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[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Proposed Rules]
[Pages 75783-75817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30699]

[[Page 75783]]

Vol. 77

Friday,

No. 246

December 21, 2012

Part V

Department of Justice

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Drug Enforcement Administration

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21 CFR Parts 1300, 1301, 1304 et al.

 Disposal of Controlled Substances; Proposed Rule

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

[[Page 75784]]

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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.

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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

[[Page 75785]]

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 mail-back 
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 mail-back 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.

[[Page 75786]]

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).
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    \1\ The Attorney General's delegation of authority to DEA may be 
found at 28 CFR 0.100.
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    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).
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    \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).
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    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\
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    \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).
    \4\ The 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.
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    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.

[[Page 75787]]

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\
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    \5\ H.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).
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    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.
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    \7\ The procedures are found today in 21 CFR 1307.21.
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    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

[[Page 75788]]

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 non-practitioners, 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\
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    \8\ The 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.
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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.
---------------------------------------------------------------------------

    \10\ Centers for Disease Control and Prevention, ``Morbidity and 
Mortality Weekly Report,'' Vol. 61, No. 1, at 10 (January 13, 2012).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \11\ Partnership for a Drug-Free America and MetLife Foundation, 
``2009 Parents and Teens Attitude Tracking Study Report,'' March 2, 
2010.
    \12\ Partnership for a Drug-Free America and MetLife Foundation, 
``2010 Partnership Attitude Tracking Study,'' April 6, 2011.
    \13\ The National Survey on Drug Use and Health (NSDUH) is an 
annual survey of the civilian, non-institutionalized, 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).
    \14\ Substance 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.
    \15\ Partnership for a Drug-Free America and MetLife Foundation, 
``2010 Partnership Attitude Tracking Study,'' April 6, 2011.
---------------------------------------------------------------------------

    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

[[Page 75789]]

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.
---------------------------------------------------------------------------

    \16\ Lloyd D. Johnson, Ph.D., et al, ``Monitoring the Future 
National Results on Adolescent Drug Use: Overview of Key Findings, 
2011,'' Institute for Social Research, The University of Michigan, 
22012.
    \17\ Lloyd 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).
---------------------------------------------------------------------------

    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--non-medically 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-year-olds abuse a 
prescription pain reliever for the first time.\21\
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    \18\ Substance 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.
    \19\ These estimates were similar to those from the 2009 survey 
but 13 percent higher than those from the 2008 survey.
    \20\ Id.
    \21\ Substance Abuse and Mental Health Services Administration, 
2010 National Survey on Drug Use and Health.
---------------------------------------------------------------------------

    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 non-medical 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 one-third involved 
drugs to treat insomnia and anxiety.\25\
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    \22\ U.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.
    \23\ Behavioral 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.
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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.
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    \26\ DEA does not address the proper disposal of listed 
chemicals by DEA registrants in this rulemaking.
---------------------------------------------------------------------------

    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 case-by-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 non-registrants 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\
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    \27\ Any 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.
---------------------------------------------------------------------------

    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

[[Page 75790]]

(60 FR 43732, August 23, 1995). Reference to a disposer category was 
inadvertently included in a previous rulemaking (68 FR 58587, October 
10, 2003).
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    \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.
---------------------------------------------------------------------------

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 
non-registrants--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, mail-back 
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 non-controlled 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 non-controlled 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

[[Page 75791]]

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) mail-back 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 
mail-back 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,

[[Page 75792]]

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 on-site 
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 Sec.  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 pre-existing 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.
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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).
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    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

[[Page 75793]]

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).
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    \30\ The 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.
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    To this end, 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). 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 mail-back 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.
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    \31\ Reverse 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.
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    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 mail-back 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.
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    \32\ For 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.
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    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

[[Page 75794]]

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 take-back 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 take-back 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.
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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.
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    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 take-
back 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 take-back 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 mail-back 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 mail-
back 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 on-site 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 DEA-registered 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

[[Page 75795]]

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 tear-resistant, 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, x-ray, 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 mail-back program; however, a 
single

[[Page 75796]]

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 post-collection tracking and accountability mechanisms, as 
well as on-site destruction by authorized collectors.
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    \34\ Mail-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.).
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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 on-site 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.
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    \35\ The 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.
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    Authorized collectors who are not registered practitioners \36\ 
shall dispose of the sealed inner liners and their

[[Page 75797]]

contents in one of the following ways: (1) Promptly destroy the sealed 
inner liners and their contents, using an on-site 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.
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    \36\ The 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.
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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.
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    \37\ For 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.
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    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 non-
controlled 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 substance-related 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

[[Page 75798]]

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 
mail-back method of disposal is the requirement that mailers be non-
descript, 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.
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    \38\ Although 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.
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    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 mail-back 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 mail-back 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

[[Page 75799]]

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.
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    \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).
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    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 pick-up at the practitioner's registered location.
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    \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).
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    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 non-
practitioners 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

[[Page 75800]]

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.
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    \41\ Current 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.
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    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 non-retrievable. 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

[[Page 75801]]

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.
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    \42\ While 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.
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    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 non-practitioner 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 pick-up 
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

[[Page 75802]]

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 
non-registrants 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

[[Page 75803]]

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 re-entering 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, long-term 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.

[[Page 75804]]

    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 non-retrievable. 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 non-retrievable 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.
---------------------------------------------------------------------------

    \43\ See Findings, Sec. 2, Secure and Responsible Drug Disposal 
Act of 2010.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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 non-registrants to utilize only one 
method of collection to dispose of their lawfully possessed controlled 
substances; (2) Open Collection, which would authorize any person to 
collect controlled substances from ultimate users for disposal, 
regardless of their status as a 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

[[Page 75805]]

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 Non-Registrant 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 Non-
Registrant 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.
---------------------------------------------------------------------------

    \45\ Clin J Pain (The Clinical Journal of Pain), Volume 22, 
Number 8, October 2006.
    \46\ Clin J Pain (The Clinical Journal of Pain), Volume 27, 
Number 3, March/April 2011.
---------------------------------------------------------------------------

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

[[Page 75806]]

(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 non-
registrants 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.
---------------------------------------------------------------------------

    \47\ The 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.
---------------------------------------------------------------------------

    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

[[Page 75807]]

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 non-registrants consistent 
with DEA regulations and federal, state, tribal, and local laws and 
regulations. Provision of these options is intended to result in 
increased collection and destruction of unused controlled substances 
and thereby prevent diversion of such unused substances to illicit uses 
and result in collection and destruction of larger quantities in 
economical and

[[Page 75808]]

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 Sec.  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:

Sec.  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 Sec.  1301.13 by revising paragraph (e)(1)(i) to read as 
follows:

Sec.  1301.13  Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

* * * * *
    (e) * * *
    (1)

[[Page 75809]]

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Application    Registration
          Business activity             Controlled  substances     DEA application forms       fee ($)     period (years)  Coincident activities allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing....................  Schedules I-V...........  New--225................           3,047               1  Schedules I-V: May distribute
                                                                 Renewal--225a...........           3,047                   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 Sec.  1301.25 by revising paragraph (i) to read as 
follows:

Sec.  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 Sec.  1301.51 to read as follows:

Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1301.52 by revising paragraph (c) to read as 
follows:

Sec.  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 Sec.  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:

Sec.  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 Sec.  1301.75 by revising paragraph (b) to read as 
follows:

Sec.  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 non-controlled substances in such a manner as 
to obstruct the theft or diversion of the controlled substances.
* * * * *
    10. Amend Sec.  1301.76 by revising paragraph (c) to read as 
follows:

Sec.  1301.76  Other security controls for practitioners.

* * * * *

[[Page 75810]]

    (c) Whenever the registrant distributes a controlled substance (as 
permitted in Sec. Sec.  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 Sec.  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 Sec.  1304.03 by revising the first two sentences of 
paragraph (a) to read as follows:

Sec.  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 Sec. Sec.  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 Sec.  1304.04 by revising paragraph (a) introductory text 
to read as follows:

Sec.  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 Sec.  1304.11 by revising paragraph (e) introductory 
text, paragraph (e)(2), and paragraph (e)(3) introductory text to read 
as follows:

Sec.  1304.11  Inventory requirements.

* * * * *
    (e) Inventories of manufacturers, distributors, dispensers, 
researchers, importers, exporters and chemical analysts. Each person 
registered or authorized (by Sec. Sec.  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 Sec.  1304.03 shall include in the 
inventory the information listed below.
* * * * *
    (2) Inventories of distributors. Except for reverse distributors 
covered by Sec.  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 Sec.  1304.22 by revising the introductory text, 
paragraph (b), and removing paragraph (e).
    The revisions read as follows:

Sec.  1304.22  Records for manufacturers, distributors, dispensers, 
researchers, importers and exporters.

    Each person registered or authorized (by Sec. Sec.  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 Sec. Sec.  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, Sec.  1317.55 of this 
chapter.
* * * * *
    16. Amend Sec.  1304.25 by revising paragraphs (a)(9) and (b)(9) to 
read as follows:

Sec.  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 Sec.  1305.03 by adding paragraph (e) to read as follows:

Sec.  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.

Sec.  1307.11  [Amended]

    20. In Sec.  1307.11, remove and reserve paragraph (a)(2).

Sec.  1307.12  [Removed]

    21. Remove Sec.  1307.12.
    22. Revise Sec.  1307.13 to read as follows:

Sec.  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

[[Page 75811]]

pursuant to part 1303 of this chapter, if such substances are disposed 
of in accordance with part 1317 of this chapter.

Sec.  1307.21  [Removed]

    23. Remove Sec.  1307.21
    24. Revise Sec.  1307.22 to read as follows:

Sec.  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 Sec.  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 non-registrants.
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.

Sec.  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.

Sec.  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 
Sec.  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

Sec.  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

[[Page 75812]]

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 non-practitioner shall 
follow the procedures set forth at Sec.  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 on-site 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 Sec.  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 Sec.  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.

Sec.  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 Sec.  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.

Sec.  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 Sec. Sec.  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 re-routed 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

[[Page 75813]]

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.

Sec.  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.

Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

Sec.  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 
Sec.  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 Sec.  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 Sec.  1317.80 
of this chapter only.

[[Page 75814]]

Sec.  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 Sec.  1317.65 of this 
chapter;
    (2) Mail-back programs in accordance with Sec.  1317.70 of this 
chapter; or
    (3) Collection receptacles located at the law enforcement agency's 
physical address and in accordance with Sec.  1317.75 of this chapter.
    (b) A law enforcement agency that conducts a take-back event or a 
mail-back program or maintains a collection receptacle should maintain 
any records of removal, storage, or destruction of the controlled 
substances collected in a manner that is consistent with that agency's 
recordkeeping requirements for illicit controlled substances evidence.
    (c) Any controlled substances collected by 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 Sec.  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 Sec.  
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.

Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  1317.05(c)(2).

Sec.  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.

Sec.  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 mail-back package and each returned mail-back 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 non-registrants 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 
Sec.  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;

[[Page 75815]]

    (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 Sec.  1317.100 of 
this chapter.
    (c) Reports to ARCOS. Authorized collectors are exempt from the 
ARCOS reporting requirements in Sec.  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.

Sec.  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 Sec. Sec.  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 Sec. Sec.  
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 
Sec.  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 Sec.  
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.

Sec.  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 tear-
resistant;
    (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.

Sec.  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 Sec.  
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

[[Page 75816]]

be collected. Controlled and non-controlled 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.

Sec.  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 Sec.  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, 
tear-resistant, 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.

Sec.  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 Sec. Sec.  1301.71 to 
1301.77 of this chapter;
    (2) At a long term care facility in accordance with Sec.  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 Sec.  
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 Sec.  
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.

[[Page 75817]]

Sec.  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 Sec.  1317.75(g) of this chapter. The 
registered retail pharmacy shall comply with all other requirements in 
Sec.  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 Sec.  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.

Sec.  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 Sec.  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

Sec.  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 non-retrievable.
    (b) Where multiple controlled substances are comingled, the method 
of destruction shall be sufficient to render all such controlled 
substances non-retrievable. When the actual substances collected for 
destruction are unknown but may reasonably include controlled 
substances, the method of destruction shall be sufficient to render 
non-retrievable 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 non-retrievable state in 
order to prevent diversion of any such substance to illicit purposes 
and to protect the public health and safety.

Sec.  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 non-retrievable.
    (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 non-retrievable; and
    (2) Two authorized employees of the registrant shall personally 
witness the destruction of the controlled substance until it is 
rendered non-retrievable.

Sec.  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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