-back 

package if from a law enforcement 

agency) received; and the size of the 

inner liner received (e.g., 5 gallon, 10 

gallon, etc.); 

(2) Upon transfer to secure storage: 

The date of storage; the address and 

DEA number of the storage location; the 

unique identification number of the 

inner liner or mail-back package stored 

(if available in the case of a law 

enforcement agency); and the size of the 

inner liner stored (e.g., 5 gallon, 10 

gallon, etc.); 

(e) Reports to ARCOS. Reverse 

distributors and distributors that acquire 

controlled substances pursuant to 

paragraphs (a) or (b) of this section are 

exempt from the ARCOS reporting 

requirements in § 1304.33 of this 

chapter with regard to any controlled 

substances acquired pursuant to 

paragraphs (a) or (b) of this section. 

(f) Order forms. Reverse distributors 

and distributors that acquire controlled 

substances pursuant to paragraphs (a) or 

(b) of this section are exempt from the 

requirements in part 1305 of this 

chapter with regard to any controlled 

substances acquired pursuant to 

paragraphs (a) or (b) of this section. 

§ 1317.60 Inner liner requirements. 

For the purpose of part 1317 of this 

chapter, an inner liner shall fulfill the 

following requirements: 

(a) The inner liner shall be 

waterproof, tamper-evident, and tearresistant; 

(b) The inner liner shall be removable 

and sealable immediately upon removal 

without emptying or touching the 

contents; 

(c) The contents of the inner liner 

shall not be viewable from the outside 

when sealed; 

(d) The size of the inner liner shall be 

clearly marked on the outside of the 

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

(e) The inner liner shall bear a 

permanent, unique identification 

number that enables the liner to be 

tracked. 

§ 1317.65 Take-back events. 

(a) Any Federal, state, tribal, or local 

law enforcement agency 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 a law 

enforcement agency to hold a collection 

take-back event in accordance with this 

section. 

(b) The law enforcement agency shall 

appoint a law enforcement officer 

employed full time by the agency to 

oversee the collection. Law enforcement 

officers employed and authorized by the 

law enforcement agency conducting a 

take-back 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 substance has occurred. 

(c) Each take-back event should have 

at least one receptacle for the collection 

of permitted substances. The collection 

receptacle should be a securely locked, 

substantially constructed container with 

an outer shell and a removable inner 

liner as specified in § 1317.60 of this 

chapter. The outer shell 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 

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be collected. Controlled and noncontrolled substances may be collected 

together and be comingled. 

(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 the law enforcement 

agency 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 any federal, state, tribal, 

or local law enforcement agency or any 

authorized collector. An authorized 

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. 

(c) A law enforcement agency or 

authorized collector that conducts 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 mail. Any person may 

partner with an authorized collector or 

law enforcement agency 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 authorized 

collector’s registered address or the 

participating law enforcement agency’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 permitted substances that 

can be sent, and notice that only 

packages provided by the authorized 

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 an authorized collector. 

The authorized collector or law 

enforcement agency 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 agency that they 

are sending one of the designated 

packages by giving the unique 

identification number on the package. 

(e) An authorized collector that 

conducts a mail-back 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. 

(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 and that the 

authorized collector did not make 

available for the collection of controlled 

substances by mail. 

(f) Only law enforcement officers 

employed by the law enforcement 

agency and authorized employees of the 

collector shall handle packages received 

through an authorized mail-back 

program. Upon receipt of a mail-back 

package by an authorized collector 

conducting a mail-back program, the 

package shall not be opened, x-rayed, 

analyzed, or otherwise penetrated. 

§ 1317.75 Collection receptacles. 

(a) Any federal, state, tribal, or local 

law enforcement agency or authorized 

collector may manage, maintain, and 

empty 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. 

(c) Only ultimate users and other 

authorized non-registrant persons in 

lawful possession of a controlled 

substance in Schedule II, III, IV, or V 

may put such substances in a collection 

receptacle at a registered location (e.g., 

ultimate user cannot transfer such 

substance to pharmacy staff to put into 

a collection receptacle). 

(d) Collection receptacles shall be 

securely placed and maintained: 

(1) At an authorized collector’s 

registered location, which shall have 

proper building security in accordance 

with §§ 1301.71 to 1301.77 of this 

chapter; 

(2) At a long term care facility in 

accordance with § 1317.80 of this 

chapter; or 

(3) At a law enforcement agency’s 

physical location. 

(e) For authorized collectors, a 

controlled substance collection 

receptacle shall: 

(1) Be securely fastened to a 

permanent structure so that it cannot be 

removed; 

(2) At a registered location, be located 

in the immediate proximity of a 

designated area where controlled 

substances are stored and at which an 

authorized employee is present (e.g., 

can be seen from the pharmacy counter); 

or at a long term care facility pursuant 

to § 1317.80, be located in a secured 

area regularly monitored by personnel 

of that long term care facility; 

(3) Meet the following design 

specifications: 

(i) A securely locked, substantially 

constructed container with a permanent 

outer shell and a removable inner liner 

as specified in § 1317.60 of this chapter. 

(ii) 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; 

(iii) The outer container shall 

prominently display a sign indicating 

that only non-controlled drugs and 

Schedule II, III, IV, or V controlled 

substances are acceptable (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 

(iv) Access to the inner liner shall be 

restricted to authorized employees of 

the authorized collector. 

(f) At a registered location, the small 

opening in the outer container of the 

collection receptacle shall be locked or 

made otherwise inaccessible to the 

public when an authorized employee is 

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

closed). 

(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 authorized 

employees of the authorized collector. 

The inner liner shall be sealed 

immediately upon removal from the 

permanent outer shell and the sealed 

inner liner shall not be opened, x-rayed, 

analyzed, or otherwise penetrated. 

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§ 1317.80 Collection receptacles at long 

term 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 resided 

at such long term care facility when 

such disposal occurs immediately, but 

no longer than three business days after 

the discontinuation of use by the 

ultimate user. A long term care facility 

shall dispose of such controlled 

substances only by transferring those 

controlled substances into an authorized 

collection receptacle located at that long 

term care facility. 

(b) Only a registered retail pharmacy 

authorized to collect at the long term 

care facility may manage and maintain 

collection receptacles at that long term 

care facility and remove or supervise the 

removal of the inner liner of the 

collection receptacles at that long term 

care facility in accordance with 

§ 1317.75(g) of this chapter. The 

registered retail pharmacy shall comply 

with all other requirements in § 1317.75 

of this chapter. 

(c) A registered retail pharmacy that 

intends to operate a collection 

receptacle at a long term care facility 

shall apply to modify its registration in 

accordance with § 1301.51 of this 

chapter and shall include in the 

application for modification in 

registration the physical location of each 

long term care facility at which the 

registered pharmacy intends to operate 

a collection receptacle. 

§ 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. 

(1) Continuing record requirements. 

Such registrant accepting recalled 

controlled substances shall maintain a 

record of each recalled controlled 

substance received from an ultimate 

user, to include the following 

information: The date of receipt, and the 

name, form, and quantity of each 

controlled substance received. 

(2) Order forms. Such registrant 

accepting recalled controlled substances 

is exempt from the requirements in part 

1305 of this chapter for the receipt of 

recalled controlled substances from 

ultimate users. 

(3) Reports to ARCOS. Such registrant 

accepting recalled controlled substances 

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 pursuant to § 1304.33 of 

this chapter. 

(b) An ultimate user that 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 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) If the controlled substances are 

transferred to a person registered under 

the Act and authorized to accept the 

controlled substances for purposes of 

disposal, two authorized employees of 

the transferring registrant shall load and 

unload or observe the loading and 

unloading of any controlled substances 

until transfer is complete. 

(b) If the controlled substances are 

transported by a registrant to the 

location of destruction, the following 

procedures shall be followed: 

(1) Transportation shall be directly to 

the destruction location; 

(2) Two authorized employees of the 

transporting registrant shall accompany 

the controlled substances to the 

destruction location; 

(3) Two authorized employees of the 

transporting registrant shall load and 

unload or observe the loading and 

unloading of the controlled substances; 

(4) Two authorized employees of the 

transporting registrant shall handle or 

observe the handling of any controlled 

substance until the substance is 

rendered non-retrievable; and 

(5) Two authorized employees of the 

transporting registrant shall personally 

witness the destruction of the controlled 

substance until it is rendered nonretrievable. 

(c) 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 authorized employees of the 

registrant shall handle or observe the 

handling of any controlled substance 

until the substance is rendered nonretrievable; and 

(2) Two authorized employees of the 

registrant shall personally witness the 

destruction of the controlled substance 

until it is rendered non-retrievable. 

§ 1317.100 Recordkeeping requirements. 

(a) In addition to any other 

recordkeeping requirements, 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 that includes 

the following information: The date of 

destruction; the method of destruction; 

the name and address of the place of 

destruction; the name and quantity of 

the controlled substances destroyed or 

the unique identification number of the 

inner liner or mail-back package 

destroyed; the size of the inner liner 

destroyed (e.g., 5 gallon, 10 gallon, etc.); 

and the name and signature of the two 

authorized employees who witnessed 

the destruction. 

(b) If the controlled substances 

destroyed were received from another 

registrant, the registrant destroying the 

controlled substances shall maintain a 

copy of the record transferring the 

substances or a copy of the DEA Form 

222. 

Dated: December 17, 2012. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2012–30699 Filed 12–20–12; 8:45 am] 

BILLING CODE 4410–09–P 

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