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[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Rules and Regulations]
[Pages 53519-53570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20926]

[[Page 53519]]

Vol. 79

Tuesday,

No. 174

September 9, 2014

Part II

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; Final Rule

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

[[Page 53520]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, 1305, 1307, and 1317

[Docket No. DEA-316]
RIN 1117-AB18

Disposal of Controlled Substances

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: This rule governs the secure disposal of controlled substances 
by registrants and ultimate users. These regulations will implement the 
Secure and Responsible Drug Disposal Act of 2010 by expanding the 
options available to collect controlled substances from ultimate users 
for the purpose of disposal, including: Take-back events, mail-back 
programs, and collection receptacle locations. These regulations 
contain specific language allowing law enforcement to voluntarily 
continue to conduct take-back events, administer mail-back programs, 
and maintain collection receptacles. These regulations will allow 
authorized manufacturers, distributors, reverse distributors, narcotic 
treatment programs (NTPs), hospitals/clinics with an on-site pharmacy, 
and retail pharmacies to voluntarily administer mail-back programs and 
maintain collection receptacles. In addition, this rule expands the 
authority of authorized hospitals/clinics and retail pharmacies to 
voluntarily maintain collection receptacles at long-term care 
facilities. This rule also reorganizes and consolidates previously 
existing regulations on disposal, including the role of reverse 
distributors.

DATES: Effective Date: This rule is effective October 9, 2014.
    Compliance Date: All Memoranda of Agreement (MOAs) and Memoranda of 
Understanding (MOUs) issued pursuant to current 21 CFR 1307.21 will not 
be effective after October 9, 2014. Registrants may consult Sec.  
1317.05(a)(5) for information on requesting new MOAs and MOUs for 
disposal of controlled substances.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Outline

I. Executive Summary
    A. Purpose of the Regulatory Action
    B. Summary of the Major Provisions of the Regulatory Action
    C. Summary of Changes in the Final Rule
II. Background and Legal Authority
III. Discussion of Comments
    A. Support for the Proposed Rule (1 Issue)
    B. Definitions and Terms (12 Issues)
    C. Types of Entities That May Operate a Collection Program (9 
Issues)
    D. Locations Where Authorized Collectors May Maintain Collection 
Receptacles or Host Take-Back Events (1 Issue)
    E. Registration Requirements for Authorized Collectors (5 
Issues)
    F. Law Enforcement (7 Issues)
    G. Collection Receptacle Design, Inner Liners, Placement, and 
Security (24 Issues)
    H. Mail-Back Programs (11 Issues)
    I. Take-Back Events (6 Issues)
    J. Prohibition on Handling, Sorting, and Inventorying Inner 
Liner Contents and Mail-Back Package Contents (8 Issues)
    K. Long-Term Care Facilities (LTCFs) (21 Issues)
    L. Disposing on Behalf of Ultimate Users (Other than Residents 
of LTCFs) (3 Issues)
    M. Registrant Return, Recall, and Transfer (3 Issues)
    N. Destruction (19 Issues)
    O. Economic Concerns (18 Issues)
    P. Recordkeeping and Reporting (8 Issues)
    Q. Hazardous Materials Transportation and Hazardous Waste 
Destruction (3 Issues)
    R. Transporting Collected Substances (3 Issues)
    S. Miscellaneous Comments (2 Issues)
IV. Regulatory Analyses

I. Executive Summary

A. Purpose of the Regulatory Action

    On October 12, 2010, the Secure and Responsible Drug Disposal Act 
of 2010 (Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858). 
Before the Disposal Act, ultimate users who wanted to dispose of 
unused, unwanted, or expired pharmaceutical controlled substances had 
limited disposal options. The Controlled Substances Act (CSA) only 
permitted ultimate users to destroy those substances themselves (e.g., 
by flushing or discarding), surrender them to law enforcement, or seek 
assistance from the United States Drug Enforcement Administration 
(DEA). These restrictions resulted in the accumulation of 
pharmaceutical controlled substances in household medicine cabinets 
that were available for abuse, misuse, diversion, and accidental 
ingestion.
    The Disposal Act amended the CSA to authorize ultimate users to 
deliver their pharmaceutical controlled substances to another person 
for the purpose of disposal in accordance with regulations promulgated 
by the Attorney General. 21 U.S.C. 822(g), 828(b)(3). This final rule 
implements regulations that expand the entities to which ultimate users 
may transfer unused, unwanted, or expired pharmaceutical controlled 
substances for the purpose of disposal, as well as the methods by which 
such pharmaceutical controlled substances may be collected. Specified 
entities may voluntarily administer any of the authorized collection 
methods in accordance with these regulations.

B. Summary of the Major Provisions of the Regulatory Action

    The DEA is implementing new regulations for the disposal of 
pharmaceutical controlled substances by ultimate users in accordance 
with the Disposal Act. In drafting the implementing regulations, the 
DEA considered the public health and safety, ease and cost of program 
implementation, and participation by various communities. To this end, 
the DEA found that in order to properly address the disposal of 
controlled substances by ultimate users, it was necessary to conduct a 
comprehensive review of DEA policies and regulations related to each 
element of the disposal process, including the transfer, delivery, 
collection, destruction, return, and recall of controlled substances, 
by both registrants and non-registrants (i.e., ultimate users). The 
reverse distributor registration category, which is pertinent to the 
process of registrant disposal, was included in this comprehensive 
review. These regulations are incorporated into a new part 1317 on 
disposal. Definitions relating to the disposal of controlled substances 
are added to Sec.  1300.05(b), including definitions for ``employee,'' 
``law enforcement officer,'' ``non-retrievable,'' and ``on-site'' and 
definitions relating to controlled substances generally are revised or 
added to Sec.  1300.01.
    The goal of this new part on disposal, consistent with Congress's 
goal in the Disposal Act, is to set parameters for controlled substance 
diversion prevention that will encourage public and private entities to 
develop a variety of methods for collecting and destroying 
pharmaceutical controlled substances in a secure, convenient, and 
responsible manner. Also, consistent with the Disposal Act's goal to 
decrease the amount of pharmaceutical controlled substances introduced 
into the environment, particularly into the water, these regulations 
provide individuals with various additional options to dispose of their 
unwanted or unused pharmaceutical controlled substances beyond 
discarding or

[[Page 53521]]

flushing the substances. As a result of these regulations, the DEA 
hopes that the supply of unused pharmaceutical controlled substances in 
the home will decrease, thereby reducing the risk of diversion or harm.
Ultimate User Disposal
    An ultimate user is defined by the CSA as a ``person who has 
lawfully obtained, and who possesses, a controlled substance for his 
own use or for the use of a member of his household or for an animal 
owned by him or by a member of his household.'' 21 U.S.C. 802(27). This 
rule provides three voluntary options for ultimate user disposal: (1) 
Take-back events, (2) mail-back programs, and (3) collection 
receptacles. Individuals lawfully entitled to dispose of an ultimate 
user decedent's property are authorized to dispose of the ultimate 
user's pharmaceutical controlled substances by utilizing any of the 
three disposal options. All of the collection methods are voluntary and 
no person is required to establish or operate a disposal program. The 
rule also does not require ultimate users to utilize any of these three 
methods for disposal of controlled substances. Although the three 
methods of disposal allowed by this rule seek to help protect the 
environment and prevent controlled substances from being diverted to 
illicit uses, this rule does not prohibit ultimate users from using 
existing lawful methods.
    The DEA regulations provide specific language that will continue to 
allow Federal, State, tribal, and local law enforcement to maintain 
collection receptacles at the law enforcement's physical location; and 
either independently or in partnership with private entities or 
community groups, to voluntarily hold take-back events and administer 
mail-back programs. 21 CFR 1317.35. Thus, ultimate users will continue 
to be able to surrender their unwanted pharmaceutical controlled 
substances to law enforcement.
    The DEA is also authorizing certain registrants (manufacturers, 
distributors, reverse distributors, narcotic treatment programs (NTPs), 
hospitals/clinics with an on-site pharmacy, and retail pharmacies) to 
be ``collectors,'' with authorization to conduct mail-back programs. 21 
CFR 1317.40 and 1317.70. All registrants that choose to establish mail-
back programs must provide specific mail-back packages to the public, 
either at no cost or for a fee, 21 CFR 1317.70. Collectors that conduct 
mail-back programs must have and utilize an on-site method of 
destruction to destroy returned packages, 21 CFR 1317.05.
    These DEA regulations authorize collectors to maintain collection 
receptacles at their registered location. 21 CFR 1317.40. Thus, 
ultimate users will be able to carry their unwanted pharmaceutical 
controlled substances to an authorized retail pharmacy or other 
authorized collector location and deposit those controlled substances 
in a secure container for disposal. Hospitals/clinics and retail 
pharmacies that are authorized to be collectors may also maintain 
collection receptacles at long-term care facilities (LTCFs). 21 CFR 
1317.40. LTCFs may dispose of pharmaceutical controlled substances on 
behalf of an ultimate user who resides, or has resided, at that LTCF, 
21 CFR 1317.80, through a collection receptacle that is maintained by 
an authorized hospital/clinic or retail pharmacy at that LTCF. 21 CFR 
1317.40 and 1317.80.
    With this rule, the DEA allows all pharmaceutical controlled 
substances collected through take-back events, mail-back programs, and 
collection receptacles to be comingled with non-controlled substances, 
although such comingling is not required. 21CFR 1317.65, 1317.70, and 
1317.75. Pharmaceutical controlled substances collected by collectors 
may not be individually counted or inventoried. 21 CFR 1317.75. This 
rule also imposes various registration, security, and recordkeeping 
requirements.
    The DEA appreciates there is a cost to entities that choose 
voluntarily to provide these methods of collection and destruction. The 
DEA acknowledges that some State and local pharmaceutical disposal 
programs receive funding and other support from numerous sources, 
including conservation groups, local governments, State grants, and 
public and private donations. These expanded methods of disposal are 
expected to benefit the public by decreasing the supply of 
pharmaceutical controlled substances available for misuse, abuse, 
diversion, and accidental ingestion, and protect the environment from 
potentially harmful contaminants by providing alternate means of 
disposal for ultimate users. However, other advantages may accrue 
directly to those entities that opt to maintain a disposal program. For 
example, those authorized registrants that choose to maintain 
collection receptacles may be enhanced by the increased consumer 
presence at their registered locations and the goodwill that develops 
from providing a valuable community service. In addition, mail-back 
program collectors may partner with third parties to make mail-back 
packages available to the public. Those authorized registrants that 
choose to administer mail-back programs may gain from the opportunity 
to distribute to consumers promotional, educational, or other 
informational materials with the mail-back packages.
DEA Registrant Disposal
    The DEA has deleted the existing rule related to registrant 
disposal, 21 CFR 1307.21, and incorporated similar requirements on 
proper disposal procedure and security in a new part 1317 on disposal. 
These changes provide consistent disposal procedures for each 
registrant category, regardless of geographic location. In addition, 
the DEA has modified DEA Form 41 and is explicitly requiring that form 
to be used to record the destruction of controlled substances that 
remain in the closed system of distribution and also to account for 
registrant destruction of pharmaceutical controlled substances 
collected from ultimate users and other non-registrants pursuant to the 
Disposal Act. As stated in the NPRM, a controlled substance dispensed 
for immediate administration pursuant to an order for medication in an 
institutional setting remains under the custody and control of that 
registered institution even if the substance is not fully exhausted 
(e.g., some of the substance remains in a vial, tube, transdermal 
patch, or syringe after administration but cannot or may not be further 
utilized, commonly referred to as ``drug wastage'' and ``pharmaceutical 
wastage''). Such remaining substance must be properly recorded, stored, 
and destroyed in accordance with DEA regulations (e.g., Sec.  
1304.22(c)), and all applicable Federal, State, tribal, and local laws 
and regulations, although the destruction need not be recorded on a DEA 
Form 41.
Reverse Distributors
    The DEA is providing regulations for entities that reverse 
distribute that are clear and consistent. Entities that reverse 
distribute are often the last registrant to possess controlled 
substances prior to destruction; however, the recordkeeping safeguards 
that exist when controlled substances are distributed between 
registrants are not present when these registrants destroy controlled 
substances. Because reverse distributors routinely acquire controlled 
substances for destruction from other registrants and may also be 
authorized as collectors, reverse distributors accumulate greater 
amounts of controlled substances that are destined for destruction in 
comparison to other registrants. The DEA is defining ``reverse 
distribute;'' revising the definition of ``reverse distributor;'' (21

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CFR part 1300) outlining security (21 CFR part 1301), inventory, 
recordkeeping requirements, and other procedures that reverse 
distributors must follow to acquire controlled substances from 
registrants and to destroy such acquired substances. 21 CFR part 1304. 
The DEA also is clarifying that these security, inventory, and 
recordkeeping requirements apply to certain specified entities that 
reverse distribute but are not registered as reverse distributors. See, 
e.g., 21 CFR 1304.11(e)(3) (``each person registered or authorized to 
reverse distribute''). The DEA believes that these regulations will 
help all registrants that reverse distribute comply with the CSA in a 
manner that decreases the risk of the diversion of controlled 
substances during the disposal process.
Return and Recall
    This rule removes the existing regulation on return and recall, 21 
CFR 1307.12, and incorporates separate return and recall requirements 
for registrants and non-registrants into new Sec. Sec.  1317.10 and 
1317.85. This rule also imposes various recordkeeping requirements 
pertaining to controlled substances acquired for the purpose of return 
or recall in Sec. Sec.  1304.22 and 1305.03. The DEA has simplified the 
requirements of Sec.  1317.10(a) to more clearly describe the records 
that registrants must keep.
Methods of Destruction
    Existing DEA regulations do not specify a standard to which 
controlled substances must be destroyed. With this final rule, the DEA 
is implementing a standard of destruction--non-retrievable--for 
registrants that destroy controlled substances, and procedures for the 
destruction of controlled substances. 21 CFR 1300.05 (``non-
retrievable''), 1317.90, and 1317.95. The DEA is not requiring a 
particular method of destruction, so long as the desired result is 
achieved. This standard is intended to allow public and private 
entities to develop a variety of destruction methods that are secure, 
convenient, and responsible, consistent with preventing the diversion 
of such substances. Destruction of controlled substances must also meet 
all other applicable Federal, State, tribal, and local laws and 
regulations. Once a controlled substance is rendered ``non-
retrievable,'' it is no longer subject to the requirements of the DEA 
regulations.
    As explained above under ``Compliance Date,'' this final rule 
supersedes all existing MOAs and MOUs that registrants may have 
pursuant to Sec.  1307.21, including MOAs and MOUs pertinent to storage 
of controlled substances. The DEA retains in the new part 1317 the 
ability for practitioners to request assistance from the local Special 
Agent in Charge (SAC) regarding the disposal of controlled substances. 
21 CFR 1317.05. Practitioners may request a new MOA or MOU pursuant to 
the new Sec.  1317.05(a)(5).

C. Summary of the Changes in the Final Rule

    The DEA carefully considered the 192 individually-submitted 
comments received in response to the Notice of Proposed Rulemaking 
(NPRM) on the Disposal of Controlled Substances.\1\ 77 FR 75784, Dec. 
21, 2012. The comment period closed on February 19, 2013. The DEA is 
making a number of significant changes after thorough consideration of 
the issues raised by the comments and the potential diversion risks 
associated with these changes.
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    \1\ All of the comments submitted, except two comments, are 
available for public inspection online at www.regulations.gov. Two 
comments are not posted (at the commenters' request) in order to 
protect confidential business information.
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    In response to concerns regarding ultimate users' ability to have 
convenient disposal options, the DEA is vastly expanding those entities 
that may be authorized as collectors, expanding the authority of those 
collectors to maintain collection receptacles at LCTFs, and relaxing 
some of the proposed security requirements related to storage and 
destruction of controlled substances.
Authorized Collectors
    In addition to manufacturers, distributors, reverse distributors, 
and retail pharmacies, the final rule also authorizes registered NTPs, 
as well as hospitals/clinics with an on-site pharmacy, to operate 
disposal programs. 21 CFR 1317.40. By permitting these additional 
registrant categories to be collectors, the DEA anticipates that 
ultimate users will now have even more locations where they can 
securely, safely, responsibly, and conveniently dispose of their 
unwanted pharmaceutical controlled substances.
    In this final rule, the DEA is permitting those entities registered 
as NTPs to become authorized collectors to manage collection 
receptacles at their registered locations. As stated in the Disposal 
Act, ``the nonmedical use of prescription drugs is a growing problem in 
the United States.'' Multiple commenters, including a national 
organization that represents NTPs, recommended that the DEA include 
NTPs as authorized collectors. The DEA recognizes the valuable role 
that NTPs have in helping those seeking substance abuse treatment. 
After considering the importance of providing secure, convenient, and 
responsible disposal options for those ultimate users currently 
receiving treatment for narcotic substance abuse or entering a narcotic 
treatment program, and the benefits of allowing NTPs to provide the 
opportunity to patients to dispose of unused controlled substances, the 
DEA is permitting NTPs to be collectors with certain enhanced security 
controls. 21 CFR 1317.75.
    Due to the nature of the healthcare provided, NTPs face unique 
security challenges and heightened diversion risks and, as such, the 
final rule requires NTPs to securely place and maintain collection 
receptacles in a room that does not contain any other controlled 
substances and is securely locked with controlled access. 21 CFR 
1317.75. The DEA understands that this security measure will require 
employees of the NTP to accompany the patient to the collection 
receptacle to facilitate the patient's disposal. See 21 CFR 1317.75. 
Additionally, as the Disposal Act and these regulations are intended to 
address the prescription drug abuse problem, NTPs and other collectors 
are not authorized to collect schedule I controlled substances. E.g., 
21 CFR 1317.75. Collectors must be vigilant in ensuring that such 
illicit substances are not collected intentionally or inadvertently. 
E.g., 21 CFR 1317.70 and 1317.75.
    After extensive review and careful deliberation, in this final 
rule, the DEA is also permitting registered hospitals/clinics with an 
on-site pharmacy to become authorized collectors to maintain collection 
receptacles inside their registered locations or at LTCFs, and to 
conduct mail-back programs. 21 CFR 1317.30, 1317.40, 1317.70, and 
1317.80. In response to the NPRM, many commenters stated that 
collection receptacles located inside of hospitals would provide 
ultimate users with an opportunity to dispose of medication that may no 
longer be needed or may be expired. In determining whether to allow 
hospitals/clinics to become authorized collectors, the DEA carefully 
weighed the diversion risks with the convenience of authorizing such 
entities to be collectors. The DEA determined that the diversion risks 
require the DEA to limit those registered hospitals/clinics that may 
become collectors to those with on-site pharmacies, and also impose 
separate security conditions on the monitoring and location of 
collection receptacles inside hospitals/

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clinics that become authorized collectors. 21 CFR 1317.75.
    The DEA is requiring these additional security measures in order to 
help protect against the diversion of collected controlled substances 
because hospitals/clinics are generally much larger and are open to a 
much larger general population than the other registrants authorized to 
be collectors; and, as discussed in the NPRM, hospitals/clinics do not 
operate under the same business model or with similar theft and loss 
prevention procedures as the other registrants authorized to become 
collectors. For example, the general public typically enters retail 
pharmacies for short durations in order to conduct retail business and 
retail pharmacies generally have open, clearly observable common areas 
with little opportunity to conceal an unlawful purpose. It would be 
unusual and suspicious for a person to spend an extended amount of time 
in a retail pharmacy without a known, specific purpose, triggering 
routine theft and loss prevention measures.
    In contrast, hospitals are generally open 24-hours per day and 
allow for unsupervised public access for extended periods of time; they 
are much larger than retail pharmacies and many interactions occur 
behind closed doors without routine theft and loss prevention measures; 
and foot traffic generally is not routinely monitored for unlawful 
purposes. The DEA believes that limiting authorized collection 
activities to hospitals/clinics with an on-site pharmacy is necessary 
to help protect against diversion because these hospitals/clinics 
routinely handle a large volume of controlled substances that are 
dispensed to in-patients as well as to the public, and these entities 
are more experienced with security, theft and loss prevention 
procedures, and inventory, recordkeeping and reporting requirements 
than those hospitals/clinics without an on-site pharmacy.
    For reasons discussed in the NPRM, this final rule generally 
requires that, when authorized collectors choose to install collection 
receptacles, those collection receptacles must be placed inside their 
registered locations in the immediate proximity of a designated area 
where controlled substances are stored and at which an employee is 
present. 21 CFR 1317.75; see also 1317.05. The DEA recognizes that 
hospitals/clinics with an on-site pharmacy can be unique in their 
design and it may be more effective to install collection receptacles 
at various locations within the hospital/clinic, depending on factors 
such as security, convenience, and accessibility. As such, it would be 
challenging for authorized hospitals/clinics to adhere to the general 
rule to place collection receptacles in the immediate proximity of 
where controlled substances are stored and at which an employee is 
present. Accordingly, the DEA is requiring hospitals/clinics that are 
collectors to place collection receptacles in locations that are 
regularly monitored by employees. 21 CFR 1317.75. In addition, the DEA 
is prohibiting such collectors from placing collection receptacles in 
the proximity of any area where emergency or urgent care is provided. 
In the DEA's experience, the risk of diversion is particularly high in 
areas where emergency or urgent care is provided because of the often 
chaotic environment and the extended amounts of time persons spend in 
such areas.
    This rule also makes clear that DEA registrants cannot use the 
collection receptacles to dispose of unused controlled substances in 
their inventory or stock. 21 CFR 1317.05 and 1317.75. Pharmaceutical 
controlled substances remain under the custody and control of the DEA 
registrant if they are dispensed by a practitioner for immediate 
administration at the practitioner's registered location (such as a 
hospital) pursuant to an order for medication. If that substance is not 
fully exhausted (e.g., some of the substance remains in a vial, tube, 
or syringe after administration but cannot or may not be further 
utilized), then the DEA registrant is obligated to destroy the 
remaining, unusable controlled substances, and record the destruction 
in accordance with Sec.  1304.22(c). The DEA registrant shall not place 
such remaining, unusable controlled substance in a collection 
receptacle as a means of disposal. Hospital/clinic staff must also not 
dispose of any controlled substances in inventory or stock in a 
collection receptacle.
    The security requirements described above are the minimum required 
in order to detect and prevent diversion in the unique circumstances of 
NTPs and hospitals/clinics. These registrants should be vigilant in the 
execution of their responsibilities as registrants to ensure that 
collected controlled substances are not diverted to illicit use, and 
that they do not collect illicit substances. Finally, all registrants 
are reminded of the responsibility to report theft and significant loss 
of controlled substances within one business day of discovery.
Long-Term Care Facilities (LTCFs)
    Significant changes are made in this final rule to help ensure that 
LTCFs have adequate disposal options. In addition to allowing retail 
pharmacies to manage and maintain collection receptacles at LTCFs, the 
DEA is also allowing hospitals/clinics with an on-site pharmacy to 
manage and maintain collection receptacles at LTCFs. The DEA hopes that 
expanding those authorized to collect at LTCFs will maximize disposal 
opportunities for LTCF residents.
    In addition, the DEA is alleviating two security requirements 
proposed to apply to collection receptacles located at LTCFs. First, 
the DEA is permitting authorized hospitals/clinics and retail 
pharmacies to store inner liners that have been sealed upon removal 
from a collection receptacle at LTCFs in a securely locked, 
substantially constructed cabinet or a securely locked room with 
controlled access for up to three business days until the liners can be 
transferred for destruction. The DEA encourages collectors to schedule 
inner liner removals and installations to coincide with existing LTCF 
visits when possible, for example, arranging a routine system in which 
medication deliveries coincide with the removal and transfer of sealed 
inner liners for appropriate destruction, thereby making storage of 
sealed inner liners unnecessary. Collectors may not transfer sealed 
inner liners from LTCFs to their primary registered location (i.e., the 
hospital/clinic or retail pharmacy location). As echoed in the 
comments, the DEA remains concerned about the security risks of 
hospital/clinic and retail pharmacy employees transporting large 
quantities of collected substances, making them potential targets for 
drug seekers. Instead, collectors should deliver sealed inner liners to 
a reverse distributor or distributor's registered location by common or 
contract carrier pick-up or by reverse distributor or distributor pick-
up at the LTCF, pursuant to Sec.  1317.05(c)(2)(iv).
    Second, the DEA relaxed the two-employee integrity requirement for 
inner liner installation, removal, storage, and transfer at LTCFs. 
Collectors will retain the option to authorize two of their own 
employees to install, remove, store, and transfer inner liners; 
however, the DEA is permitting collectors the option to designate a 
supervisor-level employee of the LTCF (e.g., a charge nurse, 
supervisor, or similar employee) to install, remove, store, or transfer 
inner liners with only one employee of the collector.
    The DEA modified the above security requirements (storage and two-
person integrity) to provide flexibility sufficient to encourage 
authorized hospitals/clinics and retail pharmacies to collect at LTCFs, 
while ensuring the minimum protections required to prevent

[[Page 53524]]

diversion at LTCFs. The DEA hopes that the inclusion of certain 
hospitals/clinics as authorized to maintain collection receptacles at 
LTCFs, and the modifications described above will result in expanded 
safe and secure disposal options for LTCF residents. The DEA emphasizes 
that if LTCFs dispose of LTCF residents' controlled substances in 
collection receptacles, such activity must be in accordance with this 
regulation and all other applicable Federal, State, tribal and local 
laws and regulations, including environmental laws and regulations.
    The DEA acknowledges that there may be some LTCFs that will not 
have a collection receptacle, and there will be instances where LTCF 
residents are incapable of disposing of their own unused or unwanted 
medication. As ultimate users, LTCF residents may use any of the 
disposal options afforded other ultimate users in this final rule 
(e.g., mail-back programs), in addition to the disposal options 
currently available to ultimate users (e.g., flushing or otherwise 
discarding) that will remain options even after this final rule is 
implemented. For example, an LTCF resident may request that LTCF 
personnel place the resident's unwanted medication in a mail-back 
package, seal the mail-back package, and deposit that package into the 
facility's outgoing mail system. 21 CFR 1317.70. LTCFs should be 
mindful however that the touchstone for this disposal method is the 
individual nature of the disposal activity; institutional facilities 
such as LTCFs should ensure that the individual patient is the 
disposer, and should be wary of establishing any protocols whereby the 
facility itself is engaging in collection activities. Simply providing 
the method of disposal (e.g., mail-back packages) does not implicate 
that concern.
Destruction
    After careful and thorough consideration of comments received 
regarding the burdens associated with the proposed 14-day destruction 
requirement, the DEA is extending the time those registrants that 
reverse distribute have to destroy controlled substances to 30 days. 21 
CFR 1317.15(d). The DEA anticipates that this extension will allow 
reverse distributors and distributors adequate time to collect and 
destroy controlled substances in a safe, convenient, and secure manner, 
while also preventing diversion and diversion opportunities.
Practitioner Physical Security
    In this final rule, the DEA is not amending Sec.  1301.75(b) 
pertaining to practitioner physical security and is instead adding a 
new paragraph (c) to clarify that practitioners shall only store sealed 
mail-back packages and inner liners containing collected substances at 
their registered location in a securely locked, substantially 
constructed cabinet or a securely locked room with controlled access. 
The DEA has made corresponding changes to Sec. Sec.  1317.05(c)(1)(ii) 
and (c)(2)(ii). Part of this requirement was included in the proposed 
rule; however, after careful consideration of a number of comments, the 
DEA believes that the proposed requirement did not provide sufficient 
controls to protect against diversion and was impracticable. Pharmacies 
and institutional practitioners cannot store sealed inner liners or 
returned mail-back packages by dispersing them throughout the stock of 
noncontrolled substances. 21 CFR 1301.75(b) and (c).
Other Changes to the Final Rule
    In addition to the changes described above, the DEA determined that 
the rule, as proposed, required other modifications, as generally 
described below. The DEA is also implementing additional technical 
modifications that will not have a substantive effect on this rule 
(e.g., relocating some sections in proposed part 1317 to other sections 
within title 21 of the CFR, re-phrasing some sections from the proposed 
rule to be simpler, clearer and easier to understand, and eliminating 
redundancy).
    In the general definitions section of the DEA regulations, the DEA 
is amending Sec.  1300.01(b) to be clear that the definitions that 
generally apply to most other parts of chapter II of title 21 of the 
CFR also apply to part 1317. In response to a number of comments, in 
Sec.  1300.01(b) the DEA is amending the definition of ``reverse 
distributor'' to clarify that a reverse distributor is a person 
registered with the DEA as a reverse distributor.
    Definitions were moved from Sec.  1317.02 to Sec.  1300.05 to 
provide consistency within the CFR pertaining to definitions. The DEA 
adds Sec.  1300.05 ``Definitions relating to the disposal of controlled 
substances,'' moves the terms ``authorized employee,'' ``law 
enforcement officer,'' and ``non-retrievable'' from part 1317 to Sec.  
1300.05(b), adds a definition of ``on-site'' to Sec.  1300.05(b), and 
deletes the definitions of ``for cause'' and ``inner liner'' that were 
in proposed part 1317. The DEA also moves the definition of 
``collection'' to Sec.  1300.01(b). These changes are in response to 
comments or related to the movement of several other requirements from 
part 1317 to other parts, as discussed below.
    In addition to moving them to Sec.  1300.05(b), the DEA amends the 
definitions of ``authorized employee'' and ``law enforcement officer.'' 
The DEA is omitting the word ``authorized'' from the definition of 
``authorized employee,'' and codifying the definition of ``employee'' 
in harmony with the general common law of agency. The DEA is modifying 
the definition of ``law enforcement officer'' in part 1317 to 
specifically include officers from law enforcement components of 
Federal agencies, and authorized police officers of the Veterans Health 
Administration and the Department of Defense. In addition, this rule 
clarifies who may qualify as a ``law enforcement officer'' for the 
purpose of disposal. The DEA is changing references to ``law 
enforcement agencies'' to ``law enforcement'' in order to include law 
enforcement components of Federal agencies.
    Although the DEA defined ``inner liner'' in the NPRM, the final 
rule does not amend the CFR to add a definition for inner liner. As 
described below, inner liners used in the collection of controlled 
substances must meet the specifications outlined in Sec.  1317.60. The 
DEA also is not amending the CFR to add a definition of ``for cause,'' 
and instead is providing an explanation of ``for cause'' as it relates 
to the sections to which it applies.
    The DEA added a definition of ``on-site'' to Sec.  1300.05(b) to 
clarify that ``on-site'' means ``located on or at the physical premises 
of the registrant's registered location'' for purposes of destruction 
and registration as a collector. Specifically, a controlled substance 
is destroyed ``on-site'' when destruction occurs on the physical 
premises of the destroying registrant's registered location, and a 
hospital/clinic has an ``on-site'' pharmacy when it has a pharmacy 
located on the physical premises of the registrant's registered 
location.
    Text was added to the registration table in Sec.  1301.13 to 
reflect that distributors, as a coincident activity to distribution, 
may acquire controlled substances from collectors for the purpose of 
destruction. The registration table was updated so that it would be 
consistent with the regulations in the final rule, which authorize 
distributors to destroy controlled substances acquired from collectors.
    The DEA received a number of comments indicating confusion 
regarding the procedures a registrant must follow to modify their DEA 
registration to become a collector. In

[[Page 53525]]

order to clarify such requirements, the DEA is further revising Sec.  
1301.51. The additional revisions clarify the requirements by listing 
them independently of other types of registration modifications (e.g., 
change of name or address) and clearly indicating that any 
modifications may be made in writing by mail or online. 21 CFR part 
1301. Also, the submission method has been modified from ``letter'' to 
``written request'' to accurately encompass the various ways the 
modification request may be submitted (e.g., online), and the phrase 
``to be paid'' was deleted from Sec.  1301.51(c) for stylistic reasons. 
Similarly, the DEA is further revising Sec.  1301.52 to clarify that 
any registrant who has been authorized as a collector and who desires 
to discontinue their collection of pharmaceutical controlled substances 
from ultimate users must notify the DEA.
    The DEA is also streamlining certain registration and security 
procedures by moving certain requirements from part 1317, as proposed 
in the NPRM, to part 1301. Reverse distributor employee security 
requirements in proposed Sec.  1317.20 were moved to Sec.  1301.74(m) 
for ease of reference and consistency. Collector security requirements 
in proposed Sec.  1317.45 were moved to Sec.  1301.71(f) for clarity 
and consistency.
    The DEA determined that inclusion of recordkeeping and reporting 
requirements in part 1317 may lead to confusion among registrants. As 
such, the DEA is moving all recordkeeping and reporting requirements 
from part 1317, as proposed in the NPRM, to part 1304--Records and 
Reports of DEA Registrants--in order to maintain consistency and 
consolidate all recordkeeping and reporting requirements into one part. 
In Sec.  1304.03, ``each'' was changed to ``every,'' and ``who'' was 
changed to ``that'' for stylistic reasons. In Sec.  1304.11(e)(2), the 
first sentence, pertaining to an exception for reverse distributors, 
was removed and incorporated into Sec.  1304.11(e)(3) of the final rule 
to accurately reflect the type of registrants to which the section 
applies.
    The DEA is expanding the locations where a collector may maintain 
records in Sec.  1304.04(a)(3). The text in Sec.  1304.21(a) was 
updated to specifically include inner liners and mail-back packages, 
which were inadvertently overlooked in the NPRM. 21 CFR Sec.  
1304.21(c) was updated to include the general recordkeeping 
requirements for collection activities as outlined in the final rule. 
The recordkeeping requirements for disposal of controlled substances in 
21 CFR Sec.  1307.21 were moved to Sec.  1304.21(e) and amended to 
include recordkeeping procedures for destruction. The title and 
introductory text in Sec.  1304.22 were updated to accurately reflect 
their contents. Additionally, Sec.  1304.22 was modified to include 
recordkeeping requirements for collected controlled substances. The 
second sentence in both Sec.  1304.25(a)(9) and Sec.  1304.25(b)(9), 
which required compliance with part 1317 when destroying narcotic 
controlled substances, were removed as superfluous. All disposal and 
destruction activities are clearly delineated in part 1317. Also, 
various Automation of Reports and Consolidated Ordering System (ARCOS) 
requirements are removed from part 1317, as proposed in the NPRM, and 
are consolidated and moved to Sec.  1304.33. In addition, the title of 
Sec.  1304.33 has been changed to add clarity, and the acronym 
``ARCOS'' is clearly spelled out. The formatting for Sec.  1304.33(f) 
was modified for ease of understanding, and ``who'' was changed to 
``that'' in two locations for consistency.
    The DEA is also amending Sec.  1305.03 to add a new paragraph (f) 
to clarify that collectors are exempt from order form requirements for 
pharmaceutical controlled substances collected through mail-back 
programs and collection receptacles for the purpose of disposal. The 
title of Sec.  1307.11 no longer references reverse distributors and 
has been changed to ``Distribution by dispenser to another 
practitioner'' because reverse distributor activities were moved to 
part 1317.
    As discussed in the preamble to the NPRM and as mentioned in 
proposed Sec.  1317.100, the DEA clarifies in Sec.  1304.21 of this 
final rule that, in addition to any other recordkeeping requirements, 
all registrants that destroy or cause the destruction of a controlled 
substance must maintain a record of that destruction on a DEA Form 41. 
This requirement had been discussed in the preamble to the proposed 
rule, and in proposed Sec.  1317.100 the DEA stated ``any registered 
person that destroys or causes the destruction of a controlled 
substance shall maintain a record of destruction on a form issued by 
DEA . . ..'' The DEA has determined that this requirement to keep such 
records on DEA Form 41 should be explicitly stated in the regulatory 
text, and not just the preamble, for registrants to clearly understand 
the requirements to which they are bound. As stated above, this 
requirement to record destruction activities on the DEA Form 41 does 
not apply to drug wastage or pharmaceutical wastage which must be 
properly recorded, stored, and destroyed in accordance with DEA 
regulations, and all applicable Federal, State, tribal, and local laws 
and regulations. 21 CFR part 1304.
    The DEA is modifying proposed Sec.  1317.70 to address the 
procedures that a collector must follow when ceasing operation of a 
mail-back program. This modification requires such collector to make 
reasonable efforts to notify the public of their intent to cease mail-
back collection activities. 21 CFR 1317.70. Such collector must also 
establish an agreement with another collector authorized to conduct a 
mail-back program to receive all remaining packages and arrange for the 
forwarding of such packages to the second collector's registered 
location. These procedures will ensure that another authorized entity 
will be responsible for receiving and destroying any mail-back packages 
that were disseminated but not received back by the collector prior to 
the time that they ceased operation of their mail-back program.
    Finally, the DEA is modifying proposed Sec.  1317.75 for two 
purposes. The first modification clarifies that collected controlled 
and non-controlled substances can be comingled, but are not required to 
be comingled. 21 CFR 1317.75. As previously discussed, the second 
modification to this section allows certain LTCF employees, as 
designated by the collector authorized to maintain a collection 
receptacle at that LTCF, to install, seal, remove, store, and transfer 
for destruction the inner liners of the collection receptacle along 
with an employee of the collector. 21 CFR 1317.80. This modification 
allows greater flexibility for collectors authorized to maintain 
collection receptacles at LTCFs.

II. Background and Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. Titles II and III are referred to as the ``Controlled 
Substances Act'' and the ``Controlled Substances Import and Export 
Act,'' respectively, but are collectively referred to as the 
``Controlled Substances Act'' or the ``CSA'' for the purpose of this 
action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while providing for a sufficient supply of controlled 
substances and listed

[[Page 53526]]

chemicals for legitimate medical, scientific, research, and industrial 
needs of the United States. Controlled substances have the potential 
for abuse and dependence and are controlled to protect the public 
health and safety. To this end, controlled substances are classified 
into one of five schedules based upon: The potential for abuse, 
currently accepted medical use, and the degree of dependence if abused. 
21 U.S.C. 812. Listed chemicals are separately classified as list I or 
list II chemicals based on their use and importance to the manufacture 
of controlled substances. 21 U.S.C. 802(33)-(35).
    The CSA establishes a closed system of distribution that requires 
the DEA to monitor and control the manufacture, distribution, 
dispensing, import, and export of controlled substances and listed 
chemicals until they reach their final lawful destination. The secure 
destruction of unused, recalled, tainted, expired, or otherwise 
unwanted pharmaceutical controlled substances is essential to 
preventing the diversion of these substances into the illicit market.
    In order to maintain this closed system of distribution, persons 
who handle (manufacture, distribute, dispense, import, export, engage 
in research, or conduct instructional activities), or propose to 
handle, controlled substances and listed chemicals are required to 
register with the DEA at each principal place of business or 
professional practice. Persons registered with the DEA are permitted to 
possess controlled substances and listed chemicals as authorized by 
their registration and must comply with the applicable requirements 
associated with their registration. 21 U.S.C. 822.
    Not all persons who possess controlled substances are required to 
register with the DEA. For example, a patient who receives a 
pharmaceutical controlled substance pursuant to a lawful prescription, 
i.e., an ultimate user, is not required to register with the DEA in 
order to receive and possess that substance. 21 U.S.C. 822(c)(3); see 
also 21 U.S.C. 957(b)(1)(C).\2\ The CSA defines an ``ultimate user'' as 
``a person who has lawfully obtained, and who possesses, a controlled 
substance for his own use or for the use of a member of his household 
or for an animal owned by him or by a member of his household.'' 21 
U.S.C. 802(27).
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    While Congress envisioned a closed system of distribution that 
would control a substance from its manufacture or import through the 
traditional chain of distribution moving from registrant to registrant 
until it reached its final lawful use (e.g., dispensed to the ultimate 
user, etc.), it did not account for circumstances in which 
pharmaceutical controlled substances were lawfully dispensed to, and 
possessed by, an ultimate user but not fully used. Although ultimate 
users are exempt from CSA registration requirements for the possession 
of pharmaceutical controlled substances, if they distribute (e.g., 
deliver or transfer) such substances without the appropriate 
registration, they are in violation of the CSA.\3\ Such unlawful 
distribution includes the transfer of pharmaceutical controlled 
substances for the purpose of disposal.\4\
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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 are not defined. For example, in the CSA, see 21 U.S.C. 822(g); 
824(f)-(g); 826(c), (e)-(f); 827(a)(3), (d)(1); 842(a)(7); 853(n); 
880(a)(2); 881(e)(1); 958(d)(6); and in the CFR, see 21 CFR 
1307.21(b) and 1304.22(a)(2)(ix). The term ``net disposal,'' 
however, is defined at 21 CFR 1300.01(b). As used, the terms refer 
to a variety of activities that ultimately result in eliminating the 
availability of controlled substances for use. For example, within 
the meaning of the CSA, a controlled substance can be ``disposed 
of'' by destruction, return, recall, sale, or through the 
manufacturing process. The Disposal Act allows an ultimate user to 
deliver a lawfully obtained controlled substance to another person 
``for the purpose of disposal.'' The DEA believes that the ultimate 
user disposal authorized by the Disposal Act includes the transfer 
or delivery of controlled substances for purposes of destruction, 
return, and recall. Such ultimate user activities are consistent 
with the intent to remove unused, unwanted, tainted, and expired 
substances from households and out of the reach of children and 
teenagers thereby reducing the risk of diversion and protecting the 
public health and safety. As used in this Final Rule, the DEA uses 
the terms ``disposal'' and ``dispose'' to generally refer to the 
wide range of activities that result in controlled substances being 
unavailable for further use. When necessary to specify a particular 
activity within the disposal process, the particular activity is 
identified (e.g., transfer, deliver, collect/collection, return, 
recall, and destroy/destruction).
---------------------------------------------------------------------------

    The Disposal Act, enacted on October 12, 2010, amended the CSA to 
allow an ultimate user to ``deliver'' a pharmaceutical controlled 
substance ``to another person for the purpose of disposal'' if the 
person receiving the substance is authorized to receive it and the 
disposal takes place in accordance with regulations issued by the 
Attorney General to prevent the diversion of controlled substances. 21 
U.S.C. 822(g)(1). The Attorney General delegated responsibility for 
promulgating the Disposal Act implementing regulations to the DEA.\5\
---------------------------------------------------------------------------

    \5\ The Attorney General's delegation of authority to the DEA 
may be found at 28 CFR 0.100.
---------------------------------------------------------------------------

    In addition to authorizing ultimate users to deliver their 
pharmaceutical controlled substances to another person for the purpose 
of disposal, the Disposal Act also authorizes any person lawfully 
entitled to dispose of an ultimate user decedent's property to deliver 
the ultimate user's pharmaceutical controlled substances to another 
person for the purpose of disposal if the ultimate user dies while in 
lawful possession of the substances. The Disposal Act also gives the 
DEA the ability, by regulation, to authorize LTCFs to dispose of 
pharmaceutical controlled substances on behalf of ultimate users who 
reside, or have resided, at the LTCF. Congress directed the DEA, in 
promulgating the Disposal Act implementing regulations, to consider the 
public health and safety, ease and cost of program implementation, and 
participation by various communities. The implementing regulations may 
not require any person to establish or operate a delivery or disposal 
program.

III. Discussion of Comments

    The DEA had received 192 comments on the NPRM when the comment 
period closed on February 19, 2013. These comments are summarized 
below, along with the DEA's responses.

A. Support for the Proposed Rule (1 Issue)

    [1] Issue: The DEA received 192 comments for this rulemaking during 
the 60-day comment period. The vast majority of the comments were 
overwhelmingly positive with the commenters agreeing that there should 
be more options for secure, convenient, and responsible disposal of 
controlled substances. Nineteen commenters supported the rule as 
written in the NPRM. Almost every other commenter supported the rule to 
some degree, although many commenters had concerns with the 
implementation of the specific disposal procedures described in the 
NPRM.
    Response: The DEA appreciates the support for this rulemaking and 
is privileged to implement regulations to allow for the collection and 
disposal of controlled substances in a secure, convenient, and 
responsible manner. The DEA considered all of the comments and 
ramifications of implementing proposed changes to the rule. In 
finalizing this rule, the DEA

[[Page 53527]]

considered public health and safety, ease and cost of program 
implementation, and participation by various communities.

B. Definitions and Terms \6\ (12 Issues)
---------------------------------------------------------------------------

    \6\ Definitions and terms specific to particular comment 
categories, such as ``Law Enforcement'' and ``Long-Term Care 
Facilities (LTCFs),'' are located in those specific sections.
---------------------------------------------------------------------------

    [1] Issue: Five commenters asked the DEA to define ``ultimate 
user.''
    Response: An ultimate user is defined by the CSA as ``a person who 
has lawfully obtained, and who possesses, a controlled substance for 
his own use or for the use of a member of his household or for an 
animal owned by him or by a member of his household.'' This definition, 
codified at 21 U.S.C. 802(27), was not amended or otherwise modified by 
the Disposal Act.
    [2] Issue: Ten commenters asked the DEA to clarify the term 
``retail pharmacy'' and to specify whether ``closed-door pharmacies,'' 
such as those that service LTCFs, ``Federal pharmacies,'' and other 
pharmacies that only provide services to a distinct population are 
considered retail pharmacies.
    Response: The intended meaning of ``retail pharmacy'' with regard 
to collectors was discussed in the NPRM but was not defined in the 
proposed rule itself. The DEA intends ``retail pharmacy'' to include 
any entity registered with the DEA as a retail pharmacy as opposed to 
those entities registered as a hospital/clinic. Depending on a variety 
of factors, including State authority and authorized business 
practices, some entities that dispense controlled substances may be 
registered with the DEA as either a retail pharmacy or a hospital/
clinic. 21 CFR part 1301. In other words, pharmacies are not registered 
with the DEA as ``Federal pharmacies,'' ``LTCF pharmacies,'' or even 
``closed-door pharmacies.'' All of these pharmacies may be registered 
as retail pharmacies provided they meet the requirements of 21 U.S.C. 
822 and 823, and they may be authorized as collectors upon proper 
application. As previously discussed, the DEA is also allowing entities 
registered as hospitals/clinics with an on-site pharmacy to be 
collectors. 21 CFR 1317.40. Therefore, patients of pharmacies that 
dispense controlled substances pursuant to a hospital/clinic 
registration may benefit if the hospital/clinic opts to modify its 
registration to become a collector.
    [3] Issue: Approximately 10 commenters asked the DEA to expand the 
definition of ``authorized employee.'' These commenters expressed 
concern that the definition of ``authorized employee'' in the NPRM was 
too limited in scope, and would result in a burden on smaller-staffed 
pharmacies, as well as pharmacies that employ contract pharmacists and 
part-time employees. One commenter asked whether or not physician-
owners will be considered authorized employees.
    Response: The DEA carefully considered the commenters' concerns and 
is modifying the proposed definition of ``authorized employee.'' 21 CFR 
Sec.  1300.05(b). In this rule, the DEA is omitting the word 
``authorized'' from the definition of ``authorized employee'' because 
the rule already specifies what conditions qualify employees to conduct 
certain disposal activities (i.e., authorized collectors may not 
employ, as an agent or employee who has access to or influence over 
collected substances, any person who has been convicted of a felony 
offense related to controlled substances or who has, at any time, had 
an application for registration with DEA denied, had a DEA registration 
revoked or suspended, or surrendered a DEA registration for cause). 
Also, the DEA is modifying the definition of ``employee'' by adopting 
the general common law of agency's definition of the term and moving 
the definition from proposed part 1317 to part 1300. As a result of 
these changes, part-time personnel and physician-owners may be 
considered ``employees'' for the purpose of disposal if they meet the 
relevant criteria.
    Where Congress does not define ``employee,'' the DEA utilizes the 
common law to determine who is an ``employee.'' Under U.S. Supreme 
Court precedent, the factors relevant to determining whether a person 
is an ``employee'' under the common law include, but are not limited 
to: The hiring party's right to control the manner and means by which 
the product is accomplished; the skill required; the source of the 
instrumentalities and tools; the location of the work; the duration of 
the relationship between the parties; whether the hiring party has the 
right to assign additional projects to the hired party; the extent of 
the hired party's discretion over when and how long to work; the method 
of payment; the hired party's role in hiring and paying assistants; 
whether the work is part of the regular business of the hiring party; 
whether the hiring party is in business; the provision of employee 
benefits; and the tax treatment of the hired party. See Nationwide Mut. 
Ins. Co. v. Darden, 503 U.S. 318, 323-24 (1992). Other applicable 
factors may be considered and no one factor is dispositive. See id. at 
324.
    After evaluating the relevant factors in the context of controlled 
substance security and diversion prevention, in the context of 
disposal, the following criteria will determine whether a person is an 
``employee'' regardless of the number of hours per week the person 
works: Persons who are directly paid by the registrant; who are subject 
to direct oversight by the registrant; who are required, as a condition 
of employment, to follow the registrant's procedures and guidelines 
pertaining to the handling of controlled substances; who receive a 
performance rating or performance evaluation on a regular/routine basis 
from the registrant; who are subject to disciplinary action by the 
registrant; and who render services at the registrant's registered 
location. This definition is incorporated in the new Sec.  1300.05, 
titled ``Definitions Relating to the Disposal of Controlled 
Substances.'' These criteria focus on the degree of management and 
control that a registrant has over the person, and thus, adherence to 
these criteria will directly impact the security of controlled 
substances within the registrant's custody and control. The DEA 
believes that these criteria are the minimum required to ensure 
controlled substances are accounted for and not diverted to illicit 
purposes. Under the definition, contract personnel who do not meet 
these criteria are not ``employees'' for the purposes of disposal.
    [4] Issue: One commenter stated that the proposed definition of 
``authorized employee'' was too expansive, and that controlled 
substances should be handled only by individuals who hold a 
professional license.
    Response: The DEA carefully considered the diversion risks 
associated with allowing various types of persons to handle collected 
substances. The definition of ``employee,'' as stated in this final 
rule, will help reduce diversion risks while ensuring that authorized 
collectors have sufficient ability to safely and securely manage the 
collection of controlled substances. 21 CFR part 1300. Individuals who 
do not hold a professional license are considered ``employees'' if they 
meet the criteria as explained above.
    [5] Issue: Five commenters asked the DEA to define the term 
``common or contract carrier.''
    Response: The DEA declines to define this term for the purpose of 
this rule. The DEA's primary concern regarding common or contract 
carriers is not about how these terms are defined, but whether there is 
adequate security to

[[Page 53528]]

prevent diversion when controlled substances are being transported. As 
explained in Sec.  1301.74(e), when shipping controlled substances, 
non-practitioner registrants are responsible for selecting common or 
contract carriers that provide adequate security to guard against in-
transit losses. In addition, non-practitioner registrants are 
responsible for employing precautions (e.g., assuring that shipping 
containers do not indicate that contents are controlled substances) to 
guard against in-transit losses. Although these specific requirements 
apply to non-practitioners, all registrants (practitioners and non-
practitioners) shall provide effective controls and procedures to guard 
against theft and diversion of controlled substances. 21 CFR part 1301.
    [6] Issue: One commenter suggested that the DEA modify the 
definition of ``non-retrievable'' to read: ``means to permanently alter 
any controlled substance's physical and/or chemical state through 
essentially irreversible means in order to render that controlled 
substance unavailable and unusable for all practical purposes. This 
definition is not intended to require destruction beyond the state at 
which a controlled substance becomes unavailable, unusable, and, 
subsequently, no longer available for diversion.''
    Response: The DEA declines to modify the definition as suggested. 
Such a change would significantly weaken the non-retrievable standard 
to a state where controlled substances could easily be diverted. The 
permanent and irreversible alteration of controlled substances is the 
cornerstone of the non-retrievable standard.
    [7] Issue: Some commenters asked the DEA to clarify the meaning of 
the terms ``regularly'' and ``practitioner'' used in the proposed Sec.  
1317.05(a)(4).
    Response: ``Practitioner'' is defined in the CSA at 21 U.S.C. 
802(21) as ``a physician, dentist, veterinarian, scientific 
investigator, pharmacy, hospital, or other person licensed, registered, 
or otherwise permitted, by the United States or the jurisdiction in 
which he practices or does research, to distribute, dispense, conduct 
research with respect to, administer, or use in teaching or chemical 
analysis, a controlled substance in the course of professional practice 
or research.'' The term ``regularly'' has its ordinary meaning, with no 
specific or technical implications. The DEA understands the ordinary 
meaning of ``regularly'' to generally be considered as being on a 
routine basis or at routine intervals.
    [8] Issue: One commenter suggested that the DEA distinguish reverse 
distributors who only collect controlled substances for the purpose of 
disposal from reverse distributors who also handle non-controlled 
substances and other waste products. This commenter suggested that the 
DEA lessen the requirements for those reverse distributors that only 
collect controlled substances for disposal.
    Response: The DEA does not distinguish between different ``types'' 
of reverse distributors. All reverse distributors receive controlled 
substances for the purpose of disposal--either through return to the 
manufacturer who accepts returns, or through destruction. 21 CFR part 
1300. The regulations impose the minimum requirements for reverse 
distributors when handling controlled substances regardless of whether 
they also handle other substances. Therefore, there is no basis to 
relax the requirements for reverse distributors whose activities are 
limited solely to the collection of pharmaceutical controlled 
substances for the purpose of disposal.
    [9] Issue: One commenter asked the DEA to clarify the difference 
between ``transfer'' and ``transport'' as used in proposed Sec.  
1317.95.
    Response: These terms have their ordinary meaning. Generally, the 
DEA uses the term ``transport'' to refer to the physical movement of an 
item from one location to another while ``transfer'' is used to refer 
to conveying possession or control (actual or constructive) from one 
entity to another.
    [10] Issue: One commenter asked the DEA to clarify the phrase 
``causes the destruction'' as it could be interpreted to mean any 
person involved in the process.
    Response: As previously discussed, proposed Sec.  1317.100 is 
relocated in this final rule to Sec.  1304.21(e). The DEA included the 
term ``causes the destruction'' to encompass such circumstances where a 
registrant does not itself destroy the controlled substance but is 
still responsible for the destruction; for example, when a registrant 
or a registrant's employee initiates the destruction process by 
engaging a third-party destruction facility that will perform the 
actual destruction pursuant to Sec.  1317.95(c). This final rule 
clarifies this distinction in Sec. Sec.  1317.95(c) and 1304.21(e).
    [11] Issue: One commenter stated that the rule should be clarified 
in use of the word ``may'' with regard to individual counting and 
inventorying of collected substances. The commenter indicated that the 
word seems open for interpretation.
    Response: The commenter is specifically referring to the NPRM 
statement ``[c]ontrolled substances collected by collectors may not be 
individually counted or inventoried.'' The DEA understands that this 
phrase may be misinterpreted to mean that authorized collectors are not 
required to count or inventory collected substances. To clarify, the 
DEA is modifying Sec. Sec.  1317.60 and 1317.70 to clearly indicate 
that sealed inner liners and returned mail-back packages ``shall not be 
opened, x-rayed, analyzed, or otherwise penetrated.'' The DEA also 
modifies Sec.  1317.75(c) to specify that this prohibition includes 
counting or inventorying collected substances prior to sealing and 
removing an inner liner that contains collected substances, as well as 
after the inner liner is sealed. The DEA discusses below the different 
requirements applying to law enforcement.
    [12] Issue: One commenter noted that the DEA used inconsistent time 
requirements throughout the proposed rule, such as ``timely,'' 
``prompt,'' and ``as soon as practicable, but no later than 14 days.'' 
Additionally, several commenters requested clarification regarding the 
definition of the word ``prompt'' in the proposed rule, and commenters 
asked for clarification regarding how the DEA would determine whether 
an action is ``prompt.'' Commenters asked for guidance as to what time 
range the DEA would find reasonably acceptable.
    Response: The DEA's use of different time standards throughout the 
proposed rule was intentional as the different circumstances of each 
requirement warrant different standards. The various timing 
requirements are intended to be flexible enough to account for 
individual circumstances while also ensuring sufficient and adequate 
controls to prevent diversion and opportunities for diversion. The DEA 
considered imposing specific timelines (e.g., three days, five days); 
however, the wide variety of business models and activities made it 
impossible in most circumstances to set a specific deadline that would 
prevent diversion and diversion opportunities. Additionally, violations 
of specific timelines would be per se violations of the regulations, 
whereas violations of the flexible ``prompt'' and ``as soon as 
practicable'' standards would be considered under each registrant's 
individual circumstances. The DEA's determination will be guided by 
whether the registrant has fulfilled its responsibility to provide 
effective controls and procedures to guard against theft and diversion. 
All controlled substances destined for destruction must be rendered 
non-retrievable in order to be destroyed in a manner

[[Page 53529]]

consistent with this rule. As such, a controlled substance will have 
been promptly destroyed if it is promptly rendered non-retrievable. 21 
CFR 1317.95. ``Timely'' refers to actions that have a specific time 
period for compliance, e.g., 30 days. Therefore, in each instance in 
which the rule uses the word ``timely'' to refer to destruction 
requirements for reverse distributors, it refers to the specific time 
period (14 days in the proposed rule, 30 days in the final rule) in 
which reverse distributors are required to destroy controlled 
substances. 21 CFR 1317.15.

C. Types of Entities That May Operate a Collection Program (9 Issues)

    [1] Issue: Several commenters asked the DEA to retain the provision 
in the proposed rule to permit retail pharmacies to maintain collection 
receptacles. These commenters stated that retail pharmacies will 
provide a convenient option for ultimate users who desire to safely and 
securely dispose of their unused or unneeded controlled substances. 
Commenters also asked the DEA to retain the provision to permit retail 
pharmacies to manage collection receptacles at LTCFs.
    Response: The DEA appreciates the support for the provisions in the 
rule that permit retail pharmacies to manage collection receptacles at 
not only the primary registered location of the retail pharmacy, but 
also LTCFs. 21 CFR 1317.40 and 1317.80. The DEA believes that these two 
provisions will provide ultimate users and others with convenient 
options to safely and securely dispose of unused controlled substances. 
The DEA retained these provisions in the final rule.
    [2] Issue: Eighteen commenters asked the DEA to permit hospitals to 
become authorized collectors so that they may maintain collection 
receptacles. An additional two commenters asked the DEA to allow 
specialized hospitals and clinics to maintain collection receptacles. 
These commenters stated that collection receptacles located inside of 
hospitals would provide ultimate users with an opportunity to dispose 
of medication that may no longer be needed or may be expired.
    Response: The DEA selected methods for disposal that provide 
opportunities for ultimate users to securely, conveniently, and 
responsibly dispose of their unused, unwanted, and expired 
pharmaceutical controlled substances while also preventing diversion. 
As previously discussed, after extensive review and careful 
deliberation, the DEA is permitting certain registered hospitals/
clinics to become authorized collectors. 21 CFR 1317.40. In order to 
counterbalance the diversion risks of allowing collection receptacles 
to be located inside hospitals/clinics, the DEA is only allowing those 
hospitals/clinics with on-site pharmacies to become collectors. The DEA 
is requiring these collectors to place collection receptacles in 
locations that are regularly monitored by employees, and is prohibiting 
these collectors from placing collection receptacles in the proximity 
of any area where emergency or urgent care is provided. 21 CFR 1317.75.
    [3] Issue: One commenter suggested that hospitals of a certain size 
be required to become authorized collectors.
    Response: The DEA is not requiring, nor is the DEA authorized to 
require, any entity to implement a collection program or maintain a 
collection receptacle. The Disposal Act explicitly states that the 
``regulations may not require any entity to establish or operate a 
delivery or disposal program.'' 21 U.S.C. 822(g)(2).
    [4] Issue: It was requested that the DEA allow military treatment 
facility pharmacies (registered with the DEA as a hospital/clinic), and 
the Indian Health Service (IHS), including IHS pharmacies (IHS, Tribal, 
and Urban programs) to become authorized collectors. One commenter also 
suggested that the DEA permit collection receptacles in select areas of 
military installations, such as ambulatory care clinics and service 
member barracks.
    Response: As previously discussed, any registered hospital/clinic 
with an on-site pharmacy and any retail pharmacy may be authorized to 
be a collector. 21 CFR 1317.40. Ambulatory care clinics and service 
member barracks are generally not registrants. As discussed in the 
NPRM, the Disposal Act did not give the DEA authority to create new 
classes of registration solely for the purpose of conducting ultimate 
user disposal activities. The DEA is allowing hospitals/clinics with an 
on-site pharmacy and retail pharmacies to be responsible for and manage 
collection receptacles in non-registrant LTCFs because the Disposal Act 
acknowledged that LTCFs ``face a distinct set of obstacles to the safe 
disposal of controlled substances due to the increased volume of 
controlled substances they handle.'' 21 CFR 1317.80. LTCF residents 
generally have limited mobility; accordingly, this final rule 
authorizes LTCFs to dispose of controlled substances on behalf of 
ultimate users who reside or have resided at the LTCF. 21 CFR 1317.30. 
Furthermore, un-registered ambulatory care clinics and service member 
barracks generally lack adequate safeguards to ensure the security of 
collected pharmaceutical controlled substances; thus, allowing 
collection receptacles at such locations poses an unacceptable risk of 
diversion and threatens the public health and safety.
    [5] Issue: Eight commenters asked the DEA to permit non-registrants 
to collect non-controlled substances for the purpose of disposal.
    Response: The DEA's authority regarding drug disposal is specific 
to pharmaceutical controlled substances. Non-registrants may collect 
non-controlled substances pursuant to all applicable Federal, State, 
tribal, and local laws and regulations; however, all regulations and 
laws relevant to controlled substances will apply if controlled 
substances are collected, even inadvertently.
    [6] Issue: One commenter asked the DEA to permit LTCFs to become 
authorized collectors.
    Response: The DEA is without authority to permit LTCFs to become 
authorized collectors. As discussed in the NPRM, authorized collectors 
must first be registrants in order for the DEA to impose and enforce 
these regulations upon them. A majority of LTCFs do not have State 
authority with respect to controlled substances--a fundamental 
prerequisite to obtaining a DEA registration. The Disposal Act 
authorized the development of regulations to permit LTCFs to dispose of 
controlled substances on behalf of ultimate users who reside or have 
resided in their facilities. The DEA is permitting hospitals/clinics 
with an on-site pharmacy and retail pharmacies to become authorized 
collectors with authority to install and maintain collection 
receptacles at LTCFs, and declines to extend this authority to the 
LTCFs themselves. 21 CFR 1317.40.
    [7] Issue: Several commenters urged the DEA to create a new status 
that permits non-registrant organizations to become authorized 
collectors for the sole purpose of collecting controlled substances 
from ultimate users and others authorized to dispose of controlled 
substances on behalf of ultimate users. One commenter asked that the 
DEA allow non-profit, non-registrant organizations to register as 
authorized collectors with a reduced fee.
    Response: The DEA is not developing a new category of registrant 
specifically for collecting pharmaceutical controlled substances from 
ultimate users. Any entity that wishes to collect controlled substances 
from ultimate users must do so in accordance with this rule, which 
includes provisions for specified

[[Page 53530]]

existing registrant categories to modify their registration to become 
authorized as collectors. Any person not already registered with the 
DEA, wishing to become authorized as a collector must first satisfy all 
of the requirements for registration identified in the CSA and its 
implementing regulations. Non-registrant organizations may partner with 
law enforcement and with registrants that are collectors. 21 CFR 
1317.65.
    [8] Issue: One commenter asked the DEA to clarify how a local 
government may register with the DEA to become an authorized collector.
    Response: As discussed above, the DEA is not creating a new 
registration category for the exclusive purpose of collecting 
controlled substances from ultimate users. Persons registered with the 
DEA as manufacturers, distributors, reverse distributors, NTPs, 
hospitals/clinics with an on-site pharmacy, or retail pharmacies may 
apply to modify their registration to become an authorized collector in 
the manner proscribed by this final rule. 21 CFR part 1301. Any person 
not already registered with the DEA, wishing to become authorized as a 
collector must first satisfy all of the requirements for registration 
identified in the CSA and its implementing regulations. These 
requirements include being authorized to handle controlled substances 
by the State in which the applicant is located unless exempt by statute 
or regulation. The DEA encourages entities that are not registrants to 
partner with authorized collectors or law enforcement. 21 CFR 1317.65. 
For example, local governments may partner with authorized mail-back 
collectors to provide mail-back packages to the public.
    [9] Issue: One commenter asked the DEA to clarify that no Federal 
or State government entity may require registrants to amend their DEA 
registration to become authorized collectors.
    Response: The Disposal Act specifically prohibits the DEA from 
requiring any entity to establish or operate a delivery or disposal 
program. 21 U.S.C. 822(g)(2). The prohibition does not extend to every 
Federal and State agency and the DEA does not have the authority to 
institute such a prohibition.

D. Locations Where Authorized Collectors May Maintain Collection 
Receptacles or Host Take-Back Events (1 Issue)

    [1] Issue: Six commenters asked the DEA to permit retail pharmacies 
to manage collection receptacles at establishments other than the 
retail pharmacy's registered location, such as community centers. 
Commenters stated other locations may be more convenient for ultimate 
users and would thus maximize participation. Two commenters asked the 
DEA to allow collection receptacles at unregistered locations such as 
permanent household hazardous waste collection sites.
    Response: The DEA acknowledges that in some locations, and under 
certain circumstances, alternative settings may be more convenient for 
ultimate users, but that is not the only consideration. The DEA 
believes that in order to adequately ensure the safety and welfare of 
the public, collection receptacles must be located inside the DEA-
registered location of authorized collectors. 21 CFR part 1317.75. 
Authorized collectors, as registrants, are readily familiar with the 
security procedures and other requirements to handle controlled 
substances. Most publicly-accessible locations where controlled 
substances are not typically handled, such as community centers and 
hazardous waste collection sites, are not targets for theft in the same 
manner as those locations where pharmaceutical controlled substances 
are regularly handled. Thus, those locations are unlikely to be 
familiar with, or to have in place, the security controls necessary to 
ensure the security of collected substances and prevent diversion of 
controlled substances. However, law enforcement may continue to conduct 
take-back events, and other persons may partner with law enforcement to 
conduct such take-back events at various locations. 21 CFR 1317.65.

E. Registration Requirements for Authorized Collectors (5 Issues)

    [1] Issue: Several commenters asked the DEA to clarify whether or 
not registration modifications for authorized collectors may be 
conducted online.
    Response: Registration modifications may be conducted online. For 
the final rule, the DEA is modifying the text of Sec.  1301.51 to 
clarify that online modifications are indeed permitted. Registrants may 
go to www.DEAdiversion.usdoj.gov to modify their registration when they 
start or stop collection activities.
    [2] Issue: Three commenters stated that it is overly burdensome to 
require authorized collectors to modify their registration each time 
they start or stop collection activities. These commenters asked that 
the DEA provide additional details regarding the registration 
modification process.
    Response: The DEA carefully reviewed the registration requirements 
and did not find indications to suggest that registration modifications 
will be overly burdensome. The rule requires that a registrant must 
apply to modify their DEA registration prior to initiating any 
collection activities. 21 CFR part 1301. Authorization as a collector 
is subject to renewal in the same manner as registration. The DEA will 
consider an authorized collector to be conducting collection activities 
until the registration is modified, revoked, surrendered, suspended, or 
otherwise terminated. If an authorized collector stops collection 
activities, he/she must modify his/her registration to indicate such. 
The requirement to modify a registration requires a simple written 
notification to the DEA. This written notification can be easily and 
quickly conducted online in a few minutes. 21 CFR part 1301. The 
registrant may go online and select the option to indicate that the 
registrant has ceased collecting. Registrants without ready access to 
the online notification method can easily and quickly communicate such 
information to the DEA in writing via the mail, which the DEA will 
process promptly upon receipt.
    [3] Issue: One commenter suggested that the DEA relax requirements 
for registration modifications regarding LTCF collection receptacles. 
This commenter was concerned that registration modifications may 
outpace the DEA's resources.
    Response: The DEA evaluated this request and determined that the 
registration requirements regarding LTCF collection receptacle 
management are necessary to ensure accountability and prevent 
diversion; the related procedures are the minimum necessary to ensure 
that authorized collectors maintain the receptacles in a manner that is 
consistent with the applicable regulations. 21 CFR part 1301.
    [4] Issue: One commenter asked the DEA to clarify whether or not an 
entity may apply for registration as a reverse distributor with the 
sole intent of providing destruction services for collected substances.
    Response: Any entity may apply for registration as a reverse 
distributor pursuant to and in accordance with 21 U.S.C. 822-823, and 
21 CFR part 1301. Reverse distributors are not required to conduct all 
activities that they are authorized to perform.
    [5] Issue: Two commenters asked the DEA to clarify whether a 
destruction facility must be registered with the DEA.
    Response: Pursuant to this rule, a destruction facility is not 
required to register with the DEA simply because a

[[Page 53531]]

registrant utilizes that facility to destroy controlled substances in a 
manner consistent with this rule and all other applicable Federal, 
State, tribal, and local laws and regulations. At this time, the DEA 
does not believe it is appropriate to require these entities to be 
registered because the destroying registrant maintains possession and 
control of the substances (and therefore retains responsibility and 
accountability) until the substances are rendered non-retrievable. 21 
CFR part 1301. All handling, monitoring, reporting, recordkeeping, and 
witnessing with regard to the destruction of pharmaceutical controlled 
substances must be performed by registrants or their employees. The DEA 
has omitted the language that was proposed for Sec.  1317.15(c)(4) in 
order to prevent confusion.

F. Law Enforcement (7 Issues)

    [1] Issue: Several commenters asked the DEA to expand the 
definition of ``law enforcement officer'' to include law enforcement 
components of Federal agencies and civilian law enforcement officers.
    Response: The final rule definition is expanded from the proposed 
rule to specifically include officers of the law enforcement components 
of Federal agencies, and police officers of the Veterans Health 
Administration and the Department of Defense. The NPRM proposed a 
definition of ``law enforcement officer'' to include persons who are 
employees of a ``law enforcement agency.'' The DEA is modifying this 
definition in the final rule to specifically include employees of law 
enforcement components of Federal agencies. Any person who meets the 
criteria for ``employee'' and ``law enforcement officer'' outlined in 
the final rule will be a qualified officer for the purposes of disposal 
of pharmaceutical controlled substances, regardless of whether the 
person is considered a ``civilian'' law enforcement officer. 21 CFR 
part 1300.
    [2] Issue: Four commenters stated it would be overly burdensome to 
require law enforcement to have a collection receptacle that fits the 
specifications in the NPRM. These commenters stated that the collection 
receptacle would pose logistical issues, and that the volume of drugs 
collected would likely exceed the volume that the receptacle could 
contain. Commenters also noted that it is unnecessary to mandate that 
law enforcement utilize collection receptacles at take-back events.
    Response: Law enforcement are not required to have a collection 
receptacle that meets all of the specifications in the rule, and the 
text of the rule is amended to clarify that the specifications apply to 
authorized collectors and not law enforcement. The only suggested 
requirements for the physical construction of collection receptacles 
maintained by law enforcement are that they be securely placed and 
maintained at the law enforcement's physical location. 21 CFR 1317.35. 
Also, law enforcement are not required to utilize collection 
receptacles at take-back events. The text of the final rule states, 
``[e]ach take-back event should have at least one receptacle for the 
collection of permitted substances . . .'' 21 CFR 1317.65. Thus, law 
enforcement should have some sort receptacle at take-back events.
    [3] Issue: Commenters expressed concern that law enforcement may 
not have the facilities to store the collected substances until they 
are shipped to a destruction facility.
    Response: The rule suggests that law enforcement store collected 
substances in a manner that is consistent with its standard procedures 
for storing illicit controlled substances. The language used in the 
text of the rule, ``should,'' is suggestive. Law enforcement are 
encouraged to follow the guidance in 21 CFR 1317.35; however, they are 
not required to do so. It should be noted that the requirements in 21 
CFR 1317.65 pertaining to law enforcement presence at take-back events 
are mandated; however, the DEA only suggests procedures for the storage 
and transportation of pharmaceutical controlled substances collected at 
take-back events.
    [4] Issue: One commenter asked the DEA to permit entities other 
than law enforcement to conduct take-back events.
    Response: If an authorized collector or other entity wishes to 
conduct a take-back event, the event must be held in partnership with 
law enforcement, as provided in the rule. 21 CFR 1317.65. Take-back 
events are intended to be limited-duration events that may take place 
at an unregistered location that is easily accessible to the public, 
such as a community center or town center. Given the likelihood of 
publicity and low physical security at such locations, the DEA believes 
that it is imperative to ensure active law enforcement participation 
for the safety of the event participants and the community, as well as 
to help deter theft and diversion of pharmaceutical controlled 
substances.
    [5] Issue: Commenters urged the DEA to relax the ``authorized 
employee'' requirement for civilian law enforcement officers. These 
commenters stated that the DEA should treat civilian law enforcement 
officers as ``authorized employees'' for the purposes of this rule. 
They stated that these officers and employees currently assist with 
take-back events, and if they were no longer permitted to, there would 
be a staffing shortage to assist with take-back events. Additionally, 
several commenters encouraged the DEA to allow civilian law enforcement 
employees to handle collected substances if they meet the same 
requirements as an employee or handle the substances in a manner 
consistent with law enforcement protocols.
    Response: In the NPRM, ``authorized employee'' referred to those 
registrant personnel who would be permitted to directly participate in 
the disposal process. ``Authorized employee'' did not pertain to law 
enforcement officers or to take-back events. In the final rule the 
definition is modified, but it still only pertains to those persons who 
may be permitted to directly participate in the disposal process. 21 
CFR part 1300. With respect to law enforcement and take-back events, as 
discussed above, any person who meets the criteria for ``employee'' and 
``law enforcement officer'' outlined in the final rule will be a 
qualified officer for the purposes of disposal of pharmaceutical 
controlled substances, regardless of whether the person is considered a 
``civilian'' law enforcement officer. The DEA declines to expand the 
law enforcement authority to specifically include civilian law 
enforcement employees. Only employed law enforcement officers, as 
defined by this final rule, may handle pharmaceutical controlled 
substances at take-back events. As discussed in the NPRM and previous 
responses to this issue, the DEA believes that this level of security 
is necessary to prevent theft and diversion and to ensure the safety of 
the public due to the highly publicized nature of take-back events and 
the fact that such events are likely to occur at locations with minimal 
security. The DEA does not believe that this requirement will hinder 
the success of take-back events. As previously discussed, only one law 
enforcement officer must oversee the take-back event, and at the 
discretion of the law enforcement agency or law enforcement component 
of a Federal agency, this officer may also be the law enforcement 
officer who maintains control and custody of the collected substances. 
21 CFR 1317.65. There are no prohibitions against other persons 
assisting law enforcement officers conduct the take-back event.
    [6] Issue: One commenter asked the DEA to address what rights 
Military

[[Page 53532]]

Provost Marshal Officers have with respect to collecting controlled 
substances from ultimate users.
    Response: Under Sec.  1317.35 of the new regulation, Federal law 
enforcement may continue to conduct take-back events and mail-back 
programs, and operate collection receptacles as further detailed in the 
regulation. If the Office of the Provost Marshal is considered 
``Federal law enforcement,'' it would be eligible to conduct such 
collection activities. Federal law enforcement can, and in some cases 
must, appoint a law enforcement officer to oversee those activities. 
The appointed officer would then have the authority granted by his/her 
agency.
    [7] Issue: One commenter asked the DEA to clarify how law 
enforcement may transport and deliver collected substances to a 
destruction facility (i.e., whether they may ship such substances using 
a common carrier) and how law enforcement can comply with Department of 
Transportation (DOT) requirements when transporting substances that may 
contain hazardous materials.
    Response: The DEA has no expertise or authority to interpret or 
apply the DOT laws, regulations, or guidelines regarding transportation 
of pharmaceutical controlled substances that may constitute hazardous 
materials. As such, interested persons are encouraged to contact the 
DOT directly with their specific circumstances, and such persons can 
obtain more information at www.phmsa.dot.gov/hazmat. However, the DEA 
understands that the DOT's Hazardous Materials Regulations apply to 
entities that place hazardous materials in commercial transportation, 
and not government vehicles operated by government personnel solely for 
non-commercial purposes. If more detailed guidance is necessary, the 
DEA encourages law enforcement and other entities to consult the DOT 
for guidance on transporting collected substances that may contain 
hazardous materials. For additional commentary on hazardous material 
disposal please see comment section ``Q.'' entitled ``Hazardous 
Materials Transportation and Hazardous Waste Destruction.''

G. Collection Receptacle Design, Inner Liners, Placement, and Security 
(24 Issues)

Clarification of Terms
    [1] Issue: One commenter noted that the DEA interchangeably used 
the terms ``container'' and ``shell'' when referring to the outer 
collection receptacle.
    Response: The DEA is modifying the final rule to consistently use 
the term ``container'' when referring to the outer portion of 
collection receptacles. This change is purely for stylistic consistency 
and makes no substantive change to the rule.
Collection Receptacle Design
    [2] Issue: The DEA specifically requested comments regarding the 
value of the use of a uniform symbol to be placed on collection 
receptacles. The DEA received 22 comments regarding the use of a 
uniform symbol. Five commenters supported the use of a uniform symbol, 
and 17 commenters opposed the use of a uniform symbol. One commenter 
suggested that the symbol be yellow. Four commenters noted that the use 
of such a symbol is unnecessary given the requirement to clearly mark 
and label the receptacles. Three commenters expressed concern that the 
use of such symbols would result in the receptacles becoming targets 
for diversion. One commenter was not opposed to the use of a uniform 
symbol but does not believe it is essential. One commenter indicated 
that the use of a uniform symbol should be contingent upon the location 
and security of the collection receptacle.
    Response: The DEA appreciates all of the comments submitted in 
response to this request. After careful consideration, the DEA declines 
to include a uniform symbol requirement in this final rule. However, 
the DEA may consider requiring a uniform symbol on collection 
receptacles after a sufficient time to observe the effects of the 
existing requirement to clearly mark and label collection receptacles.
    [3] Issue: Eleven commenters stated that any signage indicating 
what ultimate users may deposit into the collection receptacle should 
be in plain language. These commenters noted that most ultimate users 
cannot distinguish between controlled substances and non-controlled 
substances. Other commenters stated that no sign should be required at 
all, and others suggested the use of pictograms instead of words. 
Others raised concerns that signage will draw attention to the 
receptacles, thus increasing risk for theft and diversion.
    Response: The final rule does not require any specific language, 
design, or color choice for the display on the collection receptacle as 
long as the sign indicates that only schedules II-V controlled 
substances and non-controlled substances are acceptable. 21 CFR 
1317.75. As explained above, comingling is permitted but not required. 
21 CFR 1317.75. Plain language, pictograms, or a combination of the 
two, may be used, as long as it is clear that schedule I controlled 
substances, controlled substances not lawfully possessed by the 
ultimate user, and illicit or dangerous substances are not permitted to 
be placed in the container. The DEA believes that some notice regarding 
what substances may be disposed in collection receptacles is necessary 
in order to provide guidance to the public and to discourage the use of 
receptacles for disposing trash or other items. While the diversion 
risks presented by the requirement for signage is mitigated by physical 
security requirements (e.g., that the receptacle be securely fastened 
to a permanent structure), authorized collectors should be mindful that 
the selected signage not transform the receptacle into a target for 
theft or diversion.
    [4] Issue: Four commenters suggested that the collection receptacle 
sign encourage ultimate users to remove medication from its container 
before placing the medication in the collection receptacle. Several of 
the commenters who had participated in authorized pharmaceutical 
controlled substance take-back programs noted that the packaging for 
medication is voluminous, and that including such packaging will be 
burdensome since it will necessitate changing inner liners more 
frequently.
    Response: The DEA appreciates these commenters' concerns. Although 
collectors may encourage ultimate users to remove substances from their 
containers before depositing them into a collection receptacle or mail-
back package, the DEA declines to require it. The DEA has declined to 
mandate whether substances must be disposed of, with or without 
packaging, because such requirements would not necessarily affect 
security or increase the risks of diversion, and as such, should be 
left to the individual collectors and other relevant authorities who 
best know the needs and requirements of their programs and locations.
    [5] Issue: Other commenters indicated that some hazardous waste 
disposal regulations require the disposal of medication containers, 
which may not fit into the receptacles.
    Response: As discussed in the immediately preceding comment, the 
DEA is neither requiring nor prohibiting medication containers to be 
disposed of with pharmaceutical controlled substances. Moreover, there 
is no indication that the vast majority of medications will not fit 
into the ``small opening'' that the collection receptacles 
specifications require. For additional commentary on hazardous waste

[[Page 53533]]

disposal please see comment section ``Q.'', entitled ``Hazardous 
Materials Transportation and Hazardous Waste Destruction.''
    [6] Issue: The DEA received comments that the inner liner should be 
a large plastic tub or bucket within a receptacle that can be easily 
removed and the collected items either dumped into smaller containers 
or sorted before being secured into storage for disposal or prior to 
destruction.
    Response: The DEA carefully considered the specifications of both 
the inner liner and the outer container of the collection receptacle. 
To prevent diversion and protect the public health and safety, the DEA 
drafted this rule with the precisely considered objective of limiting 
the number of people who handle the collected substances. The DEA's 
extensive experiences in regulating and enforcing the closed system of 
distribution established by the CSA have demonstrated that a key factor 
in reducing diversion risk is limiting the handling of controlled 
substances. In the context of disposal, this means prohibiting the 
sorting of collected substances once they are deposited into a 
collection receptacle.
    [7] Issue: One commenter stated that the collection receptacle 
design specifications will require current collection programs for non-
controlled substances to install new collection receptacles if those 
programs wish to additionally collect pharmaceutical controlled 
substances. This commenter stated that such installations will be 
burdensome and will discourage participation for these programs.
    Response: The DEA deeply appreciates the concern and activism of 
local communities and other groups currently conducting non-controlled 
substance drug take-back programs and their wish to expand collection 
activities to pharmaceutical controlled substances. Programs such as 
these are an important and vital component of the communities they 
serve. The DEA understands that publication of this final rule may 
necessitate the need for some programs to implement new procedures and 
install new equipment in order to additionally collect pharmaceutical 
controlled substances. The DEA has not established the new requirements 
lightly or without considerable deliberation as to its impacts on 
existing programs. However, the risk of diversion for non-controlled 
substances is relatively low compared to the much higher risk of 
diversion, and the corresponding and associated risks to public health 
and safety, for pharmaceutical controlled substances. The DEA has been 
charged by Congress with the enforcement of the controlled substance 
laws of the United States, and must ensure that pharmaceutical 
controlled substances are properly secured and not easily susceptible 
to theft or diversion. Accordingly, the collection receptacle design 
specifications outlined in Sec.  1317.75 will be implemented as 
proposed.
    [8] Issue: A commenter asked the DEA to permit the use of similar 
receptacles that may already exist and were designed for the deposit 
and storage of medical waste.
    Response: The DEA is not prohibiting the use of collection 
receptacles that currently exist on the market as long as such 
receptacles meet all of the design specifications outlined in Sec.  
1317.75 of this rule.
    [9] Issue: Five commenters stated that the requirement for a 
collection receptacle to be fastened to a permanent structure is 
burdensome. Several commenters pointed out that many pharmacies do not 
own the property that is their DEA-registered location, and such 
fixtures and installments are prohibited. One commenter pointed out 
that this requirement would be particularly burdensome for small, rural 
pharmacies. Another commenter asked if the requirement applies if the 
collection receptacle is located in a locked room, inaccessible to the 
public.
    Response: The DEA appreciates the willingness of pharmacies to aid 
in the societal goal of helping to combat unauthorized access to and 
abuse of pharmaceutical controlled substances. The DEA understands that 
there may be logistical concerns for some retail pharmacies that wish 
to maintain a collection receptacle at their registered location. 
However, the DEA believes that permanently-secured, fixed containers 
are the minimum required to prevent diversion and theft of collected 
substances. The requirement that collection receptacles be securely 
fastened to a permanent structure applies to all authorized collectors' 
collection receptacles, no matter the location of the registrant. 21 
CFR 1317.75. Although the final rule does not expressly prohibit 
collection receptacles from being placed in a locked room that is 
inaccessible to the public, the final rule does mandate that collection 
receptacles at authorized collectors' registered locations must be 
accessible to ultimate users, and others authorized to dispose of 
controlled substances on behalf of ultimate users, as they are the only 
people who may deposit pharmaceutical controlled substances into a 
collection receptacle (e.g., ultimate users cannot transfer 
pharmaceutical controlled substances to pharmacy staff). 21 CFR 
1317.30. The DEA encourages retail pharmacies leasing their commercial 
space to work with their landlords to allow for the installation of 
collection receptacles under the conditions established by this rule.
    [10] Issue: Nine commenters stated that requiring an outer 
container with an inner liner is unnecessary and burdensome. These 
commenters proposed that the collection receptacle be designed in such 
a way that it can be returned to the reverse distributor as a complete 
unit.
    Response: The DEA appreciates the value in utilizing temporarily 
secured containers that can be sealed and shipped for destruction; 
however, the DEA believes that such systems present an unreasonable 
risk of diversion because, even when secured, such containers can be 
relatively easily removed when compared to a securely fastened and 
locked outer container. Relatedly, the DEA is requiring that collection 
receptacles be ``substantially constructed,'' which is intended to 
ensure that the construction is such that unauthorized access to the 
contents of the receptacle is not easily obtained. 21 CFR 1317.75. 
Accordingly, the DEA is requiring that collection receptacles have a 
substantially-constructed outer container and removable inner liners. 
21 CFR 1317.60 and 1317.75.
    [11] Issue: Three commenters stated that the collection receptacle 
should not be required to have a traditional lock, but that its opening 
be designed so that that the contents cannot be removed.
    Response: In implementing the Disposal Act to provide secure and 
responsible disposal methods for pharmaceutical controlled substances 
by ultimate users, the DEA must ensure that collected substances are 
properly secured and not easily susceptible to theft or diversion. The 
requirements pertaining to collection receptacles were carefully 
considered and designed to limit the handling of the controlled 
substances, from ultimate user to destruction. These considerations 
dictated the size of the opening. However, the NPRM and the final rule 
allow for flexibility regarding a traditional lock, and require that 
``the small opening in the outer container of the collection receptacle 
shall be locked or made otherwise inaccessible to the public when an 
employee is not present (e.g., when the pharmacy is closed).'' 21 CFR 
1317.75(f).
    [12] Issue: One commenter suggested that the DEA conduct a national 
pilot program prior to implementation of the final rule to ensure that 
collection

[[Page 53534]]

receptacle requirements are feasible and effective.
    Response: The DEA believes that the need to implement this rule in 
order to allow secure convenient options for disposal outweighs the 
delay and limited benefit that may be obtained by implementing any 
pilot programs or other testing or research. Through various outreach 
efforts, including the public meeting the DEA held in January 2011, 
comments from industry, and information obtained from pilot programs, 
the DEA believes that it has effectively researched and analyzed the 
various aspects of this rule. Also, the DEA believes that 
implementation of this rule is important to helping reduce the amount 
of unwanted pharmaceutical controlled substances available for theft, 
diversion, and accidental ingestion.
    [13] Issue: One commenter asked the DEA to allow a Special Agent in 
Charge (SAC) to approve container and inner liner designs.
    Response: As discussed in the NPRM, the DEA determined that the 
elimination of individual SAC approval for various aspects of disposal 
or destruction is necessary in order to ensure clear and consistent 
requirements throughout the United States, thus reducing the potential 
for confusion regarding requirements for ultimate users and authorized 
collectors. Specific approval of individual collection receptacles and 
inner liner designs is not required. All collection receptacles and 
inner liner designs must meet the specifications outlined in this final 
rule. 21 CFR 1317.60 and 1317.75.
    [14] Issue: One commenter suggested that national pharmacy 
organizations educate the public on proper disposal methods and various 
disposal options. This commenter suggested that such organizations post 
information online and disseminate leaflets at retail establishments.
    Response: With regard to patient information regarding disposal, 
the DEA is not requiring any entity to educate the public on proper 
disposal methods and their various disposal options. However, the DEA 
anticipates that many entities will voluntarily choose to do so. The 
DEA applauds and encourages voluntary, educational outreach to the 
public on issues related to the abuse potential and proper disposal of 
pharmaceutical controlled substances, whether it be through law 
enforcement, community groups, or professional organizations.
Collection Receptacle Inner Liners
    [15] Issue: Several commenters asked for clarification regarding 
inner liner tracking requirements. Specifically, commenters asked how 
unique identification numbers should be assigned, how tracking systems 
are to be implemented, and what entity will be responsible for placing 
identification numbers on inner liners. One commenter suggested that 
the DEA regulate the manufacture of inner liners or require that inner 
liners be sequentially numbered.
    Response: The rule outlines the design requirements and the 
recordkeeping requirements for inner liners. The purpose of a unique 
identification number is to provide for complete and accurate records 
that can be inventoried to ensure that each liner is accounted for from 
receipt, to installation, removal, storage, transfer, and destruction. 
21 CFR part 1304. The unique identification numbers therefore must be 
unique to the individual collector. 21 CFR 1317.60. The DEA does not 
intend to require any particular method for assigning such numbers and 
is modifying the text of proposed Sec.  1317.60(e) by indicating that 
only inner liners must bear a permanent, unique identification number. 
The company manufacturing the inner liners may assign the numbers. The 
DEA does not have authority to directly regulate the manufacturers of 
the inner liners.
    [16] Issue: One commenter suggested that the inner liner be clear 
so that it can be visually inspected for non-compliant items.
    Response: Due to associated increased risks for diversion, the DEA 
determined that the contents of the inner liners must not be viewable 
once the inner liner is sealed. 21 CFR 1317.60. The DEA appreciates the 
concerns regarding certain non-compliant items being placed in 
collection receptacles; however, for reasons discussed in previous 
comments, no one is permitted to handle the contents of inner liners. 
21 CFR 1317.75. The DEA would like to point out that the text of the 
rule does not prohibit items from being observed prior to being placed 
in the collection receptacle, which could be an effective way to ensure 
that such non-compliant items are not placed in the collection 
receptacle.
    [17] Issue: Several commenters indicated that the requirement to 
store sealed inner liners in the same manner as schedule II controlled 
substances will be overly burdensome and will reduce the amount of 
space available for storing schedule II inventory at retail pharmacies. 
These commenters suggested that the DEA allow the authorized collector 
to transfer collected substances in inner liners to a secure warehouse 
facility for storage until they can be picked up or shipped.
    Response: The DEA appreciates these concerns but declines to permit 
authorized collectors to transfer collected substances to warehouse 
facilities for storage. Filled inner liners must be stored only at 
primary registered locations (and at LTCFs in accordance with Sec.  
1317.80(c)) and may not be transported to off-site warehouses. The 
basis for this requirement is that the risk of diversion increases each 
time inner liners change hands or are transported. However, as 
previously discussed, this final rule expands the NPRM requirement and 
authorizes practitioners to store collected substances at their 
registered location in either a securely locked, substantially 
constructed cabinet or a securely locked room with controlled access. 
21 CFR 1317.05.
    [18] Issue: Four commenters stated that the DEA should permit 
schedule I controlled substances to be disposed of via collection 
receptacles, mail-back packages, or take-back events.
    Response: The Disposal Act addresses the issue of unused 
prescription drugs, and it allows the DEA to provide ultimate users 
with a secure and responsible method to dispose of pharmaceutical 
controlled substances. This rule does not address the disposal of 
illicit controlled substances, e.g., those substances controlled in 
schedule I of the CSA. Schedule I controlled substances, by definition, 
have no accepted medical use in treatment in the United States, and may 
not be lawfully prescribed or otherwise distributed to any person. In 
fact, any transfer of a schedule I controlled substance by an ultimate 
user is a violation of the CSA, unless the ultimate user is 
participating in an investigational use of drugs pursuant to 21 U.S.C. 
355(i) and 360b(j), and the delivery is conducted in accordance with 21 
CFR 1317.85.
Collection Receptacle Placement and Safety
    [19] Issue: Ten commenters expressed concern regarding security in 
retail pharmacies with collection receptacles. Several commenters asked 
the DEA to provide guidance for proper security measures. One commenter 
asked for clarification on an authorized collector's liability should a 
receptacle become subject to diversion or if improper substances are 
deposited.
    Response: The DEA appreciates the concerns of the commenters and 
has carefully considered the risks and benefits associated with 
collection receptacles located in authorized retail pharmacies. The 
DEA's rationale for

[[Page 53535]]

allowing collection at authorized retail pharmacies was described in 
the NPRM. As previously noted, the DEA is not requiring any pharmacy to 
provide a collection receptacle. Each registrant is free to weigh the 
risks and benefits in determining whether or not to seek status as an 
authorized collector. The DEA proposed the rule with the security 
requirement for permanently-secured, fixed containers based on a 
determination that this was the minimum required to help reduce the 
risk of diversion and theft of pharmaceutical controlled substances. 21 
CFR 1317.75. At retail pharmacies, the location of collection 
receptacles within the immediate proximity of a designated area where 
controlled substances are stored and at which an employee is present is 
anticipated to provide an additional layer of security due to the 
increased visibility of the receptacles. 21 CFR 1317.75. While 
potential violations of the CSA and its implementing regulations are 
investigated and assessed independently, this final rule imposes the 
minimum required procedures to prevent and detect diversion. Even so, 
each authorized collector's circumstances are unique. All registrants 
should be mindful of their responsibility to provide effective controls 
and procedures to guard against theft and diversion under 21 CFR 
1301.71(a), and their duty to report thefts and significant losses of 
controlled substances under 21 CFR 1301.74 and 1301.76.
    [20] Issue: One commenter suggested that the inner liners be 
nondescript and free of any markings that would indicate their 
contents. This commenter was concerned that any markings on the inner 
liners would increase diversion risks and make them potential targets 
for drug seekers.
    Response: The DEA appreciates the commenter's concern for potential 
diversion risks that inner liners might pose, and made the 
determination to require them only after careful consideration of the 
associated risks and benefits of their use, and alternatives to their 
use. The DEA is requiring the size of the inner liner to be clearly 
marked on the outside of the liner, and for the inner liner to bear a 
unique identification number in order to help ensure accountability, 
and to identify and prevent diversion. 21 CFR 1317.60. Given the 
totality of information reviewed, the DEA concluded that a requirement 
for the contents to be non-viewable once the inner liner is sealed will 
help reduce diversion risks and deter drug seekers.
    [21] Issue: One commenter stated that requiring contents of the 
inner liner to be non-viewable could lead to diversion as staff could 
record controlled substances as being disposed of without actually 
placing them into the receptacle.
    Response: The rule prohibits authorized collectors' staff from 
handling collected substances, even for the purpose of depositing them 
into the collection receptacle. Ultimate users, and those who are 
authorized to handle controlled substances on behalf of ultimate users 
for the purpose of disposal, are the only persons who may deposit 
pharmaceutical controlled substances into a collection receptacle. 21 
CFR 1317.30. Therefore, the DEA does not envision a circumstance where 
pharmaceutical controlled substances might be recorded as having been 
disposed of, but were in actuality diverted as a result of pharmacy 
staff never having placed the substances into the collection 
receptacle.
    [22] Issue: One commenter indicated that the use of an inner liner 
that is removable and sealable immediately upon removal without 
emptying or touching the contents is impractical because the contents 
may spill or fall out and then must be handled.
    Response: The DEA carefully considered the design and security 
requirements for inner liners and determined that the collection 
receptacle option will help to minimize the risk of diversion while 
ensuring safety and convenience for ultimate users and collectors. As 
discussed in the NPRM, inner liners that allow opportunities for 
collectors to sort or otherwise handle the collected substances would 
decrease security and increase the risk of diversion. The DEA does not 
believe that overfill or spillage from the inner liners will be a 
concern as the requirement that inner liners fit within the outer 
container of the collection receptacle is designed to prevent such 
occurrences. However, security requirements, such as the presence of 
two employees to remove or supervise the removal of an inner liner, 
help reduce the risk of theft and diversion if such instances do occur. 
21 CFR 1304.22, 1317.60, and 1317.75. If spillage occurs, a 
registrant's responsibility to provide effective controls and 
procedures to guard against theft and diversion of controlled 
substances would require the registrant to take corrective action to 
prevent spillage from recurring.
    [23] Issue: Several commenters asked the DEA to identify the 
maximum allowable capacity for a receptacle and the maximum duration 
that controlled substances may be stored in the receptacle.
    Response: There is no maximum or minimum capacity for collection 
receptacles at this time. Although there is no maximum duration that 
the collected substances may remain in the collection receptacle at 
this time, authorized collectors are reminded of their responsibility 
to provide effective controls and procedures to guard against theft and 
diversion, 21 CFR 1301.71(a), and their duty to report thefts and 
significant losses of controlled substances under 21 CFR 1301.74 and 
1301.76.
    [24] Issue: Several commenters asked the DEA to allow ``disposal 
companies,'' distributors, and reverse distributors to manage and 
maintain collection receptacles at the registered locations of 
authorized collector retail pharmacies and at LTCFs on behalf of the 
authorized collector retail pharmacies. These commenters also asked if 
such entities may establish a fee system for such services.
    Response: Distributors and reverse distributors will not be 
permitted to manage or maintain collection receptacles at retail 
pharmacies or LTCFs. 21 CFR 1317.40 and 1317.80. The DEA determined 
that no entities other than retail pharmacies and hospitals/clinics 
with an on-site pharmacy will be permitted to manage collection 
receptacles at LTCFs. 21 CFR 1317.40 and 1317.80. As discussed in the 
NPRM, this rule establishes a checked system of transfers where each 
registrant who handles collected substances serves as a source of 
verification for the other registrants that handle the same substances, 
thus ensuring that the collected substances reach their intended 
destination with accountability and a reduced risk of diversion. In 
order to maintain this system, all collected substances must be handled 
in the manner described in this rule, including the requirement that 
the handling of a collection receptacle inner liner be restricted to 
employees of the authorized collector as provided, with the limited 
exception for LTCFs. 21 CFR 1317.80. Such requirements ensure that 
persons handling collected substances during the disposal process are 
accountable to their employer, and the number of entities handling the 
collected substances is reduced while also providing a secure system of 
checks that increases the level of accountability.

H. Mail-Back Programs (11 Issues)

    [1] Issue: Thirteen commenters stated that the on-site destruction 
requirement for mail-back programs is severely

[[Page 53536]]

limiting due to the limited number of commercial incinerators. These 
commenters urged the DEA to allow collectors to receive mail-back 
packages whether or not they have a means of on-site destruction. 
Several commenters also asked the DEA to allow collectors to use a 
third party to destroy mail-back packages.
    Response: As discussed in the NPRM, an on-site method of 
destruction for mail-back packages is the minimum necessary to prevent 
diversion of controlled substances destined for destruction. 21 CFR 
1317.05. Importantly, an on-site method of destruction reduces the 
accumulation of controlled substances in a single location, and 
minimizes the transfer of controlled substances between various 
locations. This is intended to help minimize the risk of diversion. For 
each of the three methods of ultimate user disposal included in this 
rule, the DEA has attempted to minimize the number of entities that 
handle the collected substances in order to minimize the risk of 
diversion, which increases each time a controlled substance is 
transferred to a new person. It is emphasized that authorized 
collectors may partner with reverse distributors and other authorized 
registrants with on-site methods of destruction to promote mail-back 
programs, e.g., empty mail-back packages may be disseminated at 
hospitals/clinics and retail pharmacies and mailed back to a reverse 
distributor with an on-site method of destruction.
    [2] Issue: One commenter strongly supports the requirement that 
authorized collectors who conduct a mail-back program use an on-site 
method of destruction; however, other commenters expressed concern that 
the requirement would discourage authorized collectors from conducting 
mail-back programs. Several commenters noted that very few destruction 
facilities currently exist and there was concern that such facilities 
do not have proper security to handle controlled substances.
    Response: As indicated in the previous response, mail-back programs 
have the potential to provide a secure and responsible means of 
disposal without geographical restriction within the United States. As 
such, the existence of a small number of appropriate destruction sites 
should not impact ultimate users' ability to participate or the 
potential for mail-back programs to develop. In other words, a single 
destruction site can support many different mail-back programs and an 
unlimited number of mail-back packages may be provided to ultimate 
users at various locations throughout the United States to be mailed 
back to a single destruction site. Also, as discussed in the NPRM, the 
DEA hopes that the rule will encourage innovation and expansion of 
destruction methods beyond incineration so that additional entities may 
provide destruction services for mail-back programs in the future.
    [3] Issue: A few commenters expressed concern that no entities will 
undertake the implementation of a mail-back program because of the 
related expense, noting that the requirement that mail-back packages be 
pre-addressed with pre-paid postage will be very costly. A commenter 
also asked the DEA to clarify whether unregistered retail pharmacies 
working with a registered authorized collector would be permitted to 
make mail-back packages available to patients.
    Response: As discussed in the NPRM, authorized collectors who 
conduct mail-back programs are encouraged to collaborate to operate 
mail-back programs by partnering with other entities to assist with the 
dissemination of mail-back packages to ultimate users, in order to 
minimize costs. Additionally, pre-paid postage will ensure that the 
package is not returned to sender, which will help reduce its handling 
and therefore, the diversion risks. Pre-addressed envelopes will help 
ensure that the package is delivered to the authorized location.
    [4] Issue: One commenter asked the DEA to clarify whether there are 
specific testing requirements in regard to the packaging standards 
(e.g., water/spill proof, tear resistant, sealable, etc.). One 
commenter asked the DEA to clarify the distinction between packages 
damaged as part of normal transport and packages damaged by other 
means, such as tampering.
    Response: The DEA is not requiring specific testing requirements to 
ensure packages meet the standards provided in Sec.  1317.70 (e.g., 
water/spill proof, tear resistant, sealable, etc.). However, the 
packages must be consistent with these standards. Collectors authorized 
to receive mail-back packages must make a determination based on the 
facts and circumstances as to whether or not an apparently damaged 
package became so through normal transportation or through tampering or 
other intentional means.
    [5] Issue: Commenters expressed concern that the requirement for 
mail-back collectors to issue mail-back packages with unique 
identification numbers is burdensome and does not seem to provide any 
useful information since ultimate users are not required to notify 
collectors that they have mailed a package, and it is likely that many 
packages will not be used. Five commenters asked the DEA to explicitly 
state that authorized collectors who conduct mail-back programs will 
not be responsible for reconciling mail-back packages that were never 
returned.
    Response: The DEA believes that recording the unique identification 
numbers of mail-back packages in accordance with Sec.  1317.70 is a 
reasonable recordkeeping requirement designed to help identify and 
prevent diversion; this information can aid investigations and is 
useful for that purpose alone. The DEA recognizes that disseminated 
packages may go unused, and this alone should not form the basis for 
unreasonable scrutiny of authorized collectors. Additionally, at this 
time, authorized collectors are not responsible for tracking mail-back 
packages that were disseminated but never returned.
    [6] Issue: One commenter disagreed with the DEA's assessment that 
mail-back programs are more susceptible to diversion and therefore 
require stricter controls.
    Response: The DEA carefully considered the diversion risks in mail-
back programs. Based on the DEA's experience, the DEA believes that the 
risks of diversion associated with mail-back programs are great because 
of necessary actions including the handling of the packages, mail 
sorting, and mail delivery by non-registrants. The DEA believes that 
the security measures established by this rule are the minimum required 
to reduce the risk of diversion inherent to mail-back programs.
    [7] Issue: One commenter expressed concern that mail-back packages 
would be subject to greater risks of diversion in rural areas.
    Response: The DEA appreciates the commenter's concern. The DEA has 
considered the diversion risks for mail-back programs, including 
packages originating in rural areas. It may be true that mail-back 
packages originating in some rural areas may be subject to an increased 
risk of diversion due to fewer people being able to readily witness 
theft from a mailbox. However, it may also be true that risks of 
diversion from mail-back programs might be lower in rural areas due to 
less traffic (pedestrian, vehicular, or equine), resulting in fewer 
opportunities for tampering with or theft of mail-back packages. 
Regardless, the DEA believes that the relative risks of diversion of 
mail-back packages in rural areas are mitigated by the required 
security procedures and are outweighed by the benefits of providing 
ultimate users a means to dispose of unused, unwanted,

[[Page 53537]]

or expired pharmaceutical controlled substances.
    [8] Issue: The United States Postal Service (USPS) has raised a 
number of issues relating specifically to the mail-back program, and 
also to the disposal regulations in general. The USPS asked the DEA to 
make several changes to the terminology used in the proposed rule, so 
that the DEA regulations will be consistent with standard USPS products 
and services. The USPS also requested that the DEA clarify that all 
registrants must comply with USPS laws and regulations, including 
applicable USPS requirements for packaging and mailing pharmaceuticals.
    The USPS asked the DEA to consistently refer to ``mail-back 
packages'' as ``mailing packages'' rather than ``mailers'' as the USPS 
refers to ``mailers'' as persons or entities entering a mailing. The 
USPS also asked the DEA to remove any references to ``business reply 
mail'' that are inconsistent with the USPS's use of the term. The USPS 
asked that proposed Sec.  1317.85 specify that ultimate users may 
return recalled controlled substances to the manufacturer or other 
authorized registrant by U.S. Mail. The USPS also asked the DEA to 
clarify that inner liners are requirements for collection receptacles--
not mail-back packages.
    The USPS also requested that the DEA state that collectors 
operating a mail-back program must exclusively use the United States 
Postal Service. The USPS also asked the DEA to make all references to 
``mail system'' in the preamble refer exclusively to the United States 
Postal Service. The USPS asked that they not be prohibited from 
transporting controlled substances to a reverse distributor on behalf 
of law enforcement, especially in light of the fact that law 
enforcement may operate mail-back programs.
    Response: The DEA appreciates the time taken by the USPS to review 
the proposed rule and submit thoughtful comments with their concerns 
and suggestions. In addition, the DEA acknowledges that the USPS 
understands these regulations and has experience responsibly handling 
controlled substances. The DEA is modifying some of the terminology 
that was used in the NPRM, per the USPS's concerns and suggestions. 
Rather than use the term ``mailing packages,'' all references to 
``mailers'' are changed to ``mail-back packages.'' The DEA believes 
this will better avoid the confusion regarding ``mailers'' being 
defined as persons or entities that enter a ``mailing.'' The reference 
to ``business reply mail'' is also removed. The DEA declines to specify 
that ``mail'' or ``mail system'' refers exclusively to the USPS; 
however, the USPS is a shipping option.
    Additionally, in Sec.  1317.85, ultimate users still have the 
options to return a recalled controlled substance as is currently 
allowed under Sec.  1307.12 of the existing regulations. The text of 
the rule clearly states that all persons and entities must comply with 
applicable Federal laws and regulations, which includes USPS laws and 
regulations. Also, inner liners are requirements for collection 
receptacles--not mail-back packages. The mail-back package 
specifications are outlined in Sec.  1317.70.
    While the USPS asked that the text of the regulation specifically 
state that mail-back packages may be sent via the U.S. Postal Service 
as well as by common or contract carrier, the DEA declines to make this 
change. The DEA considers the USPS to be a common or contract carrier 
for purposes of the CSA.
    [9] Issue: One commenter asked the DEA to clarify whether the 
regulation that requires mail-back programs to include only mail-back 
packages mailed from within the United States will preclude USPS-
serviced mail-back programs in any of the areas in which it operates 
(e.g., the Caribbean District, other territories such as Guam, and 
United States military installations).
    Response: The term ``import'' means ``any bringing in or 
introduction of'' a controlled substance into any area. Pursuant to 21 
U.S.C. 952, it is unlawful to import controlled substances into the 
customs territory of the United States (the 50 States, the District of 
Columbia, and Puerto Rico), except under specific circumstances not 
relevant to ultimate user disposal. Thus, an ultimate user located 
outside of the customs territory of the United States is not permitted 
to send a mail-back package into the customs territory of the United 
States.
    [10] Issue: One commenter asked the DEA to clarify whether 
authorized collectors operating mail-back programs may use carrier 
services that allow packages to be held at a carrier facility until the 
packages can be picked up.
    Response: Although some changes to business operations may need to 
occur in order for an authorized collector to effectively establish and 
maintain a mail-back program, the requirements established by this rule 
are the minimum required to detect and prevent diversion. As described 
in this rule, mail-back packages must be pre-addressed to the 
authorized mail-back location with the on-site destruction method, and 
thus, the packages must be delivered to the authorized mail-back 
location rather than picked up by the collector. 21 CFR 1317.70. The 
pre-addressed delivery location must be capable of receiving such 
deliveries on a regular basis without interruption. Otherwise, the 
opportunities for diversion increase as the packages are delayed or 
stored during transit.
    [11] Issue: One commenter suggested that the DEA establish a 
national mail-back program.
    Response: This rule authorizes certain collectors to conduct mail-
back programs. 21 CFR 1317.40 and 1317.70. There is no limitation 
regarding the geographic coverage of mail-back programs within the 
United States if the programs comply with all applicable Federal, 
State, tribal, and local laws and regulations. At this time, the DEA 
does not have the resources to operate a national mail-back program.

I. Take-Back Events (6 Issues)

    [1] Issue: One commenter indicated it would be difficult for 
ultimate users to participate in take-back events, particularly in 
rural areas.
    Response: The DEA has attempted to expand the variety of disposal 
options while also ensuring secure and responsible drug disposal, and 
the DEA anticipates that the expansion to include certain hospitals/
clinics to become authorized as collectors will provide more disposal 
options for ultimate users, including those in rural areas. 
Additionally, the DEA encourages those persons living in rural areas 
who are unable to utilize a collection receptacle or attend a take-back 
event to dispose of unwanted pharmaceutical controlled substances in 
the same manner in which the pharmaceutical controlled substances were 
received, i.e., if the substances were delivered by a mail-order 
pharmacy, the DEA encourages the pharmacy to include a mail-back 
package for safe disposal; or, if the substances were dispensed at a 
pharmacy, the DEA encourages pharmacies to have a collection receptacle 
available for safe disposal. Nonetheless, the DEA recognizes that some 
ultimate users may not have convenient access to any of the disposal 
options available in this rule. Until the availability of these 
disposal options increases, ultimate users who wish to dispose of 
unwanted pharmaceutical controlled substances may continue to dispose 
of them in manners consistent with all applicable Federal, State, 
tribal, and local laws and regulations. The DEA's Office of Diversion 
Control Web site provides information regarding safe disposal of 
pharmaceutical controlled substances, including guidance from the FDA 
and the EPA. Ultimate users can find this information at 
www.DEAdiversion.usdoj.gov.

[[Page 53538]]

    [2] Issue: Several people asked the DEA to clarify the role of law 
enforcement at take-back events. One commenter asked the DEA to relax 
the two-employee requirement for law enforcement officers handling 
collected substances. Another commenter stated that law enforcement 
officer supervision, rather than direct participation, should suffice.
    Response: Law enforcement must appoint at least one law enforcement 
officer employed by the agency to oversee collection at the take-back 
event. 21 CFR 1317.65. ``Oversee'' has its common, everyday meaning: To 
supervise, manage, watch over, and direct in an official capacity. The 
direct participation this rule mandates is that a law enforcement 
officer must maintain custody and control of the collected substances 
from the time they are collected to the point in time that they are 
securely transferred, stored, or destroyed. 21 CFR 1317.65. This rule 
does not require two law enforcement officers to be present at take-
back events; however, law enforcement may determine that two or more 
law enforcement officers are necessary at a particular take-back event 
due to safety and security concerns. In the alternative, law 
enforcement may determine that the same law enforcement officer may 
oversee the take back event and also maintain custody and control of 
the collected substances from the time the substances are collected 
from the ultimate user or person authorized to dispose of the ultimate 
user decedent's property until secure transfer, storage, or destruction 
has occurred, as outlined in Sec.  1317.65(b). Although the 
participation of law enforcement is required at take-back events, the 
DEA is not requiring law enforcement to hold or participate in take-
back events. As discussed in the NPRM, law enforcement must determine 
how often available resources allow them to hold take-back events.
    [3] Issue: A few commenters requested that the DEA allow other 
authorized collectors, such as retail pharmacies and reverse 
distributors, to become authorized to hold take-back events. One 
commenter stated that law enforcement officers' presence should be 
optional if there is a collection receptacle at the event that meets 
the specifications in the rule.
    Response: If an authorized collector or other entity wishes to 
conduct a take-back event, the event must be held in partnership with 
law enforcement. 21 CFR 1317.65. Take-back events are intended to be 
limited-duration events that may take place at an unsecure location 
that is easily accessible to the public, such as a community center or 
town center. Given the likelihood of publicity and limited physical 
security at such locations, the DEA believes that it is important to 
ensure active law enforcement participation for the safety of the event 
participants and the community. The DEA believes that active law 
enforcement participation will help deter theft and reduce diversion 
risks. The presence of a collection receptacle at a take-back event 
does not preclude the need for law enforcement presence at the 
collection site because the publicity for the event increases the 
receptacle's visibility for drug seekers, thus increasing diversion 
risks.
    [4] Issue: A number of entities expressed concern that the 
implementation of this rule will result in the cessation of DEA-
sponsored national take-back events. These commenters felt that take-
back events will be too costly for communities and law enforcement, and 
commenters suggested that the DEA continue take-back events and provide 
a transition plan from the national take-back events until 
implementation of the rule.
    Response: The DEA-sponsored national take-back events were 
initiated as a means of providing safe and convenient disposal of 
pharmaceutical controlled substances by ultimate users until 
alternative options could be implemented. The DEA is committed to 
continuing national take-back events until the effective date of this 
final rule. The DEA believes that implementation of disposal methods is 
best tailored to local communities by local communities. The DEA 
encourages public and private partnerships to optimize the expanded 
disposal options in a cost-efficient manner.
    [5] Issue: One commenter expressed concern that existing take-back 
events would likely be unable to continue under this rule. This 
commenter was concerned that the prohibition of sorting would cause a 
burden since non-controlled substances and packaging could not be 
sorted from controlled substances. This commenter stated that it will 
be overly burdensome for programs to handle all collected substances as 
schedule II controlled substances.
    Response: The DEA does not intend for this rule to require changes 
to existing non-controlled substance take-back programs. The security 
measures required by this rule are the minimum necessary to ensure a 
safe and secure means of disposal of pharmaceutical controlled 
substances. It should be noted however, that law enforcement are not 
required to follow the physical security requirements for handling, 
sorting, or storing collected controlled substances. 21 CFR 1317.35. 
The physical security requirements applicable to law enforcement in the 
final rule at Sec. Sec.  1317.35 and 1317.65 state that law enforcement 
``should'' take certain measures; and that law enforcement ``shall'' 
appoint a law enforcement officer to oversee a take-back event and law 
enforcement officers ``shall'' maintain custody and control of the 
collected substances. Additionally, this rule provides a number of 
previously unavailable means of ultimate user disposal that are likely 
to decrease the frequency of and need for community take-back events. 
The DEA would like to clarify that comingling of controlled and non-
controlled substances is permitted, but not required, and co-sponsors 
of take-back events may specify that only controlled substances will be 
accepted. Another method to alleviate the burdens would be to provide a 
separate receptacle for non-controlled substances at the take-back 
event. Additionally, as discussed in response to previous comments, 
this rule does not require that collected substances be in their 
original packaging, and law enforcement may discourage or prohibit 
ultimate users from disposing of original packaging into the collection 
receptacle for controlled substances at take back-events.
    [6] Issue: One commenter indicated that municipalities and other 
organizations should be permitted to ``take the lead'' in organizing 
and conducting take-back events in conjunction with, and in the 
presence of, law enforcement. Other commenters raised concerns that 
such events conducted in partnership with local government and 
community groups would no longer be allowed, and that the requirements 
would prevent controlled substance take-back events from being held 
concurrently with other take-back events, such as for the disposal of 
hazardous waste and non-controlled substances.
    Response: The rule permits any entity to partner with law 
enforcement to hold a pharmaceutical controlled substances take-back 
event. 21 CFR 1317.65(a). Municipalities or other organizations may 
partner with law enforcement as long as such events are conducted in 
accordance with all applicable laws and regulations pertaining to the 
disposal of pharmaceutical controlled substances. The DEA emphasizes 
that take-back events are intended to be one-time or periodic events 
held in a community center or other convenient and accessible location, 
and that there is no

[[Page 53539]]

prohibition against holding such events in conjunction with events for 
the disposal of other substances, such as hazardous waste or non-
controlled pharmaceuticals.

J. Prohibition on Handling, Sorting, and Inventorying Inner Liner 
Contents and Mail-Back Package Contents (8 Issues)

    [1] Issue: One commenter adamantly stated that collected substances 
should not be sorted under any circumstances. This commenter expressed 
concerns about diversion risks and the brokering of unused controlled 
substances.
    Response: The DEA agrees that the diversion risks of handling, 
sorting, or inventorying collected substances outweigh any perceived 
benefits. The DEA has carefully considered all of the various 
commenters' concerns on the prohibition of handling, sorting, and 
inventorying inner liner contents and mail-back package contents, and 
will retain these prohibitions. As provided in Sec. Sec.  1317.60(c) 
and 1317.70(f), inner liners shall be sealed immediately upon removal 
from the permanent outer container; sealed inner liners and returned 
mail-back packages shall not be opened, x-rayed, analyzed, or otherwise 
penetrated. Accordingly, their contents shall not be sorted or 
inventoried subsequent to being placed into a collection receptacle or 
mail-back package. To clarify this, Sec.  1317.75(c) was modified to 
add the prohibition against individually handling substances after they 
have been deposited into a collection receptacle. These specific 
security measures are designed to help prevent and reduce the 
opportunities for diversion (including the re-introduction of tainted 
pharmaceutical controlled substances into the stream of commerce).
     [2] Issue: Twenty-four commenters stated that pharmacists and 
other volunteers should be permitted to sort collected substances, 
particularly in the presence of law enforcement officers at take-back 
events. One commenter stated that the DEA should recognize the 
accountability, expertise, and experience of healthcare professionals, 
and the DEA should utilize these experts in an effort to broaden 
medication disposal efforts.
    Response: The DEA appreciates the valuable expertise and experience 
of healthcare professionals, including pharmacists. The DEA has 
carefully considered the comments in response to the NPRM, and the 
remarks at the January 2011 public meeting. The DEA believes that the 
disposal methods outlined in this rule will provide ultimate users and 
their authorized representatives with expanded options to safely and 
securely dispose of unwanted, unused, and expired pharmaceutical 
controlled substances. Pursuant to Sec.  1317.65, law enforcement may 
continue to conduct take-back events when a law enforcement officer 
maintains control and custody of collected substances at take-back 
events and only the ultimate user transfers controlled substances to 
law enforcement control and custody. However, non-law enforcement 
personnel may assist the law enforcement officer, and the final rule 
does not prohibit healthcare professionals from voluntarily polling 
ultimate users about the substances they are discarding or from 
assisting ultimate users to separate pharmaceutical controlled 
substances from non-controlled substances during the disposal process, 
and inventorying the non-controlled substances.
    Furthermore, nothing in this rule prohibits law enforcement from 
partnering with authorized collectors or other entities to inventory or 
sort substances that have been collected by law enforcement provided 
that the collected substances remain under the control and custody of 
law enforcement. This final rule in Sec.  1317.65(b) requires that law 
enforcement maintain control and custody of the collected substances 
from the time the substances are collected until secure transfer, 
storage, and destruction has occurred. Therefore, if law enforcement 
opts to inventory or sort collected substances within their possession, 
law enforcement should provide adequate security to prevent diversion 
or theft of controlled substances within their possession and control 
as a result of, or during, inventorying or sorting.
     [3] Issue: Thirty-eight commenters stated that the DEA should 
permit collectors or certain non-registered persons to handle, sort, 
and inventory collected substances for data collection and research 
purposes. Many of these commenters urged the DEA to provide an 
exception to allow pharmacists and volunteers to inventory and sort 
controlled substances under the supervision of law enforcement 
officers. Numerous commenters stated that inventorying collected 
substances is crucial to determining a root cause analysis of 
medication waste. Others stated that such information could help guide 
prescribing practices and be used in educational settings. Several 
commenters stated that inventorying collected substances is necessary 
to determine outcome measures for grants for disposal programs. Also, 
several commenters stated that the DEA should provide an exception for 
Institutional Review Board-approved research projects.
    Response: The DEA understands and appreciates these comments. As 
discussed in the preceding response, law enforcement has the discretion 
to partner with other entities to conduct a take-back event pursuant to 
Sec.  1317.65(a). There are no restrictions on how law enforcement 
handles the collected substances so long as they maintain control and 
custody of the substance. Accordingly, law enforcement may inventory 
and sort substances that law enforcement collects. The diversion-
related concerns present when authorized registrants collect controlled 
substances from ultimate users is not present when law enforcement 
collects substances from ultimate users. Taking into account the 
totality of the various risks and benefits, the DEA believes that this 
final rule imposes the minimum necessary controls to allow a secure and 
responsible means by which ultimate users can dispose of pharmaceutical 
controlled substances. Relying on its experience, and as discussed in 
the NPRM, the DEA finds that any potential benefits of allowing 
authorized collectors or unregistered persons to independently 
inventory or sort controlled substances after receipt from the ultimate 
user do not outweigh the risks of diversion, except when the controlled 
substances remain in the control and custody of law enforcement, as 
mentioned in the previous response.
    Data collection is not impossible under the rule even though 
collected substances cannot be sorted or inventoried after they have 
been deposited into a collection receptacle or received by a collector 
through a mail-back package (unless the collection is conducted by law 
enforcement and the substances are within the custody and control of 
law enforcement). For example, authorized collectors may seek 
information voluntarily from ultimate users regarding the substances 
the ultimate user is disposing. And, data such as the weight of the 
inner liners, the number of ultimate users attending a take-back event, 
and the number of mail-back packages received in relation to the number 
of packages disseminated, can be useful measures. The rule only 
prohibits authorized collectors from physically handling the 
substances, such as taking the substances from the ultimate user, or 
sorting substances after the ultimate user has deposited them into a 
receptacle or mail-back package. 21 CFR 1317.70 and 1317.75.
     [4] Issue: Twenty-two commenters stated that contents should be 
sorted to ensure adequate storage space. Several

[[Page 53540]]

commenters stated that packaging and pill bottles should be sorted 
since they are voluminous. Other commenters stated that non-controlled 
substances should be sorted from controlled substances.
    Response: Pursuant to Sec. Sec.  1317.70(b) and 1317.75(b), 
comingling of controlled and non-controlled substances is permitted, 
but it is not required. In addition, this rule does not require 
pharmaceutical controlled substances collected from ultimate users to 
be collected and stored in the original packaging, and collectors may 
institute procedures to prevent inadvertently collecting packaging. 
Authorized collectors may address adequacy of space issues by choosing 
not to collect comingled pharmaceutical controlled substances and non-
controlled substances, refusing to accept the original controlled 
substance packaging, or by increasing destruction frequencies. In 
addition, the DEA has expanded the available storage options for 
practitioners in this final rule by allowing practitioners to store 
sealed inner liners and returned mail-back packages in a securely 
locked room with controlled access. 21 CFR 1317.05.
     [5] Issue: A commenter noted that authorized collectors should 
have direct supervision over the substances that are placed into 
collection receptacles to prevent undesirable materials from being 
deposited into collection receptacles.
    Response: Each potential authorized collector must weigh all of the 
potential risks and benefits in deciding whether to implement and 
manage any ultimate user disposal program, including any necessary 
steps to prevent the unwanted collection of regulated hazardous waste 
or otherwise undesirable materials, in a manner consistent with this 
rule and all other applicable Federal, State, tribal, and local laws 
and regulations. Authorized collectors may view what ultimate users 
deposit into collection receptacles, and they may ask what substances 
are being deposited. Although the actual disposal of a pharmaceutical 
controlled substance into a collection receptacle must be performed by 
an ultimate user in accordance with Sec.  1317.30, the authorized 
collector maintains ultimate control over that receptacle and should 
institute necessary measures to protect against the collection of 
unwanted substances so long as such measures are consistent with this 
rule and all other applicable Federal, State, tribal, and local laws 
and regulations.
     [6] Issue: Several commenters asked that the DEA permit pharmacy 
staff to deposit collected substances into collection receptacles. 
These commenters asked the DEA to consider situations where the 
pharmacy is completely blocked from the public (such as with a bullet-
proof barrier).
    Response: For the reasons discussed in the NPRM and in previous 
comment responses, the DEA declines to allow pharmacy staff to handle 
pharmaceutical controlled substances collected from ultimate users. The 
registered location of any retail pharmacy that wishes to become an 
authorized collector must satisfy the specifications for collection 
receptacles and inner liners. 21 CFR 1317.60 and 1317.75. If a retail 
pharmacy desires to be an authorized collector, that pharmacy shall 
only allow ultimate users (and others authorized to dispose of 
controlled substances on behalf of ultimate users) to deposit the 
pharmaceutical controlled substances directly into the collection 
receptacles in accordance with Sec.  1317.30. The requirements of the 
collection receptacles were carefully considered and designed to limit 
the number of hands that handled the pharmaceutical controlled 
substances in order to prevent diversion and diversion opportunities, 
as well as to prevent the re-introduction of tainted pharmaceutical 
controlled substances into the closed system of distribution.
     [7] Issue: Twenty commenters suggested that the DEA permit some 
sort of inspection for inner liner and mail-back package contents to 
ensure that unacceptable contents are removed, such as x-raying and 
scanning. These commenters were particularly concerned about mercury-
containing thermometers, iodine-containing medications, medical sharps, 
compressed cylinders, and other hazardous waste. Other commenters 
expressed concern that by allowing comingling of substances in 
collection receptacles, employees may be subjected to hazardous 
conditions if unsafe or hazardous materials are deposited.
    Response: The DEA understands and appreciates these concerns of the 
commenters; however, the DEA has concluded that allowing inspection of 
inner liners and mail-back packages presents an unacceptable risk of 
diversion. These issues were closely reviewed prior to the NPRM and re-
reviewed in association with these comments. Whether an authorized 
collector comingles ultimate users' pharmaceutical controlled 
substances with non-controlled substances is within the discretion of 
that authorized collector. This rule does not mandate comingling. 21 
CFR 1317.75. Each potential authorized collector must weigh all of the 
potential risks and benefits in deciding whether to implement and 
manage any ultimate user disposal program, including any necessary 
steps to prevent the unwanted collection of regulated hazardous waste 
or otherwise undesirable materials, in a manner consistent with this 
rule and all other applicable Federal, State, tribal, and local laws 
and regulations. As discussed in response to previous comments, 
collectors may control the substances collected, and they may view 
substances before they are deposited into collection receptacles. For 
additional commentary on hazardous waste disposal, please see comment 
section ``Q.'', entitled ``Hazardous Materials Transportation and 
Hazardous Waste Destruction.''
     [8] Issue: Some commenters urged the DEA to require authorized 
collectors to provide clear instructions on what may and may not be 
placed in mail-back packages in order to reduce instances in which 
hazardous materials/waste may be inadvertently destroyed in a manner 
that is not consistent with environmental or other applicable laws or 
regulations due to the prohibition against opening or inspecting the 
contents of mail-back packages.
    Response: The rule includes a requirement for the collector to 
provide packages with instructions indicating what substances are 
permitted to be included in the package. 21 CFR 1317.70. The rule does 
not require specific language for such instructions, which must 
ultimately be determined by the collector in a manner consistent with 
the rule.

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

Definitions and Terms Specific to LTCFs
     [1] Issue: Commenters asked the DEA to clarify the meaning of 
``LTCF'' with regard to assisted living facilities, hospice facilities, 
and residential care in private homes, as the meaning of LTCF often 
varies by State.
    Response: LTCF is defined at Sec.  1300.01(b) and ``means a nursing 
home, retirement care, mental care or other facility or institution 
which provides extended health care to resident patients.''
     [2] Issue: Commenters asked the DEA to clarify the meaning of 
``have resided'' with regard to a LTCF's ability to dispose of 
controlled substances on behalf of residents.
    Response: The phrase ``have resided,'' is utilized in the Disposal 
Act, but was not defined by Congress. The DEA has

[[Page 53541]]

not determined a need to apply a technical definition for this phrase 
apart from its ordinary meaning. The DEA understands the ordinary 
meaning of ``have resided'' to be typically understood as persons who 
have died or otherwise recently departed a location without manifesting 
intent to return. Thus, for example, as discussed in response to issue 
[7] below, when a LTCF resident is transferred to another facility, the 
resident ``has resided'' at the LTCF, and the LTCF may dispose of the 
former resident's pharmaceutical controlled substances in an authorized 
collection receptacle. 21 CFR 1317.30.
Registration of Collection Receptacles at LTCFs
     [3] Issue: Commenters asked the DEA to clarify whether an 
authorized LTCF location where an authorized collector maintains a 
collection receptacle would be considered a ``registered location'' of 
the retail pharmacy.
    Response: The location of the collection receptacle is both a 
registered location and a controlled premise. It is a registered 
location of the authorized hospital/clinic or retail pharmacy because 
the authorized collector may only install and manage a collection 
receptacle at a LTCF pursuant to the authority granted by the DEA, and 
they are limited at that location to conducting only those activities 
that are specifically authorized and required under this rule as 
necessary to the installation and maintenance of that authorized 
collection receptacle. LTCFs with authorized collection receptacles are 
``controlled premises'' pursuant to 21 U.S.C. 880(a) and 21 CFR 
1316.02(c); accordingly, the DEA may enter LTCFs and conduct 
administrative inspections in furtherance of, and in carrying out, the 
responsibilities charged to the DEA by the CSA pursuant to 21 U.S.C. 
880(b) and 21 CFR 1316.03.
Disposal Methods and Procedures at LTCFs
     [4] Issue: A commenter asked the DEA if LTCFs may use an on-site 
method of destruction. Three commenters specifically asked if LTCFs may 
continue their current drug disposal method of ``sewering.'' Other 
commenters asked the DEA to clarify how existing methods of disposal 
utilized by LTCFs will be impacted by this rule and to provide for an 
interim method of disposal for LTCFs.
    Response: Although the DEA appreciates the commenters' concerns, 
the DEA cannot comment on each potential method of disposal occurring 
at LTCFs prior to these regulations. The implementation of authorized 
disposal methods for ultimate users is strictly voluntary and, with the 
exception of law enforcement-sponsored programs, generally such 
programs have no lawful means of existence prior to the effective date 
of this rule. It is important to note that this rule provides 
additional options for disposal and does not prohibit any methods 
currently used by LTCFs that are consistent with Federal, State, 
tribal, and local laws and regulations. For example, LTCFs are not 
prohibited by this final rule from destroying patients' unwanted 
pharmaceutical controlled substances at the LTCF, on behalf of the 
resident patients, in accordance with applicable Federal, State, 
tribal, and local laws and regulations, including environmental laws 
and regulations. However, as explained further below, the DEA has 
considered the diversion risks and determined that the installation and 
maintenance of collection receptacles by authorized hospitals/clinics 
and retail pharmacies is the most secure and responsible means by which 
registrants may collect and dispose of LTCF residents' pharmaceutical 
controlled substances.
    As stated in Sec.  1317.90(a), the requirement to render controlled 
substances ``non-retrievable'' applies only to DEA registrants that 
destroy controlled substances. The ``non-retrievable'' language does 
not apply to ultimate users. As discussed in the NPRM, the DEA does not 
believe that ``sewering'' would render a pharmaceutical controlled 
substance ``non-retrievable.'' However, such a requirement would not 
apply to a LTCF unless the LTCF is itself a registrant and destroying 
its own pharmaceutical controlled substance stock pursuant to Sec.  
1317.05(a).
     [5] Issue: Many commenters indicated that the DEA should provide 
LTCFs with additional options for disposal of controlled substances on 
behalf of residents. Approximately fifteen commenters asked the DEA to 
expand which registrants are permitted to manage collection receptacles 
at LTCFs. Seven commenters asked the DEA to permit LTCFs to use mail-
back packages. Several commenters stated that LTCFs should be allowed 
to use the same disposal options that this rule affords ultimate users.
    Response: As previously discussed, this rule in Sec.  1317.40 
expands the types of registrants that may be authorized as collectors, 
and permitted to manage and maintain collection receptacles at LTCFs. 
In addition to retail pharmacies (including ``closed-door pharmacies'' 
that service LTCFs), hospitals/clinics with an on-site pharmacy may 
maintain collection receptacles at LTCFs. Furthermore, the options 
available to all ultimate users to dispose of their pharmaceutical 
controlled substances are also available to LTCF residents. As ultimate 
users (defined in 21 U.S.C. 802(27) as persons who have lawfully 
obtained, and who possess, a controlled substance for their own use or 
for the use of a member of their household), LTCF residents may avail 
themselves of all disposal methods made available by this rule to 
ultimate users, including participation in authorized mail-back 
programs. For example, on behalf of an LTCF resident, an LTCF employee 
may place the resident's unwanted pharmaceutical controlled substances 
in a mail-back package, seal it, and deposit it into the facility's 
outgoing mail system. Care should be taken to ensure that LTCF 
residents' use of mail-back programs does not result in the 
accumulation of pharmaceutical controlled substances in a single 
location susceptible to internal or external diversion threats.
    The DEA has carefully considered the risks and benefits of 
collection activities at LTCFs. Among the DEA's specific considerations 
were that LTCFs typically have large volumes of controlled substances 
on-site and that they are typically not registered with the DEA. The 
DEA also specifically considered the risks and benefits associated with 
LTCF personnel disposing of pharmaceutical controlled substances on 
behalf of persons who reside or have resided at that LTCF. The DEA 
determined that in order to adequately protect the public health and 
safety, and to prevent diversion, the collection of such substances 
must be limited to certain registrants that are well-equipped to handle 
the unique circumstances surrounding the disposal of controlled 
substances at LTCFs. After careful deliberation, the DEA determined 
such registrants should be limited to retail pharmacies and hospitals/
clinics with an on-site pharmacy. 21 CFR 1317.40. In making its 
determination, the DEA took consideration of the fact that hospitals/
clinics with on-site pharmacies, and retail pharmacies, routinely 
dispense large volumes of controlled substances in a public setting. 
Additionally, many hospitals/clinics with on-site pharmacies and retail 
pharmacies have experience working closely with LTCFs or have well-
established, on-going relationships with LTCFs. For example, many 
retail pharmacies and hospitals/clinics directly deliver pharmaceutical 
controlled substances to LTCF residents, some retail pharmacies have 
developed

[[Page 53542]]

expertise in dispensing substances at LTCFs via an automated dispensing 
system (ADS) (i.e., mechanical systems that perform operations or 
activities relative to the dispensing of medications), and some LTCFs 
share common management or ownership with hospitals/clinics.
    The DEA recognizes that other types of registrants also have 
relationships with LTCFs, and considered authorizing other types of 
registrants to install and manage collection receptacles at LTCFs. 
However, after careful consideration, the DEA determined that the 
presence of certain factors that increase opportunities for diversion 
in the specified circumstances weigh against further expanding the 
types of registrants that may collect at LTCFs.
    Specifically, the DEA declines to allow reverse distributors to 
install and maintain collection receptacles at LTCFs because reverse 
distributors are at the end of the supply chain. It would be contrary 
to the public health and safety and pose an increased risk of diversion 
to authorize a reverse distributor to independently install and 
maintain a collection receptacle at an LTCF, remove the inner liner, 
transport collected substances to the final destruction location, and 
ensure they are destroyed. One of the principal factors considered by 
the DEA in coming to this conclusion is the fact that in such a 
situation, the reverse distributor would be the sole registrant to 
maintain the only records of installation, removal, and destruction. 
Such an authorization would be contrary to the closed system of 
distribution where each registrant who handles controlled substances 
serves as a source of verification for the other registrants that 
handle the same substances, thus ensuring that controlled substances 
reach their intended destination with accountability and a reduced risk 
of diversion. The regulations implemented by this final rule 
specifically utilize this system of checks for collection activities at 
LTCFs. Retail pharmacies and hospitals/clinics with an on-site pharmacy 
are registrants. As established in this final rule, when retail 
pharmacies and hospitals/clinics maintain collection receptacles at an 
LTCF, they may not transport sealed inner liners. Rather, they are 
expected to transfer sealed inner liners to another registrant for 
destruction pursuant to Sec.  1317.05(c)(2)(iv). Two-registrant 
integrity allows the DEA to verify and cross-check each registrants' 
records. Conversely, LTCFs and destruction facilities are generally not 
registrants. Therefore, if a reverse distributor were authorized to 
install and maintain collection receptacles at LTCFs, and also pick-up, 
transport, and destroy sealed inner liners from LTCFs, the DEA would be 
unable to verify the reverse distributor's removal or destruction 
records with another registrant's records. Allowing this would not meet 
the two-registrant integrity requirement that is the minimum required 
to ensure accountability, particularly when collected substances are 
destined for destruction.
    As discussed in responses to other comments, because LTCFs are 
generally not registrants, the DEA is unable to allow such facilities 
to be authorized collectors for the purpose of disposing ultimate user-
collected substances, or handle disposed substances on behalf of 
another registrant. We note that although LTCFs may not use mail-back 
packages or administer a mail-back program, ultimate users who reside 
in LTCFs may use mail-back packages under this rule. 21 CFR 1317.30 and 
1317.70.
     [6] Issue: One commenter asked the DEA to allow a LTCF resident, 
or the resident's legal representative, to dispose of controlled 
substances through all available means, whether the resident is alive 
or deceased.
    Response: All means of disposing of pharmaceutical controlled 
substances are available to ultimate users and persons lawfully 
entitled to dispose of an ultimate user decedent's property, including 
those ultimate users who reside, or have resided, in a LTCF. 21 CFR 
1317.30.
     [7] Issue: Commenters also asked the DEA to address how LTCFs 
should handle situations in which a resident is transferred to a 
hospital and the resident leaves unwanted medication at the LTCF.
    Response: Pursuant to the Disposal Act, Congress provided the DEA 
authority to authorize LTCFs only to ``dispose of controlled substances 
on behalf of ultimate users who reside, or have resided,'' at the LTCF. 
21 CFR 1317.30. When a LTCF resident is transferred to a hospital or 
other facility, the resident ``has resided'' at the LTCF, and if the 
medication is intentionally left at the LTCF, it is ``unwanted,'' and 
the resident has discontinued use. Accordingly, the LTCF may dispose of 
the former resident's pharmaceutical controlled substances by 
depositing the substances into an authorized collection receptacle 
immediately, but no longer than three business days after 
discontinuation of use. 21 CFR 1317.80.
     [8] Issue: Several commenters indicated that the three-day 
disposal provision for LTCFs is overly restrictive and potentially 
costly for residents. These commenters stated that three days is too 
short a time span and will result in residents being forced to purchase 
additional medications when there is a short break in use as a result 
of illness, hospitalization, or a trial dosage reduction. One commenter 
stated that three days is not a long enough time period to determine if 
the patient may need the medication again in the future.
    Response: The DEA declines to extend the timeframe for LTCFs to 
dispose of pharmaceutical controlled substances on behalf of LTCF 
residents. As previously discussed, LTCFs are required to dispose of 
pharmaceutical controlled substances ``immediately, but no longer than 
three business days after the discontinuation of use'' in Sec.  
1317.80(a). With respect to ``discontinuation of use,'' the final rule 
modifies Sec.  1317.80(a) to include a permanent discontinuation as 
directed by the prescriber, as a result of the resident's transfer from 
the LTCF, or as a result of death. The DEA cannot readily foresee a 
circumstance where a short break in use as a result of illness, short-
term hospitalization, or a trial dosage reduction would be considered a 
discontinuation of use. Also, if the prescriber has not yet determined 
whether or not a medication is needed in the future, then it is likely 
that there has not yet been a ``discontinuation of use.''
Collection Receptacle Maintenance at LTCFs
     [9] Issue: Fifteen commenters indicated that the requirement to 
have two employees of the authorized collector retail pharmacy remove 
and install inner liners is burdensome, and it will discourage retail 
pharmacies from installing and maintaining collection receptacles at 
LTCFs. The commenters suggested that the DEA allow LTCF personnel to 
remove, store, and replace the inner liners. A commenter suggested that 
LTCF personnel be permitted to sort out non-controlled substances to 
reduce the amount of material collected in the receptacles.
    Response: As explained above, the DEA is amending the final rule to 
allow flexibility in the requirement that two employees of the 
authorized collector be present for the installation and removal of 
inner liners at LTCF collection receptacles. As amended, the final rule 
in Sec.  1317.80(c) provides that installation, storage, and removal 
may also be performed by one employee of the authorized collector and 
one supervisor-level employee of the LTCF (e.g., a charge nurse, 
supervisor, or similar employee) designated by the

[[Page 53543]]

hospital/clinic or retail pharmacy authorized to collect at that 
location. Hospitals/clinics and retail pharmacies that choose the 
flexibility allowed by using a supervisor-level employee from the LTCF 
are reminded that they are still ultimately responsible for the 
security of the collected substances, as well as keeping complete and 
accurate records and fulfilling reporting requirements. The contents of 
the inner liners may not be sorted once deposited into a receptacle, 
pursuant to Sec.  1317.75(c), but, as previously stated, Sec.  
1317.75(b) states that comingling of controlled and non-controlled 
substances is permitted but not required. Therefore, the authorized 
collector or the LTCF may choose to limit the collected substances to 
pharmaceutical controlled substances to maximize available space in the 
collection receptacle. This can be easily accomplished at LTCFs because 
trained medical personnel will be depositing substances into collection 
receptacles and should be well-equipped to sort controlled substances 
from non-controlled substances before depositing the substances into a 
collection receptacle. Also, as previously discussed, inner liners may 
be stored at LTCFs in accordance with Sec.  1317.80(d). Another 
available option to manage volume and the prohibition of on-site 
storage is for an authorized collector to maintain more than one 
collection receptacle at an LTCF.
    [10] Issue: Commenters asked the DEA to clarify whether reverse 
distributors are permitted to pick up collection receptacle inner 
liners from an authorized LTCF location.
    Response: In accordance with Sec.  1317.05(c)(2)(iv), reverse 
distributors may pick up inner liners from collection receptacles 
located at authorized LTCFs, and reverse distributors may receive the 
inner liners that are sent to the reverse distributor's registered 
location from the LTCF by common or contract carrier. However, the 
inner liner must be removed from the collection receptacle under the 
supervision of either two employees from the hospital/clinic or retail 
pharmacy that is managing the receptacle, or one employee from the 
managing hospital/clinic or retail pharmacy and one supervisor-level 
employee of the LTCF (e.g., a charge nurse, supervisor, or similar 
employee) designated by the authorized collector, pursuant to Sec.  
1317.80(c).
     [11] Issue: Several commenters expressed concern regarding the 
transportation and storage of substances collected from LTCFs, 
specifically with regard to the safety of employees who transport 
collected substances from LTCFs and logistical difficulties (e.g., 
storage space) that may result in fewer retail pharmacies willing to 
install and maintain collection receptacles at LTCFs.
    Response: As previously discussed, hospitals/clinics and retail 
pharmacies may store sealed inner liners at the LTCF in a securely 
locked, substantially constructed cabinet, or a securely locked room 
with controlled access for up to three business days pursuant to Sec.  
1317.80(d). However, the DEA encourages LTCFs and authorized collectors 
managing collection receptacles at LTCFs to exhaust other, more secure, 
alternatives, including: Arranging regularly scheduled pick-ups by 
reverse distributors or common or contract carriers to coincide with 
removal of the inner liner or delivery of controlled substances to the 
LTCF; operating multiple collection receptacles at a LTCF to help 
minimize overflow; and pursuing ultimate user disposal options through 
members of the patients household or other persons lawfully entitled to 
dispose of a LTCF patient's property. The DEA believes these 
alternatives are better options than storage at LTCFs. LTCFs are 
generally unregistered locations with large quantities of highly 
pilferable controlled substances in high doses. The DEA carefully 
weighed the benefits with the risks of allowing storage at LTCFs, 
including the potential for creating a new avenue of diversion at a 
location over which the DEA has limited regulatory oversight. However, 
in consideration of the circumstances unique to LTCFs, and to ease the 
burden on LTCFs and authorized collectors, the DEA is permitting in 
this final rule sealed inner liners to be stored at LTCFs in accordance 
with Sec.  1317.80(d).
    The DEA has also relaxed the rule, in Sec.  1317.80(c), to allow 
flexibility in the two-person integrity requirement with respect to 
collection at LTCFs by allowing authorized hospitals/clinics and retail 
pharmacies to designate a supervisory-level employee of the LTCF as one 
of the authorized persons to conduct or oversee the installation, 
removal, storage and transfer inner liners. However, the authorized 
collector may opt to have two or more of its own employees perform or 
oversee these activities. In addition, authorized collectors that are 
practitioners may not themselves transport collected substances to a 
destruction location. 21 CFR 1317.05. Rather, the practitioner may 
destroy the collected substances by delivering the sealed inner liners 
to a reverse distributor or distributor's registered location by common 
or contract carrier, or a reverse distributor or distributor may pick-
up sealed inner liners at the LTCF. 21 CFR 1317.05.
     [12] Issue: Commenters indicated that the installation and 
maintenance of collection receptacles by retail pharmacies at LTCFs 
will likely result in considerable costs, burdens, and other 
liabilities, and, as such, few retail pharmacies will be willing to 
install and maintain collection receptacles at LTCFs, and few LTCFs 
will want to bear the costs.
    Response: The DEA carefully considered the costs associated with 
all aspects of disposal, along with all other considerations such as 
convenience, safety, and the risk of diversion, including the security 
and design of collection receptacles. As discussed in the preamble to 
this rule, participation in any disposal program for ultimate users is 
voluntary and the DEA is not authorized to impose the burden of costs 
upon any specific entity. As such, each registrant that may become 
authorized as a collector must individually weigh the associated 
benefits and burdens in determining whether to do so. In order to 
accommodate LTCF residents, the DEA has expanded the authorized 
collectors that may maintain collection receptacles at LTCFs to include 
certain hospitals/clinics and retail pharmacies. 21 CFR 1317.40. The 
DEA has also relaxed the two-person integrity requirements with respect 
to LTCFs, and is allowing for storage of sealed inner liners at the 
LTCF in order to reduce the burdens on hospitals/clinics and retail 
pharmacies. 21 CFR 1317.80. These are the minimum requirements to 
ensure that safety and security of LTCF residents, and to deter and 
detect diversion.
     [13] Issue: Several commenters expressed concerns over liability 
when a collection receptacle is installed at a LTCF because the 
collector pharmacy is fully responsible for the receptacle but does not 
have constant, direct supervision over it. The commenters did not 
specify what type of liability (e.g., criminal, civil, administrative, 
etc.) was concerning, however, the commenters suggested that the DEA 
provide the authorized collector retail pharmacies a release from 
responsibility when installing and maintaining a collection receptacle 
at a LTCF.
    Response: It would be contrary to the public health and safety to 
authorize an entity to collect pharmaceutical controlled substances 
from ultimate users, and also absolve that entity from any 
responsibility for such collection. In any event, the DEA does not have 
authority to provide a general release from liability to all hospitals/
clinics and retail pharmacies that apply for, and are

[[Page 53544]]

authorized to, install and maintain a collection receptacle at a LTCF 
as part of their registered activities. Part of the purpose in 
authorizing only certain hospitals/clinics and retail pharmacies to 
install and maintain collection receptacles at LTCFs is to ensure that 
a responsible registrant under the regulatory authority of the DEA is 
charged with ensuring the secure and responsible collection of 
pharmaceutical controlled substances at LTCFs. As such, with regard to 
authorized collection receptacles at LTCFs, all responsibility for such 
receptacles, including compliance with the CSA and DEA regulations, 
rests with the hospital/clinic or retail pharmacy authorized to install 
and maintain the collection receptacle. The DEA designed the physical 
security controls and other accountability measures (e.g., 
recordkeeping, two-person integrity, regular monitoring by LTCF 
personnel) for collection receptacles at LTCFs in an effort to minimize 
the risk of diversion in circumstances where constant, direct 
supervision by the hospital/clinic or retail pharmacy is not feasible. 
In the event an authorized collector knows or has reason to know 
diversion from collection receptacles is occurring, the authorized 
collector must take steps to prevent the diversion, including reporting 
to the appropriate authorities pursuant to Sec. Sec.  1301.74 and 
1301.76. Such action stems from the responsibility to provide effective 
controls and procedures to guard against theft and diversion as 
required by Sec.  1301.71(a).
Security at LTCFs
     [14] Issue: One commenter asked the DEA to clarify the required 
security measures for collection receptacles at LTCFs. Two commenters 
asked the DEA to outline what LTCF staff must do to monitor the 
collection receptacle.
    Response: The required security measures outlined in Sec. Sec.  
1317.60 and 1317.75 that apply to all collection receptacles also apply 
to those located at LTCFs unless stated otherwise in the rule. The rule 
provides that a collection receptacle must be located in an area that 
is regularly monitored by LTCF personnel. 21 CFR 1317.75(d)(2)(iii). 
``Regularly monitored'' has its ordinary meaning. The goal of this 
requirement is to prevent diversion; accordingly, specific examples 
would depend on individual circumstances. However, a sub-basement or 
other seldom-used storage area would not be considered to be regularly 
monitored by LTCF personnel because those areas are not routinely 
accessed by LTCF personnel in the course of conducting the everyday the 
business of the LTCF. The requirement that the receptacle be 
``regularly monitored'' is designed to prevent diversion opportunities, 
and to ensure that diversion would be detected as soon as possible. 
Only authorized collectors may install, manage, and maintain collection 
receptacles at LTCFs, therefore, only the authorized collectors may 
remove, seal, transfer, and store or supervise the removal, sealing, 
transfer, and storage of sealed liners. 21 CFR Sec.  1317.80(b). The 
authorized collector is responsible for ensuring the regular monitoring 
of LTCF personnel and ensuring the appropriate security procedures are 
in place at LTCFs in the event of suspected tampering or diversion. If 
tampering or diversion is suspected, LTCF personnel should notify law 
enforcement authorities and the authorized collector, as the 
circumstances warrant.
     [15] Issue: Eight commenters expressed concern for the safety of 
residents of LTCFs. These commenters are concerned that collection 
receptacles in LTCFs may affect resident safety due to these locations 
becoming a potential target for drug seekers. Five commenters suggested 
that the DEA increase penalties for offenses related to collected 
substances at LTCFs. One commenter encouraged the DEA not to authorize 
the installation of collection receptacles at LTCFs because their 
presence may compromise the safety of staff and residents.
    Response: Congress authorized the DEA to implement regulations 
authorizing LTCFs to dispose of controlled substances on behalf of 
ultimate users who reside, or have resided, at such LTCFs. The DEA has 
considered the risks associated with authorizing the installation and 
maintenance of collection receptacles at LTCFs, as discussed in the 
NPRM, and determined that the security measures described in this rule, 
in Sec.  1317.75, are the minimum required to ensure the safe and 
secure disposal of pharmaceutical controlled substances at LTCFs. If 
authorized collectors or LTCFs believe the presence of a collection 
receptacle endangers the safety or security of the LTCF residents under 
particular circumstances, they should take additional measures as 
appropriate to ensure the safety of the residents and staff, and to 
ensure the security of the collected substances. And, if those other 
alternatives have failed to abate the observed dangers, the authorized 
collector can choose to discontinue placing a collection receptacle at 
a particular LTCF.
    The CSA already provides for administrative, civil, and criminal 
sanctions for individuals and registrants that violate the CSA. The DEA 
is without authority to mandate enhanced penalties for violations of 
the CSA that involve LTCFs.
     [16] Issue: Two commenters expressed concern about security issues 
due to potential stockpiling of unwanted controlled substances at 
LTCFs. These commenters listed the following reasons as the bases for 
their concerns: The three business day disposal requirement, the lack 
of guidance on the frequency at which inner liners must be removed, the 
two employee requirement for installing and removing inner liners, and 
lack of a realistic alternative for disposal if no retail pharmacy 
manages a collection receptacle at the facility. These commenters 
stated that stockpiling would increase diversion risks and would be a 
liability for the LTCF.
    Response: As discussed in the NPRM and in response to comments in 
this final rule, these new regulations expand the options available to 
ultimate users (including LTCF residents) to dispose of excess 
pharmaceutical controlled substances. A resident, a member of the 
resident's household, and an individual lawfully entitled to dispose of 
the decedent resident's property all may dispose of a resident's 
pharmaceutical controlled substances using any of the several methods 
of disposal mentioned here. 21 CFR 1317.30.
    If there is a collection receptacle at the LTCF, the collected 
substances should not accumulate under the procedures outlined in this 
rule. One of the primary goals of the procedures outlined in these new 
regulations is to prevent the accumulation of collected substances 
while awaiting destruction. For example, LTCFs are required to deposit 
pharmaceutical controlled substances into collection receptacles 
``immediately, but no longer than three business days after the 
discontinuation of use,'' pursuant to Sec.  1317.80(a). Although the 
DEA has not specifically proposed regulations regarding the frequency 
at which the inner liners of collection receptacles must be replaced, 
an authorized collector that maintains a collection receptacle at a 
LTCF should coordinate with that LTCF in order to ensure that the inner 
liners are replaced at a frequency suitable to ensure continuous safe 
and secure disposal by the LTCF. This type of coordination is part of 
an authorized collector's responsibility to provide effective controls 
and procedures to guard against theft and diversion as required by 
Sec.  1301.71(a). Controls against diversion are ineffective when 
stockpiling of unused pharmaceutical controlled

[[Page 53545]]

substances at a LTCF is the result of an authorized collector's failure 
to adequately maintain a collection receptacle. It is emphasized that 
there is no limit on the number of collection receptacles that an 
authorized collector may install and maintain at a LTCF. Accordingly, 
the number of receptacles may be increased to account for volume and/or 
pick-up schedules.
    As previously discussed, this rule allows but does not require 
authorized collectors to store sealed inner liners at a LTCF for up to 
three business days in a securely locked, substantially constructed 
cabinet or a securely locked room with controlled access, pursuant to 
Sec.  1317.80(d). However, the DEA encourages collectors to schedule 
inner liner removals and installations to coincide with existing LTCF 
visits when possible, for example, arranging a routine system in which 
medication deliveries coincide with the removal and transfer of sealed 
inner liners for appropriate destruction, thereby making sealed inner 
liner storage unnecessary.
Other Concerns Regarding LTCF Drug Disposal
     [17] Issue: One commenter expressed concern that the DEA's 
assumption that controlled substances in LTCFs have been dispensed to, 
and are thus the property of, a resident may result in the reluctance 
of LTCFs to use automated dispensing systems to dispense to an ultimate 
user as needed.
    Response: Congress has defined ``dispense'' to mean the delivery of 
a controlled substance to an ultimate user by, or pursuant to the 
lawful order of, a practitioner. 21 U.S.C. 802(10). The DEA is bound to 
this definition. Accordingly, once a pharmaceutical controlled 
substance has been dispensed to a patient, including a resident of a 
LTCF, the substance is the property of the patient or ultimate user. 
The use of an automated dispensing system (ADS) does not change the 
analysis. An ADS is conceptually similar to a vending machine. A 
pharmacy stores bulk drugs in the machine in separate bins or 
containers and programs and controls the ADS remotely. Only authorized 
staff at the LTCF would have access to its contents, which are 
dispensed on a single-dose basis at the time of administration pursuant 
to a prescription. The ADS electronically records each dispensing, thus 
maintaining dispensing records for the pharmacy. Because the controlled 
substances are not considered dispensed until the system provides them, 
substances in the ADS are counted as pharmacy stock. Even though ADSs 
in LTCFs are used to dispense medications for administration on an as-
needed basis (i.e., one dose at a time) in accordance with a 
practitioner's prescription, the substance is the property of the LTCF 
resident once dispensed. Even though a pharmaceutical controlled 
substance is the property of the ultimate user once dispensed from the 
ADS, the LTCF may dispose of the medication on behalf of an ultimate 
user who resides, or has resided at an LTCF by depositing the 
medication into an authorized collection receptacle located in the 
LTCF. 21 CFR Sec.  1317.80. Controlled substances held within the ADS 
that have not been dispensed to a patient are considered inventory or 
stock of the registrant and therefore must be disposed of by the 
registrant in accordance with 21 CFR Sec.  1317.05.
     [18] Issue: Commenters indicated that LTCFs may be serviced by 
multiple pharmacies which could result in controlled substances from 
multiple servicing pharmacies being disposed of in a single receptacle 
installed by one such pharmacy and asked the DEA to clarify how to 
manage such situations (e.g., how other pharmacies would contribute to 
the efforts of collection; whether drugs dispensed by other pharmacies 
can be disposed of in the receptacle). Commenters also asked the DEA to 
clarify the process and requirements for the collection receptacle when 
the LTCF changes ownership or pharmacy service.
    Response: This rule allows certain hospitals/clinics and retail 
pharmacies to become collectors at LTCFs pursuant to Sec.  1317.40, 
after properly modifying their registrations, in accordance with part 
1301. This rule does not require authorized collectors to have any pre-
existing or other relationships with the LTCF. Depending on the 
circumstances, there may be more than one authorized collection 
receptacle at a single LTCF. Other than the regulations specific to the 
installation and maintenance of collection receptacles and all related 
laws and regulations, the DEA is not, at this time, regulating the 
relationship between the authorized collector and the LTCF, or between 
multiple authorized collectors that have relationships with the LTCF, 
and the DEA is not prohibiting collectors from refusing to collect any 
certain specified pharmaceutical controlled substances. However, 
conduct that implements exclusionary or anti-competitive actions at an 
LTCF that adversely affects competing registrants will be referred to 
the appropriate authorities for action. It is important to remind 
authorized collectors with collection receptacles at LTCFs that they 
are solely responsible for the security, integrity, and maintenance of 
their own collection receptacles and they must be vigilant and ensure 
complete accountability for any pharmaceutical controlled substances 
they collect at LTCFs. If a LTCF changes ownership and changes its 
name, the authorized collector must modify its registration in 
accordance with Sec.  1301.51(b)(2) to reflect the new name of the 
LTCF.
     [19] Issue: One commenter specifically suggested that the DEA 
restrict collection receptacles at LTCFs to the collection of 
controlled substances and to require signage indicating such in order 
to ensure compliance with State Medicaid program directives requiring 
the recovering of non-controlled drugs for potential credit or 
restocking.
    Response: The DEA is modifying the final rule in Sec. Sec.  
1317.70(b) and 1317.75(b) to clearly indicate that comingling of 
controlled and non-controlled substances is permitted but not required. 
The DEA's authority is limited to controlled substances. As such, the 
DEA cannot promulgate regulations requiring signage pertaining to 
compliance with State Medicaid programs or any other programs outside 
the DEA's scope of authority, but collectors are free to post signage 
pertaining to non-controlled substances. Moreover, collectors may post 
any information they deem appropriate for the safe and secure disposal 
of controlled substances. All collections that may include 
pharmaceutical controlled substances, whether comingled or not, must be 
consistent with this rule, and all other applicable Federal, State, 
tribal, and local laws and regulations.
     [20] Issue: Two commenters referenced prescription labeling 
requirements that prohibit the transfer of controlled substances to a 
person other than to whom it was prescribed. The commenters asked for 
clarification regarding such transfers and transfers to a person 
lawfully entitled to dispose of an ultimate user decedent's property. 
The commenters indicated that such transfers could be considered 
dispensing and therefore outside of the authority of the LTCF employee. 
Additional concerns included State laws that prohibit LTCFs from giving 
back unused controlled substances to the resident or another person and 
those that require such substances to be destroyed at the facility.
    Response: Pursuant to 21 U.S.C. 825(c), FDA regulations require 
that when a schedule II, III, or IV controlled substance is dispensed 
to or for a patient, the label include a warning that Federal law 
``prohibits the transfer of

[[Page 53546]]

the drug to any person other than the patient for whom it was 
prescribed.'' 21 CFR 290.5. This is not a regulation within the DEA's 
authority; however, the regulation does not appear to be inconsistent 
with the Disposal Act. As described in detail in the NPRM, the CSA 
expressly provides that it is unlawful to distribute a controlled 
substance except as provided. The CSA permits an ultimate user who has 
lawfully obtained a pharmaceutical controlled substance to deliver the 
controlled substance to another person for the purpose of disposal only 
if that person is authorized to receive such substance and in 
accordance with the implementing regulations. The CSA further provides 
that if a person dies while lawfully in possession of a pharmaceutical 
controlled substance, any person lawfully entitled to dispose of the 
decedent's property may deliver the substance to another person for the 
purpose of disposal under the same conditions described above. Pursuant 
to the Disposal Act, a LTCF may dispose of a resident's pharmaceutical 
controlled substances in accordance with these regulations. When a LTCF 
deposits a pharmaceutical controlled substance into a collection 
receptacle in accordance with these regulations, it is not 
``dispensing.'' As discussed, ``dispense'' means the delivery of a 
controlled substance to an ultimate user by, or pursuant to the lawful 
order of, a practitioner. 21 U.S.C. 802(10).
    With regard to State laws, the DEA cannot comment on the laws of 
each individual State because these laws are outside of the DEA's 
purview. The DEA is tasked by Congress with implementing Federal laws 
related to controlled substances. However, nothing contained within the 
DEA regulations should be construed as authorizing or permitting any 
person to do any act he/she is not authorized or permitted to do under 
other Federal laws or under the law of the State in which he/she 
desires to perform such act, nor shall compliance with the DEA's 
regulations be construed as compliance with other Federal or State 
laws. 21 CFR 1307.02.
     [21] Issue: One commenter asked the DEA to discuss whether the HHS 
reviewed the rule with regard to their ``anti-kickback'' statute. This 
commenter expressed concern over whether or not the HHS would permit a 
retail pharmacy that dispenses to a particular LTCF to provide 
collection services to the same LTCF free of charge.
    Response: All collection and disposal of controlled substances must 
be conducted in accordance with all applicable laws and regulations, 
including HHS regulations. This rule neither imposes requirements or 
regulations for the funding of disposal programs, nor imposes 
requirements or regulations regarding fees that registrants may charge 
to operate disposal programs.

L. Disposing on Behalf of Ultimate Users (Other Than Residents of 
LTCFs) (3 Issues)

     [1] Issue: Commenters asked the DEA to clarify how hospitals, 
schools, summer camps, or other entities may dispose of controlled 
substances that unintentionally end up in their possession (e.g., when 
persons abandon controlled substances and return is not possible). 
Also, several commenters asked the DEA to explain how controlled 
substances may be disposed of when the ultimate user or other 
authorized person is unable to dispose of them due to death or 
incapacitation.
    Response: The DEA has limited authority regarding who may deliver 
pharmaceutical controlled substances for the purpose of disposal. 
Pursuant to the Disposal Act, Congress granted the DEA authority to 
authorize three groups of people to deliver controlled substances for 
the purpose of disposal. First, an ``ultimate user'' who has lawfully 
obtained a pharmaceutical controlled substance may deliver the 
substance to another person who is authorized to accept it for the 
purpose of disposal. The CSA defines ``ultimate user'' as ``a person 
who has lawfully obtained, and who possesses, a controlled substance 
for his own use or for the use of a member of his household or for an 
animal owned by him or by a member of his household.'' 21 U.S.C. 
802(27). Second, if a person dies while lawfully in possession of a 
pharmaceutical controlled substance, any person lawfully entitled to 
dispose of the decedent's property may deliver the substance to another 
person for the purpose of disposal. 21 CFR 1317.30. Third, LTCFs may 
dispose of pharmaceutical controlled substances on behalf of ultimate 
users who reside or have resided at such facilities. 21 U.S.C. 822(g). 
The DEA has no authority to expand the types of individuals and 
entities lawfully permitted to deliver pharmaceutical controlled 
substances for the purpose of disposal. The DEA has carefully 
considered its statutory authority, diversion risks, public safety, 
convenience for ultimate users, and the interests of the public. The 
DEA believes that this rule provides safe and convenient disposal 
options for ultimate users and other authorized persons. The DEA 
understands that there may be circumstances where there is no 
authorized person to dispose of the controlled substances, such as when 
controlled substances are abandoned at a school or summer camp, and 
return to the ultimate user is not feasible. In such instances, the 
affected entities should contact local law enforcement or their local 
DEA office for guidance on proper disposal procedures.
     [2] Issue: The DEA received a number of comments regarding the 
lack of provisions for hospice and other homecare programs to dispose 
of controlled substances on behalf of patients. According to the 
commenters, many hospices have written policies and procedures in place 
for the management and disposal of controlled substances in the 
patient's home. Given the available options for ultimate user disposal, 
commenters expressed concern that hospices may no longer be able to 
assist families in disposing of a deceased patient's drugs. Commenters 
suggested that the DEA allow hospice staff to dispose of a decedent's 
controlled substances by sewering or landfill disposal.
    Response: The DEA appreciates the difficulties facing home hospice 
staff with regard to the disposal of pharmaceutical controlled 
substances. The Disposal Act provides that ``if a person dies while 
lawfully in possession of a controlled substance for personal use, any 
person lawfully entitled to dispose of the decedent's property may 
deliver the controlled substance to another person for the purpose of 
disposal under the same conditions as provided'' for ultimate users. 21 
U.S.C. 822(g)(4). Otherwise, home hospice and homecare personnel are 
not authorized to receive pharmaceutical controlled substances from 
ultimate users for the purpose of disposal. In addition, an ultimate 
user includes ``a person who has lawfully obtained, and possesses, a 
controlled substance for his own use or for the use of a member of his 
household.'' 21 U.S.C. 802(27). Accordingly, a member of the hospice 
patient's household may dispose of the patient's pharmaceutical 
controlled substances, but the home hospice or homecare provider cannot 
do so unless otherwise authorized by law (for example, under state law) 
to dispose of the decedent's personal property.
    This rule provides a number of options for ultimate users and 
persons lawfully entitled to dispose of a deceased ultimate user's 
property to safely and securely dispose of pharmaceutical controlled 
substances, yet the DEA does not require ultimate users to utilize 
these options. However, it is unlawful for ultimate users to transfer 
pharmaceutical controlled

[[Page 53547]]

substances to unauthorized persons, and it is unlawful for unauthorized 
persons to receive such substances. It is also unlawful for any person 
to possess a controlled substance unless authorized to do so under the 
CSA (i.e., an ultimate user, an entity registered with the DEA, or an 
entity exempt from registration with the DEA). 21 U.S.C. 844(a). Home 
hospice and other homecare providers are encouraged to assist their 
patients, and their patients' families, in disposing of pharmaceutical 
controlled substances in accordance with the CSA and its implementing 
regulations. While education is paramount, home healthcare agencies are 
also encouraged to partner with authorized collectors to promote or 
jointly conduct mail-back programs.
     [3] Issue: One commenter asked the DEA to clarify the authority 
for a hospice employee to utilize a LTCF's collection receptacle for 
the disposal of controlled substances of a LTCF resident who is also a 
patient of the hospice.
    Response: This rule does not specifically address hospice care or 
hospice employees, who are typically not registrants. As discussed, it 
is unlawful to possess a controlled substance unless authorized to do 
so under the CSA. 21 U.S.C. 844(a). The DEA has, however, provided 
options for the disposal of pharmaceutical controlled substances by a 
LTCF on behalf of a person who resides, or has resided, at the LTCF, 
regardless of whether or not that person is also receiving hospice 
care. The Disposal Act authorized the Attorney General to allow LTCFs 
to dispose of controlled substances on behalf of ultimate users who 
reside, or have resided, at the LTCF, in a manner determined by the 
Attorney General. 21 U.S.C. 822(g)(3). LTCF is defined as ``a nursing 
home, retirement care, mental care, or other facility or institution 
which provides extended health care to resident patients.'' 21 CFR part 
1300. Congress specifically allowed the Attorney General to consider 
permitting LTCFs to dispose of pharmaceutical controlled substances on 
behalf of LTCF residents. This allowance did not extend to other 
persons who are simply attending to a person who is resident of the 
LTCF. As such, a hospice employee is not authorized to dispose of 
pharmaceutical controlled substances on behalf of a person who resides 
or has resided at a LTCF.

M. Registrant Return, Recall, and Transfer (3 Issues)

     [1] Issue: One commenter urged the DEA to retain the existing 
regulations in part 1307. This commenter stated that part 1307 
adequately addresses registrant return, recall, and transfer. The 
commenter stated that part 1307 functions properly; thus, there is no 
need to change it, and the commenter expressed concern that the new 
regulations will disrupt existing business practices. The commenter was 
particularly concerned that most controlled substances returned to 
distributors are re-salable and ``not intended for disposal.'' Other 
commenters indicated confusion with regard to registrants seeking 
assistance from a SAC when disposing of controlled substances.
    Response: The DEA first notes that the terms ``disposal'' and 
``destruction'' are not interchangeable in the context of the rule. As 
described in the NPRM at footnote 4 and in this final rule at footnote 
4, the terms ``disposal,'' ``dispose,'' and ``disposition'' appear 
several times in the CSA but are not defined. In the NPRM and this 
final rule, the DEA uses the terms ``disposal'' and ``dispose'' to 
refer generally to the wide range of activities that result in 
controlled substances being unavailable for further use or one entity 
ridding themselves of such substances (e.g., returns). Within the CSA, 
a controlled substance can be ``disposed of'' by destruction, return, 
recall, sale, or through the manufacturing process. As such, the 
modified regulations regarding registrant disposal codify existing 
practice, expand available options, and implement consistent procedures 
among registrants in accordance with their authorized business 
activities. This required deleting the existing regulations at Sec.  
1307.21 which authorized the SACs to individually authorize disposal. 
The new rule eliminates the authority of the SACs to individually 
authorize disposal methods for non-practitioners, and retains this 
option for practitioners. 21 CFR 1317.05. Otherwise, the new 
regulations maintain existing disposal practices for registrant 
inventory and authorize: Prompt on-site destruction; prompt delivery of 
controlled substances to a reverse distributor; and prompt delivery 
(for the purposes of return and recall) to the person from whom the 
controlled substance was obtained, the manufacturer, or a registrant 
authorized to accept returns on the manufacturer's behalf. 
Additionally, non-practitioners may promptly transport the controlled 
substances to a reverse distributor, a destruction location, or the 
location of any person authorized to receive the controlled substances 
for the purpose of return or recall. 21 CFR 1317.05. The DEA 
appreciates that by eliminating the option for a SAC to authorize 
specific disposal procedures on a case-by-case basis for non-
practitioners, some reverse distributors may need to alter their 
disposal practices. Although this change may impact current business 
practices, as discussed in the NPRM, nationwide consistency is 
necessary in the disposal pharmaceutical controlled substances.
     [2] Issue: One commenter asked the DEA to clarify what method of 
return is permitted other than via a freight forwarding facility 
pursuant to Sec.  1317.10.
    Response: With regard to the use of freight forwarding facilities 
pursuant to 21 CFR 1317.10(c), use of the word ``may'' indicates that 
the use of freight forwarding facilities is permitted but not required. 
Other authorized methods of transferring pharmaceutical controlled 
substances for the purpose of return or recall are outlined in Sec.  
1317.05(a)(3) and (4) for practitioners, and in 21 CFR 1317.05(b)(3) 
and (4) for non-practitioners.
     [3] Issue: One commenter stated that it will be difficult for 
reverse distributors to adjust current business operations to meet the 
14-day destruction requirement for recalled controlled substances, 
because product returns may be received from thousands of customers 
across the country. Additionally, this requirement may not be 
consistent with other agencies' regulations and policies governing 
manufacturers' voluntary recalls and other product recalls.
    Response: As explained further below, the 14-day destruction 
requirement (which this final rule extends to 30 days) does not apply 
to recalled pharmaceutical controlled substances. 21 CFR 1317.15.

N. Destruction (19 Issues)

Non-Retrievable Destruction Standard
     [1] Issue: Forty commenters asked the DEA to outline performance 
standards and parameters for the ``non-retrievable'' destruction 
standard. Although many commenters applauded the DEA for proposing a 
standard that will permit future innovation, many commenters felt that 
innovation may be hindered by the uncertain terms. Commenters asked the 
DEA to list currently-approved methods, and to outline how the DEA will 
evaluate new technology intended to render controlled substances ``non-
retrievable.''
    Response: In the NPRM, the DEA indicated that incineration and 
chemical digestion are some examples of current technology that may be 
utilized to achieve the non-retrievable

[[Page 53548]]

standard. The preamble of the NPRM states that sewering (disposal by 
flushing down a toilet or sink) and landfill disposal (mixing 
controlled substances with undesirable items such as kitty litter or 
coffee grounds and depositing in a garbage collection) are examples of 
current methods of disposal that do not meet the non-retrievable 
standard. The term non-retrievable is defined in the rule and is 
results-oriented because the DEA's concern is that the substance be 
permanently rendered to an unusable state. The performance standard is 
that the method renders the substance so that it cannot be transformed 
to a physical or chemical condition or state as a controlled substance 
or controlled substance analogue. 21 CFR part 1300. The DEA will not be 
routinely engaged in evaluating new technologies intended to render 
controlled substances ``non-retrievable.'' Much like the DEA does not 
evaluate, review, or approve the specific processes or methods utilized 
to produce, synthesize or propagate a controlled substance, the DEA 
will not evaluate, review, or approve the processes or methods utilized 
to render a controlled substance non-retrievable, as long as the 
desired result is achieved.
     [2] Issue: Twenty commenters asked the DEA to include the language 
regarding sewering and landfill disposal in the text of the regulation. 
These commenters applauded the DEA for stating that sewering and 
landfill disposal do not meet the ``non-retrievable'' standard; 
however, these commenters asked the DEA to include this same language 
in the text of the regulation.
    Response: The DEA has determined that the most effective way of 
ensuring that the non-retrievable standard of destruction remains 
current with continuously changing technology is to provide a required 
end result rather than specify what means achieve or fail to achieve 
that result. A substance is rendered non-retrievable when its physical 
or chemical state is permanently and irreversibly altered and it may be 
unique to a substance's chemical or physical properties; the same means 
of destruction may not render every controlled substance non-
retrievable. 21 CFR part 1300. Thus, the DEA declines to amend the text 
of the regulation to include such a broad prohibition. In consideration 
of the Disposal Act's goal to decrease the amount of pharmaceutical 
controlled substances introduced into the environment, the DEA 
emphasizes that sewering and landfill alone do not meet the non-
retrievable standard. Once a controlled substance is rendered non-
retrievable, it is no longer subject to the requirements of the DEA 
regulations.
    [3] Issue: Several commenters requested that the DEA review and 
approve new destruction methods prior to allowing their use.
    Response: As discussed in the immediately preceding responses, the 
DEA will not be engaged in reviewing or approving new destruction 
methods prior to allowing their use.
    [4] Issue: One commenter suggested that the DEA provide a 
transition period to allow for additional research into the means by 
which a non-retrievable state may be achieved. This commenter proposed 
a timeframe, such as five years, to allow appropriate technology to 
develop. This commenter also suggested that the DEA permit sewering and 
landfill disposal in the interim.
    Response: The DEA believes that technology by which pharmaceutical 
controlled substances may be rendered non-retrievable currently exists, 
thus providing existing opportunities for compliance with this rule and 
negating the need for a transition period beyond the effective date of 
this rule.
    [5] Issue: Several commenters suggested that the DEA collaborate 
with the United States Environmental Protection Agency (EPA) to develop 
best practices for achieving a non-retrievable state using 
environmentally responsible methods.
    Response: The DEA appreciates the environmental concerns 
surrounding the destruction of pharmaceutical controlled substances. 
The DEA has worked with, and is continuing to work with, the EPA 
regarding secure and responsible drug disposal, particularly for 
pharmaceutical controlled substances that may also be considered 
hazardous wastes. Additionally, the DEA has clearly stated in the rule 
that all methods of destruction must comply with all applicable 
Federal, State, tribal, and local laws and regulations, including EPA 
regulations.
    [6] Issue: A commenter asked the DEA to clarify whether or not the 
non-retrievable standard of destruction applies to substances disposed 
from households, and this commenter stated that the DEA should develop 
and endorse a practical solution for in-home disposal.
    Response: Ultimate users may continue to dispose of their own 
pharmaceutical controlled substances in the manner recommended by other 
Federal and State agencies, such as the FDA, Office of National Drug 
Control Policy (ONDCP), and EPA. The non-retrievable standard is only 
applicable to inventoried controlled substances (i.e., a registrant's 
stock) and collected controlled substances (i.e., substances collected 
from ultimate users by authorized collectors) to be disposed of by 
registrants, pursuant to Sec.  1317.90. The non-retrievable standard 
does not apply to non-registrants.
    [7] Issue: Several commenters asked the DEA to clarify whether or 
not controlled substances that were rendered ``non-retrievable'' will 
be regulated by the DEA.
    Response: As provided in the definition, a controlled substance is 
considered non-retrievable when it cannot be transformed to a physical 
or chemical condition or state as a controlled substance or controlled 
substance analogue. 21 CFR part 1300. Once a substance is rendered non-
retrievable, it is no longer subject to the requirements of the DEA 
regulations. The DEA believes that further regulations regarding 
substances that have been rendered non-retrievable are currently 
unnecessary because a non-retrievable substance cannot be abused and 
diversion to illicit use is futile.
Incineration and Chemical Digestion Destruction Methods
    [8] Issue: Several commenters asked the DEA to specifically 
recommend incineration as the preferred method to achieve a non-
retrievable state.
    Response: The DEA believes that any actual or perceived endorsement 
or recommendation of a specific destruction method, beyond the 
provision of examples of current methods in the preamble, could 
suppress exploration and implementation of new technologies as people 
may assume that the endorsed or recommended methods are required at the 
exclusion of other methods. As such, the DEA is specifying a required 
result--non-retrievable--rather than a required method for achieving 
that result. 21 CFR 1317.90.
On-Site Destruction Methods
    [9] Issue: Several commenters asked the DEA to clarify what ``on-
site destruction'' means.
    Response: As provided in Sec.  1300.05(b) of the final rule, on-
site destruction means that the controlled substances are destroyed on 
the physical premises of the destroying registrant's registered 
location. Collectors that are authorized to conduct mail-back programs 
must have and utilize an on-site method of destruction, pursuant to 21 
CFR 1317.05(c)(1). The requirement for an on-site method of destruction 
does not apply to non-registrants.
    [10] Issue: Commenters also expressed concern that distributors are 
unlikely to have an existing on-site

[[Page 53549]]

method of destruction because they are not typically licensed as waste 
handlers and suggested that the DEA provide alternatives to on-site 
destruction for hospitals and other medical facilities.
    Response: This rule does not require any distributor or other 
registrant to utilize an on-site method of destruction except under 
certain circumstances in order to conduct a voluntary activity (e.g., 
receipt of mail-back packages as an authorized collector in accordance 
with Sec.  1317.05(c)(1)).
    [11] Issue: One commenter asked the DEA to consider the use of 
collection receptacles with deactivation technology.
    Response: This rule does not prohibit on-site destruction of 
pharmaceutical controlled substances by authorized collectors with 
``deactivation'' capability so long as such destruction is consistent 
with the standards set forth in the rule and the destruction results in 
a non-retrievable state. 21 CFR 1317.90.
Other Destruction-Related Concerns
    [12] Issue: Approximately 20 commenters stated that the 14-day 
destruction requirement is impractical. These commenters suggested that 
the DEA allow more time since there are a limited number of commercial 
incinerators in the United States. Several commenters stated that 
reverse distributors must accumulate large amounts of controlled 
substances in order to obtain favorable pricing. Other commenters 
stated that the requirement will make it difficult for reverse 
distributors to properly process and record all transactions, and it 
will impose substantial financial and operational restrictions on 
reverse distributors as most reverse distributors do not have on-site 
destruction and may need to travel long distances to reach an 
appropriate destruction facility.
    Response: The DEA has carefully and thoroughly considered these 
concerns, and the final rule in Sec.  1317.15(d) extends the 
destruction requirement timeframe from 14 calendar days to 30 calendar 
days and eliminates the ``as soon as practicable'' standard with 
respect to this destruction requirement. The DEA remains concerned 
about increased diversion risks due to pharmaceutical controlled 
substances remaining at a single location for extended periods of time. 
As discussed in detail in the NPRM, prescription drug abuse is an 
American epidemic, and it is America's fastest growing drug problem. 
When large volumes of pharmaceutical controlled substances accumulate, 
they become an attractive target for drug seekers and drug abusers. 
Accordingly, regardless of the applicable timeframe to destroy 
controlled substances, reverse distributors are reminded that they must 
be vigilant and adhere to the requirements in the CSA and the 
implementing regulations. Finally, these registrants are reminded of 
their responsibility to provide effective controls and procedures to 
guard against theft and diversion, and their responsibility to notify 
the DEA of any theft or significant loss of any controlled substances 
within one business day of discovery. 21 CFR part 1301. The DEA 
continuously monitors compliance with the CSA and applicable 
regulations to ensure that controlled substances are not diverted to 
illicit purposes. If necessary, the DEA may consider revising the 
requirements applicable to reverse distributors' destruction 
activities, or imposing additional security requirements.
    [13] Issue: Several commenters asked the DEA to clarify the day the 
clock starts for the 14-day destruction requirement.
    Response: As discussed above, the final rule extends the timeframe 
from 14 days to 30 days. Day 1 is the day the substances are physically 
acquired through pick-up or delivery. 21 CFR 1317.15.
    [14] Issue: One commenter asked the DEA to clarify whether or not 
the 14-day destruction requirement applies to law enforcement.
    Response: This destruction requirement does not apply to law 
enforcement. Law enforcement guidelines are outlined in Sec.  1317.35.
    [15] Issue: One commenter suggested that the DEA apply the 14-day 
destruction requirement to all authorized collectors that destroy or 
cause the destruction of controlled substances, not just reverse 
distributors.
    Response: As previously discussed, the final rule extends the 
destruction requirement timeframe from 14 days to 30 days. 21 CFR 
1317.15. This requirement applies to reverse distributors destroying 
any controlled substance, as well as distributors when destroying 
sealed inner liners acquired from authorized collectors for 
destruction. Pursuant to Sec.  1317.05(c), authorized collectors that 
maintain mail-back programs or collection receptacles must promptly 
destroy mail-back packages and inner liners, without adhering to a 
certain number of days in order to provide them some flexibility 
depending upon their particular circumstances.
    [16] Issue: Two commenters stated that all management and disposal 
of controlled substances should be restricted to DEA-registered 
hazardous waste disposal companies.
    Response: The DEA believes that restricting the management and 
disposal of controlled substances as suggested would severely burden 
registrants without adding benefit. Pursuant to this rule, a 
destruction facility is not required to register with the DEA simply 
because a registrant utilizes that facility to destroy pharmaceutical 
controlled substances in a manner consistent with this rule and all 
other applicable Federal, State, tribal, and local laws and 
regulations. The DEA does not find it necessary to register these 
entities because the destroying registrant maintains possession and 
control of the substances (and therefore retains responsibility and 
accountability) until the substances are rendered non-retrievable. This 
is because all handling, monitoring, security, recordkeeping, and 
witnessing with regard to the pharmaceutical controlled substances is 
performed or supervised by registrants.
    [17] Issue: One commenter indicated that the DEA should provide for 
broader Federal approval for methods of destruction rather than 
allowing for regionally-based guidance through the relevant SAC.
    Response: As discussed, this rule expands the options available to 
registrants for proper disposal, but does not require any particular 
method of destruction, so long as the substances are rendered non-
retrievable. This rule does not authorize SACs to specifically 
authorize any particular method of destruction, but it does allow a 
practitioner to seek guidance from the relevant SAC regarding the 
disposal of controlled substances. 21 CFR 1317.05.
    [18] Issue: Several commenters asked for clarification regarding 
the means by which an authorized collector may promptly destroy 
collected substances, and whether chemical treatment of controlled 
substances until such time as controlled substances can be retrieved 
for destruction would be considered prompt destruction.
    Response: As discussed, the DEA is not requiring any particular 
method or means of destruction. All controlled substances destined for 
destruction must be rendered non-retrievable in order to be destroyed 
in a manner consistent with this rule. 21 CFR 1317.90. If chemical 
treatment renders a substance non-retrievable, it has been properly 
destroyed and is no longer subject to the DEA's regulations.
    [19] Issue: One commenter suggested that the DEA require controlled 
substances to be partially destroyed prior to disposal in collection

[[Page 53550]]

receptacles, such as by grinding them up and mixing them with kitty 
litter.
    Response: With regard to mixing pharmaceutical controlled 
substances with other substances prior to depositing them in a 
collection receptacle, this rule neither prohibits nor requires such 
activity. Some authorized collectors may find it desirable to direct 
ultimate users to mix pharmaceutical controlled substances with non-
hazardous items, such as kitty litter, prior to depositing in 
receptacles; however, the DEA declines to mandate such a requirement 
for all authorized collectors. The security controls required by this 
rule are the minimum required to ensure the safe and secure disposal of 
pharmaceutical controlled substances.

O. Economic Concerns (18 Issues)

Continuation of Existing Programs
     [1] Issue: Eighteen commenters with experience operating a 
disposal program stated that following the new regulations will be 
prohibitively costly, and their current program will be forced to stop 
collection activities. These commenters stated that they sort 
controlled substances from non-controlled substances and packaging. 
According to these commenters, controlled substances represent a small 
fraction of their total volume of collected substances, and the sorting 
prohibition will substantially increase costs.
    Response: As explained above, comingling of controlled and non-
controlled substances is permitted by the rule in Sec.  1317.75, but it 
is not required, and this rule does not require pharmaceutical 
controlled substances collected from ultimate users to be collected and 
stored in the original packaging. Authorized collectors may choose to 
address adequacy of space issues by choosing not to collect comingled 
controlled substances and non-controlled substances and by excluding 
packaging materials from being deposited into the collection 
receptacle. Also, law enforcement continues to have autonomy regarding 
their collection activities, and this rule does not prohibit law 
enforcement from handling collected substances. Prior to the effective 
date of this rule, it is unlawful for ultimate users to transfer 
controlled substances to any entity (excluding law enforcement), except 
in the limited circumstances allowed under 21 CFR 1307.21(a)(2).
    [2] Issue: Several commenters stated that they would have to hire 
additional help for their program to continue, and that they would no 
longer be able to rely on volunteers or other personnel that did not 
meet the NPRM's ``authorized employee'' definition.
    Response: As discussed, in Sec.  1300.05(b) the final rule modifies 
the proposed definition of ``authorized employee'' to omit the word 
``authorized.'' In this final rule, the DEA is adopting the general 
common law of agency's definition of the term ``employee.'' Any person 
who meets certain criteria may have access to or influence over 
collected substances on behalf of an authorized collector. Also, under 
this rule, volunteers may assist with disposal programs or take-back 
events as long as they do not have access to or influence over the 
collected controlled substances.
Two Employee Requirement
     [3] Issue: Approximately 30 commenters felt that it would be 
infeasible for two employees to oversee disposal procedures due to 
limited personnel. Commenters suggested allowing an ``authorized 
employee'' of another registrant, such as a reverse distributor, to 
satisfy the second ``authorized employee'' requirement. One commenter 
stated that the DEA should clarify that under proposed Sec.  
1317.75(g), installation and removal of inner liners may be performed 
by a law enforcement officer instead of two employees.
    Response: The DEA believes that the two-employee integrity 
requirement is a necessary security measure to effectively guard 
against diversion and to ensure that the controlled substances are 
handled, transferred, and recorded in a manner that is consistent with 
all applicable laws and regulations. The DEA carefully considered the 
various concerns and took steps to alleviate some of these concerns. 
First, as just discussed, the final rule modifies the proposed 
definition of ``authorized employee'' to instead adopt the common law 
of agency's definition of the term ``employee,'' thus including 
employees that were excluded by the definition proposed in the NPRM 
(e.g., part-time employees and off-duty law enforcement officers). 21 
CFR part 1300. Second, as previously discussed, the final rule relaxes 
the two employee requirement for collection receptacles located at 
LTCFs in Sec.  1317.80(c). The DEA is making this exception because of 
the unique circumstances faced by LTCFs, as recognized by the Disposal 
Act, and in keeping with the DEA's historically accommodating 
regulations with respect to LTCFs (e.g., Sec. Sec.  1306.11(f) and 
1306.13(b) regarding faxing schedule II prescriptions and dispensing 
partial prescriptions). The DEA believes that the above changes will 
alleviate some of the concerns expressed by the commenters while 
maintaining the necessary security to reduce diversion risks.
     [4] Issue: Twenty-seven commenters stated that the requirement to 
have two employees from the pharmacy present to remove and install a 
collection receptacle's inner liner is excessive and too costly. 
Several commenters noted that this requirement alone will dissuade 
retail pharmacies from managing collection receptacles. Several 
commenters stated that small pharmacies may not have two employees 
working during the same shift, or even have two people employed full-
time by the pharmacy. Two commenters suggested requiring a dual-lock 
system on collection receptacles, where the collector registrant 
retains one key and a reverse distributor retains the other.
    Response: The DEA carefully considered the commenters' concerns, 
and amended the text of the rule to address this issue. In the context 
of this issue, the two-employee requirement only applies to 
installation and removal of the inner liners which does not need to be 
accomplished by two employees on the same shift. Also, dual-locks on 
collection receptacles at retail pharmacies are not a reasonable 
alternative because collectors are authorized only at their own 
registered location or controlled premise. If a retail pharmacy 
employee retained one key in a dual-lock system, and a reverse 
distributor retained the other key, then the reverse distributor would 
be handling collected substances at the retail pharmacy's registered 
location or controlled premise, an activity that is not permitted. 
Reasonable alternatives include installing and removing an inner liner 
during a shift change, or other times when there is more than one 
employee present. The final rule also modifies the proposed definition 
of ``authorized employee,'' by adopting the common law of agency's 
definition of ``employee'' and correspondingly eliminating the 
requirement that employees authorized to conduct disposal activities be 
employed full-time by the authorized collector. 21 CFR part 1300. The 
DEA believes that the two-employee integrity requirement is a necessary 
security measure to effectively guard against diversion and to ensure 
that the controlled substances are handled, transferred, and recorded 
in a manner that is consistent with all applicable laws and 
regulations.
     [5] Issue: Several commenters stated that the requirement that two 
employees from a retail pharmacy be present to

[[Page 53551]]

install and remove inner liners at LTCFs is prohibitively burdensome. 
Several commenters stated that most retail pharmacies do not have a 
vehicle for this purpose, and it is a liability to have pharmacy 
employees traveling to LTCFs to change inner liners. Two commenters 
suggested that the requirement should be one employee from the pharmacy 
and one employee from the LTCF.
    Response: The DEA carefully considered alternatives that will 
provide convenient options for the unique population of LTCF residents, 
but will also provide safe and secure disposal. As amended, the final 
rule in Sec.  1317.80(c) provides that inner liner installations, 
storage, removals, and transfers at LTCFs may be performed either by 
two employees of the authorized collector, or by one employee of the 
authorized collector and a supervisor-level employee of the LTCF 
designated by the authorized collector. The DEA believes that this 
modification is important to encourage hospitals/clinics and retail 
pharmacies to maintain collection receptacles for LTCF residents, by 
easing the burdens on authorized collectors who maintain collection 
receptacles at LTCFs--the only collectors who maintain collection 
receptacles at locations away from their primary registered locations. 
Additionally, the DEA recognizes that some authorized collectors do not 
have a vehicle specifically for the purpose of travelling to LTCFs, or 
currently allow employees to travel. The DEA notes that no particular 
vehicle is required to transport employees of the authorized collector 
to the LTCF, and, as discussed above, the DEA encourages authorized 
collectors managing a collection receptacle at a LTCF to coordinate 
removal of inner liners with the delivery of controlled substances 
dispensed to LTCF residents.
     [6] Issue: Fifteen commenters stated that it will be economically 
burdensome to have two employees of the reverse distributor accompany 
the collected substances to the point of destruction to witness the 
destruction. These commenters noted that waste management companies 
often travel hundreds of miles to reach a destruction facility. The 
commenters stated that it is unreasonable to have two employees of the 
reverse distributor accompany the collected substances and witness the 
destruction, and some commenters suggested that the DEA permit other 
security mechanisms, such as GPS devices and security cameras, to serve 
in lieu of the second employee.
    Response: The DEA believes that the two-employee integrity 
requirement is a necessary security measure to effectively guard 
against diversion and to ensure that the collected substances are 
handled, transferred, and recorded in a manner that is consistent with 
all applicable laws and regulations. 21 CFR 1317.95. The DEA notes that 
the DEA registrants who expressed concern regarding this requirement 
already adhere to it in their current business practices. However, the 
DEA has thoroughly and carefully considered the commenters' concerns 
and considered the following alternatives to the two-person integrity 
requirement: (1) Requiring destruction facilities to register with the 
DEA; (2) requiring the transferring registrant (e.g., retail 
pharmacies, hospitals/clinics, etc.) to accompany the controlled 
substances to the point of destruction; (3) requiring on-site 
destruction; (4) requiring additional recordkeeping and witnessing at 
the point of destruction by the non-registrant destruction facility; 
and (5) requiring GPS devices or security cameras to serve in lieu of 
the second employee. The DEA did not elect these alternatives because 
the DEA is without sufficient authority to impose them, or the 
alternatives were impractical, excessive, did not provide adequate 
security, would result in voluminous, difficult to maintain and verify 
records, and/or would reduce the disposal options available to ultimate 
users.
    The two-person integrity requirement is of paramount importance 
when transporting controlled substances to the point of destruction 
because these persons are uniquely entrusted with ensuring the 
substances are destroyed and not diverted to illicit purposes. 
Registrants that destroy on-site also face diversion risks and security 
concerns and must adhere to the two-person integrity requirement when 
destroying controlled substances. These diversion risks and security 
concerns increase substantially in the case of reverse distributors 
because they routinely acquire from other registrants large volumes of 
controlled substances destined for destruction, and they routinely 
transport those substances to a remote, un-registered location for 
destruction, yet there is no independent mechanism to ensure or verify 
that the substances within their possession are actually destroyed and 
not diverted.
    Furthermore, as explained previously, in every other transfer of 
controlled substances in the closed system of distribution, there are 
two registrants on each side of the transfer to ensure accountability 
and identify and prevent diversion. When controlled substances are 
transferred for destruction, there may not be a registrant verifying 
the destruction of the controlled substances. Adherence to the two-
employee integrity requirement will provide accountability for the 
controlled substances during the destruction process, preventing 
possible loss, possible theft, and diversion of the controlled 
substances.
    Similarly, the DEA declines to allow GPS devices or security 
cameras to serve in lieu of a second employee. These types of security 
measures can be compromised, and do not provide the same level of 
deterrence or risk mitigation as the presence of a second person 
because they are strictly after-the-fact methods of diversion control 
as opposed to providing security throughout the transportation and 
destruction process. GPS devices cannot provide information as to 
whether or not controlled substances were removed from the transporting 
vehicle, and cameras cannot observe transportation and destruction from 
all angles. For example, a single driver being monitored by GPS and 
video could drive to the destruction facility on the approved route, 
remove the controlled substances from the vehicle, move with the 
controlled substances out of the view of the camera, and place the 
controlled substances into a separate vehicle or hidden spot off camera 
rather than destroying them. In such a scenario, neither the GPS, nor 
the camera would indicate any sort of diversion, whereas a second 
person would be present throughout transportation and destruction to 
serve as a deterrent and ensure that the controlled substances were 
actually destroyed.
    For these reasons, the DEA believes that the two-person integrity 
requirement is the most reasonable, secure, and economic substitute for 
another registrant serving as an independent verification method at the 
end of the closed system of distribution.
Implementation Costs
     [7] Issue: One commenter indicated that the enhanced security 
procedures proposed for the disposal process will be overly burdensome 
and costly. This commenter recommended that the DEA meet with industry 
stakeholders to identify options that will allow innovation while 
maintaining security.
    Response: The security requirements in this rule are the minimum 
needed to protect the public health and safety, to ensure 
accountability, and to reduce the risk of diversion during the disposal 
process. In addition, there were multiple opportunities for industry 
stakeholders (and any other interested persons) to participate in the

[[Page 53552]]

rulemaking process for this rule through participation in the public 
meeting held in January 2011, and the submission of written comments 
during the open comment period. The DEA carefully considered discussion 
from the meeting, as well as the written comments submitted in response 
to the NPRM.
     [8] Issue: Eleven commenters stated that the regulations proposed 
in the NPRM are too costly, and the costs will discourage potential 
collectors from participating. Several commenters expressed concern 
about the costs associated with retail pharmacies managing collection 
receptacles, particularly at LTCFs.
    Response: As provided in the Disposal Act and discussed in the 
NPRM, the DEA cannot require any entity to establish or maintain a 
disposal program. Based on information received from the public and 
industry during the public meeting in 2011, as well as information 
received in response to the NPRM, the DEA believes that many entities 
are eager to voluntarily establish disposal programs. Entities may 
choose to establish disposal programs for various reasons, including 
for profit, to build goodwill in the community, to attract customers, 
to advertise businesses, and to preserve the environment.
     [9] Issue: Several commenters provided feedback regarding costs 
related to voluntary implementation and maintenance of disposal 
programs, although none provided any actual data that could be applied 
to the cost analysis except for a suggestion that the DEA review 
information from a report on waste collection, and one commenter that 
provided an estimate without any supporting data. Generally, commenters 
indicated that the proposed methods of collection would have associated 
costs incurred through recordkeeping, purchase of inner liners, changes 
in procedures, increases in destruction costs, and development of mail-
back packages and collection receptacles. Commenters encouraged the DEA 
to further explore the potential costs of the proposed options as well 
as additional alternatives.
    Response: The DEA appreciates the commenters' concerns regarding 
potential costs associated with the implementation and maintenance of 
disposal programs. The DEA has updated its economic analysis to 
address, directly, the costs of this rule with respect to those 
registrants that do choose to establish a collection program. Such 
implementation, however, is strictly voluntary; thus, any entity that 
does not wish to incur the related costs may choose not to participate. 
Additionally, as described in the NPRM, the DEA anticipates that a 
variety of interest groups, corporations, community groups, and other 
entities will work together to provide secure and responsible disposal 
options pursuant to this rule.
     [10] Issue: One commenter suggested that the DEA provide an 
exception for analytical labs from the requirements of proposed Sec.  
1317.95(c) (Sec.  1317.95(d) in the final rule), which requires that 
two employees handle the destruction of controlled substances, in 
instances where the testing renders a substance non-retrievable.
    Response: The DEA declines to provide a blanket exception for 
analytical laboratories for the described situation. The DEA believes 
that such instances as described by the commenter will be incidental to 
testing. If the testing is specifically designed to develop new methods 
of destruction or destruction is otherwise not incidental to testing, 
all destruction must be in accordance with the provisions in subpart C 
of this rule.
     [11] Issue: One commenter expressed concern that this rule will 
impose obligations on authorized collectors that are inconsistent with 
obligations imposed by other agencies, particularly the FDA, EPA, and 
DOT. The commenter stated that the potential liability stemming from 
such conflicts will discourage participation.
    Response: The DEA has worked directly with other Federal agencies 
regarding the implementation of this rule, including the EPA and DOT. 
The DEA believes that authorized collectors may comply with this rule 
and other agency regulations. Authorized collectors should contact 
applicable agencies for further guidance if they believe that their 
specific circumstances may lead to conflicts.
Funding and Incentives
     [12] Issue: One commenter asked the DEA to allow private/public 
partnerships for collection receptacles, mail-back programs, and take-
back events.
    Response: This rule does not dictate what funding sources are 
permitted or prohibited. Entity partnerships are not prohibited as long 
as the authorized collector follows all procedures outlined in this 
rule.
     [13] Issue: Ten commenters expressed concern that there is no 
mandate, funding, or incentive for collectors to participate. Two 
commenters suggested that the DEA establish incentives to encourage 
participation, or require all pharmacies to install and maintain 
collection receptacles. Several commenters indicated that without a 
clear source of funding, cost mitigation, or participation incentive, 
it is unlikely that registrants will voluntarily accept the financial 
burdens associated with the provision of collection opportunities.
    Response: The DEA appreciates the suggestions and concerns of the 
commenters regarding funding for voluntary controlled substances 
collection programs. The DEA points out that the Disposal Act did not 
authorize the DEA to assign responsibility of funding to any entity, 
and the Disposal Act specifically required the DEA to promulgate the 
implementing regulations in such a way that participation would not be 
mandatory. The DEA's intent in soliciting comments regarding this 
rule's potential economic impact was to gain knowledge regarding 
potential costs--not which entities should fund disposal programs. The 
DEA has attempted to provide regulations that minimize the financial 
burden while retaining a level of security to ensure public safety and 
reduce diversion risks. This rule does not address the responsibility 
of costs associated with any collection program. The DEA recognizes 
that collection programs will have associated costs and each entity 
that chooses to establish and maintain such a program must determine 
how to manage such costs.
Other Economic Concerns
     [14] Issue: A number of commenters urged the DEA not to impose 
additional fees on registrants that choose to become authorized 
collectors. These commenters asked the DEA to clarify whether or not 
there will be any cost to modify a registration to become an authorized 
collector. One commenter suggested that the DEA offer a reduced fee for 
non-profit organizations to become registered as reverse distributors.
    Response: Section 1301.51(c) states that no fee will be required to 
modify a registration to become authorized as a collector. Pursuant to 
21 U.S.C. 886a, fees charged by the DEA under its diversion control 
program must be set at a level that ensures the recovery of the full 
costs of operating the various aspects of the program. The DEA last 
modified the registration fees on April 16, 2012. 77 FR 15234. If the 
DEA determines in the future that such fees should be modified in order 
to ensure the recovery of the full costs of the diversion control 
program, including those contained in this rule, the DEA will propose a 
modified fee schedule

[[Page 53553]]

pursuant to the notice-and-comment rulemaking process. The DEA 
currently provides limited exceptions and exemptions from registration 
fees to very specific groups and entities as identified in part 1301. 
At this time, the DEA does not anticipate expanding such exceptions and 
exemptions as a result of or in conjunction with the implementation of 
this rule.
     [15] Issue: A few commenters noted that DEA's Economic Impact 
Analysis estimated the universe of potential respondents to include 
distributors, reverse distributors, manufacturers, and retail 
pharmacies, without considering hospitals, surgery centers, dental 
clinics, veterinary practices, or physicians' offices.
    Response: The DEA's analysis included a universe of potential 
respondents comprised of only those entities that may be affected by 
the rule--those registrants that are eligible to become authorized 
collectors (i.e., distributors, reverse distributors, manufacturers, 
NTPs, and hospitals/clinics with an on-site pharmacy, and retail 
pharmacies).
     [16] Issue: Two commenters stated that the DEA did not 
appropriately calculate the costs associated with the proposed rule. 
One commenter stated that the DEA should acknowledge the costs 
associated with recordkeeping requirements, purchasing inner liners, 
purchasing mail-back packages, procedural changes, and increased 
destruction costs.
    Response: As discussed previously, the economic analysis of the 
final rule takes into account costs associated with voluntary 
performance of collection activities even though the provisions that 
facilitate non-registrant disposal are completely voluntary, not 
mandated. Any collector, reverse distributor, distributor, or law 
enforcement that chooses to engage in the voluntary activities 
described in this section, does so based on its own evaluation of costs 
and benefits (tangible and intangible).
     [17] Issue: One commenter stated that the economic impact analysis 
is inadequate because it does not acknowledge that parts of this rule 
are an ``indirect'' mandate for LTCFs. This commenter referred to 
incidents where LTCFs will have no other options for controlled 
substance disposal if patients are unable to dispose of the medication 
and there is no other person authorized to dispose of the controlled 
substances.
    Response: In response to this comment, the final rule modifies the 
language of Sec.  1317.80(a), as proposed, which appeared to prohibit 
LTCFs from using any disposal method other than a collection 
receptacle. Under the final rule, LTCFs may dispose of controlled 
substances on behalf of an ultimate user who resides, or has resided, 
at such LTCF. 21 CFR 1317.30 and 1317.80. The DEA notes that the 
decision to implement and manage a collection program for ultimate user 
disposal is voluntary. It should be noted that LTCF residents are 
ultimate users themselves and they, members of their households, and 
persons lawfully entitled to dispose of a decedent's personal property, 
may avail themselves of all disposal methods made available by this 
rule. 21 CFR 1317.30.
     [18] Issue: One commenter stated that the DEA did not consider 
veterinary practices, prisons, or clinics when calculating the economic 
impact analysis.
    Response: In the proposed rule, the DEA considered veterinary 
practices, prisons, and clinics in the accompanying calculations 
concerning economic impact to the extent that these entities would be 
registered as practitioners or non-practitioners. For the final rule, 
the DEA calculated the economic impact on these entities to the extent 
that they could become collectors. Not all registrants are eligible to 
become authorized collectors. Of this specified list of entities 
inquired about by the commenter, only a small subsection, specifically 
hospitals/clinics with on-site pharmacies, may become authorized as 
collectors in accordance with this final rule. 21 CFR 1317.40 and 
1317.70.

P. Recordkeeping and Reporting (8 Issues)

    [1] Issue: One commenter asked the DEA to clarify whether or not 
the recordkeeping requirements in the rule apply to all registrants or 
only authorized collectors.
    Response: The new recordkeeping requirements contained in this rule 
are applicable to all registrants, including authorized collectors. To 
clarify this important distinction, the DEA moved the recordkeeping 
provisions in proposed part 1317 to part 1304.
    [2] Issue: Several commenters urged the DEA to remove the inventory 
and recordkeeping requirements for mail-back packages and inner liners. 
The commenters believe that such recordkeeping will be challenging and 
provide limited benefits. One commenter suggested that the DEA instead 
adopt tracking procedures currently used in some non-controlled 
substance collection programs.
    Response: As described in the NPRM, inventory and recordkeeping 
requirements for collected substances are necessary for a number of 
reasons, including accountability of collected substances within the 
possession and control of authorized collectors. The inventory and 
recordkeeping requirements included in this rule are generally 
consistent with those otherwise required of registrants, thus 
minimizing burden. The DEA believes that these inventory and 
recordkeeping requirements are necessary to help minimize the risk of 
diversion and to identify diversion of controlled substances destined 
for destruction.
    [3] Issue: One commenter suggested that the DEA eliminate ARCOS 
reporting requirements for reverse distributors regarding collected 
substances from ultimate users. Another commenter asked the DEA to 
clarify what information is required for ARCOS reporting.
    Response: In this final rule, Sec.  1304.33(g) (relocated from 
proposed Sec.  1317.50) exempts reverse distributors and distributors 
that acquire controlled substances from collectors or law enforcement 
from reporting to ARCOS with respect to pharmaceutical controlled 
substances collected through mail-back programs and collection 
receptacles.
    [4] Issue: One commenter asked the DEA to clarify what records 
reverse distributors must keep when receiving collected substances from 
law enforcement.
    Response: The recordkeeping requirements in Sec.  1304.22(e)(4) 
that apply to controlled substances acquired by registrants that 
reverse distribute from collectors also apply to those acquired from 
law enforcement. The final rule also adds a new paragraph in Sec.  
1304.11(e)(3)(iii) specifying the information relating to controlled 
substances acquired from collectors and law enforcement that a 
registrant that reverse distributes must maintain in its inventories. 
Under the revised Sec.  1304.03(a), these provisions relating to 
reverse distributors apply to any entity that reverse distributes, as 
defined in Sec.  1300.01(b), whether or not it is registered with the 
DEA as a reverse distributor. Finally, the requirement in Sec.  
1304.21(e) to maintain a DEA Form 41 applies to the destruction of a 
sealed inner liner or mail-back package by a registrant that reverse 
distributes.
    [5] Issue: Commenters asked the DEA to clarify who is responsible 
for tracking the mail-back packages, and how mail-back packages that 
were disseminated but not returned to the authorized collector will be 
reconciled with the inventory.
    Response: There is currently no requirement for the authorized 
collector to reconcile the inventory in order to

[[Page 53554]]

determine which packages were not returned. As discussed in the NPRM, 
the DEA does not believe that requiring authorized collectors to 
institute a tracking or notification system for ultimate users is 
necessary at this time, although such systems are not prohibited so 
long as the collector does not require the ultimate user to provide 
personally identifiable information, as specified in Sec.  1317.70(d).
    [6] Issue: Commenters asked the DEA to eliminate the following 
recordkeeping requirements for inner liners: Tracking unused inner 
liners on hand, recording the acquisition date, recording the 
installation date, and the requirement that two employees witness the 
removal and installation of inner liners.
    Response: As previously discussed, the DEA believes that all of the 
inventory and recordkeeping requirements in part 1304 are the minimum 
necessary to ensure accountability and identify diversion.
    [7] Issue: Two commenters asked the DEA if reporting to the FDA is 
sufficient to satisfy the DEA's reporting requirements for cases of 
controlled substance recalls.
    Response: No. Regardless of any other Federal, State, tribal, or 
local agency requirements, each registrant must maintain records and 
make reports to the DEA in a manner consistent with the requirements of 
chapter II of title 21 of the CFR.
    [8] Issue: One commenter asked the DEA to clarify the recordkeeping 
requirements of Sec.  1317.50(b)(2)(iii)--specifically, the requirement 
to record the registration number of the collection location when the 
collection occurs at a LTCF, which typically does not have a 
registration number.
    Response: The final rule moves the referenced requirements to new 
Sec.  1304.22(f). The record should include the approved collection 
location address of the LTCF and the authorized collector's 
registration number.

Q. Hazardous Materials Transportation and Hazardous Waste Destruction 
(3 Issues)

    [1] Issue: Approximately 20 commenters expressed concern that the 
requirements outlined in this rule for the transportation of collected 
substances conflict with current regulations under the DOT's Pipeline 
and Hazardous Materials Safety Administration (PHMSA). One concern 
involved the comingling of collected substances that the DOT considers 
``hazardous materials'' with nonhazardous materials or hazardous 
materials of a different class. Other concerns included how inner 
liners from collection receptacles that contain hazardous materials 
should be labeled and packaged for transport, and other notice 
requirements for hazardous waste under the DOT's PHMSA.
    Response: All drug disposal activities must be conducted in a 
manner consistent with this rule and all other applicable Federal, 
State, tribal, and local laws and regulations. Compliance with the 
destruction requirements outlined in subpart C of this rule does not 
exempt any entity from complying with other Federal, State, tribal, or 
local laws or regulations. It is not within DEA's expertise or 
authority to opine what pharmaceutical controlled substances could be 
hazardous materials subject to DOT regulations. However, the DEA 
consulted with the DOT during various stages of this rulemaking. The 
DEA has been informed that if collected substances include hazardous 
materials, the transportation of those materials is subject to all 
applicable DOT regulations, including the ``Hazardous Materials 
Regulations'' (HMR). The DEA encourages entities to consult 
www.phmsa.dot.gov/hazmat for information regarding the HMR. In 
particular, the DEA encourages entities to contact the DOT's PHMSA 
regarding its ``Approvals and Permits Program.'' PHMSA issues approvals 
and special permits to entities that apply for authorization to use 
agency approved alternatives to the HMR. Interested entities may 
consult www.phmsa.dot.gov/hazmat/regs/sp-a. for more information. The 
DEA has worked with the DOT to facilitate this process in an effort to 
ensure maximum participation in the collection of controlled substances 
for secure and responsible disposal, and the DEA will continue to work 
with the DOT to facilitate registrant compliance with all applicable 
laws and regulations. For these purposes, it should be noted that 
sealed collection receptacle inner liners may be transported inside of 
a shipping container that is labeled and packaged for transport with 
the necessary notice requirements applicable to hazardous waste under 
the DOT's PHMSA.
    [2] Issue: One commenter asked whether or not law enforcement must 
comply with the DOT's PHMSA requirements for transporting collected 
substances that may contain hazardous materials.
    Response: It is not within the DEA's expertise or authority to 
opine on the applicability of DOT regulations. However, the DEA 
believes that the DOT's Hazardous Materials Regulations apply to 
entities that place hazardous materials in commercial transportation, 
and not government vehicles operated by government personnel solely for 
non-commercial purposes. However, State and local governments may have 
different regulations that do apply to government entities or law 
enforcement. The DEA encourages these entities to consult the DOT as 
well as their State and local governments for specific guidance on 
transporting collected substances that may contain hazardous materials.
    [3] Issue: Commenters asked the DEA whether or not collected 
substances must be destroyed as hazardous waste under the EPA's 
Resource Conversation and Recovery Act (RCRA).
    Response: It is not within the DEA's expertise or authority to 
opine what pharmaceutical controlled substances could be hazardous 
waste subject to EPA regulations. The DEA does not have the authority 
to regulate hazardous waste and thus cannot advise on whether or not 
collected substances must be destroyed as hazardous waste pursuant to 
RCRA. However, the DEA has worked with the EPA at various stages of 
this rulemaking, and the DEA continues to work with the EPA to ensure 
the secure and responsible disposal of controlled substances, including 
those that may be considered hazardous waste. The DEA believes that 
there is a small portion of pharmaceuticals that are regulated as 
hazardous waste, and an even smaller portion of pharmaceuticals that 
are regulated as both controlled substances and hazardous waste. 
However, pharmaceutical controlled substances that are collected 
directly from ultimate users via mail-back programs or collection 
receptacles may fall under RCRA's Household Hazardous Waste Exemption; 
if so, EPA RCRA regulations would not apply in those instances. The DEA 
acknowledges that some state and local regulations may be more 
stringent.
    The DEA is working with the EPA to ensure that this final rule will 
enable LTCF residents to responsibly, securely, and safely dispose of 
controlled substances that may also be considered hazardous waste. 
Collected substances from LTCFs may pose a unique challenge since the 
EPA currently uses a bifurcated system to determine whether 
pharmaceutical waste from LTCFs must be treated as hazardous waste 
under the RCRA. If the waste is generated by the resident, it does not 
have to be treated as hazardous waste and is exempt under the Household 
Hazardous Waste Exemption. If the waste is generated by the LTCF, it 
must be treated as hazardous waste unless it is otherwise exempt. 
Hazardous waste generated by LTCFs may be exempt if

[[Page 53555]]

the LTCF is a ``conditionally-exempt small quantity generator.'' To 
qualify under such exemption, the LTCF must generate less than or equal 
to 100 kilograms of non-acute hazardous waste, and less than or equal 
to one kilogram of acute hazardous waste on a monthly basis. The DEA 
believes that most LTCFs may qualify under this conditional exemption. 
Also, the DEA acknowledges that many pharmaceuticals that are 
recognized as acute hazardous waste (e.g., blood thinners) are non-
controlled substances. The DEA hopes that authorized collectors and 
LTCFs will collaborate to minimize the impact that disposing of such 
pharmaceuticals may have on collection efforts by separating these non-
controlled substances from controlled substances to be deposited into 
collection receptacles.
    The EPA is aware of the concerns regarding collected substances at 
LTCFs, and according to the Fall 2013 Regulatory Agenda, the EPA is 
currently drafting regulations to address hazardous waste 
pharmaceuticals, including the small group of pharmaceutical controlled 
substances that the EPA classifies as hazardous waste under the RCRA, 
when discarded. According to the Regulatory Agenda, the EPA's proposal, 
``Management Standards for Hazardous Waste Pharmaceuticals,'' may 
propose to ``revise the regulations to improve management and disposal 
of hazardous waste pharmaceuticals,'' and clarify regulation of reverse 
distribution. The abstract for the proposal may be viewed at 
www.reginfo.gov. Interested persons are encouraged to follow the 
progress of this pending regulatory action.
    The DEA encourages authorized collectors and others to seek 
guidance directly from the EPA, and the DEA encourages such persons to 
consult www.epa.gov for more information. All drug disposal and 
destruction must be conducted in a manner consistent with this rule and 
all other applicable Federal, State, tribal, and local laws and 
regulations.

R. Transporting Collected Substances (3 Issues)

    [1] Issue: One commenter indicated that transporting collected 
substances directly to the destruction location will be virtually 
impossible because drivers must stop for rest breaks.
    Response: The DEA recognizes that transportation to destruction 
facilities may occur over long distances. The requirement to transport 
collected substances directly to the destruction facility means that 
the collected substances should be constantly moving towards their 
final destruction destination and unnecessary or unrelated stops, and 
stops of an extended duration should not occur. The final rule in 
Sec. Sec.  1317.05(b)(4) and 1317.95(c)(1) is modified to specify this 
requirement, which is designed to reduce the opportunities for 
diversion.
    [2] Issue: Several commenters were concerned that this rule will 
change their existing transport procedures that were already approved 
by their local SAC.
    Response: In promulgating this rule, the DEA carefully considered 
the impact of these changes to existing procedures and is requiring the 
minimum procedures necessary to ensure safe and secure means of 
transporting controlled substances. The rule provides a nationwide 
standard, and allows non-practitioners the flexibility to determine the 
best method of transportation considering their own individual 
circumstances while also ensuring accountability and reducing theft and 
diversion risks. Any previous waivers, Memorandums of Understanding, or 
Memorandums of Agreement issued in accordance with Sec.  1307.21 shall 
be superseded by this final rule once it becomes effective. However, 
practitioners may seek assistance from their local SAC pursuant to 
Sec.  1317.05(a)(4).
    [3] Issue: Other commenters sought guidance on whether or not the 
DEA will limit the quantity of controlled substances that may be 
transported, and whether or not there will be additional requirements 
for interstate transport of collected substances.
    Response: This final rule does not impose any transportation 
quantity limits or any requirements specific to interstate transport of 
controlled substances.

S. Miscellaneous Comments (2 Issues)

    [1] Issue: Approximately eight commenters asked the DEA to expand 
the rule to include procedures for controlled substances that have been 
``partially administered'' or ``partially dispensed.'' These commenters 
referred to institutional settings where transdermal patches are used, 
as these used patches may contain residual amounts of controlled 
substances.
    Response: As previously discussed, destruction of the residual 
amounts of controlled substances administered by a practitioner to a 
patient that remain in the delivery apparatus (in this instance, the 
transdermal patch) must continue to be recorded in accordance with 
existing Sec.  1304.22(c). In accordance with the revised Sec.  
1304.21, these destructions are not required to be recorded on DEA Form 
41. All disposals of inventory must be accomplished in accordance with 
Sec.  1317.05(a), and all other applicable recordkeeping and inventory 
requirements.
    [2] Issue: One commenter indicated that Sec. Sec.  1317.15 and 
1317.95 may conflict in that Sec.  1317.15 allows for storage by a 
reverse distributor while Sec.  1317.95 does not.
    Response: The DEA has reviewed the relevant portions of this rule 
and determined that Sec. Sec.  1317.15 and 1317.95 do not conflict. 
Section 1317.15 encompasses the wider topic of reverse distributor 
activities, including the acquisition and storage of controlled 
substances from other registrants, whereas Sec.  1317.95 deals 
exclusively with the actual destruction process and the procedures that 
are required for destruction once substances are in the possession and 
control of the reverse distributor (including securely stored 
substances).

IV. Regulatory Analyses

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act of 1980 (RFA) (5 U.S.C. 601-612), has reviewed this rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. In developing this 
rule, the DEA considered numerous alternatives for each requirement and 
method of collection and evaluated the impact of this rule on small 
entities. The DEA has concluded that the rule will not have a 
significant economic impact on a substantial number of small entities. 
The DEA updated the economic impact analysis after considering comments 
made by the public in response to the NPRM. The updated economic impact 
analysis of the final rule may be viewed in the rulemaking docket at 
www.regulations.gov.
    In developing this rule, the DEA considered several options for 
both registrant and non-registrant disposal and reverse distributor 
destruction requirements. The DEA analyzed alternative methodology 
approaches keeping in mind its obligations under the CSA. The DEA 
considered three options for non-registrant disposal: (1) ``Single 
Collection,'' which would permit non-registrants to utilize only one 
method of collection to dispose of their lawfully possessed controlled 
substances; (2) ``Open Collection,'' which would authorize any person 
to collect controlled substances from ultimate users for disposal, 
regardless of their status as a registrant; and (3)

[[Page 53556]]

``Multiple Collection,'' which would authorize non-registrants to 
utilize more than one method of collection to transfer controlled 
substances for the purpose of disposal to law enforcement and certain 
registrants. In addition, the DEA considered two options for registrant 
disposal: (1) ``Retain Existing Regulations,'' which would make no 
changes to the existing registrant disposal regulations (Sec. Sec.  
1307.12 and 1307.21); and (2) ``Establish Consistent National 
Standards,'' which would eliminate existing regulations on the disposal 
of controlled substances (Sec. Sec.  1307.12 and 1307.21) and 
promulgate a new part that would comprehensively outline the process 
and procedure for the disposal of controlled substances by registrants 
and non-registrants.
    Finally, the DEA considered four options for reverse distributors: 
(1) ``On-site Requirement,'' which would require reverse distributors 
to have and utilize an on-site method of destruction; (2) ``Prompt 
Requirement,'' which would require reverse distributors, like all other 
registrants, to promptly destroy controlled substances; (3) ``No 
Requirement,'' which would retain the current destruction standard and 
would not put a deadline on when reverse distributors must destroy 
controlled substances acquired for destruction; and (4) ``No Later Than 
30 Calendar Day Requirement,'' which would require reverse distributors 
to destroy controlled substances received for the purpose of 
destruction no later than 30 calendar days from receipt. The DEA 
performed a qualitative analysis of each of these alternatives and 
selected the ``Multiple Collection'' option for non-registrant 
disposal, the ``Establish Consistent National Standards'' option for 
registrant disposal, and the ``No Later than 30 Calendar Day 
Requirement'' option for reverse distributors.
    In accordance with the RFA, the DEA evaluated the impact of this 
rule on small entities. While all 1.5 million DEA registrants must 
comply with the rule as it relates to the disposal of pharmaceutical 
controlled substances, only a small subset of the registrants are 
associated with activities where the rule imposes new mandatory 
requirements or provides options for voluntary activities. Therefore, 
the DEA examined the impact of two mandatory provisions in the rule: 
The 30-day destruction requirement for reverse distributors and the two 
employee transportation requirement for manufacturers, distributors, 
and reverse distributors. Additionally, the DEA estimated the level of 
voluntary participation in collection activities in accordance with the 
rule and the resulting cost impact.
    The mandatory provisions and voluntary participation activities are 
estimated to affect 53,533 entities (439 manufacturers, 585 
distributors, 55 reverse distributors, 656 narcotic treatment programs 
(NTPs), 3,068 hospitals/clinics, 29,582 pharmacies, and 19,148 long 
term care facilities (LTCFs). Of the 53,533 affected entities, 50,714 
(423 manufacturers, 555 distributors, 38 reverse distributors, 610 
NTPs, 1,346 hospitals/clinics, 29,328 pharmacies, and 18,414 long term 
care facilities), or 94.7% are estimated to be small entities.
    Both the 30-day destruction and the two employee transportation 
requirements associated with the mandatory portions of the rule will 
apply to the 55 reverse distributors that receive controlled substances 
from other registrants for disposal, of which 38 were estimated to be 
small entities. The potential increase in destruction, transport, 
travel, and labor cost associated with these two requirements was 
analyzed for each of the 38 small entities. Additionally, reverse 
distributors with on-site destruction facilities may receive 
authorization to voluntarily operate a mail-back program. The DEA 
estimates that the three small reverse distributors with on-site 
destruction facilities will each operate a mail-back program. The DEA 
does not estimate that any reverse distributors will operate collection 
receptacles at their registered locations because of the small numbers 
of employees that work at those locations. However, reverse 
distributors will be impacted by the destruction of controlled 
substances from collection receptacles that are transferred to them for 
destruction. The total estimated cost of the mandatory portions and 
voluntary participation aspects of the rule was compared to the 
estimated annual revenue for each of the small reverse distributors. 
The economic impact of the mandatory portion and voluntary 
participation aspects of this rule is estimated to be significant, 
greater than one percent of annual revenue, for two (5%) of 38 affected 
small businesses.
    The two-person transportation requirement associated with the 
mandatory portions of the rule also affects 423 small manufacturers and 
555 small distributors that transport to reverse distributors or to an 
unregistered, off-site location for destruction. The potential increase 
in labor cost associated with the two-person requirement was analyzed 
for manufacturers and distributors. Additionally, a small number of 
manufacturers and distributors are estimated to volunteer to operate 
collection receptacles at their registered locations primarily for use 
by their employees. However, the DEA believes that manufacturers and 
distributors will not operate collection receptacles at their 
registered locations unless they believe there will be a benefit to 
them for the service. The economic impact of the mandatory portion and 
voluntary participation aspects of this rule is estimated to be 
significant for none (0.0%) of the 423 small manufacturers and none 
(0.0%) of the 555 small distributors.
    The rule also permits certain other registrant categories to 
voluntarily conduct collection activities. The DEA estimates some 
retail pharmacies, hospitals/clinics with on-site pharmacies, and NTPs 
will voluntarily participate as collectors by operating collection 
receptacles at their locations. Some retail pharmacies and hospitals/
clinics with an on-site pharmacy are also estimated to operate 
collection receptacles at LTCFs. The level of participation and 
operating costs were estimated to determine the number of small 
entities with impact greater than 1% of revenue.
    In summary, the DEA estimates that zero (0.0%) of the 423 small 
manufacturers, zero (0.0%) of the 555 small distributors, two (5.0%) of 
38 small reverse distributors, 62 (10.2%) of the small NTPs, zero 
(0.0%) of the 1,349 small hospitals/clinics, 810 (2.8%) of the 29,328 
small pharmacies, and zero (0.0%) of the 18,414 small long term care 
facilities may be significantly impacted by this rule (that is, where 
the annual cost is estimated to be greater than 1% of annual revenue). 
But DEA emphasizes that these estimates are entirely dependent on the 
level of voluntary participation by these entities. All of the 
provisions relating to collection activities by manufacturers, 
distributors, NTPs, hospitals/clinics, pharmacies, and LTCFs are 
completely voluntary and these entities would be free to choose whether 
or not to participate based on their own review of the cost to them and 
the anticipated benefits in providing collection receptacles.
    In total, the DEA estimates that 874 (1.7%) of the 50,714 affected 
small entities may be significantly affected by this rule. The DEA's 
assessment of economic impact by size category indicates that the rule 
will not have a significant effect on a substantial number of these 
small business entities.
    In accordance with the RFA (5 U.S.C. 605(b)), the Administrator 
hereby certifies that this rulemaking has been

[[Page 53557]]

drafted consistent with the RFA, that a regulatory analysis on the 
effects or impacts of this rulemaking on small entities has been done, 
and that the rule will not have a significant economic impact on a 
substantial number of small entities.

Executive Orders 12866 and 13563

    This rule was developed in accordance with the principles of 
Executive Orders 12866 and 13563. Based on the completed economic 
analysis, the DEA does not anticipate that this rulemaking will have an 
annual effect on the economy of $100 million or more or adversely 
affect, in a material way, the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities. An 
economic analysis of the final rule can be found in the rulemaking 
docket at www.regulations.gov. Public comment was received in public 
meetings held on January 19-20, 2011, and through a solicitation for 
comment in the NPRM to help inform and develop these rules. Although 
not an economically significant rule, this rule on the disposal of 
controlled substances has been reviewed by the Office of Management and 
Budget (OMB).
    The DEA has determined that reverse distributors currently destroy 
controlled substances within the ``No Later than 30 Calendar Day'' 
requirement the majority of the time. However, it is recognized that 
there may be instances when reverse distributors do not currently meet 
this requirement. Additionally, many manufacturers, distributors, and 
reverse distributors currently employ two persons to transport 
controlled substances for destruction. However, it is recognized that 
there may be instances when manufacturers, distributors, and reverse 
distributors do not currently meet this requirement. For these 
instances, the DEA estimated the cost to accommodate the requirements 
and has determined the cost is not a significant economic impact.
    Moreover, the DEA estimated a range of costs of voluntary 
participation for manufacturers, distributors, reverse distributors, 
narcotic treatment programs, hospitals/clinics with an on-site 
pharmacy, and retail pharmacies that may participate to collect 
ultimate user pharmaceutical controlled substances.
    In summary, the DEA estimates that the annual total cost to the 
economy as a result of the rule is $2,719,319 for the mandatory 
provisions of this rule and the total annualized cost of the mandatory 
provisions and the voluntary participation aspects of the rule ranges 
from $44,896,787 to $73,222,427. The DEA estimates the highest cost in 
any given year occurs in the first year, ranging from $45,282,242 to 
$99,075,339. Accordingly, the DEA does not anticipate that this 
rulemaking will have an annual effect on the economy of $100 million or 
more or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities.
    Since the aspects of the rule that facilitate non-registrant 
disposal are completely voluntary (not mandated), manufacturers, 
distributors, reverse distributors, narcotic treatment programs, 
hospitals/clinics with an on-site pharmacy, and retail pharmacies may 
become collectors if they choose to engage in the voluntary activities 
based on its own evaluation of costs and benefits (tangible and 
intangible). For the purposes of this analysis, the DEA assumes that an 
entity will volunteer to perform the activities to facilitate 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 their collection activities. Any collector that chooses 
to engage in these voluntary activities can decide to cease these 
activities at any time. Therefore, for the purposes of this analysis, 
the DEA estimates that the cost of the voluntary participation aspects 
of this rule are offset by the benefits of the voluntary participation 
aspects of this rule and have a net zero economic impact. The total 
cost of the mandatory provisions and voluntary participation aspects of 
the rule ($73,222,427 at the highest voluntary participation rate) is 
compared to the benefit of this rule. In evaluating the costs and 
benefits of the rule, the annual cost of the rule is compared with the 
anticipated reduction in the growth rate of costs associated with 
diversion of controlled substances into the illicit market. The cost-
benefit analysis uses the costs associated with the nonmedical use of 
prescription opioids, $8.6 billion in 2001 \7\ and $53.4 billion in 
2006.\8\ These are conservative estimates of the rapidly growing total 
cost associated with diversion of controlled substances into the 
illicit market. Although there is a lack of evidence to quantify the 
cost savings or public health impacts of the rule, the DEA believes 
that this rule reduces the growth in the cost of the diversion of 
controlled substances into the illicit market by at least $44.9 to 
$73.2 million annually and, therefore, this rule will have positive net 
economic benefits, including benefits related to the health and safety 
of the citizens and residents of the United States.
---------------------------------------------------------------------------

    \7\ Clin. J. Pain (The Clinical Journal of Pain), Volume 22, 
Number 8, October 2006.
    \8\ Clin. J. Pain (The Clinical Journal of Pain), Volume 27, 
Number 3, March/April 2011.
---------------------------------------------------------------------------

Paperwork Reduction Act

    Pursuant to Sec.  3507(d) of the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501 et seq.), the DEA has identified the following 
collections of information related to this rule and has submitted these 
collection requests to the OMB for review and approval. This rule 
implements the Disposal Act, in addition to reorganizing and 
consolidating existing regulations on disposal into a comprehensive 
regulatory framework for the destruction of controlled substances. In 
accordance with the CSA, which establishes a closed system of 
distribution for all controlled substances, registrants are required to 
make a biennial inventory and maintain, on a current basis, a complete 
and accurate record of each controlled substance manufactured, 
received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827(a) 
and 958. These records must be in accordance with and contain such 
relevant information as may be required by regulations promulgated by 
the DEA. 21 U.S.C. 827(b)(1).
    In this rule, the DEA revises existing, and adds a minimum amount 
of new, registrant recordkeeping requirements. These requirements are 
consistent with requirements already required by statute and 
regulation.

Title: Implementation of Registrant Recordkeeping Requirements Pursuant 
to the CSA, 21 U.S.C. 827

    The records that registrants are required to maintain pursuant to 
law are a vital component of the DEA's enforcement and control 
responsibilities--such records alert the DEA to problems of diversion 
and ensure that the system of controlled substances distribution is 
open only to legitimate handlers of such substances.
    The DEA is revising the information that reverse distributors are 
currently required to record for clarity and consistency, and adding a 
minimum amount of new requirements. For all controlled substance 
records, reverse distributors will be required to maintain their 
existing business records so that

[[Page 53558]]

the record of receipt is maintained with the corresponding record of 
return or destruction. By maintaining all relevant business records 
together, the DEA will be able to trace each substance received by a 
reverse distributor from its acquisition to its disposition, whether by 
destruction or return to the manufacturer.
    The DEA estimates that there will be 60 respondents to this 
information collection and that their estimated frequency of response 
will vary because, in accordance with 21 U.S.C. 827 and 958, 
registrants make an initial and biennial inventory and maintain, on a 
current basis, a complete and accurate record of each controlled 
substance manufactured, received, sold, delivered, or otherwise 
disposed of. Under existing law, reverse distributors are required to 
maintain, for at least two years, inventory records and records of 
controlled substances received, delivered, destroyed, or returned to 
the manufacturer. The annual hour burden for recordkeeping for reverse 
distributors is estimated to increase by 34 hours due to the 
requirements in this final rule, and the annualized cost to respondents 
is estimated to be $719. The DEA is also modifying information that 
registrants are required to record in the return and recall process. 
The DEA is eliminating the previous rule on return and recall, Sec.  
1307.12, and implementing separate rules on the return and recall of 
controlled substances for registrants and non-registrants in part 1317. 
The return and recall recordkeeping requirements reflect these changes.
    The DEA estimates that the universe of potential respondents to 
this information collection will be 1,511,389 respondents (all 
registrants may transfer controlled substances for return or recall). 
The DEA estimates that the frequency of response will vary, because, in 
accordance with 21 U.S.C. 827(a), registrants must make an initial and 
biennial inventory and maintain, on a current basis, a complete and 
accurate record of each controlled substance manufactured, received, 
sold, delivered, or otherwise disposed of. Because registrants are 
already required to maintain records in accordance with 21 U.S.C. 
827(a)-(b), the DEA anticipates that the annual hour burden will not be 
increased by this rule.
    The DEA is implementing new recordkeeping requirements for 
registrants that collect controlled substances from ultimate users and 
other non-registrants in accordance with the new authority provided in 
the Disposal Act. The implementation of the Disposal Act regulations 
will provide ultimate users, LTCFs, and other non-registrants safe and 
convenient options to transfer controlled substances for the purpose of 
disposal: Take-back events, mail-back programs, and collection 
receptacles. Registered manufacturers, distributors, reverse 
distributors, narcotic treatment programs, hospitals/clinics with an 
on-site pharmacy, and retail pharmacies may obtain authorization from 
the DEA to be a collector pursuant to Sec.  1317.40. A collector is a 
registered manufacturer, distributor, reverse distributor, narcotic 
treatment program, hospital/clinic with an on-site pharmacy, or retail 
pharmacy that is authorized under this rule to receive a pharmaceutical 
controlled substance from an ultimate user for the purpose of 
destruction, as defined in part 1300. The DEA is requiring information 
that collectors must record based on the particular ultimate user 
collection method implemented (i.e., mail-back program or collection 
receptacle).
    The DEA estimates that the universe of potential participants to 
this information collection will be 87,736 respondents (Manufacturers--
536, Distributors--829, Reverse Distributors--60, Narcotic Treatment 
Programs--1,332, Hospitals/Clinics--15,953, Retail Pharmacies--
69,026).\9\ However, the DEA estimates that the participants to this 
information collection will be 54,457 respondents (Manufacturers--107, 
Distributors--166, Reverse Distributors--10, Narcotic Treatment 
Programs--999, Hospitals/Clinics--2862, Retail Pharmacies--34,513, and 
an additional 15,800 hospitals/clinics and retail pharmacies operating 
collection receptacles at LTCFs). The DEA estimates that the frequency 
of response will vary, because, in accordance with 21 U.S.C. 827(a), 
registrants must make an initial and biennial inventory and maintain, 
on a current basis, a complete and accurate record of each controlled 
substance manufactured, received, sold, delivered, or otherwise 
disposed of. The DEA notes, however, that the option to become a 
collector is voluntary and no entity is required to establish or 
operate a disposal program as a collector. While the authorization to 
collect is a new activity, the DEA has estimated the level of 
participation. The estimated 54,457 respondents are estimated to have 
an annualized hour burden of 89,406 with an estimated annualized cost 
of $1,670,064. The DEA will continue to monitor and analyze the 
potential burden of the new requirements imposed by this rule.
---------------------------------------------------------------------------

    \9\ The universe of potential participants includes all 
registrants that could potentially become collectors. It is likely 
that this estimate will be adjusted downward once the DEA obtains 
more information.
---------------------------------------------------------------------------

    The DEA is authorizing reverse distributors to acquire controlled 
substances from law enforcement and authorized collectors that have 
acquired controlled substances from ultimate users and other non-
registrants. The DEA is also authorizing distributors to acquire 
controlled substances from authorized collectors that collect 
controlled substances from ultimate users. The DEA is requiring these 
reverse distributors and distributors to maintain complete and accurate 
records, in accordance with part 1304, of controlled substances 
received, delivered, or otherwise transferred for the purpose of 
destruction.
    The DEA estimates that the universe of potential respondents to 
this information collection will be 889 respondents (Distributors--829, 
Reverse Distributors--60). The DEA estimates that the frequency of 
response will vary, because, in accordance with 21 U.S.C. 827(a), 
registrants must make an initial and biennial inventory and maintain, 
on a current basis, a complete and accurate record of each controlled 
substance manufactured, received, sold, delivered, or otherwise 
disposed of. The authorization for reverse distributors to acquire 
controlled substances collected by law enforcement and collectors, and 
the authorization for distributors to acquire controlled substances 
from collectors, is new. Although the DEA has estimated the level of 
participation, the DEA is unable to estimate the number of information 
collection events because destruction of multiple acquisitions of 
controlled substances can be on a single form. The DEA's initial 
estimate for the annual hour burden is 472 hours (32 minutes per 
event), with an estimated annualized cost of $10,037. The DEA will 
continue to analyze the potential burden of the new requirements 
imposed by this rule.

Title: Registrant Record of Controlled Substances Destroyed--DEA Form 
41

    OMB Control Number: 1117-0007.
    Form Number: DEA Form 41.
    The records that registrants are required to maintain pursuant to 
law are a vital component of the DEA's enforcement and control 
responsibilities--such records alert the DEA to diversion and ensure 
that the system of controlled substances distribution is open only to 
legitimate handlers of such substances. The DEA is requiring 
registrants involved in the destruction of controlled substances to 
record certain information. The record

[[Page 53559]]

of destruction must include the signature of the two employees of the 
registrant that witnessed the destruction, in addition to other 
information about the controlled substance disposed of and the method 
of destruction utilized. The DEA is modifying existing DEA Form 41 to 
record the destruction of controlled substances that remain in the 
closed system of distribution and to account for registrant destruction 
of controlled substances collected from ultimate users and other non-
registrants outside the closed system pursuant to the Disposal Act. DEA 
Form 41 has previously been approved by the OMB and assigned OMB 
control number 1117-0007. In accordance with the CSA, registrants that 
destroy controlled substances and utilize DEA Form 41 will be required 
to keep and make available the information in the specified format, for 
at least two years, for inspection and copying by officers or employees 
of the United States authorized by the Attorney General. 21 U.S.C. 
827(b).
    The DEA estimates that there will be 87,736 respondents 
(Manufacturers--536, Distributors--829, Reverse Distributors--60, 
Narcotic Treatment Programs--1,332, Hospitals/Clinics--15,953, Retail 
Pharmacies--69,026) to this information collection. The number of 
respondents (87,736) represents the total number of registrants in 
business activities that are most likely to destroy controlled 
substances. The DEA estimates that the frequency of response will vary, 
because in accordance with 21 U.S.C. 827(a), registrants must maintain, 
on a current basis, a complete and accurate record of each controlled 
substance manufactured, received, sold, delivered, or otherwise 
disposed of, and, as a result, will make a record of destruction each 
time they destroy a controlled substance. The DEA estimates that the 
average time per response will be 30 minutes and that the total annual 
burden will be 43,868 hours, with an estimated total annual cost burden 
of $928,247.

Executive Order 12988

    This rule meets the applicable standards set forth in Sec. Sec.  
3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, 
minimize litigation, establish clear legal standards, and reduce 
burden.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of State 
law, impose enforcement responsibilities on any State or diminish the 
power of any State to enforce its own laws. Accordingly, this 
rulemaking does not have federalism implications warranting the 
application of Executive Order 13132.

National Environmental Policy Act (NEPA)

    This rule provides options for the collection of controlled 
substances by registrants and non-registrants consistent with DEA 
regulations and Federal, State, tribal, and local laws and regulations. 
Provision of these options is intended to result in increased 
collection and destruction of unused controlled substances and thereby 
prevent diversion of such unused substances to illicit uses and result 
in collection and destruction of larger quantities in economical and 
environmentally sound manners. This rule establishes legal requirements 
for the handling of controlled substances. Destruction of controlled 
substances must be consistent with Federal, State, tribal and local 
laws and regulations.
    The DEA and registrants have disposed of controlled substances 
since passage of the CSA. By regulation, the U.S. Department of Justice 
categorically excluded the DEA from further NEPA analysis with respect 
to regulations relating to the storage and destruction of controlled 
substances. This rule does not authorize any new methods of storage, 
transportation, or destruction of controlled substances, but is limited 
to the procedures and records pertaining to the collection of 
controlled substances for destruction. Accordingly, this proposed rule 
does not significantly affect the quality of the human environment. The 
DEA has, therefore, determined that this rule does not have significant 
individual or cumulative effects on the human environment and is 
excluded from detailed analysis pursuant to 28 CFR part 61, Appendix B.

Unfunded Mandates Reform Act

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995 
(2 U.S.C. 1501 et seq.), on the basis of information contained in the 
``Regulatory Flexibility Act'' section above, the DEA has determined 
and certifies pursuant to the UMRA that this action would not result in 
any Federal mandate that may result ``in the expenditure by State, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $100,000,000 or more (adjusted for inflation) in any one 
year. . . .'' Therefore, neither a Small Government Agency Plan nor any 
other action is required under provisions of the UMRA of 1995.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. The rule does not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (5 U.S.C. 804). This rule will not result in an annual 
effect on the economy of $100,000,000 or more, a major increase in 
costs or prices, or have significant adverse effects on competition, 
employment, investment, productivity, innovation, or the ability of 
United States-based companies to compete with foreign based companies 
in domestic and export markets.

Rule Text

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1305

    Drug traffic control.

21 CFR Part 1307

    Drug traffic control.

21 CFR Part 1317

    Drug traffic control, Security measures.
    For the reasons stated in the preamble, the DEA amends 21 CFR 
chapter II as follows:

PART 1300--DEFINITIONS

0
1-2. The authority citation for part 1300 is revised to read as 
follows:

    Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).

0
3. In Sec.  1300.01, amend paragraph (b) as follows:
0
a. Revise the introductory text;
0
b. Add a definition of ``Collection'' in alphabetical order;
0
c. Revise the last sentence in the definition of ``Freight forwarding 
facility'';
0
d. Add a definition of ``Reverse distribute'' in alphabetical order; 
and

[[Page 53560]]

0
e. Revise the definition of ``Reverse distributor''.
    The revisions and additions read as follows:

Sec.  1300.01  Definitions relating to controlled substances.

* * * * *
    (b) As used in parts 1301 through 1308, 1312, and 1317 of this 
chapter, the following terms shall have the meanings specified:
* * * * *
    Collection means to receive a controlled substance for the purpose 
of destruction from an ultimate user, a person lawfully entitled to 
dispose of an ultimate user decedent's property, or a long-term care 
facility on behalf of an ultimate user who resides or has resided at 
that facility. The term collector means a registered manufacturer, 
distributor, reverse distributor, narcotic treatment program, hospital/
clinic with an on-site pharmacy, or retail pharmacy that is authorized 
under this chapter to so receive a controlled substance for the purpose 
of destruction.
* * * * *
    Freight forwarding facility * * * For purposes of this definition, 
a distributing registrant is a person who is registered with the 
Administration as a manufacturer, distributor (excluding reverse 
distributor), and/or importer.
* * * * *
    Reverse distribute means to acquire controlled substances from 
another registrant or law enforcement for the purpose of:
    (1) Return to the registered manufacturer or another registrant 
authorized by the manufacturer to accept returns on the manufacturer's 
behalf; or
    (2) Destruction.
    Reverse distributor is a person registered with the Administration 
as a reverse distributor.
* * * * *
0
4. Add Sec.  1300.05 to read as follows:

Sec.  1300.05  Definitions relating to the disposal of controlled 
substances.

    (a) Any term not defined in this part or elsewhere in this chapter 
shall have the definition set forth in section 102 of the Act (21 
U.S.C. 802).
    (b) As used in part 1317 of this chapter, the following terms shall 
have the meanings specified:
    Employee means an employee as defined under the general common law 
of agency. Some of the factors relevant to the determination of 
employee status include: The hiring party's right to control the manner 
and means by which the product is accomplished; the skill required; the 
source of the instrumentalities and tools; the location of the work; 
the duration of the relationship between the parties; whether the 
hiring party has the right to assign additional projects to the hired 
party; the extent of the hired party's discretion over when and how 
long to work; the method of payment; the hired party's role in hiring 
and paying assistants; whether the work is part of the regular business 
of the hiring party; whether the hiring party is in business; the 
provision of employee benefits; and the tax treatment of the hired 
party. Other applicable factors may be considered and no one factor is 
dispositive. The following criteria will determine whether a person is 
an employee of a registrant for the purpose of disposal: The person is 
directly paid by the registrant; subject to direct oversight by the 
registrant; required, as a condition of employment, to follow the 
registrant's procedures and guidelines pertaining to the handling of 
controlled substances; subject to receive a performance rating or 
performance evaluation on a regular/routine basis from the registrant; 
subject to disciplinary action by the registrant; and required to 
render services at the registrant's registered location.
    Law enforcement officer means a person who is described in 
paragraph (1), (2) or (3) of this definition:
    (1) Meets all of the following criteria:
    (i) Employee of either a law enforcement agency, or law enforcement 
component of a Federal agency;
    (ii) Is under the direction and control of a Federal, State, 
tribal, or local government;
    (iii) Acting in the course of his/her official duty; and
    (iv) Duly sworn and given the authority by a Federal, State, 
tribal, or local government to carry firearms, execute and serve 
warrants, make arrests without warrant, and make seizures of property;
    (2) Is a Veterans Health Administration (VHA) police officer 
authorized by the Department of Veterans Affairs to participate in 
collection activities conducted by the VHA; or
    (3) Is a Department of Defense (DOD) police officer authorized by 
the DOD to participate in collection activities conducted by the DOD.
    Non-retrievable means, for the purpose of destruction, the 
condition or state to which a controlled substance shall be rendered 
following a process that permanently alters that controlled substance's 
physical or chemical condition or state through irreversible means and 
thereby renders the controlled substance unavailable and unusable for 
all practical purposes. The process to achieve a non-retrievable 
condition or state may be unique to a substance's chemical or physical 
properties. A controlled substance is considered ``non-retrievable'' 
when it cannot be transformed to a physical or chemical condition or 
state as a controlled substance or controlled substance analogue. The 
purpose of destruction is to render the controlled substance(s) to a 
non-retrievable state and thus prevent diversion of any such substance 
to illicit purposes.
    On-site means located on or at the physical premises of the 
registrant's registered location. A controlled substance is destroyed 
on-site when destruction occurs on the physical premises of the 
destroying registrant's registered location. A hospital/clinic has an 
on-site pharmacy when it has a pharmacy located on the physical 
premises of the registrant's registered location.

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
5. The authority citation for part 1301 is revised to read as follows:

    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 953, 956, 957, 958, 965.

0
6. In Sec.  1301.13, revise paragraphs (e)(1)(i) and (ii) 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 53561]]

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Application fee    Registration     Coincident activities
           Business activity              Controlled substances      DEA application forms          ($)         period (years)           allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing.....................  Schedules I-V............  New--225 Renewal--225a...            3,047                1  Schedules I-V: May
                                                                                                                                 distribute that
                                                                                                                                 substance or class for
                                                                                                                                 which registration was
                                                                                                                                 issued; may not
                                                                                                                                 distribute any
                                                                                                                                 substance or class for
                                                                                                                                 which not registered.
                                                                                              ...............  ...............  Schedules II-V: May
                                                                                                                                 conduct chemical
                                                                                                                                 analysis and
                                                                                                                                 preclinical research
                                                                                                                                 (including quality
                                                                                                                                 control analysis) with
                                                                                                                                 substances listed in
                                                                                                                                 those schedules for
                                                                                                                                 which authorization as
                                                                                                                                 a mfr. was issued.
(ii) Distributing.....................  Schedules I-V............  New--225 Renewal--225a...            1,523                1  May acquire Schedules II-
                                                                                                                                 V controlled substances
                                                                                                                                 from collectors for the
                                                                                                                                 purposes of
                                                                                                                                 destruction.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
7. In Sec.  1301.25, revise 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.
0
8. 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 or to change 
his/her name or address by submitting a written request to the 
Registration Unit, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec.  1321.01 of this chapter for the current 
mailing address. Additionally, such a request may be submitted on-line 
at www.DEAdiversion.usdoj.gov.
    (1) The request shall contain:
    (i) The registrant's name, address, and registration number as 
printed on the certificate of registration;
    (ii) The substances and/or schedules to be added to the 
registration or the new name or address; and
    (iii) A signature in accordance with Sec.  1301.13(j).
    (2) If the registrant is seeking to handle additional controlled 
substances listed in Schedule I for the purpose of research or 
instructional activities, the registrant shall attach three copies of a 
research protocol describing each research project involving the 
additional substances, or two copies of a statement describing the 
nature, extent, and duration of such instructional activities, as 
appropriate.
    (b) Any manufacturer, distributor, reverse distributor, narcotic 
treatment program, hospital/clinic with an on-site pharmacy, or retail 
pharmacy registered pursuant to this part, may apply to modify its 
registration to become authorized as a collector by submitting a 
written request to the Registration Unit, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec.  1321.01 
of this chapter for the current mailing address. Additionally, such 
request may be submitted on-line at www.DEAdiversion.usdoj.gov.
    (1) The request shall contain:
    (i) The registrant's name, address, and registration number as 
printed on the certificate of registration;
    (ii) The method(s) of collection the registrant intends to conduct 
(collection receptacle and/or mail-back program); and
    (iii) A signature in accordance with Sec.  1301.13(j).
    (2) If a hospital/clinic with an on-site pharmacy or retail 
pharmacy is applying for a modification in registration to authorize 
such registrant to be a collector to maintain a collection receptacle 
at a long-term care facility in accordance with Sec.  1317.80 of this 
chapter, the request shall also include the name and physical location 
of each long-term care facility at which the hospital/clinic with an 
on-site pharmacy, or the retail pharmacy, intends to operate a 
collection receptacle.
    (c) No fee shall be required for modification. The request for 
modification shall be handled in the same manner as an application for 
registration. If the modification of registration is approved, the 
Administrator shall issue a new certificate of registration (DEA Form 
223) to the registrant, who shall maintain it with the old certificate 
of registration until expiration.

0
9. In Sec.  1301.52, revise the last sentence of paragraph (c) and add 
paragraph (f) to read as follows:

Sec.  1301.52  Termination of registration; transfer of registration; 
distribution upon discontinuance of business.

* * * * *
    (c) * * * Any controlled substances in his/her possession may be 
disposed of in accordance with part 1317 of this chapter.
* * * * *
    (f) Any registrant that has been authorized as a collector and 
desires to discontinue its collection of controlled substances from 
ultimate users shall notify the Administration of its intent by 
submitting a written notification to the Registration Unit, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec.  1321.01 of this chapter for the current mailing address. 
Additionally, such notice may be submitted on-line at 
www.DEAdiversion.usdoj.gov. When ceasing collection activities of an 
authorized mail-back program, the registrant shall provide the 
Administration with the name, registered address, and registration 
number of the collector that will receive the remaining mail-back 
packages in accordance with Sec.  1317.70(e)(3) of this chapter.

0
10. In Sec.  1301.71, add paragraph (f) to read as follows:

Sec.  1301.71  Security requirements generally.

* * * * *
    (f) A collector shall not employ, as an agent or employee who has 
access to or influence over controlled substances acquired by 
collection, any person who has been convicted of any felony offense 
relating to controlled substances or who, at any time, had an 
application for registration with DEA denied, had a DEA registration 
revoked or suspended,

[[Page 53562]]

or has surrendered a DEA registration for cause. For purposes of this 
subsection, ``for cause'' means in lieu of, or as a consequence of, any 
Federal or State administrative, civil, or criminal action resulting 
from an investigation of the individual's handling of controlled 
substances.

0
11. In Sec.  1301.72, revise 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, finished products which are controlled substances 
listed in Schedule I or II (except GHB that is manufactured or 
distributed in accordance with an exemption under section 505(i) of the 
Federal Food Drug and Cosmetic Act which shall be subject to the 
requirements of paragraph (b) of this section), and sealed mail-back 
packages and inner liners acquired in accordance with part 1317 of this 
chapter, shall be stored in one of the following secured areas:
* * * * *

0
12. In Sec.  1301.74, add paragraph (m) to read as follows:

Sec.  1301.74  Other security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs.

* * * * *
    (m) A reverse distributor shall not employ, as an agent or employee 
who has access to or influence over controlled substances, any person 
who has been convicted of any felony offense relating to controlled 
substances or who, at any time, had an application for registration 
with the DEA denied, had a DEA registration revoked or suspended, or 
has surrendered a DEA registration for cause. For purposes of this 
subsection, ``for cause'' means in lieu of, or as a consequence of, any 
Federal or State administrative, civil, or criminal action resulting 
from an investigation of the individual's handling of controlled 
substances.

0
13. In Sec.  1301.75, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (e) and add a new paragraph (c) to read as follows:

Sec.  1301.75  Physical security controls for practitioners.

* * * * *
    (c) Sealed mail-back packages and inner liners collected in 
accordance with part 1317 of this chapter shall only be stored at the 
registered location in a securely locked, substantially constructed 
cabinet or a securely locked room with controlled access, except as 
authorized by Sec.  1317.80(d).
* * * * *

0
14. In Sec.  1301.76, revise paragraph (c) to read as follows:

Sec.  1301.76  Other security controls for practitioners.

* * * * *
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor as permitted in Sec. Sec.  
1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), he/
she shall comply with the requirements imposed on non-practitioners in 
Sec.  1301.74(a), (b), and (e).
* * * * *

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
15. The authority citation for part 1304 is revised to read as follows:

    Authority:  21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 
965, unless otherwise noted.

0
16. Amend Sec.  1304.03 by revising the first and second sentences of 
paragraph (a) to read as follows:

Sec.  1304.03  Persons required to keep records and file reports.

    (a) Every registrant, including collectors, shall maintain the 
records and inventories and shall file the reports required by this 
part, except as exempted by this section. Any registrant that is 
authorized to conduct other activities without being registered to 
conduct those activities, pursuant to Sec. Sec.  1301.22(b), 1307.11, 
1307.13, or part 1317 of this chapter, shall maintain the records and 
inventories and shall file the reports required by this part for 
persons registered or authorized to conduct such activities. * * *
* * * * *

0
17. In Sec.  1304.04, add paragraph (a)(3) to read as follows:

Sec.  1304.04  Maintenance of records and inventories.

    (a) * * *
    (3) A collector that is authorized to maintain a collection 
receptacle at a long-term care facility shall keep all records required 
by this part relating to those collection receptacles at the registered 
location, or other approved central location.
* * * * *

0
18. In Sec.  1304.11, revise paragraphs (e) introductory text and 
(e)(2) and (3) and add paragraphs (e)(6) and (7) to read as follows:

Sec.  1304.11  Inventory requirements.

* * * * *
    (e) Inventories of manufacturers, distributors, registrants that 
reverse distribute, importers, exporters, chemical analysts, 
dispensers, researchers, and collectors. Each person registered or 
authorized (by Sec. Sec.  1301.13, 1307.11, 1307.13, or part 1317 of 
this chapter) to manufacture, distribute, reverse distribute, dispense, 
import, export, conduct research or chemical analysis with controlled 
substances, or collect controlled substances from ultimate users, and 
required to keep records pursuant to Sec.  1304.03 shall include in the 
inventory the information listed below.
* * * * *
    (2) Inventories of distributors. Each person registered or 
authorized to distribute controlled substances shall include in the 
inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1)(iii) and (iv) of this section.
    (3) Inventories of registrants that reverse distribute. Each person 
registered or authorized to reverse distribute controlled substances 
shall include in the inventory, the following information:
    (i) The name of the substance, and
    (ii) The total quantity of the substance:
    (A) For controlled substances in bulk form, to the nearest metric 
unit weight consistent with unit size;
    (B) For each controlled substance in finished form: Each finished 
form of the substance (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter); the number of units or 
volume of each finished form in each commercial container (e.g., 100-
tablet bottle or 3-milliliter vial); and the number of commercial 
containers of each such finished form (e.g., four 100-tablet bottles or 
six 3-milliliter vials); and
    (C) For controlled substances in a commercial container, carton, 
crate, drum, or other receptacle that has been opened: If the substance 
is listed in Schedule I or II, make an exact count or measure of the 
contents; or if the substance is listed in Schedule III, IV, or V, make 
an estimated count or measure of the contents, unless the container 
holds more than 1,000 tablets or capsules in which case an exact count 
of the contents shall be made; or
    (iii) For controlled substances acquired from collectors and law 
enforcement: The number and size (e.g., five 10-gallon liners, etc.) of 
sealed inner liners on hand, or
    (iv) For controlled substances acquired from law enforcement: the

[[Page 53563]]

number of sealed mail-back packages on hand.
* * * * *
    (6) Inventories of dispensers and researchers. Each person 
registered or authorized to dispense or conduct research with 
controlled substances shall include in the inventory the same 
information required of manufacturers pursuant to paragraphs 
(e)(1)(iii) and (iv) of this section. In determining the number of 
units of each finished form of a controlled substance in a commercial 
container that has been opened, the dispenser or researcher shall do as 
follows:
    (i) If the substance is listed in Schedules I or II, make an exact 
count or measure of the contents; or
    (ii) If the substance is listed in Schedule III, IV, or V, make an 
estimated count or measure of the contents, unless the container holds 
more than 1,000 tablets or capsules in which case he/she must make an 
exact count of the contents.
    (7) Inventories of collectors. Each registrant authorized to 
collect controlled substances from ultimate users shall include in the 
inventory the following information:
    (i) For registrants authorized to collect through a mail-back 
program, the record shall include the following information about each 
unused mail-back package and each returned mail-back package on hand 
awaiting destruction:
    (A) The date of the inventory;
    (B) The number of mail-back packages; and
    (C) The unique identification number of each package on hand, 
whether unused or awaiting destruction.
    (ii) For registrants authorized to collect through a collection 
receptacle, the record shall include the following information about 
each unused inner liner on hand and each sealed inner liner on hand 
awaiting destruction:
    (A) The date of the inventory;
    (B) The number and size of inner liners (e.g., five 10-gallon 
liners, etc.);
    (C) The unique identification number of each inner liner.

0
19. In Sec.  1304.21, revise paragraphs (a), (c), and (d) and add 
paragraph (e) to read as follows:

Sec.  1304.21  General requirements for continuing records.

    (a) Every registrant required to keep records pursuant to Sec.  
1304.03 shall maintain, on a current basis, a complete and accurate 
record of each substance manufactured, imported, received, sold, 
delivered, exported, or otherwise disposed of by him/her, and each 
inner liner, sealed inner liner, and unused and returned mail-back 
package, except that no registrant shall be required to maintain a 
perpetual inventory.
* * * * *
    (c) Separate records shall be maintained by a registrant for each 
independent activity and collection activity for which he/she is 
registered or authorized, except as provided in Sec.  1304.22(d).
    (d) In recording dates of receipt, importation, distribution, 
exportation, other transfers, or destruction, the date on which the 
controlled substances are actually received, imported, distributed, 
exported, otherwise transferred, or destroyed shall be used as the date 
of receipt, importation, distribution, exportation, transfer, or 
destruction (e.g., invoices, packing slips, or DEA Form 41).
    (e) Record of destruction. In addition to any other recordkeeping 
requirements, any registered person that destroys a controlled 
substance pursuant to Sec.  1317.95(d), or causes the destruction of a 
controlled substance pursuant to Sec.  1317.95(c), shall maintain a 
record of destruction on a DEA Form 41. The records shall be complete 
and accurate, and include the name and signature of the two employees 
who witnessed the destruction. Except, destruction of a controlled 
substance dispensed by a practitioner for immediate administration at 
the practitioner's registered location, when the substance is not fully 
exhausted (e.g., some of the substance remains in a vial, tube, or 
syringe after administration but cannot or may not be further 
utilized), shall be properly recorded in accordance with Sec.  
1304.22(c), and such record need not be maintained on a DEA Form 41.

0
20. In Sec.  1304.22, revise the section heading, introductory text, 
and paragraph (e) and add paragraph (f) to read as follows:

Sec.  1304.22  Records for manufacturers, distributors, dispensers, 
researchers, importers, exporters, registrants that reverse distribute, 
and collectors.

    Each person registered or authorized (by Sec. Sec.  1301.13(e), 
1307.11, 1307.13, or part 1317 of this chapter) to manufacture, 
distribute, dispense, import, export, reverse distribute, destroy, 
conduct research with controlled substances, or collect controlled 
substances from ultimate users, shall maintain records with the 
information listed in paragraphs (a) through (f) of this section.
* * * * *
    (e) Records for registrants that reverse distribute. Each person 
registered or authorized to reverse distribute controlled substances 
shall maintain records with the following information for each 
controlled substance:
    (1) For controlled substances acquired for the purpose of return or 
recall to the manufacturer or another registrant authorized by the 
manufacturer to accept returns on the manufacturer's behalf pursuant to 
part 1317 of this chapter:
    (i) The date of receipt; the name and quantity of each controlled 
substance received; the name, address, and registration number of the 
person from whom the substance was received; and the reason for return 
(e.g., recall or return); and
    (ii) The date of return to the manufacturer or other registrant 
authorized by the manufacturer to accept returns on the manufacturer's 
behalf; the name and quantity of each controlled substance returned; 
the name, address, and registration number of the person from whom the 
substance was received; the name, address, and registration number of 
the registrant to whom the substance was returned; and the method of 
return (e.g., common or contract carrier).
    (2) For controlled substances acquired from registrant inventory 
for destruction pursuant to Sec.  1317.05(a)(2), (b)(2), and (b)(4) of 
this chapter:
    (i) The date of receipt; the name and quantity of each controlled 
substance received; and the name, address, and registration number of 
the person from whom the substance was received; and
    (ii) The date, place, and method of destruction; the name and 
quantity of each controlled substance destroyed; the name, address, and 
registration number of the person from whom the substance was received; 
and the name and signatures of the two employees of the registrant that 
witnessed the destruction.
    (3) The total quantity of each controlled substance shall be 
recorded in accordance with the following:
    (i) For controlled substances in bulk form: To the nearest metric 
unit weight or volume consistent with unit size;
    (ii) For controlled substances in finished form: Each finished form 
(e.g., 10-milligram tablet or 10-milligram concentration per fluid 
ounce or milliliter); the number of units or volume of finished form in 
each commercial container (e.g., 100-tablet bottle or 3-milliliter 
vial); and the number of commercial containers of each such finished 
form (e.g., four 100-tablet bottles or six 3-milliliter vials); and
    (iii) For controlled substances in a commercial container, carton, 
crate, drum, or other receptacle that has been opened: If the substance 
is listed in

[[Page 53564]]

Schedule I or II make an exact count or measure of the contents; or if 
the substance is listed in Schedule III, IV, or V, make an estimated 
count or measure of the contents, unless the container holds more than 
1,000 tablets or capsules in which case an exact count of the contents 
shall be made.
    (4) For each sealed inner liner acquired from collectors or law 
enforcement and each sealed mail-back package acquired from law 
enforcement pursuant to Sec.  1317.55 of this chapter:
    (i) The number of sealed inner liners acquired from other persons, 
including the date of acquisition, the number and, for sealed inner 
liners the size (e.g., five 10-gallon liners, etc.), of all sealed 
inner liners and mail-back packages acquired to inventory, the unique 
identification number of each sealed inner liner and mail-back package, 
and the name, address, and, for registrants, the registration number of 
the person from whom the sealed inner liners and mail-back packages 
were received, and
    (ii) The date, place, and method of destruction; the number of 
sealed inner liners and mail-back packages destroyed; the name, 
address, and, for registrants, the registration number of the person 
from whom the sealed inner liners and mail-back packages were received; 
the number and, for sealed inner liners the size (e.g., five 10-gallon 
liners, etc.), of all sealed inner liners and mail-back packages 
destroyed; the unique identification number of each sealed inner liner 
and sealed mail-back package destroyed; and the name and signatures of 
the two employees of the registrant that witnessed the destruction.
    (5) For all records, the record of receipt shall be maintained 
together with the corresponding record of return or destruction (DEA 
Form 41).
    (f) Records for collectors. Each person registered or authorized to 
collect controlled substances from ultimate users shall maintain the 
following records:
    (1) Mail-Back Packages:
    (i) For unused packages that the collector makes available to 
ultimate users and other authorized non-registrants at the collector's 
registered address: The date made available, the number of packages, 
and the unique identification number of each package;
    (ii) For unused packages provided to a third party to make 
available to ultimate users and other authorized non-registrants: The 
name of the third party and physical address of the location receiving 
the unused packages, date sent, and the number of unused packages sent 
with the corresponding unique identification numbers;
    (iii) For sealed mail-back packages received by the collector: Date 
of receipt and the unique identification number on the individual 
package; and
    (iv) For sealed mail-back packages destroyed on-site by the 
collector: Number of sealed mail-back packages destroyed, the date and 
method of destruction, the unique identification number of each mail-
back package destroyed, and the names and signatures of the two 
employees of the registrant who witnessed the destruction.
    (2) Collection receptacle inner liners:
    (i) Date each unused inner liner acquired, unique identification 
number and size (e.g., 5-gallon, 10-gallon, etc.) of each unused inner 
liner acquired;
    (ii) Date each inner liner is installed, the address of the 
location where each inner liner is installed, the unique identification 
number and size (e.g., 5-gallon, 10-gallon, etc.) of each installed 
inner liner, the registration number of the collector, and the names 
and signatures of the two employees that witnessed each installation;
    (iii) Date each inner liner is removed and sealed, the address of 
the location from which each inner liner is removed, the unique 
identification number and size (e.g., 5-gallon, 10-gallon, etc.) of 
each inner liner removed, the registration number of the collector, and 
the names and signatures of the two employees that witnessed each 
removal;
    (iv) Date each sealed inner liner is transferred to storage, the 
unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) 
of each sealed inner liner stored, and the names and signatures of the 
two employees that transferred each sealed inner liner to storage;
    (v) Date each sealed inner liner is transferred for destruction, 
the address and registration number of the reverse distributor or 
distributor to whom each sealed inner liner was transferred, the unique 
identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of 
each sealed inner liner transferred, and the names and signatures of 
the two employees that transferred each sealed inner liner to the 
reverse distributor or distributor; and
    (vi) For sealed inner liners destroyed on-site by the collector: 
The same information required of reverse distributors in paragraph 
(e)(4)(ii) of this section.

0
21. In Sec.  1304.25, revise the section heading and paragraphs (a)(9) 
and (b)(9) to read as follows:

Sec.  1304.25  Records for treatment programs that compound narcotics 
for treatment programs and other locations.

* * * * *
    (a) * * *
    (9) The quantity disposed of by destruction, including the reason, 
date, and manner of destruction.
    (b) * * *
    (9) The number of units of finished forms and/or commercial 
containers destroyed in any manner by the registrant, including the 
reason, date, and manner of destruction.

0
22. Amend Sec.  1304.33 by revising the section heading and paragraph 
(f) and adding paragraph (g) to read as follows:

Sec.  1304.33  Reports to Automation of Reports and Consolidated Orders 
System (ARCOS).

* * * * *
    (f) Exceptions. (1) A registered institutional practitioner that 
repackages or relabels exclusively for distribution or that distributes 
exclusively to (for dispensing by) agents, employees, or affiliated 
institutional practitioners of the registrant may be exempted from 
filing reports under this section by applying to the ARCOS Unit of the 
Administration.
    (2) Registrants that acquire recalled controlled substances from 
ultimate users pursuant to Sec.  1317.85 of this chapter may report as 
a single transaction all recalled controlled substances of the same 
name and finished form (e.g., all 10-milligram tablets or all 5-
milligram concentration per fluid ounce or milliliter) received from 
ultimate users for the purpose of reporting acquisition transactions.
    (g) Exemptions. (1) Collectors that acquire controlled substances 
from ultimate users are exempt from the ARCOS reporting requirements 
only with respect to controlled substances collected through mail-back 
programs and collection receptacles for the purpose of disposal.
    (2) Reverse distributors and distributors that acquire controlled 
substances pursuant to Sec.  1317.55(a) or (b) of this chapter are 
exempt from the ARCOS reporting requirements in this section with 
regard to any controlled substances acquired pursuant to Sec.  
1317.55(a) or (b) of this chapter.
* * * * *

PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

0
23. The authority citation for part 1305 continues to read as follows:

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

0
24. In Sec.  1305.03, add paragraphs (e), (f), and (g) to read as 
follows:

Sec.  1305.03  Distributions requiring a Form 222 or a digitally signed 
electronic order.

* * * * *

[[Page 53565]]

    (e) Deliveries to an authorized DEA registrant by an ultimate user, 
a long-term care facility on behalf of an ultimate user who resides or 
has resided at that facility, or a person authorized to dispose of the 
ultimate user decedent's property.
    (f) Distributions to reverse distributors and distributors by 
collectors and law enforcement pursuant to Sec.  1317.55 of this 
chapter.
    (g) Deliveries of controlled substances from ultimate users for the 
purpose of recalls pursuant to Sec.  1317.85 of this chapter.

PART 1307--MISCELLANEOUS

0
25. The authority citation for part 1307 continues to read as follows:

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

0
26. In Sec.  1307.11, revise section heading and remove and reserve 
paragraph (a)(2).
    The revision reads as follows:

Sec.  1307.11  Distribution by dispenser to another practitioner.

* * * * *

Sec.  1307.12  [Removed]

0
27. Remove Sec.  1307.12.

0
28. 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 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]

0
29. Remove Sec.  1307.21.

0
30. In Sec.  1307.22, revise the section heading and the first sentence 
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.
* * * * *

0
31. Add part 1317 to read as follows:

PART 1317--DISPOSAL

Sec.
1317.01 Scope.
Subpart A--Disposal of Controlled Substances by Registrants
1317.05 Registrant disposal.
1317.10 Registrant return or recall.
1317.15 Reverse distributor registration requirements and authorized 
activities.
Subpart B--Disposal of Controlled Substances Collected From Ultimate 
Users and Other Non-Registrants
1317.30 Authorization to collect from non-registrants.
1317.35 Collection by law enforcement.
1317.40 Registrants authorized to collect and authorized collection 
activities.
1317.55 Reverse distributor and distributor acquisition of 
controlled substances from collectors or law enforcement.
1317.60 Inner liner requirements.
1317.65 Take-back events.
1317.70 Mail-back programs.
1317.75 Collection receptacles.
1317.80 Collection receptacles at long-term care facilities.
1317.85 Ultimate user delivery for the purpose of recall or 
investigational use of drugs.
Subpart C--Destruction of Controlled Substances
1317.90 Methods of destruction.
1317.95 Destruction procedures.

    Authority: 21 U.S.C. 821, 822, 823, 827, 828, 871(b), and 958.

Sec.  1317.01  Scope.

    This part sets forth the rules for the delivery, collection, and 
destruction of damaged, expired, returned, recalled, unused, or 
otherwise unwanted controlled substances that are lawfully possessed by 
registrants (subpart A) and non-registrants (subpart B). The purpose of 
such rules is to provide prompt, safe, and effective disposal methods 
while providing effective controls against the diversion of controlled 
substances.

Subpart A--Disposal of Controlled Substances by Registrants

Sec.  1317.05  Registrant disposal.

    (a) Practitioner inventory. Any registered practitioner in lawful 
possession of a controlled substance in its inventory that desires to 
dispose of that substance shall do so in one of the following ways:
    (1) Promptly destroy that controlled substance in accordance with 
subpart C of this part using an on-site method of destruction;
    (2) Promptly deliver that controlled substance to a reverse 
distributor's registered location by common or contract carrier pick-up 
or by reverse distributor pick-up at the registrant's registered 
location;
    (3) For the purpose of return or recall, promptly deliver that 
controlled substance by common or contract carrier pick-up or pick-up 
by other registrants at the registrant's registered location to: The 
registered person from whom it was obtained, the registered 
manufacturer of the substance, or another registrant authorized by the 
manufacturer to accept returns or recalls on the manufacturer's behalf; 
or
    (4) Request assistance from the Special Agent in Charge of the 
Administration in the area in which the practitioner is located.
    (i) The request shall be made by submitting one copy of the DEA 
Form 41 to the Special Agent in Charge in the practitioner's area. The 
DEA Form 41 shall list the controlled substance or substances which the 
registrant desires to dispose.
    (ii) The Special Agent in Charge shall instruct the registrant to 
dispose of the controlled substance in one of the following manners:
    (A) By transfer to a registrant authorized to transport or destroy 
the substance;
    (B) By delivery to an agent of the Administration or to the nearest 
office of the Administration; or
    (C) By destruction in the presence of an agent of the 
Administration or other authorized person.
    (5) In the event that a practitioner is required regularly to 
dispose of controlled substances, the Special Agent in Charge may 
authorize the practitioner to dispose of such substances, in accordance 
with subparagraph (a)(4) of this section, without prior application in 
each instance, on the condition that the practitioner keep records of 
such disposals and file periodic reports with the Special Agent in 
Charge summarizing the disposals. The Special Agent in Charge may place 
such conditions as he/she deems proper on practitioner procedures 
regarding the disposal of controlled substances.
    (b) Non-practitioner inventory. Any registrant that is a non-
practitioner in lawful possession of a controlled substance in its 
inventory that desires to dispose of that substance shall do so in one 
of the following ways:

[[Page 53566]]

    (1) Promptly destroy that controlled substance in accordance with 
subpart C of this part using an on-site method of destruction;
    (2) Promptly deliver that controlled substance to a reverse 
distributor's registered location by common or contract carrier or by 
reverse distributor pick-up at the registrant's registered location;
    (3) For the purpose of return or recall, promptly deliver that 
controlled substance by common or contract carrier or pick-up at the 
registrant's registered location to: The registered person from whom it 
was obtained, the registered manufacturer of the substance, or another 
registrant authorized by the manufacturer to accept returns or recalls 
on the manufacturer's behalf; or
    (4) Promptly transport that controlled substance by its own means 
to the registered location of a reverse distributor, the location of 
destruction, or the registered location of any person authorized to 
receive that controlled substance for the purpose of return or recall 
as described in paragraph (b)(3) of this section.
    (i) If a non-practitioner transports controlled substances by its 
own means to an unregistered location for destruction, the non-
practitioner shall do so in accordance with the procedures set forth at 
Sec.  1317.95(c).
    (ii) If a non-practitioner transports controlled substances by its 
own means to a registered location for any authorized purpose, 
transportation shall be directly to the authorized registered location 
and two employees of the transporting non-practitioner shall accompany 
the controlled substances to the registered destination location. 
Directly transported means the substances shall be constantly moving 
towards their final location and unnecessary or unrelated stops and 
stops of an extended duration shall not occur.
    (c) Collected controlled substances. Any collector in lawful 
possession of a controlled substance acquired by collection from an 
ultimate user or other authorized non-registrant person shall dispose 
of that substance in the following ways:
    (1) Mail-back program. Upon receipt of a sealed mail-back package, 
the collector shall promptly:
    (i) Destroy the package in accordance with subpart C of this part 
using an on-site method of destruction; or
    (ii) Securely store the package and its contents at the collector's 
registered location in a manner consistent with Sec.  1301.75(c) of 
this chapter (for practitioners), or in a manner consistent with the 
security requirements for Schedule II controlled substances (for non-
practitioners) until prompt on-site destruction can occur.
    (2) Collection receptacles. Upon removal from the permanent outer 
container, the collector shall seal it and promptly:
    (i) Destroy the sealed inner liner and its contents;
    (ii) Securely store the sealed inner liner and its contents at the 
collector's registered location in a manner consistent with Sec.  
1301.75(c) of this chapter (for practitioners), or in a manner 
consistent with Sec.  1301.72(a) of this chapter (for non-
practitioners) until prompt destruction can occur; or
    (iii) Securely store the sealed inner liner and its contents at a 
long-term care facility in accordance with Sec.  1317.80(d).
    (iv) Practitioner methods of destruction. Collectors that are 
practitioners (i.e., retail pharmacies and hospitals/clinics) shall 
dispose of sealed inner liners and their contents by utilizing any 
method in paragraph (a)(1), (a)(2), or (a)(4) of this section, or by 
delivering sealed inner liners and their contents to a distributor's 
registered location by common or contract carrier pick-up or by 
distributor pick-up at the collector's authorized collection location.
    (v) Non-practitioner methods of destruction. Collectors that are 
non-practitioners (i.e., manufacturers, distributors, narcotic 
treatment programs, and reverse distributors) shall dispose of sealed 
inner liners and their contents by utilizing any method in paragraph 
(b)(1), (b)(2), or (b)(4) of this section, or by delivering sealed 
inner liners and their contents to a distributor's registered location 
by common or contract carrier or by distributor pick-up at the 
collector's authorized collection location for destruction. Freight 
forwarding facilities may not be utilized to transfer sealed inner 
liners and their contents.

Sec.  1317.10  Registrant return or recall.

    (a) Each registrant shall maintain a record of each return or 
recall transaction in accordance with the information required of 
manufacturers in Sec.  1304.22(a)(2)(iv) of this chapter.
    (b) Each registrant that delivers a controlled substance in 
Schedule I or II for the purpose of return or recall shall use an order 
form in the manner described in part 1305 of this chapter.
    (c) Deliveries for the purpose of return or recall may be made 
through a freight forwarding facility operated by the person to whom 
the controlled substance is being returned provided that advance notice 
of the return is provided and delivery is directly to an agent or 
employee of the person to whom the controlled substance is being 
returned.

Sec.  1317.15  Reverse distributor registration requirements and 
authorized activities.

    (a) Any person that reverse distributes a controlled substance 
shall be registered with the Administration as a reverse distributor, 
unless exempted by law or otherwise authorized pursuant to this 
chapter.
    (b) A reverse distributor shall acquire controlled substances from 
a registrant pursuant to Sec. Sec.  1317.05 and 1317.55(a) and (c) in 
the following manner:
    (1) Pick-up controlled substances from a registrant at the 
registrant's registered location or authorized collection site; or
    (2) Receive controlled substances delivered by common or contract 
carrier or delivered directly by a non-practitioner registrant.
    (i) Delivery to the reverse distributor by an authorized registrant 
directly or by common or contract carrier may only be made to the 
reverse distributor at the reverse distributor's registered location. 
Once en route, such deliveries may not be re-routed to any other 
location or person, regardless of registration status.
    (ii) All controlled substance deliveries to a reverse distributor 
shall be personally received by an employee of the reverse distributor 
at the registered location.
    (c) Upon acquisition of a controlled substance by delivery or pick-
up, a reverse distributor shall:
    (1) Immediately store the controlled substance, in accordance with 
the security controls in parts 1301 and 1317 of this chapter, at the 
reverse distributor's registered location or immediately transfer the 
controlled substance to the reverse distributor's registered location 
for secure storage, in accordance with the security controls in parts 
1301 and 1317 of this chapter, until timely destruction or prompt 
return of the controlled substance to the registered manufacturer or 
other registrant authorized by the manufacturer to accept returns or 
recalls on the manufacturer's behalf;
    (2) Promptly deliver the controlled substance to the manufacturer 
or another registrant authorized by the manufacturer to accept returns 
or recalls on the manufacturer's behalf; or
    (3) Timely destroy the controlled substance in a manner authorized 
in subpart C of this part.
    (d) A reverse distributor shall destroy or cause the destruction of 
any controlled substance received for the purpose of destruction no 
later than 30 calendar days after receipt.

[[Page 53567]]

Subpart B--Disposal of Controlled Substances Collected From 
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 the Administration to be a 
collector pursuant to Sec.  1317.40; and
    (2) Federal, State, tribal, or local law enforcement when in the 
course of official duties and pursuant to Sec.  1317.35.
    (b) The following non-registrant persons in lawful possession of a 
controlled substance in Schedules II, III, IV, or V may transfer that 
substance to the authorized persons listed in paragraph (a) of this 
section, and in a manner authorized by this part, for the purpose of 
disposal:
    (1) An ultimate user in lawful possession of a controlled 
substance;
    (2) Any person lawfully entitled to dispose of a decedent's 
property if that decedent was an ultimate user who died while in lawful 
possession of a controlled substance; and
    (3) A long-term care facility on behalf of an ultimate user who 
resides or resided at such long-term care facility and is/was in lawful 
possession of a controlled substance, in accordance with Sec.  1317.80 
only.

Sec.  1317.35  Collection by law enforcement.

    (a) Federal, State, tribal, or local law enforcement may collect 
controlled substances from ultimate users and persons lawfully entitled 
to dispose of an ultimate user decedent's property using the following 
collection methods:
    (1) Take-back events in accordance with Sec.  1317.65;
    (2) Mail-back programs in accordance with Sec.  1317.70; or
    (3) Collection receptacles located inside law enforcement's 
physical address.
    (b) Law enforcement that conducts a take-back event or a mail-back 
program or maintains a collection receptacle should maintain any 
records of removal, storage, or destruction of the controlled 
substances collected in a manner that is consistent with that agency's 
recordkeeping requirements for illicit controlled substances evidence.
    (c) Any controlled substances collected by law enforcement through 
a take-back event, mail-back program, or collection receptacle should 
be stored in a manner that prevents the diversion of controlled 
substances and is consistent with that agency's standard procedures for 
storing illicit controlled substances.
    (d) Any controlled substances collected by law enforcement through 
a take-back event, mail-back program, or collection receptacle should 
be transferred to a destruction location in a manner that prevents the 
diversion of controlled substances and is consistent with that agency's 
standard procedures for transferring illicit controlled substances.
    (e) Law enforcement that transfers controlled substances collected 
from ultimate users pursuant to this part to a reverse distributor for 
destruction should maintain a record that contains the following 
information: If a sealed inner liner as described in Sec.  1317.60 is 
used, the unique identification number of the sealed inner liner 
transferred, and the size of the sealed inner liner transferred (e.g., 
5-gallon, 10-gallon, etc.); if a mail-back package as described in 
Sec.  1317.70 is used, the unique identification number of each 
package; the date of the transfer; and the name, address, and 
registration number of the reverse distributor to whom the controlled 
substances were transferred.

Sec.  1317.40  Registrants authorized to collect and authorized 
collection activities.

    (a) Manufacturers, distributors, reverse distributors, narcotic 
treatment programs, hospitals/clinics with an on-site pharmacy, and 
retail pharmacies that desire to be collectors shall 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 that is authorized to collect 
ceases activities as a collector, such registrant shall notify the 
Administration in accordance with Sec.  1301.52(f) of this chapter.
    (b) Collection by registrants shall occur only at the following 
locations:
    (1) Those registered locations of manufacturers, distributors, 
reverse distributors, narcotic treatment programs, hospitals/clinics 
with an on-site pharmacy, and retail pharmacies that are authorized for 
collection; and
    (2) Long-term care facilities at which registered hospitals/clinics 
or retail pharmacies are authorized to maintain collection receptacles.
    (c) Collectors may conduct the following activities:
    (1) Receive and destroy mail-back packages pursuant to Sec.  
1317.70 at an authorized registered location that has an on-site method 
of destruction;
    (2) Install, manage, and maintain collection receptacles located at 
their authorized collection location(s) pursuant to Sec. Sec.  1317.75 
and 1317.80; and
    (3) Promptly dispose of sealed inner liners and their contents as 
provided for in Sec.  1317.05(c)(2).

Sec.  1317.55  Reverse distributor and distributor acquisition of 
controlled substances from collectors or law enforcement.

    (a) A reverse distributor is authorized to acquire controlled 
substances from law enforcement that collected the substances from 
ultimate users. A reverse distributor is authorized to acquire 
controlled substances collected through a collection receptacle in 
accordance with Sec. Sec.  1317.75 and 1317.80.
    (b) A distributor is authorized to acquire controlled substances 
collected through a collection receptacle in accordance with Sec. Sec.  
1317.75 and 1317.80.
    (c) A reverse distributor or a distributor that acquires controlled 
substances in accordance with paragraph (a) or (b) of this section 
shall:
    (1) Acquire the controlled substances in the manner authorized for 
reverse distributors in Sec.  1317.15(b)(1) and (2);
    (2) Dispose of the controlled substances in the manner authorized 
for reverse distributors Sec.  1317.15(c) and (d); and
    (3) Securely store the controlled substances in a manner consistent 
with the security requirements for Schedule II controlled substances 
until timely destruction can occur.

Sec.  1317.60  Inner liner requirements.

    (a) An inner liner shall meet the following requirements:
    (1) The inner liner shall be waterproof, tamper-evident, and tear-
resistant;
    (2) The inner liner shall be removable and sealable immediately 
upon removal without emptying or touching the contents;
    (3) The contents of the inner liner shall not be viewable from the 
outside when sealed;
    (4) The size of the inner liner shall be clearly marked on the 
outside of the liner (e.g., 5-gallon, 10-gallon, etc.); and
    (5) The inner liner shall bear a permanent, unique identification 
number that enables the inner liner to be tracked.
    (b) Access to the inner liner shall be restricted to employees of 
the collector.
    (c) The inner liner shall be sealed by two employees immediately 
upon removal from the permanent outer container and the sealed inner 
liner shall not be opened, x-rayed, analyzed, or otherwise penetrated.

[[Page 53568]]

Sec.  1317.65  Take-back events.

    (a) Federal, State, tribal, or local law enforcement may conduct a 
take-back event and collect controlled substances from ultimate users 
and persons lawfully entitled to dispose of an ultimate user decedent's 
property in accordance with this section. Any person may partner with 
law enforcement to hold a collection take-back event in accordance with 
this section.
    (b) Law enforcement shall appoint a law enforcement officer 
employed by the agency to oversee the collection. Law enforcement 
officers employed and authorized by the law enforcement agency or law 
enforcement component of a Federal agency conducting a 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 substances 
has occurred.
    (c) Each take-back event should have at least one receptacle for 
the collection of controlled substances. The collection receptacle 
should be a securely locked, substantially constructed container with 
an outer container and a removable inner liner as specified in Sec.  
1317.60 of this chapter. The outer container should include a small 
opening that allows contents to be added to the inner liner, but that 
does not allow removal of the inner liner's contents.
    (d) Only those controlled substances listed in Schedule II, III, 
IV, or V that are lawfully possessed by an ultimate user or person 
entitled to dispose of an ultimate user decedent's property may be 
collected. Controlled and non-controlled substances may be collected 
together and be comingled, although comingling is not required.
    (e) Only ultimate users and persons entitled to dispose of an 
ultimate user decedent's property in lawful possession of a controlled 
substance in Schedule II, III, IV, or V may transfer such substances to 
law enforcement during the take-back event. No other person may handle 
the controlled substances at any time.

Sec.  1317.70  Mail-back programs.

    (a) A mail-back program may be conducted by Federal, State, tribal, 
or local law enforcement or any collector. A collector conducting a 
mail-back program shall have and utilize at their registered location a 
method of destruction consistent with 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, although comingling is not 
required.
    (c) Collectors or law enforcement that conduct a mail-back program 
shall make packages available (for sale or for free) as specified in 
this paragraph to ultimate users and persons lawfully entitled to 
dispose of an ultimate user decedent's property, for the collection of 
controlled substances by common or contract carrier. Any person may 
partner with a collector or law enforcement to make such packages 
available in accordance with this section. The packages made available 
shall meet the following specifications:
    (1) The package shall be nondescript and shall not include any 
markings or other information that might indicate that the package 
contains controlled substances;
    (2) The package shall be water- and spill-proof; tamper-evident; 
tear-resistant; and sealable;
    (3) The package shall be preaddressed with and delivered to the 
collector's registered address or the participating law enforcement's 
physical address;
    (4) The cost of shipping the package shall be postage paid;
    (5) The package shall have a unique identification number that 
enables the package to be tracked; and
    (6) The package shall include instructions for the user that 
indicate the process for mailing back the package, the substances that 
can be sent, notice that packages may only be mailed from within the 
customs territory of the United States (the 50 States, the District of 
Columbia, and Puerto Rico), and notice that only packages provided by 
the collector will be accepted for destruction.
    (d) Ultimate users and persons lawfully entitled to dispose of an 
ultimate user decedent's property shall not be required to provide any 
personally identifiable information when mailing back controlled 
substances to a collector. The collector or law enforcement may 
implement a system that allows ultimate users or persons lawfully 
entitled to dispose of an ultimate user decedent's property to notify 
the collector or law enforcement that they are sending one of the 
designated packages by giving the unique identification number on the 
package.
    (e) A collector that conducts a 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 and packages that are lawfully forwarded 
to the collector pursuant to paragraph (e)(3) of this section.
    (2) Within three business days of receipt, notify the Field 
Division Office of the Administration in their area of the receipt of a 
package that likely contains controlled substances that the collector 
did not make available or did not agree to receive pursuant to 
subparagraph (e)(3) of this section.
    (3) When discontinuing activities as a collector or ceasing an 
authorized mail-back program:
    (i) Make a reasonable effort to notify the public prior to 
discontinuing such activities or ceasing the authorized mail-back 
program; and
    (ii) Obtain the written agreement of another collector that has and 
utilizes at its registered location a method of destruction consistent 
with Sec.  1317.90 of this chapter to receive all remaining mail-back 
packages that were disseminated but not returned and arrange for the 
forwarding of only such packages to that location.
    (f) Only law enforcement officers employed by the law enforcement 
agency or law enforcement component of a Federal agency and employees 
of the collector shall handle packages received through an authorized 
mail-back program. Upon receipt of a mail-back package by a collector 
conducting a mail-back program, the package shall not be opened, x-
rayed, analyzed, or otherwise penetrated.

Sec.  1317.75  Collection receptacles.

    (a) Collectors or Federal, State, tribal, or local law enforcement 
may manage and maintain collection receptacles for disposal.
    (b) Only those controlled substances listed in Schedule II, III, 
IV, or V that are lawfully possessed by an ultimate user or other 
authorized non-registrant person may be collected. Controlled and non-
controlled substances may be collected together and be comingled, 
although comingling is not required.
    (c) Collectors shall only allow ultimate users and other authorized 
non-registrant persons in lawful possession of a controlled substance 
in Schedule II, III, IV, or V to deposit such substances in a 
collection receptacle at a registered location. Collectors shall not 
permit an ultimate user to transfer such substance to any person for 
any reason. Once a substance has been deposited into a collection 
receptacle, the substance shall not be counted,

[[Page 53569]]

sorted, inventoried, or otherwise individually handled.
    (d) Collection receptacles shall be securely placed and maintained:
    (1) Inside a collector's registered location, inside law 
enforcement's physical location, or at an authorized long-term care 
facility;
    (2) At a registered location, be located in the immediate proximity 
of a designated area where controlled substances are stored and at 
which an employee is present (e.g., can be seen from the pharmacy 
counter). Except as follows:
    (i) At a hospital/clinic: A collection receptacle shall be located 
in an area regularly monitored by employees, and shall not be located 
in the proximity of any area where emergency or urgent care is 
provided;
    (ii) At a narcotic treatment program: A collection receptacle shall 
be located in a room: That does not contain any other controlled 
substances and is securely locked with controlled access;
    (iii) At a long-term care facility: A collection receptacle shall 
be located in a secured area regularly monitored by long-term care 
facility employees.
    (e) A controlled substance collection receptacle shall meet the 
following design specifications:
    (1) Be securely fastened to a permanent structure so that it cannot 
be removed;
    (2) Be a securely locked, substantially constructed container with 
a permanent outer container and a removable inner liner as specified in 
Sec.  1317.60 of this chapter;
    (3) The outer container shall include a small opening that allows 
contents to be added to the inner liner, but does not allow removal of 
the inner liner's contents;
    (4) The outer container shall prominently display a sign indicating 
that only Schedule II-V controlled and non-controlled substances, if a 
collector chooses to comingle substances, are acceptable substances 
(Schedule I controlled substances, controlled substances that are not 
lawfully possessed by the ultimate user, and other illicit or dangerous 
substances are not permitted); and
    (f) Except at a narcotic treatment program, the small opening in 
the outer container of the collection receptacle shall be locked or 
made otherwise inaccessible to the public when an employee is not 
present (e.g., when the pharmacy is closed), or when the collection 
receptacle is not being regularly monitored by long-term care facility 
employees.
    (g) The installation and removal of the inner liner of the 
collection receptacle shall be performed by or under the supervision of 
at least two employees of the authorized collector.

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 has resided, at such long-term care facility by 
transferring those controlled substances into an authorized collection 
receptacle located at that long-term care facility. When disposing of 
such controlled substances by transferring those substances into a 
collection receptacle, such disposal shall occur immediately, but no 
longer than three business days after the discontinuation of use by the 
ultimate user. Discontinuation of use includes a permanent 
discontinuation of use as directed by the prescriber, as a result of 
the resident's transfer from the long-term care facility, or as a 
result of death.
    (b) Only authorized retail pharmacies and hospitals/clinics with an 
on-site pharmacy may install, manage, and maintain collection 
receptacles at long-term care facilities and remove, seal, transfer, 
and store, or supervise the removal, sealing, transfer, and storage of 
sealed inner liners at long-term care facilities. Collectors authorized 
to install, manage, and maintain collection receptacles at long-term 
care facilities shall comply with all requirements of this chapter, 
including Sec. Sec.  1317.60, 1317.75, and 1317.80.
    (c) The installation, removal, transfer, and storage of inner 
liners shall be performed either: By or under the supervision of one 
employee of the authorized collector and one supervisor-level employee 
of the long-term care facility (e.g., a charge nurse or supervisor) 
designated by the authorized collector; or, by or under the supervision 
of two employees of the authorized collector.
    (d) Upon removal, sealed inner liners may only be stored at the 
long-term care facility for up to three business days in a securely 
locked, substantially constructed cabinet or a securely locked room 
with controlled access until transfer in accordance with Sec.  
1317.05(c)(2)(iv).
    (e) Neither a hospital/clinic with an on-site pharmacy nor a retail 
pharmacy shall operate a collection receptacle at a long-term care 
facility until its registration has been modified in accordance with 
Sec.  1301.51 of this chapter.

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.
    (b) An ultimate user who is participating in an investigational use 
of drugs pursuant to 21 U.S.C. 355(i) and 360b(j) and wishes to deliver 
any unused controlled substances received as part of that research to 
the registered dispenser from which the ultimate user obtained those 
substances may do so in accordance with regulations promulgated by the 
Secretary of Health and Human Services pursuant to 21 U.S.C. 355(i) and 
360b(j).

Subpart C--Destruction of Controlled Substances

Sec.  1317.90  Methods of destruction.

    (a) All controlled substances to be destroyed by a registrant, or 
caused to be destroyed by a registrant pursuant to Sec.  1317.95(c), 
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) Transfer to a person registered or authorized to accept 
controlled substances for the purpose of destruction. If the controlled 
substances are transferred to a person registered or authorized to 
accept the controlled substances for the purpose of destruction, two 
employees of the transferring registrant shall load and

[[Page 53570]]

unload or observe the loading and unloading of any controlled 
substances until transfer is complete.
    (b) Transport to a registered location. If the controlled 
substances are transported by a registrant to a registered location for 
subsequent destruction, the following procedures shall be followed:
    (1) Transportation shall be directly to the registered location 
(the substances shall be constantly moving towards their final location 
and unnecessary or unrelated stops and stops of an extended duration 
shall not occur);
    (2) Two employees of the transporting registrant shall accompany 
the controlled substances to the registered location;
    (3) Two employees of the transporting registrant shall load and 
unload or observe the loading and unloading of the controlled 
substances until transfer is complete;
    (c) Transport to a non-registered location. If the controlled 
substances are transported by a registrant to a destruction location 
that is not a registered location, the following procedures shall be 
followed:
    (1) Transportation shall be directly to the destruction location 
(the substances shall be constantly moving towards their final 
destruction location and unnecessary or unrelated stops and stops of an 
extended duration shall not occur);
    (2) Two employees of the transporting registrant shall accompany 
the controlled substances to the destruction location;
    (3) Two employees of the transporting registrant shall load and 
unload or observe the loading and unloading of the controlled 
substances;
    (4) Two employees of the transporting registrant shall handle or 
observe the handling of any controlled substance until the substance is 
rendered non-retrievable; and
    (5) Two employees of the transporting registrant shall personally 
witness the destruction of the controlled substance until it is 
rendered non-retrievable.
    (d) On-site destruction. If the controlled substances are destroyed 
at a registrant's registered location utilizing an on-site method of 
destruction, the following procedures shall be followed:
    (1) Two employees of the registrant shall handle or observe the 
handling of any controlled substance until the substance is rendered 
non-retrievable; and
    (2) Two employees of the registrant shall personally witness the 
destruction of the controlled substance until it is rendered non-
retrievable.

    Dated: August 25, 2014.
Michele M. Leonhart,
Administrator.
[FR Doc. 2014-20926 Filed 9-8-14; 8:45 am]
BILLING CODE 4410-09-P
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