Rules - 2012
[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Proposed Rules]
[Pages 75783-75817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30699]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, 1305, 1307, 1317, and 1321
[Docket No. DEA-316]
RIN 1117-AB18
Disposal of Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice of proposed rulemaking.
SUMMARY: This rule proposes requirements to govern the secure disposal
of controlled substances by both DEA registrants and ultimate users.
These regulations would implement the Secure and Responsible Drug
Disposal Act of 2010 (Pub. L. 111-273) by expanding the options
available to collect controlled substances from ultimate users for
purposes of disposal to include: Take-back events, mail-back programs,
and collection receptacle locations. These proposed regulations contain
specific language to continue to allow law enforcement agencies to
voluntarily conduct take-back events, administer mail-back programs,
and maintain collection receptacles. These regulations propose to allow
authorized manufacturers, distributors, reverse distributors, and
retail pharmacies to voluntarily administer mail-back programs and
maintain collection receptacles. In addition, this proposed rule
expands the authority of authorized retail pharmacies to voluntarily
maintain collection receptacles at long term care facilities. This
proposed rule also reorganizes and consolidates existing regulations on
disposal, including the role of reverse distributors.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before February 19, 2013. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after midnight Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments, please reference
"Docket No. DEA-316" on all electronic and written correspondence.
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that
site. An electronic copy of this document is also available at the
http://www.regulations.gov Web site for easy reference. Paper comments
that duplicate the electronic submission are not necessary as all
comments submitted to http://www.regulations.gov will be posted for
public review and are part of the official docket record. Should you,
however, wish to submit written comments via regular or express mail,
they should be sent to the Drug Enforcement Administration, Attention:
DEA Office of Diversion Control (OD/DX), 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record and are made available for public inspection online at
http://www.regulations.gov and in the DEA's public docket. Such
information includes personal identifying information (such as your
name, address, etc.) voluntarily submitted by the commenter.
If you would like to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
it to be posted online or made available in the public docket, you must
include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you would like to submit confidential business information as
part of your comment, but do not want it to be posted online or made
available in the public docket, you must include the phrase
"CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your
comment. You must also prominently identify confidential business
information to be redacted within the comment. If a comment has so much
confidential business information that it cannot be effectively
redacted, all or part of that comment may not be posted online or made
available in the public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the FOR FURTHER INFORMATION paragraph.
Outline
I. Executive Summary
A. Purpose of the Regulatory Action
B. Summary of the Major Provisions of the Regulatory Action
II. Background
A. Legal Authority
B. History of Disposal of Controlled Substances
C. Existing DEA Regulations
III. Prescription Drug Abuse Epidemic
IV. Scope of Proposed Rule
V. Proposed Disposal Act Implementing Regulations
A. Disposal of Controlled Substance by Ultimate Users--Authorized Persons
B. Disposal of Controlled Substances by Ultimate Users--Authorized Methods
C. Disposal of Controlled Substances by Registrants
D. Return and Recall
E. Methods of Destruction
VI. Miscellaneous Changes
VII. Regulatory Analyses
Executive Summary
Purpose of the Regulatory Action
On October 12, 2010, the Secure and Responsible Drug Disposal Act
of 2010 (Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858).
Before the Disposal Act, ultimate users who wanted to dispose of
unused, unwanted, or expired controlled substance pharmaceuticals had
limited disposal options. The Controlled Substances Act (CSA) only
permitted ultimate users to destroy those substances themselves, for
example by flushing or discarding, or to dispose of such substances by
surrendering them to law enforcement or by seeking assistance from the
U.S. Drug Enforcement Administration (DEA). These restrictions resulted
in the accumulation of controlled substances in household medicine
cabinets that were available for abuse, misuse, and accidental
ingestion. The Disposal Act amended the CSA to authorize ultimate users
to deliver their controlled substances to another person for the
purpose of disposal in accordance with regulations promulgated by the
Attorney General. 21 U.S.C. 822(g) and 828(b)(3). The Attorney General
delegated responsibility for promulgating the Disposal Act implementing
regulations to DEA. These proposed regulations expand the entities to
which ultimate users may transfer unused, unwanted, or expired
controlled substances for the purpose of disposal, as well as the
methods by which such controlled substances may be collected. Specified
entities may voluntarily administer any
[[Page 75785]]
of the authorized collection methods in accordance with these proposed
regulations.
Summary of the Major Provisions of the Regulatory Action
DEA is proposing new regulations for the disposal of controlled
substances by ultimate users in accordance with the Disposal Act. In
drafting the implementing regulations, DEA considered the public health
and safety, ease and cost of program implementation, and participation
by various communities. To this end, DEA found that in order to
properly address the disposal of controlled substances by ultimate
users, it was necessary to conduct a comprehensive review of DEA
policies and regulations related to each element of the disposal
process, including the transfer, delivery, collection, destruction,
return, and recall of controlled substances, by both registrants and
non-registrants (e.g., ultimate users). The reverse distributor
registration category, which is pertinent to the process of registrant
disposal, was included in this comprehensive review. These regulations
will be incorporated into a new part 1317 on disposal.
The goal of this proposed new part on disposal, consistent with
Congress's goal in passing the Disposal Act, is to set controlled
substance diversion prevention parameters that will encourage public
and private entities to develop a variety of methods for collecting and
destroying controlled substances in a secure, convenient, and
responsible manner. Also consistent with Congress's goal in passing the
Disposal Act to decrease the amount of controlled substances introduced
into the environment, particularly into the water, these regulations
provide individuals various additional options to dispose of their
unwanted or unused controlled substances beyond discarding or flushing
the substances. As a result of these regulations, the supply of unused
controlled substances in the home should decrease, thereby reducing the
risk of unintentional diversion or harm.
Ultimate User Disposal
This rule proposes three voluntary options for ultimate user
disposal: (1) Take-back events, (2) mail-back programs, and (3)
collection receptacles. In addition to ultimate users, individuals
lawfully entitled to dispose of ultimate user decedent's property are
authorized to dispose of the ultimate user's substances by utilizing
any of the three options for disposal. All of the proposed collection
methods are voluntary and no person is required to establish or operate
a disposal program.
DEA proposes specific language that will continue to authorize
federal, state, tribal, and local law enforcement agencies, either
independently or in partnership with private entities or community
groups, to voluntarily hold take-back events and administer mail-back
programs. DEA also proposes to authorize certain registrants
(manufacturers, distributors, reverse distributors, and retail
pharmacies) to be "collectors," with authorization to conduct mail-
back programs. All mail-back programs must provide specific mail-back
packages to the public, either at no cost or for a fee, and collectors
that conduct mail-back programs must have and utilize an on-site method
of destruction.
Finally, DEA proposes that law enforcement agencies voluntarily
maintain collection receptacles at that agency's physical location and
to authorize collectors to maintain collection receptacles at their
registered location. Retail pharmacies that are authorized to be
collectors may maintain collection receptacles at long term care
facilities (LTCFs). LTCFs are permitted to dispose of controlled
substances on behalf of an ultimate user that resides or has resided at
that LTCF only through a collection receptacle that is maintained by a
retail pharmacy at that LTCF.
DEA proposes to allow all controlled substances collected through
take-back events, mail-back programs, and collection receptacles to be
comingled with non-controlled substances. Controlled substances
collected by collectors may not be individually counted or inventoried.
In addition, DEA proposes various collection security and recordkeeping
requirements.
DEA appreciates that there is a cost to voluntarily providing these
methods of collection and destruction. DEA notes that some state and
local pharmaceutical disposal programs receive funding and other
support from numerous sources, including conservation groups, local
governments, state grants, and public and private donations. These
expanded methods of disposal benefit the public by decreasing the
supply of controlled substances available for misuse, abuse, and
accidental ingestion, and protect the environment from potentially
harmful contaminants. However, other advantages may accrue directly to
those entities that opt to maintain a disposal program. For example,
those authorized registrants that choose to maintain collection
receptacles may be enhanced by the increased consumer presence at their
registered locations and the goodwill that develops from providing a
valuable community service. In addition, the proposed regulation
specifies that mail-back program collectors may partner with third
parties to make mailers available to the public. Those authorized
registrants that choose to administer mail-back programs may gain from
the opportunity to distribute to consumers promotional, educational, or
other informational materials with the mailers.
Registrant Disposal
DEA proposes to delete the existing rule related to registrant
disposal, 21 CFR 1307.21, and incorporate similar requirements on
proper disposal procedure, security, and recordkeeping in a new part
1317 on disposal. DEA proposes these changes in order to provide
consistent disposal procedures for each registrant category, regardless
of geographic location. In addition, DEA proposes to modify existing
DEA Form 41 to record the destruction of controlled substances that
remain in the closed system of distribution and to account for
registrant destruction of controlled substances collected from ultimate
users and other non-registrants outside the closed system pursuant to
the Disposal Act.
Reverse Distributors
DEA proposes revised regulations for reverse distributors that are
clear, consistent, and consolidated into one part. Reverse distributors
are often the last registrant to possess controlled substances prior to
destruction because they are at the end of the closed system and the
same recordkeeping safeguards that exist when controlled substances are
distributed between registrants are not present. Because reverse
distributors routinely acquire controlled substances for destruction
from other registrants and may also be authorized as collectors,
reverse distributors accumulate greater amounts of controlled
substances that are destined for destruction in comparison to other
registrants. DEA believes that the proposed regulations will help
reverse distributors comply with the Controlled Substances Act in a
manner that effectively decreases the risk of the diversion of
controlled substances during the disposal process. DEA proposes to
revise the definition of reverse distributor in addition to proposing
new procedures that reverse distributors must follow to acquire
controlled substances from registrants and other security and
recordkeeping requirements.
[[Page 75786]]
Return and Recall
DEA proposes to delete the existing rule on return and recall, 21
CFR 1307.12, and incorporate into a new part 1317 clarified and
separate return and recall requirements for registrants and non-
registrants.
Methods of Destruction
DEA proposes a standard of destruction--non-retrievable--for
persons that intend to destroy controlled substances. In particular,
DEA is not requiring a particular method of destruction, so long as the
desired result is achieved. This standard is intended to allow public
and private entities to develop a variety of destruction methods that
are secure, convenient, and responsible, consistent with preventing the
diversion of such substances. Destruction of controlled substances must
also meet all other applicable Federal, state, Tribal, and local laws
and regulations.
Background
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
Titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970 and the Controlled Substances Import and Export Act
(21 U.S.C. 801-971), as amended, and referred to as the Controlled
Substances Act (CSA).\1\ DEA publishes the implementing regulations for
these statutes in Title 21 of the Code of Federal Regulations (CFR),
parts 1300 to 1321. The CSA and its implementing regulations are
designed to prevent, detect, and eliminate the diversion of controlled
substances and listed chemicals into the illicit market while providing
for a sufficient supply of controlled substances and listed chemicals
for legitimate medical, scientific, research, and industrial purposes.
Controlled substances have the potential for abuse and dependence and
are controlled to protect the public health and safety. To this end,
controlled substances are classified into one of five schedules based
upon: The potential for abuse, currently accepted medical use, and the
degree of dependence if abused. 21 U.S.C. 812. Listed chemicals are
separately classified based on their use and importance to the
manufacture of controlled substances (List I or List II chemicals). 21
U.S.C. 802(33)-(35).
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\1\ The Attorney General's delegation of authority to DEA may be
found at 28 CFR 0.100.
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The CSA establishes a closed system of distribution that requires
DEA to monitor and control the manufacture, distribution, dispensing,
import, and export of controlled substances and listed chemicals until
they reach their final lawful destination. The secure destruction of
unused, recalled, tainted, expired, or otherwise unwanted controlled
substances is essential to preventing the diversion of controlled
substances into the illicit market.
In order to maintain this closed system of distribution, persons
that manufacture, distribute, dispense, import, export, or conduct
research or chemical analysis with controlled substances and listed
chemicals are required to register with DEA at each principal place of
business or professional practice. Persons registered with DEA are
permitted to possess controlled substances and listed chemicals as
authorized by their registration and must comply with the applicable
requirements associated with their registration. 21 U.S.C. 822.
Not all persons that possess controlled substances are required to
register with DEA. For example, a patient who receives a controlled
substance pursuant to a lawful prescription, also known as an ultimate
user, is not required to register with DEA in order to receive and
possess that controlled substance. 21 U.S.C. 822(c)(3); see also 21
U.S.C. 957(b)(1)(C).\2\ The CSA defines an "ultimate user" as "a
person who has lawfully obtained, and who possesses, a controlled
substance for his own use or for the use of a member of his household
or for an animal owned by him or by a member of his household." 21
U.S.C. 802(27).
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\2\ 21 U.S.C. 822(c)(3) and 957(b)(1)(C) except "ultimate
users" who possess substances for purposes referenced in 21 U.S.C.
802(25); however, "ultimate user" is defined in 21 U.S.C. 802(27).
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While Congress envisioned a closed system of distribution that
would control a substance from its manufacture or import through the
traditional chain of distribution moving from registrant to registrant
until it reached its final lawful use (e.g., dispensed to the ultimate
user, etc.), it did not account for circumstances in which controlled
substances were lawfully dispensed to and possessed by an ultimate user
but not fully used. Although ultimate users are exempt from CSA
registration requirements for the possession of controlled substances,
if they distribute (i.e., deliver or transfer) such controlled
substances without the appropriate registration, they are in violation
of the CSA.\3\ Such unlawful distribution includes the transfer of
controlled substances for the purpose of disposal.\4\
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\3\ It is unlawful to knowingly or intentionally manufacture,
distribute, dispense, or possess with the intent to manufacture,
distribute, or dispense, a controlled substance without the
appropriate registration. 21 U.S.C. 841(a).
\4\ The terms "disposal," "dispose," or "disposition"
appear several times in the CSA and its implementing regulations,
but these terms are not defined. For example, in the CSA, see 21
U.S.C. 822(g); 824(f) and (g); 826(c), (e), and (f); 827(a)(3) and
(d)(1); 842(a)(7); 853(n); 880(a)(2); 881(e)(1); and 958(d)(6); and
in the CFR, see 21 CFR 1307.21(b). The term "net disposal,"
however, is defined at 21 CFR 1300.01(b). As used, the terms refer
to a variety of activities that ultimately result in eliminating the
availability of controlled substances for use. For example, within
the meaning of the CSA, a controlled substance can be "disposed
of" by destruction, return, recall, sale, or through the
manufacturing process. The Disposal Act allows an ultimate user to
deliver a lawfully obtained controlled substance to another person
"for the purpose of disposal." DEA believes that the ultimate user
disposal authorized by the Disposal Act includes the transfer or
delivery of controlled substances for purposes of destruction,
return, and recall. Such ultimate user activities are consistent
with the intent to remove unused, unwanted, tainted, and expired
substances from households and out of the reach of children and
teenagers thereby reducing the risk of diversion and protecting the
public health and safety. As used in this Notice of Proposed
Rulemaking, DEA uses the terms "disposal" and "dispose" to refer
generally to the wide range of activities that result in controlled
substances being unavailable for further use. When necessary to
specify a particular activity within the disposal process, the
particular activity is identified, e.g., transfer, deliver, collect/
collection, return, recall, destroy/destruction.
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On October 12, 2010, the Secure and Responsible Drug Disposal Act
of 2010 (Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858).
The Disposal Act amended the CSA to allow an ultimate user to
"deliver" a controlled substance "to another person for the purpose
of disposal" if the person receiving the controlled substance is
authorized to receive that substance and the disposal takes place in
accordance with regulations issued by the Attorney General to prevent
the diversion of controlled substances. 21 U.S.C. 822(g)(1). The
Attorney General delegated responsibility for promulgating the Disposal
Act implementing regulations to DEA.
In addition to authorizing ultimate users to deliver their
controlled substances to another person for the purpose of disposal,
the Disposal Act also authorized any person lawfully entitled to
dispose of an ultimate user decedent's property to deliver the ultimate
user's controlled substance to another person for the purpose of
disposal if the ultimate user dies while in lawful possession of the
controlled substance. The Disposal Act also gave DEA the ability, by
regulation, to authorize long term care facilities (LTCFs) to dispose
of controlled substances on behalf of ultimate users who reside or have
resided at the LTCF.
[[Page 75787]]
Congress directed DEA, in promulgating the Disposal Act implementing
regulations, to consider the public health and safety, ease and cost of
program implementation, and participation by various communities. The
implementing regulations may not require any person to establish or
operate a delivery or disposal program.
History of Disposal of Controlled Substances
In 1970, Congress created the CSA after consolidating more than 50
laws related to the control of narcotics and dangerous drugs. The
statute was "designed to improve the administration and regulation of
the manufacturing, distribution, and dispensing [and import/export] of
controlled substances by providing for a 'closed' system of drug
distribution for legitimate handlers of such drugs" with criminal
penalties for transactions outside the legitimate chain.\5\ With the
enactment of the CSA, the Attorney General delegated the responsibility
for promulgating the CSA's implementing regulations to DEA's
predecessor, the Bureau of Narcotics and Dangerous Drugs (BNDD).\6\
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\5\ H.R. Rep. No. 91-1444 (1970), reprinted in 1970 U.S.C.C.A.N.
4566, 4571-4572.
\6\ In 1973, the BNDD was abolished and all BNDD functions were
transferred to DEA. Reorganization Plan No. 2 of 1973, 38 FR 18380
(July 2, 1973).
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BNDD recognized that to maintain the closed system of distribution,
secure avenues for the destruction of controlled substances were
essential. The implementing regulations specifically addressed the
issue of the disposal of controlled substances (36 FR 7776, April 24,
1971). In particular, the implementing regulations outlined a process
under which any person lawfully in possession of a controlled substance
could distribute such substance to the person from whom he/she obtained
it or return it to the manufacturer or the manufacturer's registered
agent, and created procedures for any person in possession of a
controlled substance, with instruction from DEA, to either deliver or
transfer the substance to another for destruction, or to destroy that
substance themselves. 21 CFR 1307.12 and 1307.21. These procedures have
changed little since 1971.
DEA Registrant Disposal--Reverse Distributors
Through the mid-1990s, DEA accepted controlled substances from
registrants for destruction or authorized registrants to destroy
controlled substances pursuant to 21 CFR 1307.21. Manufacturers also
accepted returns of controlled substances from their customers as an
additional service. Eventually, a group of brokers emerged with the
sole purpose to collect controlled substances from registrants for
destruction pursuant to the procedures outlined in DEA's
regulations.\7\ Initially, this group registered with DEA as
distributors and called the services that they provided "reverse
distribution." At about the same time, another group emerged called
"inventory control processors/auditors" whose primary purpose was to
identify expired substances in a registrant's inventory and prepare
them for disposal by the registrant pursuant to 21 CFR 1307.21, or
return to the person from whom it was obtained or to the manufacturer.
This group was not required to register with DEA in order to conduct
their activities because they did not take possession of the
substances. Any inventory control processors/auditors that wanted to
take possession of controlled substances were required to register with
DEA as distributors. To reduce the risk of diversion from these
activities, and ensure accountability during the disposal process, DEA
and the registered distributors entered into memorandums of
understanding (MOUs) that outlined acceptable disposal procedures until
permanent regulations were finalized.
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\7\ The procedures are found today in 21 CFR 1307.21.
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Initially, DEA proposed to codify these MOUs by issuing a Notice of
Proposed Rulemaking to define and register a new category of
manufacturer registration called "disposers" that would authorize
those registrants to receive controlled substances for the primary
purpose of destruction (60 FR 43732, August 23, 1995). This rule was
never finalized. In 2003, DEA readdressed the issue of registrant
disposal in an Interim Final Rule (IFR) to define and register
"reverse distributors" (68 FR 41222, July 11, 2003). In 2005, DEA
published a final rule, thereby finalizing a new category of
distributor registration called "reverse distributors" (70 FR 22591,
May 2, 2005). The final rule authorized reverse distributors to acquire
controlled substances from DEA registrants for the purpose of return to
the manufacturer or manufacturer's agent or for processing those
substances for disposal in accordance with 21 CFR 1307.21. The final
rule also codified security, recordkeeping, reporting, and order form
requirements applicable to reverse distributors.
Non-Registrant Disposal
As discussed above, prior to passage of the Disposal Act, the CSA
did not address the disposal of controlled substances by ultimate
users. Congress envisioned a closed system of distribution that would
control a substance from its manufacture or import through the
traditional chain of distribution moving from registrant to registrant
until it reached its final lawful use (e.g., dispensed to the ultimate
user, etc.). The CSA did not, however, account for circumstances in
which controlled substances were lawfully dispensed to and possessed by
an ultimate user, but not fully used. To this end, the CSA did not
authorize the ultimate user to transfer unwanted and unused controlled
substances to another person for the purpose of disposal.
Moreover, the CSA did not address the disposal of controlled
substances by long term care facilities (LTCFs). DEA defines a LTCF as
"a nursing home, retirement care, mental care or other facility or
institution which provides extended health care to resident patients."
21 CFR 1300.01(b). Generally, controlled substances are prescribed by a
LTCF resident's physician and dispensed by the resident's pharmacist;
such controlled substances are owned by the resident. This is in
contrast with patients in a hospital where controlled substances are
dispensed dose by dose and remain under the possession and control of
the registered dispenser, the hospital. Accordingly, a LTCF may secure
its residents' controlled substances for custodial purposes only. The
controlled substances remain in the lawful possession of the resident,
the ultimate user. As with any other ultimate user, prior to the
enactment of the Disposal Act, a LTCF resident in lawful possession of
dispensed controlled substances could not distribute those substances
to another person, even for the purpose of disposal.
In anticipation of the growing need of ultimate users and LTCFs to
dispose of unused and unwanted controlled substances, DEA published an
Advance Notice of Proposed Rulemaking to solicit information on the
disposal of controlled substances by ultimate users and LTCFs (74 FR
3480, January 21, 2009). Subsequently, as discussed above, on October
12, 2010, the Secure and Responsible Drug Disposal Act of 2010 was
enacted.
Existing DEA Regulations
Existing DEA regulations on the disposal of controlled substances
are codified at 21 CFR 1307.12 and 1307.21. The process for returns is
outlined in 21
[[Page 75788]]
CFR 1307.12 and permits any person in lawful possession of a controlled
substance to distribute that substance, without being registered to
distribute, to the person from whom the substance was obtained or to
the manufacturer or manufacturer's registered agent.
The procedure governing the transfer of controlled substances for
disposal is outlined in 21 CFR 1307.21. In the existing regulations,
any person in possession of any controlled substance that desires or is
required to dispose of such substance may request authority and
instructions for disposal from the DEA Special Agent in Charge (SAC) in
the region in which they are located. The SAC must authorize and
instruct applicants to dispose in one of four ways, by: (1) Transfer to
a DEA registrant authorized to possess the substance; (2) delivery to
an agent of DEA or to the nearest DEA office; (3) destruction in the
presence of an agent of DEA or other authorized person; or (4) such
other means that the SAC determines to assure that the substance does
not become available to unauthorized persons. 21 CFR 1307.21(b).
Registrants requesting authority and instructions from the SAC to
dispose of controlled substances must submit to the SAC three copies of
DEA Form 41 listing the controlled substances that the registrant would
like to dispose. 21 CFR 1307.21(a). Registrants required to regularly
dispose of controlled substances may ask the SAC for authorization to
dispose of those substances without prior approval from DEA in each
instance if the registrant agrees to keep records of disposal. Further,
the SAC may place additional conditions upon the ongoing approval to
dispose. 21 CFR 1307.21(c).
Reverse Distributors
DEA currently defines a reverse distributor as "a registrant who
receives controlled substances acquired from another DEA registrant for
the purpose of--(1) Returning unwanted, unusable, or outdated
controlled substances to the manufacturer or the manufacturer's agent;
or (2) Where necessary, processing such substances or arranging for
processing such substances for disposal." 21 CFR 1300.01(b). Reverse
distributors are required to meet general security requirements, the
security requirements applicable to non-practitioners, and specific
inventory, recordkeeping, and reporting requirements. DEA registrants
are authorized to distribute their lawfully possessed controlled
substances to a registered reverse distributor to the extent authorized
by their registration and in conformity with the CSA and its
implementing regulations. 21 U.S.C. 822(b) and 958(g); See, e.g., 21
CFR 1301.13(e) and 1307.11. Manufacturers, distributors, importers, and
practitioners are currently authorized to distribute their lawfully
possessed controlled substances to a reverse distributor without prior
authorization from the SAC in the region they are located. 21 CFR
1301.13(e)(i), (ii), (viii) and 1307.11(a)(2).
Law Enforcement Agencies and Ultimate User Take-Back Events
Until DEA finalizes the implementing regulations for the Disposal
Act and expanded options for disposal are available, ultimate users may
not deliver their lawfully obtained controlled substances to any other
person for the purpose of disposal other than by surrender to law
enforcement or under the direction of the DEA Special Agent in Charge
in the area in which the person is located. In the interim, DEA has
established National Take-Back Days.\8\ DEA organized these nationwide
one day events as a collaborative effort with state and local law
enforcement agencies. The National Take-Back Days provide the public
with a convenient and secure way to surrender pharmaceutical controlled
substances to law enforcement for destruction.\9\
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\8\ The National Take-Back Days were held on September 25, 2010,
April 30, 2011, October 29, 2011, April 28, 2012, and September 29,
2012.
\9\ DEA registrants are not authorized to dispose of controlled
substances at these events; DEA registrants must comply with the
current DEA regulations regarding disposal of controlled substance
stock/inventory.
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Prescription Drug Abuse Epidemic
Before the Disposal Act, the CSA did not address the disposal of
controlled substances by ultimate users. To dispose of their controlled
substances, ultimate users were permitted to destroy the substances
themselves (e.g., mix the substances with coffee grounds, place in a
plastic bag, and throw into the garbage or flush) or surrender the
substances to law enforcement or DEA. There is concern, however, that
throwing controlled substances into the garbage or flushing them can
contribute to harming the environment. Because the public has limited
options for disposal, outdated and unwanted controlled substances often
accumulate in medicine cabinets, easily within reach of children and
teenagers. In passing the Disposal Act, Congress recognized that the
secure disposal of controlled substances is important because of the
significant prescription drug abuse problem in the United States. The
Centers for Disease Control and Prevention declared prescription drug
overdoses an epidemic.\10\ Studies show the adverse consequences
associated with the substantially high levels of abuse and misuse (non-
medical use) of prescription drugs.
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\10\ Centers for Disease Control and Prevention, "Morbidity and
Mortality Weekly Report," Vol. 61, No. 1, at 10 (January 13, 2012).
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The availability of outdated or unwanted prescription drugs is
problematic because there is a concern that young people may perceive
prescription and/or over-the-counter drugs as "safer" than illegal
drugs because of their intended, legitimate medical use.\11\ This
misperception may be shared by parents. Over 20 percent of parents
believe that it is acceptable to give a teen a prescription drug that
was not prescribed to them.\12\ The 2010 National Survey on Drug Use
and Health (NSDUH)\13\ indicates that over 70 percent of Americans
twelve and older who used pain relievers non-medically in the previous
year obtained the drugs from a friend or relative.\14\ Another study
found that more than 50 percent of teens obtained prescription drugs
from their own family's medicine cabinet.\15\
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\11\ Partnership for a Drug-Free America and MetLife Foundation,
"2009 Parents and Teens Attitude Tracking Study Report," March 2,
2010.
\12\ Partnership for a Drug-Free America and MetLife Foundation,
"2010 Partnership Attitude Tracking Study," April 6, 2011.
\13\ The National Survey on Drug Use and Health (NSDUH) is an
annual survey of the civilian, non-institutionalized, population of
the United States aged twelve or older. The survey is conducted by
the Department of Health and Human Services Office of Applied
Studies, Substance Abuse and Mental Health Services Administration
(SAMHSA).
\14\ Substance Abuse and Mental Health Services Administration,
"Results from the 2010 National Survey on Drug Use and Health:
Volume I, Summary of National Findings," Office of Applied Studies,
2011 (NSDUH Series H-41, HHS Publication No. SMA 11-4658), http://www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.
\15\ Partnership for a Drug-Free America and MetLife Foundation,
"2010 Partnership Attitude Tracking Study," April 6, 2011.
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The prevalence of controlled substance prescription drug abuse
among teenagers is right behind their abuse of marijuana (to include
organic marijuana and synthetic cannabinoids). The 2011 "Monitoring
the Future" survey of teenagers found that 8.1 percent of high school
seniors reported non-medical use of Vicodin (a brand name for Schedule
III hydrocodone combination products) in the past year, and 4.9 percent
reported non-medical use of OxyContin (a brand name for Schedule II
oxycodone sustained release products) in the past year.\16\ This is
[[Page 75789]]
consistent with reports by high school students of increased non-
medical use of painkillers in the past five years.\17\ According to a
2009 survey by the Partnership at Drugfree.org, more than 50 percent of
teenagers (grades 9-12) believe that prescription drugs are easier to
obtain than illegal drugs.
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\16\ Lloyd D. Johnson, Ph.D., et al, "Monitoring the Future
National Results on Adolescent Drug Use: Overview of Key Findings,
2011," Institute for Social Research, The University of Michigan,
22012.
\17\ Lloyd D. Johnston, Ph.D., et al, "Monitoring the Future
National Results on Adolescent Drug Use: Overview of Key Findings,
2009," National Institute of Drug Abuse, 2010 (NIH Publication No.
10-7583).
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Prescription drug abuse is the fastest growing drug problem in the
United States. Findings from the 2010 NSDUH estimate that 7.0 million
persons aged twelve or older used prescription-type psychotherapeutic
drugs--pain relievers, anti-anxiety medications, stimulants, and
sedatives--non-medically in the previous month.\18\ This represents 2.7
percent of the U.S. population.\19\ In 2010, 2 million persons aged
twelve or older used pain relievers non-medically for the first
time.\20\ On average, every day 2,046 12 to 17-year-olds abuse a
prescription pain reliever for the first time.\21\
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\18\ Substance Abuse and Mental Health Services Administration,
"Results from the 2010 National Survey on Drug Use and Health:
Volume I, Summary of National Findings," Office of Applied Studies,
2011 (NSDUH Series H-41, HHS Publication No. SMA 11-4658), http://www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf.
\19\ These estimates were similar to those from the 2009 survey
but 13 percent higher than those from the 2008 survey.
\20\ Id.
\21\ Substance Abuse and Mental Health Services Administration,
2010 National Survey on Drug Use and Health.
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Non-medical prescription drug use, particularly among young adults,
is having a devastating effect on the United States. According to the
Centers for Disease Control and Prevention, poisoning deaths, which
include drug overdoses such as those from prescription drugs, are the
leading cause of injury death in the United States; nearly nine out of
ten poisoning deaths are caused by drugs and more than 40% of those
involve opioid analgesics.\22\ According to SAMHSA's latest Drug Abuse
Warning Network (DAWN) data, of the 4.6 million emergency department
visits in 2009 associated with drug use, about 1.2 million visits
involved the non-medical use of pharmaceuticals.\23\ Emergency
department visits involving non-medical use of pharmaceuticals (misuse
or abuse) almost doubled between 2004 and 2009 from 627,291 in 2004 to
1,244,679 visits in 2009 (a 98.4 percent increase).\24\ About half of
the 2009 emergency department visits related to misuse or abuse of
pharmaceuticals involved painkillers and more than one-third involved
drugs to treat insomnia and anxiety.\25\
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\22\ U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Center for Injury
Prevention and Control, "Drug Poisoning Deaths in the United
States, 1980-2008," December 2011.
\23\ Behavioral Health Statistics and Quality, "Highlights of
the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related
Emergency Department Visits," The DAWN Report, December 28, 2010.
\24\ Id. at 4.
\25\ Id. at 3.
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Scope of Proposed Rule
In response to this growing problem, DEA is proposing new, expanded
regulations for the disposal of controlled substances by ultimate users
in accordance with the Disposal Act. These regulations will provide
ultimate users with more options for disposal of their controlled
substances so that the controlled substances will not accumulate and be
available for misuse, abuse, and accidental ingestion by children and
the elderly. In drafting the implementing regulations, DEA considered
the public health and safety, ease and cost of program implementation,
and participation by various communities. To this end, DEA found that
in order to properly address the disposal of controlled substances by
ultimate users, it was necessary to conduct a comprehensive review of
DEA policies and regulations related to each element of the disposal
process, including the transfer, delivery, collection, destruction,
return, and recall of controlled substances, by both registrants and
non-registrants (e.g., ultimate users).\26\ The reverse distributor
registration category, which is pertinent to the process of registrant
disposal, was included in this comprehensive review.
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\26\ DEA does not address the proper disposal of listed
chemicals by DEA registrants in this rulemaking.
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As discussed above, DEA currently regulates the disposal of
controlled substances by registrants and other persons in accordance
with 21 CFR 1307.21 and regulates the returns process through 21 CFR
1307.12. The existing disposal regulation gives DEA Special Agents in
Charge (SACs) the discretion to authorize disposal in a manner that
reduces the risk of diversion from this activity on a case-by-case
basis. These regulations have changed little since the CSA was enacted.
While this approach is effective, with the enactment of the Disposal
Act and the increasing need for the responsible disposal of controlled
substances by registrants and non-registrants alike, DEA believes that
in order to securely and effectively dispose of unwanted or unused
controlled substances, consistent nationwide standards on disposal are
necessary. As a result, DEA proposes to delete 21 CFR 1307.12 on
"Distribution to supplier or manufacturer" and 21 CFR 1307.21 on
"Disposal of controlled substances" and promulgate a new part 1317
that will expand available disposal options, establish nationwide
standards for the disposal of controlled substances, and
comprehensively outline the process and procedure for the disposal of
controlled substances by registrants, ultimate users, and other non-
registrants such as long term care facilities.\27\
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\27\ Any previous waivers, MOUs, and MOAs issued in accordance
with 21 CFR 1307.21 shall be superseded by this rulemaking on the
"Disposal of Controlled Substances" if and when it is finalized.
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The goal of this proposed new part on disposal, consistent with
Congress's goal in passing the Disposal Act, is to set controlled
substance diversion prevention parameters that will allow public and
private entities to develop a variety of methods for collecting and
destroying controlled substances in a secure, convenient, and
responsible manner. DEA believes that the new part on disposal will
provide registrants and non-registrants alike clear and consistent
requirements for the disposal of controlled substances. It is intended
to maximize cost efficiency, voluntary participation, and public
accessibility while simultaneously promoting the secure and responsible
disposal of controlled substances in order to prevent diversion.
In accordance with the changes described above, DEA proposes to
delete any reference to 21 CFR 1307.12 and 1307.21 and replace it with
a reference to the new 21 CFR part 1317, where appropriate.\28\ DEA
also proposes to revise 21 CFR 1301.13(e)(1)(i) to delete reference to
a disposer category of registration in the coincident activity column
for manufacturers. A disposer category of registration was proposed by
DEA in 1995, but was never finalized
[[Page 75790]]
(60 FR 43732, August 23, 1995). Reference to a disposer category was
inadvertently included in a previous rulemaking (68 FR 58587, October
10, 2003).
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\28\ DEA proposes in 21 CFR 1301.76 to delete reference to
1307.12 and replace it with reference to 21 CFR part 1317; in 21 CFR
1304.11(e) and the introductory paragraph of 1304.22 to delete
reference to 21 CFR 1307.12; in 21 CFR 1301.25(i), 1301.52(c), and
1307.13 to delete reference to 21 CFR 1307.21 and replace it with
reference to 21 CFR part 1317; in 21 CFR 1304.25(a)(9) and
1304.25(b)(9) to delete reference to 21 CFR 1307.22 and replace it
with reference to 21 CFR part 1317; and in 21 CFR 1304.04(a) to add
reference to 21 CFR part 1317. DEA also proposes in 21 CFR 1307.22
to delete reference to 21 CFR 1307.21, and replace it with reference
to 21 CFR part 1317. DEA proposes to revise the title of 21 CFR
1307.22 to "Delivery of surrendered and forfeited controlled
substances" for clarity.
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January 19-20, 2011 Public Meeting
On January 19 and 20, 2011, DEA held a well-attended public meeting
to receive information from interested parties and the public and
gather ideas for drafting regulations for the newly enacted Disposal
Act. (The Notice of Meeting was published in the Federal Register on
December 22, 2010, 75 FR 80536.) This meeting provided an opportunity
for all interested persons --the general public, including ultimate
users, parents, pharmacies, waste management companies, long term care
and pharmaceutical related industries, as well as federal, state, and
local agencies, including law enforcement personnel, and others--to
express their views regarding safe and effective methods of disposal of
controlled substances consistent with the CSA. Representatives of
various industries and organizations as well as federal, state, and
local agencies made presentations at the meeting and many submitted
written comments prior to the meeting.
In drafting the Disposal Act implementing regulations, DEA gathered
information about disposal from the more than 70 written comments and
44 oral presentations that were submitted and transcribed from the two
day public meeting. Information and experience resulting from pilot
projects around the United States involving mail-back programs, take-
back events, and collection receptacles for pharmaceuticals were shared
and helped inform this proposed rule. Representatives of law
enforcement agencies provided information on their experience, existing
procedures, and perspective, particularly with respect to take-back
events as a method of collection. Representatives from DEA registrant
and other affected groups, such as pharmacies, reverse distributors,
and the waste management industry, provided insights on technology and
existing destruction procedures. Presentations by the Environmental
Protection Agency, the Food and Drug Administration, the U.S. Postal
Service, the U.S. Army, and state and local agencies provided
information on relevant federal, state, and local laws and procedures
pertaining to the disposal and transportation of controlled substances,
particularly pharmaceuticals. DEA appreciated and considered all
information provided at or submitted in response to the Notice of
Meeting in drafting this NPRM.
Proposed Disposal Act Implementing Regulations
Disposal of Controlled Substances by Ultimate Users--Authorized Persons
In accordance with the Disposal Act, DEA proposes new regulations
for the disposal of controlled substances by ultimate users and other
non-registrants--in particular: (1) Persons lawfully entitled to
dispose of ultimate user decedent's property and (2) LTCFs on behalf of
ultimate users that reside or have resided at that LTCF. In drafting
these proposed implementing regulations, DEA considered the public
health and safety, ease and cost of program implementation, and
participation by various communities. To this end, DEA proposes three
options for ultimate users to dispose of controlled substances: (1)
Take-back events; (2) mail-back programs; and (3) collection receptacle
locations. These proposed options are voluntary and no person is
required to establish or operate a disposal program, although any
person who chooses to do so and is authorized by DEA to do so must
adhere to the final regulations.
DEA proposes to authorize ultimate users and persons lawfully
entitled to dispose of an ultimate user decedent's property to deliver
lawfully possessed controlled substances in Schedules II, III, IV, and
V to law enforcement agencies through take-back events, mail-back
programs, and collection receptacles, and to authorized collectors
through mail-back programs and collection receptacles. DEA is also
proposing to authorize LTCFs, on behalf of an ultimate user that
resides or has resided at that LTCF, to deliver a resident's lawfully
possessed controlled substances in Schedule II, III, IV, or V to
certain on-site collection receptacles operated by a registered retail
pharmacy that is an authorized collector. The collection of Schedule I
controlled substances is not permitted because, generally, ultimate
users cannot lawfully possess Schedule I substances unless they are
participating in an investigational use of drugs pursuant to 21 U.S.C.
355(i) and 360b(j). For ultimate users in lawful possession of Schedule
I substances for investigational use, DEA proposes that they follow the
disposal procedures in 21 CFR 1317.85(b). Furthermore, the proposed
collection methods are intended for the collection and destruction of
lawfully possessed controlled substances, not as an avenue for the
disposal of substances that were illegally obtained.
DEA proposes in sections 1317.65--1317.80 that controlled
substances collected from ultimate users and other authorized non-
registrant persons may be comingled with non-controlled substances--
both controlled and non-controlled substances may be collected together
so long as the requirements outlined for controlled substances are
followed. Comingling reduces the risk of diversion and is practical,
efficient, and economical. Members of the public cannot easily identify
the difference between controlled and non-controlled substances. As
collection pilot programs demonstrate, the requirement that controlled
and non-controlled substances be collected separately is expensive,
time-consuming, and hampers the collection process. In addition,
comingling controlled substances is another way to minimize the risk of
diversion of collected controlled substances. For example, many
pharmacies and institutional practitioners disperse controlled
substances throughout the stock of non-controlled substances in order
to deter the theft or diversion of the controlled substances. See 21
CFR 1301.75(b).
DEA proposes in section 1317.30 that federal, state, tribal, and
local law enforcement agencies continue with authority to collect
ultimate user controlled substances, and that certain registrants
authorized by DEA to be a "collector" be authorized to collect
controlled substances from ultimate users, persons lawfully entitled to
dispose of ultimate user decedent's property, and, in some
circumstances, long term care facilities. DEA is authorizing certain
registrant categories to be "collectors" so that DEA can ensure
sufficient physical security controls are in place, thereby minimizing
the risk of diversion. Registrants are subject to controls related to
their DEA registration. These pre-existing controls will protect
against the diversion of controlled substances in the process of
ultimate user collection.
Possession for Disposal
Once a controlled substance is lawfully dispensed to an ultimate
user, the ultimate user is in possession of that substance. Only the
ultimate user or other authorized persons (i.e., persons lawfully
entitled to dispose of an ultimate user decedent's property and, in
some cases, the LTCF where the ultimate user resides or has resided)
may dispose of such controlled substances in accordance with DEA's
proposed ultimate user disposal regulations. In contrast, a controlled
[[Page 75791]]
substance dispensed for immediate administration pursuant to an order
for medication in an institutional setting remains in the possession of
that registered institution, even if the substance is not fully
exhausted (e.g., some of the substance remains in a vial, tube, or
syringe after administration but cannot or may not be further
utilized). Such remaining substance must be properly recorded, stored,
and destroyed in accordance with DEA regulations, and all applicable
federal, state, tribal, and local laws and regulations. These same
principles would apply to hospice settings, which may be registered by
DEA as an institutional practitioner or may be unregistered like many
LTCFs.
Law Enforcement Agencies
DEA proposes specific language in section 1317.35 to continue to
authorize law enforcement agencies, on a voluntary basis, to collect
controlled substances from ultimate users and persons lawfully entitled
to dispose of an ultimate user decedent's property through: (1) Take-
back events, (2) mail-back programs, and (3) collection receptacles
located at the law enforcement agency's physical address.
DEA recommends that law enforcement agencies electing to
participate in ultimate user disposal maintain any records of receipt
or collection in a manner that is consistent with that agency's
recordkeeping requirements for illicit controlled substance evidence
handling and store any controlled substances collected in a manner that
reasonably prevents the diversion of controlled substances and is
consistent with that agency's standard procedures for storing illicit
controlled substances. Destruction of controlled substances must be in
accordance with applicable federal, state, tribal, and local laws and
regulations. DEA recommends that law enforcement agencies also keep a
record of any transfer of controlled substances to reverse distributors
for destruction; such records may assist DEA in ensuring that reverse
distributors are keeping proper records of those controlled substances
they acquire from law enforcement agencies that conduct ultimate user
disposal activities. DEA recognizes that law enforcement agencies have
existing procedures regarding the handling, storage, or transfer for
destruction of controlled substances. These proposed rules do not
require changes to those procedures. DEA anticipates that those
existing procedures will provide the necessary security to prevent the
diversion of controlled substances.
DEA proposes that law enforcement agencies that choose to conduct
mail-back programs within their jurisdiction must make available to
ultimate users packages described in proposed section 1317.70. Such
packages may, however, be made available pursuant to a partnership or
other agreement between the law enforcement agency and another person
for the purpose of funding, dissemination, production, or other non-
collection activity meant to facilitate the law enforcement agency's
mail-back program. Such standards will help to alleviate the primary
security concerns related to mail-back programs. As explained below,
many such concerns exist regardless of the destination of the mail-back
packages; thus, security standards related to the mail-back packages
must be maintained even if the program is conducted by a law
enforcement agency. DEA emphasizes, however, that the authority of law
enforcement agencies to conduct ultimate user disposal programs is not
a mechanism by which registrants may circumvent these proposed
regulations or any other applicable laws or regulations. Any person,
group, or entity that partners with a law enforcement agency to
implement an ultimate user disposal program must comply with all
applicable laws and regulations. In specific terms, any authorized
collector that partners with a law enforcement agency to jointly
conduct a collection program must adhere to these proposed regulations
and any other applicable laws and regulations.
DEA appreciates that implementing some of the proposed disposal
methods may present challenges to some state, tribal, and local law
enforcement agencies. When implementing any new community service, all
government agencies must balance available resources against
established priorities. DEA hopes that these regulations will provide
flexibility and opportunities for communities, interest groups,
registrants, and law enforcement agencies to partner together to
provide cost effective, safe, and convenient methods of ultimate user
disposal. DEA looks forward to receiving suggestions from state,
tribal, and local law enforcement agencies concerning its proposed
regulations for the disposal of controlled substances by law
enforcement agencies.
Collectors
DEA proposes in section 1300.01(b) to define a "collector" as a
registered manufacturer, distributor, reverse distributor, or retail
pharmacy that is authorized to receive a controlled substance for the
purpose of destruction from an ultimate user, person lawfully entitled
to dispose of an ultimate user decedent's property, or a long term care
facility on behalf of an ultimate user that resides or has resided at
that facility. In section 1317.40(a), DEA proposes that registered
manufacturers, distributors, reverse distributors, and retail
pharmacies may obtain authorization from DEA to be a collector. No
manufacturer, distributor, reverse distributor, or retail pharmacy is
required to be a collector.
In proposing which DEA registrants could become authorized
collectors, DEA considered public health and safety, diversion control,
and convenience and accessibility. In particular, DEA is proposing to
authorize registered retail pharmacies to become collectors because
such registrants are open to the public and have theft and loss
prevention measures within the pharmacy processing area as well as
outside the confines of the prescription processing and pick-up area,
which easily lends itself to secure collection receptacle placement.
Retail pharmacy personnel also routinely handle controlled substances
intended for the ultimate user in a public setting while keeping such
substances secure, and they have experience comingling controlled and
non-controlled substances in the receipt and storage process. As public
retail establishments, retail pharmacies generally have experience with
the general public as customers and routinely implement theft and loss
prevention measures.
For the foregoing reasons, retail pharmacies co-located with
hospitals may be authorized to maintain collection receptacles in
accordance with these regulations. Registered hospitals themselves,
however, may not be authorized as collectors. This should have limited
adverse impact on the ability of hospital patients to participate in
ultimate user disposal because DEA believes many hospitals are co-
located with registered retail pharmacies as a convenient service for
outpatients. DEA proposes to restrict hospitals from being authorized
collectors because they do not generally operate under the same
business model or with similar theft and loss prevention procedures as
retail pharmacies. For example, the general public is expected to enter
retail pharmacies for short durations in order to conduct retail
business. The physical layout of retail pharmacies is designed for
open, clearly observable common areas and practically no areas to
conceal an unlawful purpose. It would be unusual and suspicious for a
person to spend an extended amount of time in a retail pharmacy without
a known,
[[Page 75792]]
specific purpose, triggering routine theft and loss prevention
measures. In contrast, hospitals are generally open 24-hours per day
and allow for unsupervised public access; they are much larger than
retail pharmacies and many interactions occur behind closed doors
without routine theft and loss prevention measures; and foot traffic is
not routinely monitored for unlawful purposes. These differences reduce
the effectiveness of the proposed regulation's diversion control
mechanisms and substantially increase the risk of diversion at
hospitals if hospitals were authorized as collectors.
The above discussed risks in allowing hospitals as collectors are
not necessary in light of the many other options available to ultimate
users to dispose of unwanted or unused controlled substances.
In addition to the increased risk of diversion at hospitals, there
is a risk of inadequate recordkeeping if hospitals are permitted as
collectors. Unlike retail pharmacies, registered hospitals do not
dispense controlled substances to ultimate users pursuant to legitimate
prescriptions. Rather, registered hospitals administer controlled
substances to inpatients dose by dose, and the controlled substances
remain within the possession and control of the registered dispenser,
the hospital. As such, registered hospitals may not dispose of
controlled substances in collection receptacles, but must follow the
revised regulations for registrant destruction, and keep records of
such destruction.
DEA is also proposing to allow retail pharmacies to operate
collection receptacles in LTCFs under certain circumstances, as
discussed below, because--unlike hospitals--LTCFs "face a distinct set
of obstacles to the safe disposal of [ultimate user] controlled
substances due to the increased volume of controlled substances they
handle." Pub. L. 111-273, 2, 124 Stat. 2858. DEA is further proposing
to authorize registered manufacturers, distributors, and reverse
distributors to become collectors because, although such registrants
have registered locations that generally are not open to the public,
they do have heightened security requirements and are accustomed to
receiving, securing, and distributing large amounts of controlled
substances on a daily basis. DEA believes that expanding collector
authorization to these registrants will provide the necessary
convenience and accessibility to the public while ensuring the public
health and safety and minimizing potential diversion.
To obtain authorization to be a collector, a manufacturer,
distributor, reverse distributor, or retail pharmacy must apply for a
modification to their registration in accordance with 21 CFR 1301.51,
which DEA is proposing to revise in order to reflect these changes.
Upon DEA approval of this modification in registration, each authorized
registrant's DEA Certificate of Registration will specify that
registrant's status as a "collector" and the location(s) approved for
collection. Once approved to be a collector, the option for renewal
will be available to authorized registrants when they renew their
registration.
DEA proposes in section 1317.40(a) that if the registrant that is
authorized to collect ceases activities as a collector, such registrant
must modify their registration in accordance with 21 CFR 1301.51 to
indicate that they no longer collect. In accordance with 21 CFR
1301.52, the registration of any person and any modifications,
including authorization to be a collector, terminates if and when such
person dies, ceases legal existence, discontinues business or
professional practice, or surrenders a registration. Any registrant
that ceases legal existence or discontinues business or professional
practice must notify the Administrator promptly of such fact. 21 CFR
1301.52(a). Additionally, a registrant's authorization to collect is
dependent upon the registration status of the manufacturer,
distributor, reverse distributor, or retail pharmacy. Accordingly, the
expiration, revocation, suspension, or surrender of a DEA registration
will also result in the loss of the registrant's authorization to be a
collector.
DEA proposes in section 1317.40(c) that authorized collectors may
conduct the following activities: (1) Receive mail-back packages from
ultimate users and persons lawfully entitled to dispose of an ultimate
user decedent's property if the collector has and utilizes an on-site
method of destruction; (2) install, manage, and maintain collection
receptacles at locations for which the registrant is authorized to
collect; and (3) promptly dispose of sealed inner liners and their
contents as provided for in Sec. 1317.05(c)(2). DEA proposes in
section 1317.40(b) that collection may occur only at the registered
locations of manufacturers, distributors, reverse distributors, and
retail pharmacies that are authorized to collect at those locations and
at long term care facilities (LTCFs) at which registered retail
pharmacies are authorized to maintain a collection receptacle (see
discussion on LTCFs below).
DEA proposes to authorize as collectors those persons already
registered as manufacturers, distributors, reverse distributors, and
retail pharmacies because, as registrants, these persons are
accountable, have experience handling large volumes of controlled
substances on a routine basis, and they are subject to controls related
to their DEA registration. These pre-existing controls also protect
against the diversion of controlled substances in the process of
ultimate user collection. Further, DEA believes that ultimate user
collection should occur at DEA registered locations because these
premises are subject to DEA inspection, security, and other
controls.\29\ Such requirements ensure that proper security and other
controls are in place to minimize the risk of diversion from the
collection of controlled substances. Finally, with the passage of the
Disposal Act, Congress did not provide DEA the authority to register
persons specifically for the purpose of collecting and disposing of
controlled substances from ultimate users. DEA is therefore restricted
to operating within its previously existing statutory authority with
regard to registration.
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\29\ In accordance with the Disposal Act, which permitted DEA
to, by regulation, authorize LTCFs to dispose of controlled
substances on behalf of ultimate users that reside or have resided
at the LTCF (see 21 U.S.C. 822(g)(3)), DEA is also proposing to
authorize the collection of controlled substances at those LTCFs for
which a registered retail pharmacy is authorized to maintain a
collection receptacle (see discussion of LTCFs below).
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In section 1317.45, DEA proposes that authorized collectors employ
as an agent or employee with access to or influence over controlled
substances acquired pursuant to their status as a collector, only those
persons that have never been convicted of any felony offense related to
controlled substances and have never, at any time, had an application
for registration with DEA denied, had a DEA registration revoked or
suspended, or surrendered a DEA registration for cause. DEA is
proposing security requirements for collectors in order to strengthen
the accountability of the ultimate user collection process, which
occurs outside the closed system of distribution, by ensuring that only
those employees that have met certain employee screening requirements
have access to or influence over controlled substances collected from
ultimate users. This requirement is similar to the employee screening
requirements for registered practitioners in 21 CFR 1301.76, where
there is also a high risk of diversion.
The information that collectors must maintain in their records is
proposed in
[[Page 75793]]
section 1317.50. In accordance with the CSA, every DEA registrant must
make a biennial inventory and maintain, on a current basis, a complete
and accurate record of each controlled substance manufactured,
received, sold, delivered, or otherwise disposed of. 21 U.S.C.
827(a).\30\ These records must be maintained separately from all other
records of the registrant or, alternatively, in the case of non-
narcotic controlled substances, be in such a form that required
information is readily retrievable from the ordinary business records
of the registrant. 21 U.S.C. 827(b)(2). The records must be kept and be
available for at least two years for inspection and copying by officers
or employees of the Attorney General. 21 U.S.C. 827(b)(3). DEA may
promulgate regulations that specify the information that registrants
are required to maintain in their records. 21 U.S.C. 827(b).
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\30\ The recordkeeping requirements differ depending on whether
the records pertain to the registrant's inventory or stock, or the
registrant's activities as an authorized collector. The requirements
contained in the current regulations are those imposed on
registrants with regard to their stock on hand (i.e., their
inventory of controlled substances). Controlled substances collected
from ultimate users are not part of a registrant's inventory and
would not be counted as such.
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To this end, DEA is proposing information that collectors must
record based on the particular ultimate user collection method utilized
(i.e., mail-back program or collection receptacle). The inner liners
and mail-back packages that DEA proposes to be utilized in the
collection of ultimate user controlled substances are intended for the
disposal of controlled substances. As a result, DEA is requiring that
collectors make an inventory of all inner liners and mail-back packages
and maintain records on the use and destruction of such liners and
packages in order to properly account for the disposal of controlled
substances in accordance with the CSA. Once sealed, inner liners and
mail-back packages shall not be opened, x-rayed, or otherwise
penetrated and the substances contained in the inner liners and mail-
back packages may not be individually handled, counted, inventoried, or
otherwise discerned.
DEA is also proposing in section 1317.50 that collectors be exempt
from the ARCOS requirements in 21 CFR 1304.33 and the order form
requirements in 21 CFR part 1305 only when they collect controlled
substances from ultimate users or other authorized non-registrant
persons. Such substances are outside the closed system of distribution,
and these tracking and accountability mechanisms are designed for
substances within the closed system of distribution.
Registered Reverse Distributors and Distributors
DEA appreciates that law enforcement agencies and authorized
collectors may not have the resources to destroy controlled substances
received from ultimate users. Such persons may use the services of a
registered reverse distributor for this purpose. DEA proposes in
section 1317.55(a) to authorize registered reverse distributors to
acquire for purposes of destruction controlled substances that have
been collected by: (1) Law enforcement agencies; and (2) authorized
collectors through collection receptacles. DEA also proposes in section
1317.55(b) to authorize registered distributors, in addition to
registered reverse distributors, to acquire for purposes of destruction
controlled substances collected by authorized collectors through
collection receptacles.\31\ DEA is proposing in section 1317.55(c) that
registered reverse distributors and registered distributors that choose
to acquire such collected controlled substances from authorized
collectors do so in the manner prescribed for acquiring registrants'
controlled substance inventory for purposes of disposal. This
consistent procedure will help provide certainty in the disposal
process, and help prevent errors during the acquisition process. Such
acquisitions may be made pursuant to pick-up by the reverse distributor
or distributor at the registrant's registered or authorized collection
location, by delivery by common or contract carrier to the reverse
distributor's or distributor's registered location, or by direct
delivery from a non-practitioner to the reverse distributor's or
distributor's registered location.
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\31\ Reverse distributors or distributors may acquire controlled
substances that have been collected by collection receptacle at
either an authorized collector's registered location or, pursuant to
sections 1317.75(g) and 1317.80(d), at a long term care facility for
which a registered retail pharmacy is authorized to collect. See
subsequent discussion for more detail on reverse distributors.
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DEA proposes that authorized collectors that conduct mail-back
programs must have and use an on-site method of destruction, and, as a
result, these collectors will not be authorized to deliver or transfer
those substances to a registered reverse distributor or distributor.
The requirement to destroy on-site would not apply to law enforcement
agencies that conduct mail-back programs; law enforcement agencies may
continue to transfer any collected substance to an authorized reverse
distributor.
Registered reverse distributors and distributors do not have to be
authorized collectors to acquire collected controlled substances from
law enforcement agencies or authorized collectors. In such
circumstances, the substances being acquired have already been
collected by law enforcement agencies and authorized collectors and
should already be securely sealed in an inner liner or mail-back
package in accordance with sections 1317.65-1317.80.
DEA also proposes in section 1317.55(c) that those registered
reverse distributors and distributors that acquire controlled
substances from law enforcement agencies and authorized collectors must
destroy such controlled substances or securely transfer and store the
controlled substances utilizing applicable procedures described in
section 1317.15(c) until timely destruction can occur. In addition,
reverse distributors and distributors must destroy the controlled
substances as soon as practicable but no later than fourteen calendar
days of pick-up or delivery, pursuant to proposed section 1317.15(d).
Consistent procedures for the acquisition and disposal of registrant
inventory and ultimate user collected controlled substances will
streamline practices and help prevent confusion and error in the
transfer, storage, and destruction processes. Any storage of such
substances at the registered location of the reverse distributor or
distributor must be in a manner consistent with the security
requirements for Schedule II controlled substances. This is to minimize
the risk of diversion because inner liners and mail-back packages shall
not be opened once they are sealed and their contents will not be
known, and, as a result, such liners and packages should be stored as
though each contains a Schedule II controlled substance.
DEA also proposes in sections 1317.55(d) and 1317.100 to require
that these reverse distributors and distributors keep records regarding
the receipt, storage, transfer, and destruction of those controlled
substances acquired from law enforcement agencies and authorized
collectors.\32\ Such records will help to ensure that the collected
substances are accounted for and properly destroyed.
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\32\ For clarity, DEA proposes in 21 CFR 1304.11(e)(2) and
1304.22(b) to cross reference these reverse distributor and
distributor recordkeeping requirements covered by 21 CFR 1317.55.
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Finally, DEA proposes in section 1317.55(e) and (f) to exempt
reverse distributors and distributors that acquire collected controlled
substances from law enforcement agencies or authorized collectors from
the ARCOS
[[Page 75794]]
requirements in 21 CFR 1304.33 and the order form requirements in 21
CFR part 1305, only when they acquire controlled substances that have
been collected from ultimate users by law enforcement agencies or
authorized collectors. Such substances are outside the closed system of
distribution, and these tracking and accountability mechanisms are
designed for substances within the closed system of distribution.
Disposal of Controlled Substances by Ultimate Users--Authorized Methods
Take-Back Events
The first method of collection that DEA proposes, in section
1317.65, is take-back events. Ultimate users and persons lawfully
entitled to dispose of an ultimate user decedent's property would be
authorized to utilize a take-back event in accordance with 1317.65 to
dispose of their controlled substances in Schedules II, III, IV, and V.
As mentioned above, DEA is proposing specific language that will
continue to authorize law enforcement agencies to conduct take-back
events. DEA believes that take-back events should be conducted only by
law enforcement agencies because such events are highly publicized, are
often held at easily accessible locations within a community, and do
not have the same security controls as permanent collection locations.
As such, take-back events are more vulnerable to diversion. Although
only law enforcement agencies would continue to be authorized to
conduct take-back events, DEA proposes in section 1317.65(a) that
private entities or community groups may continue to partner with law
enforcement to hold community take-back events, thereby allowing for
greater community involvement, education, and outreach, while
minimizing the risk of diversion.
Many of the provisions that DEA proposes in section 1317.65, with
respect to take-back events, are recommendations ("should" instead of
"shall") because DEA has no intent to change existing law enforcement
procedures regarding the handling, storage, transfer, or destruction of
controlled substances. DEA is, however, proposing some requirements
that law enforcement agencies must follow in order to hold a take-back
event. For example, in section 1317.65(b), DEA proposes that any law
enforcement agency that conducts a take-back event shall appoint a law
enforcement officer, who must be employed full time by the agency, to
oversee the collection. Further, law enforcement officers employed \33\
and authorized by the law enforcement agency conducting the take-back
event must maintain control and custody of the collected substances
from the time the substances are collected from the ultimate user or
person authorized to dispose of the ultimate user decedent's property
until secure transfer or destruction has occurred. DEA believes that
designated law enforcement officers should be required to maintain
control and custody of the controlled substances at all times in order
to protect against theft and diversion.
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\33\ DEA proposes in section 1317.02 to define "law enforcement
officer" for the purpose of 21 CFR part 1317. In order to prevent
the appearance that a third party has access to or influence over
controlled substances, for example by directly or indirectly funding
law enforcement disposal activities, DEA is requiring the law
enforcement officer to be directly employed full time by a law
enforcement agency, be under the direction and control of the
federal, state, tribal, or local government, be acting in the course
of their official duty, and be duly sworn and given the authority by
the federal, state, tribal, or local government to: (1) Carry
firearms; (2) execute and serve warrants; (3) make arrests without
warrant; and (4) make seizures of property.
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Take-back events provide ultimate users the opportunity to dispose
of Schedule II, III, IV, and V controlled substances, which they
legally possess, at a designated place and time. DEA proposes in
section 1317.65(c) that each take-back event should have at least one
receptacle for the collection of permitted substances. Although this is
only a recommendation for law enforcement agencies that conduct take-
back events, DEA believes that optimal security and protection of
public health and safety can be achieved if controlled and non-
controlled substances are collected in a collection receptacle that is
securely locked and substantially constructed with an outer shell and
removable inner liner.
DEA also proposes in section 1317.65(e) that only an ultimate user
or person lawfully entitled to dispose of an ultimate user decedent's
property may transfer controlled substances to the law enforcement
agency during the take-back event. No other person, such as a take-back
event volunteer, may handle or touch the controlled substances at any
time. DEA is proposing this requirement to limit the number of hands
through which the substances pass because the risk of diversion
increases each time a controlled substance is transferred to a new
person.
Mail-Back Programs
The second method of collection that DEA proposes, in section
1317.70, is mail-back programs. Ultimate users and persons lawfully
entitled to dispose of an ultimate user decedent's property are
authorized to utilize a mail-back program in accordance with 1317.70 to
dispose of their controlled substances in Schedules II, III, IV, and V.
DEA proposes in section 1317.70(a) specific language to continue to
authorize law enforcement agencies to voluntarily conduct mail-back
programs; and mail-back programs may be conducted by registered
manufacturers, distributors, reverse distributors, or retail pharmacies
that: (1) Are authorized as collectors; and (2) have and utilize an on-
site method of destruction at their registered location. The security
requirements proposed with respect to the other proposed collection
methods (take-back events and collection receptacles) are adequate to
ensure that controlled substances are collected and maintained in a
manner that prevents diversion until transfer and destruction can
occur. Designing regulations that ensure the security of controlled
substances in the context of mail-back programs is challenging because,
unlike take-back events and collection receptacle locations, there is a
third party who handles the controlled substances as they are
transferred from the ultimate user to the authorized collector in mail-
back programs--the mail system. This unique circumstance provides
opportunities for diversion that do not exist with the other collection
methods, thus requiring more stringent controls than the other methods.
As a result, DEA proposes to allow mail-back programs to be voluntarily
conducted by DEA registrants that are authorized collectors that have
and utilize an on-site method of destruction and by law enforcement
agencies in order to minimize the transfer of controlled substances
between various locations. This is intended to minimize the risk of
diversion.
DEA also proposes in section 1317.70(c) that any authorized
collector or law enforcement agency that conducts a mail-back program
must produce and provide specified packages, either at no cost or for a
fee, to ultimate users for the collection of controlled substances
through the mail, and may do so in partnership with third parties for
convenience, funding, or any other lawful purpose. One example of such
a partnership would be when an authorized collector with an on-site
method of destruction (e.g., a DEA-registered reverse distributor)
produces appropriate mail-back packages, and allows a third party
business partner that is frequently accessed by the public (e.g., a
retail pharmacy) to provide these packages to patronizing customers. In
this circumstance, the registered reverse
[[Page 75795]]
distributor would be responsible for operating the mail-back program,
including recordkeeping and security, and it must receive the mail-back
packages directly at its registered location for on-site destruction.
DEA proposes that packages used for collection by mail-back must meet
certain specifications. The proposed package requirements include only
those specifications necessary to ensure that controlled substances
sent through the mail, outside of the closed system of distribution,
can be tracked with a high degree of confidence in their security.
These requirements are intended to protect public health and safety and
prevent the diversion of controlled substances.
In particular, the packages are proposed to be postage paid (e.g.,
business reply), preaddressed to the authorized mail-back location,
nondescript, tamper-evident and tear-resistant, among other things.
This is to ensure that the mailers are not delayed or diverted through
address changes, theft, or because the package has inadequate postage.
Such mailers must be addressed to the authorized collector's registered
location with the on-site method of destruction or to the law
enforcement agency's physical address and cannot be addressed to any
other location, such as a post office box.
DEA is also proposing to require that each package must have a
unique identification number so that each package can be tracked. In an
effort to increase the ease of program implementation and to enhance
the security of the mail-back option, DEA is also proposing that each
package include instructions for the user that indicate the process for
mailing back the package, the permitted substances that can be sent,
and notice that only packages provided by the authorized collector will
be accepted for destruction.
DEA considered requiring registrants to establish a system that
would allow ultimate users to notify the collector when the ultimate
user mailed back a package containing controlled substances, similar to
pilot projects described in the public hearing. However, the burden of
requiring a notification system outweighed the benefits of such a
system, particularly when other security-enhancing measures are
proposed. DEA believes that the collector inventory and recordkeeping
requirements--that a collector conducting a mail-back program must keep
inventory of mailers created and record the unique identification
number of each mail-back package received--coupled with the stringent
package specifications--for example the package must be postage paid
and preaddressed--are sufficient controls to help protect against
diversion while minimizing the burden on ultimate users. However, while
DEA is not proposing to require collectors to create and maintain a
notification system, such a system is not prohibited by the proposed
regulations. To ensure privacy, the proposed language of section
1317.70(d) specifies that the public cannot be required to provide any
personally identifiable information when mailing back controlled
substances to an authorized collector.
DEA proposes in section 1317.70(e) that the authorized collector
shall accept for the purpose of on-site destruction only those packages
that they made available, directly or in partnership with a third
party, for the collection of controlled substances. This requirement is
designed so that authorized collectors, who control the production of
uniform mail-back packages that are both nondescript and not readily
identified as containing controlled substances, can easily identify
authorized packages and thereby increase the likelihood that they
accept only those packages that they are authorized to accept.
If the authorized collector inadvertently and unknowingly accepts
controlled substances from an ultimate user in a package that they did
not make available for the collection of controlled substances, the
authorized collector shall notify the DEA office in their area of the
receipt of the package within three business days of receipt and store
the package, in a manner consistent with the routine mail-back package
storage requirements discussed below, until the collector receives
further instructions from DEA.
The "three business day" requirement allows the registrant enough
time to process the packages received while still ensuring that DEA is
notified of the incident in a timely manner thus allowing further
investigation if necessary. The requirements for postage paid and
preaddressed packages are designed to reduce the likelihood that
authorized collectors will receive unauthorized controlled substances
via mail-back programs because the sender would have to address such
package and pay for postage. Ultimate users will likely not engage in
such inconveniences when postage paid and preaddressed mailers are
available.
DEA proposes in section 1317.70(f) that law enforcement officers
employed by the law enforcement agency and "authorized employees" of
a collector be the only individuals permitted to handle packages
collected through a mail-back program. Under the proposed definition in
1317.02(a), an "authorized employee" is a person directly employed by
the registrant full time (i.e., not employed as a contractor or agent
of a third party) and must not have been convicted of any felony
offense related to controlled substances and not have had at any time
an application for registration with DEA denied, had a DEA registration
revoked or suspended, or surrendered a DEA registration for cause.
These enhanced security requirements are proposed consistent with
existing security screening procedures for employees of certain
registrants and will strengthen the integrity of the mail-back process
by ensuring that only trusted employees have access to or influence
over controlled substances.
DEA proposes in section 1317.70(f) that upon receipt of a package
through a mail-back program, an authorized collector shall not open the
package, x-ray, analyze, or otherwise penetrate the package. DEA
proposes in section 1317.05(c)(1) that the authorized collector must
promptly destroy the package on-site or securely store the package
until prompt on-site destruction or timely notification to DEA of
receipt of an unauthorized package in accordance with 1317.70(e) can
occur. DEA is proposing the flexible "prompt" destruction and secure
storage standard for collectors rather than a specific time frame to
ensure that controlled substances do not accumulate while pending
destruction or secure storage and are destroyed in a prompt manner,
thus reducing the opportunities for diversion, while still accounting
for the individual circumstances of registrants that destroy controlled
substances. If the authorized collector is a reverse distributor,
however, such destruction must occur as soon as practicable but no
later than fourteen calendar days of receipt in accordance with
proposed section 1317.15(d), which is discussed below.
Mail-back programs provide a convenient means of disposal for
ultimate users who may not otherwise have access to a safe method of
disposal. Mail-back programs are valuable because they may be made
available to a large number of ultimate users regardless of geographic
location. Because this method of ultimate user disposal presents high
risks of diversion, DEA has carefully weighed many options and proposes
the outlined requirements. The proposed requirements may limit the
number of persons authorized to conduct a mail-back program; however, a
single
[[Page 75796]]
authorized mail-back program is capable of receiving packages from any
location within the U.S.\34\ The mail-back method of disposal for
ultimate users is a valuable and convenient option, however, the high
risk of diversion inherent to this method requires stringent controls,
including post-collection tracking and accountability mechanisms, as
well as on-site destruction by authorized collectors.
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\34\ Mail-back programs are restricted to the receipt of mailers
initiated within the U.S. in order to be consistent with the import
requirements of the CSA as provided in Subchapter II of Chapter 13
of Title 21 of the U.S. Code (21 U.S.C. 951 et. seq.).
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Collection Receptacles
The third voluntary method of collection that DEA proposes, in
section 1317.75, is collection receptacles. DEA proposes specific
language in section 1317.75(a) to continue authorization for any
federal, state, tribal, or local law enforcement agency to maintain a
collection receptacle at the law enforcement agency's physical location
as well as to authorize any DEA registered manufacturer, distributor,
reverse distributor, or retail pharmacy authorized as a collector to
maintain a collection receptacle at their DEA registered location.
Collection receptacles may be located at a collector's registered
location (and certain authorized LTCFs, as discussed below) or at a law
enforcement agency's physical location--they may not be placed at non-
registered locations such as libraries or community centers. DEA is
proposing collection receptacles be placed at registered locations to
ensure that controlled substances are collected at those locations that
have existing security controls in place, with the exception of LTCFs,
thereby reducing the risk of diversion while still providing for a
convenient option for ultimate user disposal.
Like take-back events and mail-back programs, DEA proposes in
sections 1317.75(b) and (c) and 1317.80(a) that the only persons that
may transfer controlled substances to the authorized collector's
collection receptacle are the ultimate user, persons lawfully entitled
to dispose of an ultimate user decedent's property, and, as discussed
below, a LTCF on behalf of an ultimate user that resides or has resided
at that LTCF when a collection receptacle is located at that LTCF. This
requirement is proposed in order to limit the number of hands through
which the substance passes because the risk of diversion increases each
time a controlled substance is transferred to a new person.
The proposed collection receptacle requirements in section
1317.75(d) and (e) are intended to protect against diversion. In
particular, DEA is proposing the minimum collection receptacle
requirements necessary to protect against diversion while allowing
flexibility. The collection receptacles used by authorized collectors
must have a permanent outer container with a removable inner liner. The
outer container must have an opening big enough to allow contents to be
added to the inner liner, but small enough to prevent removal of the
inner liner contents. The opening must be capable of being locked at
times when an authorized employee is not present, unless the collection
receptacle is located in a secured area of a long term care facility
which is regularly monitored by LTCF personnel.
DEA defines an inner liner in section 1317.02 and proposes
requirements for inner liners in section 1317.60. In particular, like
the mail-back packages, the inner liner must be waterproof, tamper-
evident, and tear-resistant. The inner liner must be removable and
sealable immediately upon removal without emptying or touching the
contents and the contents of the inner liner shall not be viewable from
the outside when sealed. The size of the inner liner must be clearly
marked on the outside of the liner, for example, be clearly marked "5
gallon" or "10 gallon." Finally, the inner liner must bear a
permanent, unique identification number that enables the liner to be
tracked. DEA is proposing these inner liner requirements to ensure that
controlled substances are collected and destroyed in an accountable,
secure, and convenient way in order to both prevent the diversion of
controlled substances and to protect public health and safety.
In an effort to increase the ease of program implementation, to
increase the security of collection by collection receptacle and to
remind the public that illicit substances shall not be collected, DEA
is also proposing that the outer container prominently display a sign
indicating that only non-controlled drugs and Schedule II, III, IV, or
V controlled substances are acceptable for collection. DEA seeks
comment on the value and utility of requiring that a specific, uniform
symbol be placed on each collection receptacle.
DEA is also proposing other security measures, including the
requirement that collection receptacles be securely fastened to a
permanent structure such as a wall, floor, or immovable countertop so
that they cannot be removed. At a registered location, the collection
receptacle must be located within the immediate proximity of a
designated area where controlled substances are stored and where an
authorized employee is present. At a long term care facility, the
collection receptacle must be located in a secured area monitored by
personnel of that long term care facility. In addition, access to the
inner liner is restricted to authorized employees. Containers secured
in compliance with the proposed requirements are intended to deter and
prevent theft and pilferage.
DEA proposes in section 1317.75(g) that the removal of the inner
liner of the collection receptacle shall be performed by or under the
supervision of at least two authorized employees of the authorized
collector. To this end, a registered reverse distributor or distributor
is permitted to remove and take the inner liner of the collection
receptacle for destruction so long as the removal is performed under
the supervision of at least two authorized employees of the authorized
collector. In accordance with section 1317.05(c)(2), upon removal of
the inner liner of the collection receptacle, the authorized collector
shall promptly: (1) Destroy the inner liner and its contents; or (2)
store the inner liner and its contents at the collector's registered
location in a manner consistent with the security requirements for
Schedule II controlled substances until prompt destruction can occur.
Authorized collectors who are registered practitioners \35\ shall
dispose of the sealed inner liners and their contents in one of the
following ways: (1) Promptly destroy the sealed inner liners and their
contents, using an on-site method of destruction in accordance with
Subpart C of part 1317 of this chapter; (2) promptly deliver the sealed
inner liners and their contents by common or contract carrier to the
registered location of a reverse distributor or distributor for
destruction, or by reverse distributor pick-up at the collector's
registered or authorized location; or (3) request assistance from the
Special Agent in Charge of the Administration in the area in which the
practitioner is located by submitting one copy of DEA Form 41
identifying what is to be disposed.
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\35\ The basis for distinguishing between practitioners and non-
practitioners when specifying disposal procedures is explained in
detail below under the discussion of controlled substance inventory
disposal, beginning on page 61.
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Authorized collectors who are not registered practitioners \36\
shall dispose of the sealed inner liners and their
[[Page 75797]]
contents in one of the following ways: (1) Promptly destroy the sealed
inner liners and their contents, using an on-site method of destruction
in accordance with Subpart C of part 1317 of this chapter; (2) promptly
deliver the sealed inner liners and their contents by common or
contract carrier to the registered location of a reverse distributor or
distributor, or by reverse distributor pick-up at the collector's
registered or authorized location; or (3) promptly transport the sealed
inner liners and their contents by the collector's own means to the
registered location of a reverse distributor or distributor, or to the
location of destruction. DEA is proposing the flexible "prompt"
destruction, transfer, and storage standard for collectors rather than
a specific time frame to ensure that controlled substances do not
accumulate while pending destruction, transfer, or storage, while still
accounting for the individual circumstances of registrants that operate
and maintain collection receptacles. If the authorized collector is a
reverse distributor, however, such destruction must occur as soon as
practicable but no later than fourteen calendar days of receipt in
accordance with proposed section 1317.15(d), which is discussed below.
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\36\ The basis for distinguishing between practitioners and non-
practitioners when specifying disposal procedures is explained in
detail below under the discussion of controlled substance inventory
disposal, beginning on page 61.
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Long Term Care Facilities
The Disposal Act authorized the Attorney General to develop
regulations to permit long term care facilities to dispose of
controlled substances on behalf of ultimate users who reside or have
resided at such facilities in a manner that provides effective controls
against diversion and is consistent with public health and safety. As
such, DEA proposes in section 1317.80 to allow collection receptacles
to be placed at long term care facilities for the disposal of
controlled substances in accordance with outlined requirements.
DEA is proposing that only a registered retail pharmacy that
receives authorization to collect at a specific long term care facility
may manage and maintain collection receptacles at that long term care
facility and remove or supervise the removal of the inner liner of the
collection receptacles at that long term care facility. Such registered
retail pharmacies that desire to operate a collection receptacle at a
long term care facility must apply to modify their registration in
accordance with 21 CFR 1301.51 and include in their application for
modification in registration the physical location of each long term
care facility at which the registered pharmacy intends to operate a
collection receptacle. If the retail pharmacy that is authorized to
collect ceases activities as a collector, such registrant must modify
their registration in accordance with 21 CFR 1301.51 to indicate that
they no longer collect or have ceased collection at a particular
physical location.\37\ The requirements in 21 CFR 1301.52(a) related to
the termination of registration also apply.
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\37\ For the purposes of 21 U.S.C. 880(a), collection
receptacles at long term care facilities maintained by a registered
retail pharmacy authorized as a collector is a "controlled
premise" of that registered retail pharmacy.
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A registered retail pharmacy authorized to maintain a collection
receptacle at a long term care facility shall comply with the proposed
requirements in 21 CFR 1317.75 that govern collection receptacles. At a
long term care facility, the collection receptacle must be located in a
secured area monitored by personnel of that long term care facility. In
addition, access to the inner liner is restricted to authorized
employees of the registered retail pharmacy. Because an authorized
employee must be employed full time by the registrant, employees of the
long term care facility will not have access to the inner liner of the
collection receptacle, unless they are also a full time employee of the
registered retail pharmacy that maintains that collection receptacle.
In addition, DEA is proposing that two authorized employees of the
retail pharmacy must remove or supervise the removal of the inner liner
from the collection receptacle. In an effort to increase security and
control of controlled substances collected, no employee of the long
term care facility will have access to or influence over the contents
of the collection receptacle, except to deposit controlled substances
into it.
DEA is proposing that long term care facilities be permitted to
dispose of controlled substances in Schedules II through V on behalf of
an ultimate user who resides or has resided at such long term care
facility. As with all other collection methods, controlled and non-
controlled substances may be comingled in the collection receptacle.
DEA proposes that the long term care facility be required to transfer
controlled substances into collection receptacles (on behalf of
ultimate users who reside or have resided at the long term care
facility) immediately, but no longer than three business days after it
is determined that the ultimate user no longer needs or wants, or
should discontinue use of the controlled substance. DEA proposes this
requirement on the transfer of controlled substances at a long term
care facility in an effort to prevent the accumulation of ultimate user
controlled substances at long term care facilities. DEA believes that
this requirement balances security concerns with the ease of long term
care facility participation by allowing these facilities to determine
whether it is appropriate for them to dispose on behalf of an ultimate
user.
Pursuant to 21 U.S.C. 822(g)(3), DEA is proposing that a long term
care facility must dispose of those controlled substances only by
depositing the substances into an authorized collection receptacle at
the long term care facility. The long term care facility is not
permitted to deliver or transfer the controlled substances off-site. If
the long term care facility does not have access to an on-site
collection receptacle, they are not otherwise permitted to dispose of a
controlled substance on behalf of an ultimate user. Rather, the
ultimate user or persons lawfully entitled to dispose of ultimate user
decedent's property should dispose of those controlled substances. See
21 U.S.C. 822(g)(1) and 822(g)(4).
Because ultimate user medications are concentrated in and often
administered by long term care facilities, DEA considered proposing to
authorize long term care facilities to dispose of controlled substances
on behalf of an ultimate user through mail-back programs and through
take-back events. However, the majority of such facilities are not
registered by DEA to handle controlled substances, and, therefore, do
not have in place physical security controls and other requirements
that minimize the risk of diversion such as the obligation to maintain
effective controls against diversion, report thefts and losses, and
screen certain employees for controlled substance-related felony
convictions. DEA believes that only authorized DEA registrants and law
enforcement agencies should be authorized to collect controlled
substances from ultimate users because they have in place the proper
security and other controls to help guard against diversion. Because
long term care facilities are typically not registered with DEA and
face the unique challenge of disposing of controlled substances on
behalf of an ultimate user, DEA is proposing an option for LTCFs that
balances convenience with security.
The on-site collection receptacles will reduce the risk that
controlled substances may be removed from the facilities by employees
(e.g., to transport substances to a take-back event for disposal) who
will not be subject to the same screening procedures as employees of
authorized collectors, such as the requirement that authorized
[[Page 75798]]
employees who have access to or influence over controlled substances
have no felony convictions related to controlled substances.
Additionally, DEA believes that the mail-back option is not suitable
because of the likelihood that long term care facilities may need to
dispose of large quantities of controlled substances or dispose of
controlled substances on a frequent basis. One security aspect of the
mail-back method of disposal is the requirement that mailers be non-
descript, so as not to be readily identifiable as containing controlled
substances. If a large number of such mailers are consistently sent
from an unregistered facility whose residents are likely to possess
controlled substances, such as a long term care facility, that security
measure loses much of its efficacy, thereby increasing the risk of
diversion, and may even have the unintended effect of making a long
term care facility's mailing system a target for diversion.\38\ DEA is,
therefore, proposing to only permit long term care facilities to use an
on-site collection receptacle that is under the control of an
authorized retail pharmacy registrant to dispose of controlled
substances on behalf of an ultimate user. DEA believes that a secure
on-site collection receptacle is the best method to protect against
diversion and is consistent with public health and safety.
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\38\ Although reverse distributors and other collectors
conducting mail-back programs will likewise receive a large number
of mailers, DEA does not anticipate that the same risk exists.
Collectors authorized to conduct mail-back programs will be DEA
registrants that already routinely receive controlled substances and
have in place security controls. A long term care facility, however,
is likely not a DEA registrant, does not already routinely send out
controlled substances, and will not have in place the same types of
security controls.
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Although LTCFs may only dispose of their residents' controlled
substances through collection receptacles at the LTCF, LTCF residents
themselves may utilize any other disposal method available to ultimate
users, including mail-back programs and take-back events. Care should
be taken to ensure that LTCF residents' use of mail-back programs and
take-back events does not result in the accumulation of controlled
substances in a single location susceptible to internal or external
diversion threats, as discussed above.
Additional Security Controls for the Collection of Controlled
Substances Through Mail-Back Programs and Collection Receptacles
As discussed above, sealed mail-back packages and inner liners
acquired by collectors and registered reverse distributors and
distributors must be stored in a manner consistent with the physical
security requirements for Schedule II controlled substances. Registered
reverse distributors, distributors, and manufacturers authorized as
collectors and that store mail-back packages and inner liners acquired
from an ultimate user must follow the physical security controls for
storing Schedule II controlled substances in accordance with 21 CFR
1301.72, which DEA proposes to revise. An authorized collector that is
a retail pharmacy must follow the physical security controls for
storing Schedule II controlled substances in accordance with 21 CFR
1301.75; however, such sealed mail-back packages and inner liners may
not be dispersed through the practitioner's stock of non-controlled
substances as described in 21 CFR 1301.75(b), which DEA proposes to
revise. DEA understands that storing sealed mail-back packages and
inner liners as though they are Schedule II controlled substances is a
stringent requirement; however the majority of authorized collectors,
as registrants, are likely to already have these storage capabilities
in place. DEA is proposing these physical security requirements because
Schedule II is the highest schedule of controlled substances that is
lawfully permitted to be included in the mail-back packages and inner
liners. Because mail-back packages and inner liners may not be opened
and their contents will not be known, such packages and liners should
be stored as though each package and liner contains a Schedule II
controlled substance.
In the event of theft, pilferage, or loss, registrants must notify
DEA, in accordance with 21 CFR 1301.76(b) and 1301.74(c). DEA considers
any theft or loss from a collection receptacle or mail-back program to
be a "significant loss" within the meaning of the regulation because
such losses would be attributable to the unique activities involving
the disposal of controlled substances. 21 CFR 1301.74(c)(3). Also,
because the controlled substances collected cannot be individually
handled or sorted, it must be assumed that the loss includes Schedule
II controlled substances. 21 CFR 1301.74(c)(2) and 1301.76(b). Finally,
collection receptacles and mail-back packages are likely candidates for
diversion because these collection methods are highly publicized and
accessible to the public, and, as a result, any theft or loss from
these collection methods is considered significant. 21 CFR
1301.74(c)(5) and 1301.76(b)(5).
Tracking Controlled Substances Collected From Ultimate Users and Other
Authorized Non-Registrants From Collection to Destruction
In accordance with the closed system and the statutory framework of
the CSA, DEA must ensure that all controlled substances collected from
ultimate users are properly and promptly secured, stored, and
destroyed. DEA considered allowing authorized persons to count or
otherwise inventory controlled substances collected from ultimate
users. Any effort to count, identify, or otherwise inventory the
contents of sealed packages or inner liners, however, would require
individualized identification of the contents, increase the number of
hands through which controlled substances pass, and require that the
packages and inner liners remain opened and exposed for extended
periods of time. These factors greatly increase the risk of diversion
and, when combined with the increased costs associated with such
efforts, outweigh the potential benefit.
As a result of these security and diversion prevention
considerations, DEA is proposing a system of collection that requires
the ultimate user or other authorized non-registrant person in lawful
possession of a controlled substance to personally handle such
substance at all times until it is safely and securely placed in an
authorized mail-back package or in an appropriate collection receptacle
at an authorized location or at a take-back event. Additionally, an
authorized collector would be required to collect items only in a
collection receptacle with an inner liner or in a mail-back package,
both of which must be uniquely identifiable, sealable, waterproof,
tamper-evident, and tear-resistant. No person may open or otherwise
access any secured mail-back package or inner liner.
DEA is proposing that each inner liner and mail-back package
provided by an authorized collector must have a unique identification
number that enables the liner and package to be tracked. The authorized
collector must record the unique identification number located on the
inner liner or mail-back package so that it can be properly tracked
from collection to destruction. Law enforcement agencies are
encouraged, but not required, to implement similar recordkeeping and
tracking procedures. DEA believes that the proposed recordkeeping and
tracking system is the most effective and efficient way to ensure that
those controlled substances collected from ultimate users and other
authorized non-registrants are secure until destruction, and are
actually
[[Page 75799]]
destroyed. DEA has proposed a rule that allows authorized collectors
the flexibility to create a tracking system that is proportionate to
the scope and method of their desired disposal program while also
meeting the applicable security and control requirements proposed by
DEA.
Disposal of Controlled Substances by Registrants
The procedures for the disposal of controlled substances by
registrants are often determined on a case-by-case basis by the DEA
Special Agent in Charge (SAC) in the area where the registrant is
located. In many circumstances, the SAC has the discretion to determine
how to authorize and instruct registrants to dispose of controlled
substances, including how the substances may be destroyed. 21 CFR
1307.21(a) and (b).
DEA proposes to expand the inventory \39\ disposal options
available to registrants, delete the existing rule related to
registrant disposal (21 CFR 1307.21), and incorporate similar
requirements on proper disposal procedure, security, and recordkeeping
into a new part 1317 on disposal. DEA is proposing these changes to
ensure consistency in disposal procedures among registrant categories,
regardless of geographic location. Such regulations will reduce the
burden on registrants by eliminating the existing requirement for every
registrant to contact the SAC in their area when they wish to destroy
controlled substances. Also, the procedures and security and
recordkeeping requirements that DEA proposes are intended to codify
existing practice and to set singular and consistent procedures for DEA
registrants in accordance with their authorized business activities
while protecting the public health and safety and minimizing the risk
of diversion.
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\39\ "Inventory" means "all factory and branch stocks in
finished form of a basic class of controlled substance manufactured
or otherwise acquired by a registrant, whether in bulk, commercial
containers, or contained in pharmaceutical preparations in the
possession of the registrant (including stocks held by the
registrant under separate registration as a manufacturer, importer,
exporter, or distributor)." 21 CFR 1300.01(b).
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Registration requirements and authorized activities vary depending
on the type of controlled substance business activity in which a person
is engaged. Accordingly, if a registrant desires to deliver controlled
substances for any lawful purpose, the registrant must be authorized by
his registration to conduct the delivery--the registrant must be
authorized to engage in such conduct either as a business activity or
coincident activity. This general rule also applies if a registrant
desires to deliver controlled substances to an authorized person by
transporting the substances itself and maintaining custody and control
of the substances during transportation.
Pursuant to the Controlled Substances Act, registration to
distribute conveys broad authority to deliver controlled substances for
a lawful purpose. "Distribute" means to "deliver (other than by
administering or dispensing) a controlled substance or a listed
chemical. The term 'distributor' means a person who so delivers a
controlled substance or listed chemical." 21 U.S.C. 802(11).
Accordingly, registrants authorized to distribute controlled substances
(e.g., non-practitioners such as manufacturers, distributors, and
reverse distributors) may themselves deliver such substances to
authorized persons for the purpose of disposal in accordance with
applicable security and recordkeeping procedures. In contrast, the
Controlled Substances Act narrows the authorization of practitioners
\40\ (e.g., physicians, pharmacies, and hospitals) to "dispense,"
which means "to deliver a controlled substance to an ultimate user or
research subject by, or pursuant to the lawful order of, a
practitioner, including the prescribing and administering of a
substance * * *" 21 U.S.C. 802(10) (emphasis added). Authorization to
dispense does not include authorization to distribute and vice versa.
See 21 U.S.C. 802(11) (specifically excluding "dispense" from the
definition of "distribute"). As such, registration to dispense
specifically conveys narrow authority to deliver a controlled substance
to an ultimate user pursuant to the lawful order of a practitioner.
Registrants who are only authorized to dispense controlled substances
(e.g., practitioners) are therefore not authorized to deliver these
substances themselves to any entity other than an ultimate user, even
for the purpose of disposal. Instead, practitioners may only deliver
these substances to authorized persons by common or contract carrier or
by pick-up at the practitioner's registered location.
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\40\ Defined by the CSA as "a physician, dentist, veterinarian,
scientific investigator, pharmacy, hospital, or other person
licensed, registered, or otherwise permitted, by the United States
or the jurisdiction in which he practices or does research, to
distribute, dispense, conduct research with respect to, administer,
or use in teaching or chemical analysis, a controlled substance in
the course of professional practice or research." 21 U.S.C.
802(21). Under the CSA, "[t]he Attorney General shall register
practitioners * * * to dispense, or conduct research with,
controlled substances * * * ." 21 U.S.C. 823(f).
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As discussed, non-practitioners (e.g., manufacturers, distributors,
and reverse distributors) are not similarly limited in their authority
to lawfully deliver controlled substances. DEA therefore proposes in
section 1317.05(b) to allow non-practitioners to deliver (i.e.,
transfer) controlled substances themselves for the purpose of disposal
provided that such substances are transported directly to the
destruction location and accompanied by two authorized employees. This
proposed requirement is consistent with existing practices by
registered manufacturers, distributors, and reverse distributors when
transporting and disposing of controlled substances. These non-
practitioners generally follow these procedures (in addition to various
other procedures) as a counter-measure against theft and diversion. DEA
proposes these procedures, along with the procedures set forth at
section 1317.95, as the minimum required to help ensure the physical
security of highly pilferable controlled substances and as a deterrent
to theft and diversion.
Consistent with the requirements of the Controlled Substances Act,
DEA proposes in section 1317.05(b) to authorize non-practitioners to
dispose of their controlled substance inventory in one of four ways:
(1) Promptly destroy the substance using an on-site method of
destruction in accordance with applicable federal, state, tribal, and
local laws and regulations (as required by section 1317.90); (2)
promptly deliver the substance to a registered reverse distributor at
its registered location by common or contract carrier, or by reverse
distributor pick-up; (3) for the purpose of return or recall, promptly
deliver the substance by common or contract carrier or pick-up at the
registrant's registered location to the person from whom it was
obtained, the registered manufacturer of the substance, or another
registrant authorized by the manufacturer to accept returns or recalls;
or (4) promptly transport the substance by its own means to the
registered location of a reverse distributor, the location of
destruction, or the registered location of any person authorized to
receive the substance for the purpose of return or recall.
As discussed, a practitioner's registration does not convey
authority to distribute, deliver, or otherwise transfer controlled
substances to any entity other than an ultimate user. Accordingly, DEA
proposes in section 1317.05(a) to authorize practitioner registrants to
dispose of their controlled substance inventory in one of four ways:
(1) Promptly destroy the substance using an
[[Page 75800]]
on-site method of destruction in accordance with applicable federal,
state, tribal, and local laws and regulations (as required by section
1317.90); (2) promptly deliver the substance to a reverse distributor
at its registered location by common or contract carrier, or by reverse
distributor pick-up; \41\; (3) for the purpose of return or recall,
promptly deliver the substance to the registered person from whom the
substance was obtained, the registered manufacturer of the substance,
or another registrant authorized to accept returns or recalls by common
or contract carrier or by pick-up at the registrant's registered
location; or (4) request assistance from the Special Agent in Charge of
the Administration in the area in which the practitioner is located.
DEA proposes to allow practitioner registrants to retain the existing
ability to request assistance from the SAC in the area in which the
practitioner is located to dispose of their controlled substances,
similar to the existing provisions of section 1307.21, in order to
expand the options available for practitioners to destroy controlled
substances or cause controlled substances to be destroyed. DEA proposes
that the SAC in the practitioner's area may authorize the practitioner
to: Transfer the controlled substances to a person registered under the
Act and authorized to transport and destroy the substance; deliver the
substances to an agent of the DEA or the nearest DEA office; or destroy
the substances in the presence of an agent of the DEA or other
authorized person. In circumstances in which a practitioner regularly
destroys controlled substances, the practitioner may do so on a regular
basis upon instructions from the relevant SAC.
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\41\ Current DEA regulations at 21 CFR 1307.11(a)(2) discuss
practitioner distribution of controlled substances to a reverse
distributor. DEA proposes to clarify that provision at the proposed
section 1317.05. As such, DEA proposes to delete 21 CFR
1307.11(a)(2) to eliminate redundancy.
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Registrants that destroy controlled substances must do so promptly,
unless otherwise specified. DEA is proposing the flexible "prompt"
destruction standard rather than a specific time frame for destruction
to ensure that controlled substances do not accumulate while pending
destruction and are destroyed in a timely manner, while still
accounting for the individual circumstances of registrants that destroy
controlled substances.
For all registrants that destroy controlled substances or cause
controlled substances to be destroyed (e.g., by transferring the
substance to an authorized reverse distributor or transporting the
substance to an off-site, unregistered location for destruction), DEA
proposes in section 1317.95 that such registrants be required to follow
certain security procedures related to employees, transportation,
loading and unloading, handling, and destruction. DEA is proposing
enhanced security requirements in order to strengthen the integrity of
the disposal process, which has been expanded to include more disposal
options and eliminates the requirement of prior notice of destruction
to DEA, by filing DEA Form 41 prior to destruction, in every instance
except when practitioners seek disposal assistance pursuant to proposed
section 1317.05(a)(4). When a DEA registrant that destroys or causes
the destruction of controlled substances is the last registered person
to possess such substances, the registrant must follow increased
security measures at the point of destruction to ensure accountability
and effectively minimize the risk of diversion.
For registrants that destroy controlled substances on-site, that
maintain possession of controlled substances until they are rendered
non-retrievable (e.g., when transporting substances to an unregistered
location for destruction), or that transfer custody to an authorized
person for disposal, DEA is proposing employee security requirements in
section 1317.95 to ensure that only employees that have satisfied
certain employee screening requirements are authorized to oversee the
handling of controlled substances during the destruction process. Under
the proposed definition in 1317.02(a), an "authorized employee" is a
person directly employed by the registrant full time (i.e., not
employed as a contractor or agent of a third party) who must not have
been convicted of any felony offense related to controlled substances
and not have had at any time an application for registration with DEA
denied, had a DEA registration revoked or suspended, or surrendered a
DEA registration for cause.
The proposed security measures include the requirement that two
authorized employees load and unload (or observe the loading and
unloading of) controlled substances during transfer of the substances
to another registrant; and, if the substances are destroyed on a
registrant's registered premises, two authorized employees shall
personally witness the destruction and shall handle (or observe the
handling of) the substance until it is rendered non-retrievable. This
two-person integrity requirement is necessary because the destroying
registrant is the last person authorized to handle the substance before
destruction and this requirement will reduce the opportunity for
diversion and help to ensure that the controlled substances are
actually destroyed and not diverted to illicit use.
Additionally, DEA proposes in section 1317.100 that a registrant
that destroys controlled substances or causes the destruction of
controlled substances is required to maintain a record of the
destruction in a form to be issued by DEA. This form will be DEA Form
41. At present, DEA Form 41 is used as a record of destruction by
registrants. DEA is proposing to modify DEA Form 41 to act as the
record of destruction, including the signature of the two authorized
employees witnessing the destruction. In an effort to minimize the
burden on registrants, and in accordance with the proposed
comprehensive new part on disposal, registrants that destroy or cause
the destruction of controlled substances and utilize DEA Form 41 will
no longer be required to submit three copies of DEA Form 41 to the SAC
in their area, except one copy shall be submitted by practitioners
seeking assistance pursuant to section 1317.05(a). Rather, in
accordance with the CSA, such registrants will be required to keep and
make available that record, for at least two years, for inspection and
copying by officers or employees of the United States authorized by the
Attorney General. 21 U.S.C. 827. Furthermore, all methods of
destruction must be conducted in accordance with all applicable
federal, state, local, and tribal laws and regulations.
Reverse Distributors
Reverse distributors are a unique group of registrants whose
primary function is to possess controlled substances for the purpose of
destruction or return. In this regard, reverse distributors provide a
valuable service to other registrants in the disposal process. In the
distribution of controlled substances between registrants, each
registrant serves as a check on the other and verifies whether the
controlled substance has reached its lawful destination. This is
accomplished through existing reporting, recordkeeping, and order form
requirements. 21 U.S.C. 827-828; 21 CFR part 1304 and 21 CFR part 1305.
However, a reverse distributor that acquires controlled substances from
another registrant for destruction is the last person to possess such
substance before destruction so there is no recipient to verify that
the substance has been destroyed. Furthermore, reverse distributors
accumulate greater amounts of controlled substances that are
[[Page 75801]]
destined for destruction in comparison to other registrants. This is
because reverse distributors routinely acquire controlled substances
for destruction from other registrants and may also be authorized as
collectors. As a result, DEA is proposing security and recordkeeping
requirements that apply specifically to a reverse distributor's unique
function.
The existing regulations pertaining to reverse distributors are
located in different parts of the CFR. DEA is proposing revised
regulations for reverse distributors that are clear, consistent, and
consolidated into one part.\42\ DEA believes that these proposed
regulations will help reverse distributors comply with the Controlled
Substances Act in a manner that effectively decreases the risk of
diversion of controlled substances during the disposal process.
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\42\ While reverse distributor-specific regulations are
consolidated into proposed new 21 CFR part 1317, registered reverse
distributors will still be required to follow all other applicable
regulations that fall outside 21 CFR part 1317.
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DEA proposes to revise the definition of reverse distributor in
section 1300.01(b). In the existing regulations, a reverse distributor
is permitted to acquire controlled substances from other registrants
for the purpose of return to the manufacturer or manufacturer's agent,
or "to process for or arrange the processing for" disposal. DEA
proposes to revise the definition of "reverse distributor" by first
defining "reverse distribute" to mean "to acquire controlled
substances from another DEA registrant or a law enforcement agency for
the purpose of: (1) Return to the manufacturer or another registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf, or (2) destruction." A "reverse distributor" is a person who
reverse distributes a controlled substance.
In the existing definition of reverse distributor, a reverse
distributor is permitted to acquire controlled substances from other
registrants for the purpose of return to the manufacturer or
manufacturer's agent. DEA proposes revising the definition to authorize
a reverse distributor to acquire controlled substances from another DEA
registrant for the purpose of return to the manufacturer or another
registrant authorized by the manufacturer to accept returns on the
manufacturer's behalf. This revision is proposed so that the reverse
distribute definition is consistent with the proposed revisions to
return and recall in sections 1317.05 and 1317.85 (discussed below).
DEA believes that this new definition clearly and accurately reflects
the proper role of a reverse distributor.
DEA proposes in section 1317.15(b) to authorize registered reverse
distributors to acquire controlled substances from other registrants in
one of two ways: (1) Pick-up the controlled substance from a registrant
at the registrant's registered location ("pick-up"), or (2) receive
the controlled substance from a registrant at the reverse distributor's
registered location, delivered directly by a non-practitioner or by
common or contract carrier ("delivery"). Once en route from a
registrant's registered location to a reverse distributor's registered
location, shipments or packages of controlled substances may not be re-
routed to another person or location, even if that person or location
is registered with DEA. DEA believes that re-routing shipments or
packages destined for one registrant to another registrant
substantially increases the likelihood of diversion.
DEA proposes in section 1317.15(c) that upon acquisition of a
controlled substance from a registrant, a reverse distributor must
either: (1) Immediately store the controlled substance at, or transfer
the controlled substance to, the reverse distributor's registered
location for secure storage until timely destruction or timely return
to the registered manufacturer of the substance can occur, (2)
immediately deliver the controlled substance to the manufacturer or
manufacturer's agent, (3) timely destroy the controlled substance, or
(4) immediately deliver the controlled substance to the place of
destruction for timely destruction. The requirement for "immediate"
transfer or delivery is intended to ensure that shipments or packages
are continuously moving towards their ultimate, secure destination.
Such continuous movement reduces the risk of diversion by limiting the
opportunity for theft or loss. Consistent with 21 CFR 1301.12(b)(4) and
the existing definition of "freight forwarding facility" in 21 CFR
1300.01(b), a reverse distributor may not operate freight forwarding
facilities for purposes of transporting controlled substances. DEA
proposes to clarify this by specifically excluding reverse distributors
from the definition of "freight forwarding facility" in section
1300.01(b).
DEA is also proposing in section 1317.15(d) to require reverse
distributors to destroy or cause the destruction of any controlled
substances received for the purpose of destruction as soon as
practicable but no later than within fourteen calendar days of pick-up
or delivery. A reverse distributor that acquires a controlled substance
for destruction is the last person to possess such substance before
destruction and, therefore, must follow increased security measures.
The "as soon as practicable but no later than fourteen calendar day"
requirement is unique to reverse distributors--other registrants that
destroy must do so promptly and do not have to follow a specific time
limit--because the primary business activity of reverse distributors,
unlike other registrants, is to acquire controlled substances for the
purpose of destruction or return. As a result, reverse distributors
generally accumulate greater amounts of controlled substances that are
destined for destruction in comparison to other registrants. They are
typically the last registrant to handle the controlled substance with
no other registrant reporting and recording receipt of the substance as
a check against diversion. The "as soon as practicable but no later
than fourteen calendar day" requirement will ensure that reverse
distributors destroy or cause the destruction of controlled substances
in a timely manner while also enabling them sufficient time to prepare
the necessary records required for destruction. In addition, the "as
soon as practicable but no later than fourteen calendar day"
requirement will reduce the risk of diversion by limiting the
opportunity for theft or loss. This is necessary because, just as there
is a greater risk of diversion when controlled substances are being
transported for the purposes of destruction, there is a greater risk of
diversion the longer a substance destined for destruction remains in
storage awaiting destruction.
DEA is proposing to specify a maximum time limit for reverse
distributors to destroy or cause the destruction of any controlled
substance received for the purpose of destruction--as soon as
practicable but no later than fourteen calendar days of receipt (pick-
up or delivery). While DEA believes that the majority of reverse
distributors already destroy or cause the destruction of controlled
substances received for the purpose of destruction 'as soon as
practicable' but no later than fourteen calendar days of receipt, DEA
recognizes that some may not. For the reverse distributors that do not
currently meet this standard, this requirement may cause these reverse
distributors to incur additional costs through more frequent
transportation of controlled substances to the point of destruction and
destruction of partial loads. For purposes of this proposal, DEA
assumes that some reverse distributors may have
[[Page 75802]]
to adjust current business operations in order to comply with this new
requirement, such as by restricting the receipt of deliveries to their
registered location to specific days and/or amounts, or by changing
pick-up routes to accommodate the requirement that any controlled
substance received for the purpose of destruction be destroyed as soon
as practicable but no later than fourteen calendar days of receipt.
DEA believes that the proposed "as soon as practicable but no
later than fourteen calendar day" requirement is reasonable and will
reduce the risks of diversion. However, DEA also acknowledges that
there are assorted federal, state, and local transportation and
environmental laws and regulations that reverse distributors must
comply with in addition to those under the CSA and these proposed
regulations. DEA also acknowledges that these proposed regulations may
result in reverse distributors choosing to be responsible for much more
controlled substances than they are currently responsible. Accordingly,
DEA invites comments on the practicability of implementing the "as
soon as practicable but no later than fourteen calendar day"
requirement while also maintaining effective controls against
diversion. Considering there are currently a limited number of
registered reverse distributors with significant variations in current
business practices across the United States, DEA seeks information
regarding how the "as soon as practicable but no later than fourteen
calendar day" destruction requirement would impact business practices,
if at all, with specific focus on the potential long-term and short-
term costs of implementing this requirement, and whether such costs
would be offset by other measures. DEA also invites comment regarding
the effects that shorter and longer time limits for destruction--
specifically, as soon as practicable but no later than seven calendar
days or thirty calendar days for destruction--would have on current
business practices, including the physical security controls and
operating procedures that would be implemented or modified in order to
guard against theft and diversion, and the potential costs that may be
incurred as a result of alternative time limits.
DEA is also proposing in section 1317.20 enhanced employee security
requirements for reverse distributors. DEA proposes that reverse
distributors be prohibited from employing, as an agent or employee who
has access to or influence over controlled substances, any person that
has ever been convicted of any felony offense related to controlled
substances or has ever had an application for registration with DEA
denied, had a DEA registration revoked or suspended, or surrendered a
DEA registration for cause. DEA is proposing these enhanced security
requirements for reverse distributors in order to strengthen the
integrity of the disposal process by ensuring that only certain
employees are authorized to have access to or influence over controlled
substances. This requirement is similar to existing employee security
requirements for registered practitioners in 21 CFR 1301.76(a), where
there is a high risk of diversion and limited physical security
requirements.
DEA is also proposing in 1317.25 to streamline and clarify
recordkeeping requirements for registered reverse distributors that
acquire controlled substances from other registrants so that they are
consistent and accurately reflect reverse distributor authorized
activities in compliance with the Controlled Substances Act. These
requirements are separate from the recordkeeping requirements for
reverse distributors that acquire controlled substances from law
enforcement agencies and authorized collectors, as discussed above, in
proposed section 1317.55.
First, the existing regulations require registered reverse
distributors to record in an inventory, information regarding specific
quantities of controlled substances that is different from the
information required in continuing records. 21 CFR 1304.11(e)(3) and
1304.22(e). To reconcile this discrepancy, DEA proposes in sections
1317.25(b) and (c) that in both inventory and continuing records, a
reverse distributor must record the quantity of a controlled substance
in both finished and bulk form, and the quantity contained in a
commercial container, carton, crate, drum, or other receptacle that has
been opened.
Second, in accordance with the CSA, every DEA registrant must
maintain, on a current basis, a complete and accurate record of each
controlled substance manufactured, received, sold, delivered, or
otherwise disposed of. 21 U.S.C. 827(a). These records must be
maintained separately from all other records of the registrant or,
alternatively, in the case of non-narcotic controlled substances, be in
such a form that required information is readily retrievable from the
ordinary business records of the registrant. 21 U.S.C. 827(b)(2). The
records must be kept and be available for at least two years for
inspection and copying by officers or employees of the Attorney
General. 21 U.S.C. 827(b)(3). Under its statutory authority, DEA may
promulgate regulations that specify the information that registrants
are required to maintain in their records. 21 U.S.C. 827(b).
To this end, DEA proposes in section 1317.25(c) to require
registered reverse distributors to: (1) Keep records regarding each
controlled substance received from another registrant for the purpose
of return to a manufacturer or, if designated, to another registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf, and (2) keep records regarding each controlled substance
destroyed, including information pertaining to the receipt and
destruction of the controlled substance. These records, similar to the
current requirements in 21 CFR 1304.22(e) that DEA proposes to delete,
are necessary for inspection to maintain the integrity of the closed
system and to assist in the detection and prevention of diversion.
DEA proposes in section 1317.25(c)(4) that for all controlled
substance records, reverse distributors will be required to maintain
the record of receipt with the corresponding record of return or
destruction. By maintaining all relevant records together, DEA will be
able to account for each substance received by a reverse distributor
from its acquisition to its disposition, whether by destruction or
return to the manufacturer. DEA also emphasizes that each registrant
must prepare and maintain separate and independent records in order to
ensure accountability of each registrant, and the integrity of the
closed system of distribution.
Return and Recall
DEA is proposing to delete the existing rule on return and recall,
21 CFR 1307.12, and to clarify and separate the role of registrants and
non-registrants in the return and recall of controlled substances. This
is because of the different circumstances surrounding registrant and
ultimate user return and recall.
Return and Recall by Registrants
DEA proposes procedures for the return and recall of controlled
substances by DEA registrants in sections 1317.05(a)(3), 1317.05(b)(3),
and 1317.05(b)(4), and recordkeeping and order form requirements in a
new section 1317.10, which are similar to the existing rule on return
and recall in 21 CFR 1307.12. The proposed new sections, however,
clarify which registrants are authorized to distribute and receive
returns and recalls and clarifies the recordkeeping and order form
requirements. DEA proposes in sections 1317.05(a)(3), 1317.05(b)(3),
and 1317.05(b)(4) that registrants in
[[Page 75803]]
lawful possession of a controlled substance may return that substance
for the purpose of return or recall to: (1) The registered person from
whom it was obtained; (2) the registered manufacturer of the substance;
or (3) another registrant authorized by the manufacturer to accept
returns or recalls on the manufacturer's behalf. The procedures
governing return of the substance are determined by the returning
registrant's authorization as a practitioner or non-practitioner, as
discussed above. This is consistent with the intent of the Controlled
Substances Act to prevent opportunities for diversion because the
substances are being transferred within the closed system of
distribution for the purpose of disposal (i.e., return or recall)
without having left the closed system of distribution, and
accountability is ensured by pertinent recordkeeping requirements.
DEA proposes in section 1317.10(a) information that must be
maintained in the records of registrants returning controlled
substances and registrants receiving returns. In addition, pursuant to
proposed section 1317.10(b), DEA Form 222 must be used by each
registrant that distributes a controlled substance in Schedule I or II
for the purpose of return and recall in accordance with 21 CFR part
1305. The freight forwarding provision of the existing rule is also
retained in section 1317.10(c).
Ultimate User Product Recall
DEA proposes in section 1317.85 procedures for the recall or return
of controlled substances by ultimate users. Currently, DEA authorizes
ultimate user distribution for the purpose of recall under existing 21
CFR 1307.12, but the language in this section is overly broad. The
proposed section 1317.85(a) reduces ambiguity that exists under current
regulations by specifying to whom an ultimate user is permitted to
deliver their recalled controlled substance and by outlining consistent
and clear requirements for registrants authorized to receive those
recalled substances from ultimate users.
In particular, DEA proposes in section 1317.85(a) to authorize an
ultimate user in lawful possession of a controlled substance in
Schedules II, III, IV, or V to deliver the recalled controlled
substance to the manufacturer of the substance or another registrant
authorized by the manufacturer to accept returns or recalls on the
manufacturer's behalf. In the event of a product recall, the
manufacturer of the recalled controlled substance or another registrant
authorized by the manufacturer to accept returns or recalls on the
manufacturer's behalf is authorized to receive recalled controlled
substances from an ultimate user and does not need to be an authorized
collector to do so. This is because the necessary security and
experience in handling controlled substances is already in place.
Recalled controlled substances received by authorized registrants from
ultimate users are re-entering the closed system of distribution and
must be handled (stored, destroyed, etc.), unless otherwise specified,
in accordance with procedures that the registrant is otherwise required
to follow.
DEA proposes in 1317.85(a)(1) that registrants authorized to
receive recalled controlled substances from ultimate users maintain a
record of recalled controlled substances received from ultimate users.
Those registrants, however, are exempted under section 1317.85(a)(2)
from the requirements in 21 CFR part 1305 pertaining to DEA Form 222
for substances received from non-registrants. In accordance with the
Disposal Act, the delivery of a Schedule II controlled substance for
the purpose of disposal by an ultimate user, long-term care facility,
or other person acting in accordance with the Disposal Act is exempt
from order form requirements (i.e., an ultimate user or long-term care
facility may transfer a Schedule II controlled substance to another
person for the purpose of disposal without a written order of the
person to whom such substance is transferred). 21 U.S.C. 828(b)(3). In
other words, when an ultimate user delivers a recalled controlled
substance to an authorized registrant for the purpose of disposal, in
this case recall, such transactions are exempt from the requirements
found in 21 CFR part 1305.
DEA is also proposing in section 1317.85(a)(3) that the authorized
registrant report all recalled controlled substance acquisition
transactions pursuant to 21 CFR 1304.33. Such registrants may report
either each individual receipt or a single transaction that includes
all recalled controlled substances of the same name and finished form
(e.g., all 10-milligram tablets or all 5-milligram concentration per
fluid ounce or milliliter) received from ultimate users.
Finally, DEA proposes in 1317.85(b) that an ultimate user that is
participating in an investigational use of drugs pursuant to 21 U.S.C.
355(i) and 360b(j) and wishes to deliver any unused controlled
substance received as part of that research to the registered dispenser
from which it was obtained, may do so in accordance with regulations
promulgated by the Secretary of Health and Human Services pursuant to
21 U.S.C. 355(i) and 360b(j).
Methods of Destruction
DEA is proposing a standard of destruction--non-retrievable--for
persons that destroy or cause the destruction of controlled substances.
Some examples of current technology that may achieve the non-
retrievable standard are incineration and chemical digestion. Flushing
and mixing controlled substances with coffee grounds or kitty litter
are examples of existing methods of destruction that do not meet the
non-retrievable standard. These examples are not exhaustive and DEA is
not requiring, endorsing, authorizing, or recommending any particular
method of destruction so long as the desired result is achieved and the
method is compliant with all applicable federal, state, tribal, and
local laws and regulations. This standard is intended to allow public
and private entities to develop a variety of destruction methods that
are secure, convenient, and responsible, consistent with preventing the
diversion of such substances. DEA is proposing a standard of
destruction that provides communities the flexibility to tailor
disposal options to meet their resources and needs and allows for
advances in technology.
Non-Retrievable
Each controlled substance has its own inherent chemical and/or
physical properties. Accordingly, the objective of "destruction" is
to render the substance no longer susceptible to diversion for an
illicit or non-medical use. DEA intends to provide maximum flexibility
to allow for technological innovation and development in controlled
substance destruction processes. As such, DEA solicits comments on the
proposed requirement that all destruction processes be applied in such
a manner that the controlled substances are rendered "non-
retrievable."
Any destruction method applied to a controlled substance must
render it "non-retrievable." The proposed definition of "non-
retrievable" means to permanently alter any controlled substance's
physical and/or chemical state through irreversible means in order to
render that controlled substance unavailable and unusable for all
practical purposes. This definition is not intended to require
destruction beyond the state at which a controlled substance becomes
unavailable, unusable and, subsequently, no longer available for
diversion.
[[Page 75804]]
In the case of ultimate user disposal where most people are unable
to differentiate between controlled and non-controlled substances and
because cataloging or taking inventory of substances may be detrimental
to efforts to prevent diversion, all of the proposed collection methods
allow comingling of pharmaceuticals. As a result, this proposed rule
would require a method of destruction sufficient to render all included
controlled substances non-retrievable. Likewise, where the actual
substances collected are unknown, but may reasonably include controlled
substances, the proposed rule would require selection of a method of
destruction sufficient to render non-retrievable any controlled
substance likely to be present. Information received at the January
2011 public meeting held by DEA indicated that incineration in
accordance with federal, state, and local law may be the currently
most-used method of destruction to achieve this result. Even so, DEA is
proposing a standard that allows flexibility so long as the desired
result is achieved, thus allowing for technological innovation and
development. Regardless of the destruction method, the destruction must
be conducted in accordance with all federal, state, tribal, and local
laws and regulations.
Environmental Considerations
In passing the Disposal Act to provide those individuals seeking to
dispose of unwanted or unused controlled substances in their household
with more disposal options beyond discarding or flushing the
substances, Congress expected that there would be fewer such substances
introduced into the environment, particularly into the water.\43\ DEA
also recognizes that the establishment of alternative, lawful means for
disposing of unused or expired pharmaceutical controlled substances may
alleviate some existing environmental concerns. For example, recent
studies have reported on the presence of pharmaceutical chemicals in
varying concentrations in water supplies. DEA is hopeful that the
increased availability of methods for citizens to safely and securely
dispose of unwanted prescription drugs will have a positive impact on
reducing the introduction of chemical contaminants into the water
supply. However, collection and destruction of unwanted and unused
pharmaceuticals cannot and will not address water contamination that
occurs from other means such as bodily elimination or excretion of such
substances.
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\43\ See Findings, Sec. 2, Secure and Responsible Drug Disposal
Act of 2010.
---------------------------------------------------------------------------
The requirements of this proposed rule only govern compliance with
the Controlled Substances Act. Any selected method of destruction of
controlled substances meeting the requirements of this proposed rule
must also comply with all applicable federal, state, and local laws and
regulations applicable at the time of the destruction. Because of the
broad range of such environmental and other laws and regulations, this
proposed rule does not purport to address what laws may or may not be
applicable in a particular circumstance now or at some future date.
As DEA and public and private entities introduce proposed options
for disposal of controlled substances to the general public and in
specific communities, it is anticipated that the environmental benefits
of proper collection and destruction will be emphasized in the public
education and publicity surrounding the disposal of unwanted or unused
controlled substances. Public health and safety is protected and
improved both in preventing diversion of controlled substances during a
national epidemic of pharmaceutical drug abuse and in providing options
for collection that result in secure and environmentally sound
destruction consistent with federal, state, tribal, and local laws and
regulations.
Miscellaneous Changes
In accordance with the changes described above, DEA proposes to
delete any reference to 21 CFR 1307.12 and 1307.21 and replace it with
a reference to the new 21 CFR part 1317, where appropriate.\44\ DEA
also proposes to revise 21 CFR 1301.13(e)(1)(i) to delete reference to
a disposer category of registration in the coincident activity column
for manufacturers. A disposer category of registration was proposed by
DEA in 1995, but was never finalized (60 FR 43732, August 23, 1995).
Reference to a disposer category was inadvertently included in a
previous rulemaking (68 FR 58587, October 10, 2003).
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\44\ DEA proposes in 21 CFR 1301.76 to delete reference to
1307.12 and replace it with reference to 21 CFR part 1317; in 21 CFR
1304.11(e) and the introductory paragraph of 1304.22 to delete
reference to 21 CFR 1307.12; in 21 CFR 1301.25(i), 1301.52(c), and
1307.13 to delete reference to 21 CFR 1307.21 and replace it with
reference to 21 CFR part 1317; in 21 CFR 1304.25(a)(9) and
1304.25(b)(9) to delete reference to 21 CFR 1307.22 and replace it
with reference to 21 CFR part 1317; and in 21 CFR 1304.04(a) to add
reference to 21 CFR part 1317. DEA also proposes in 21 CFR 1307.22
to delete reference to 21 CFR 1307.21, but not replace it with
reference to 21 CFR part 1317. This revision to 21 CFR 1307.22 will
allow existing practices for seizure and forfeiture to continue. DEA
proposes to revise the title of 21 CFR 1307.22 to "Delivery of
forfeited controlled substances" for clarity.
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Regulatory Analyses
Regulatory Flexibility Act
Under the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601-
612), federal agencies must evaluate the impact of rules on small
entities and consider less burdensome alternatives. As discussed in the
preceding sections of the regulatory preamble, DEA has considered
numerous alternatives for each proposed requirement and method of
collection and evaluated the impact of this proposed rule on small
entities. DEA has concluded that the rule will not, if promulgated,
have a significant economic impact on a substantial number of small
entities. An economic analysis of the Proposed Rule can be found in the
rulemaking docket at http://www.regulations.gov.
In developing this proposed rule, DEA considered several options
for both registrant and non-registrant disposal and reverse distributor
destruction requirements. DEA analyzed alternative methodology
approaches keeping in mind its statutory obligations under the CSA. DEA
considered three options for non-registrant disposal: (1) Single
Collection, which would authorize non-registrants to utilize only one
method of collection to dispose of their lawfully possessed controlled
substances; (2) Open Collection, which would authorize any person to
collect controlled substances from ultimate users for disposal,
regardless of their status as a DEA registrant; and (3) Multiple
Collection, which would authorize non-registrants to utilize more than
one method of collection to transfer controlled substances for purposes
of disposal to law enforcement agencies and certain DEA registrants. In
addition, DEA considered two options for registrant disposal: (1)
Retain Existing Regulations, which would make no changes to the
existing registrant disposal regulations (21 CFR 1307.12 and 1307.21);
and (2) Establish Consistent National Standards, which would delete
existing regulations on the disposal of controlled substances (21 CFR
1307.12 and 1307.21) and promulgate a new part that would
comprehensively outline the process and procedure for the disposal of
controlled substances by registrants and non-registrants.
Finally, DEA considered four options for reverse distributors: (1)
On-site Requirement, which would require reverse distributors to have
and utilize
[[Page 75805]]
an on-site method of destruction; (2) Prompt Requirement, which would
require reverse distributors, like all other registrants, to promptly
destroy controlled substances; (3) No Requirement, which would retain
the current destruction standard and would not put a timeline on when
reverse distributors must destroy controlled substances acquired for
destruction; and (4) As Soon As Practicable But No Later Than Fourteen
Calendar Day Requirement, which would require reverse distributors to
destroy controlled substances received for the purpose of destruction
as soon as practicable but no later than fourteen calendar days of
receipt. DEA performed a qualitative analysis of each of these
alternatives and selected the "Multiple Collection" option for non-
registrant disposal, the "Establish Consistent National Standard"
option for registrant disposal, and the "As Soon As Practicable But No
Later Than Fourteen Calendar Day Requirement" option for reverse
distributors.
In accordance with the RFA, DEA evaluated the impact of this rule
on small entities and anticipates that this rule will not have a
significant economic impact on a substantial number of small entities.
If promulgated, this proposed rule would affect all 1.4 million
controlled substance registrants, which corresponds to approximately
381,386 businesses affected by the proposed rule. DEA estimates that
370,133 (97 percent) of the affected businesses are considered "small
entities" in accordance with the RFA and Small Business Administration
(SBA) standards. 5 U.S.C. 601(6) and 15 U.S.C. 632. DEA estimates that
there should be minimal to no economic impact as a result of this
proposed rule.
In accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), the Administrator hereby certifies that this proposed
rulemaking has been drafted consistent with the Act and that a
regulatory analysis on the effects or impacts of this proposed
rulemaking on small entities has been done and that the proposed rule
will not have a significant economic impact on a substantial number of
small entities.
Executive Orders 12866 and 13563
This proposed rule was developed in accordance with the principles
of Executive Orders 12866 and 13563. Based on an economic analysis, DEA
does not anticipate that this rulemaking will have an annual effect on
the economy of $100 million or more or adversely affect in a material
way the economy, a sector of the economy, productivity, competition,
jobs, the environment, public health or safety, or state, local, or
tribal governments or communities. An economic analysis of the Proposed
Rule can be found in the rulemaking docket at http://www.regulations.gov. Public comment was received in public meetings
held on January 19-20, 2011, to help inform and develop these proposed
rules. Public comment is encouraged on this proposed rule through the
internet with easy access to supporting information found at http://www.regulations.gov. Although not an economically significant rule,
this proposed rule on the disposal of controlled substances has been
reviewed by the Office of Management and Budget.
For DEA registrants that destroy controlled substances as described
above, DEA anticipates that this rulemaking will have minimal or no
economic impact and that modified DEA Form 41 could result in some
level of cost savings. In addition, for registered reverse
distributors, DEA anticipates that the security and recordkeeping
requirements contained in the proposed rule will result in minimal or
no costs.
DEA has determined that reverse distributors currently destroy
controlled substances within the proposed "as soon as practicable but
no later than fourteen calendar day" requirement the majority of the
time. However, it is recognized that there may be instances when
reverse distributors do not currently meet this proposed requirement.
For these instances, DEA believes reverse distributors will be able to
make modifications to their pick-up/receipt and destruction schedule to
accommodate the proposed requirements with minimal to no economic
impact. Moreover, DEA conservatively estimates that the voluntary
provisions for collectors, reverse distributors, distributors, and law
enforcement agencies will have a net economic impact of nearly zero,
and invites comment on this estimate. The proposed provisions that
facilitate Non-Registrant Disposal are completely voluntary, not
mandated. Any collector, reverse distributor, distributor, or law
enforcement agency may choose to engage in the voluntary activities
based on its own evaluation of costs and benefits (tangible and
intangible). For the purposes of this analysis, DEA assumes that an
entity will volunteer to perform the activities to facilitate Non-
Registrant Disposal only if there is a net zero or positive benefit to
the entity. For example, a pharmacy may derive tangible benefits, such
as additional revenue from increased retail traffic to the pharmacy.
Collectors may also derive tangible benefits such as public safety and
good will from its collection activities. Any collector, reverse
distributor, distributor, or law enforcement agency that chooses to
engage in these voluntary activities can decide to cease these
activities at any time. Therefore, for the purposes of this analysis,
DEA estimates that the voluntary provisions in this section have net
zero economic impact on the regulated entities.
In summary, DEA estimates that there should be minimal to no annual
total cost to the economy as a result of the proposed rule.
Accordingly, DEA does not anticipate that this rulemaking will have an
annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local, or tribal governments or communities.
In evaluating the costs and benefits of the rule, the annual cost
of the rule is compared with the anticipated reduction in the growth
rate of costs associated with diversion of controlled substances and
listed chemicals into the illicit market. The cost-benefit analysis
uses the costs associated with the nonmedical use of prescription
opioids, $8.6 billion in 2001 \45\ and $53.4 billion in 2006.\46\ These
are conservative estimates of the rapidly growing total cost associated
with diversion of controlled substances and listed chemicals into the
illicit market. As DEA has determined this rule poses minimal to no
economic impact, DEA concludes that this rule reduces the growth in the
cost of the diversion of controlled substances and listed chemicals
into the illicit market, therefore, this rule will have a positive
benefit for the health and safety of the citizens and residents of the
United States.
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\45\ Clin J Pain (The Clinical Journal of Pain), Volume 22,
Number 8, October 2006.
\46\ Clin J Pain (The Clinical Journal of Pain), Volume 27,
Number 3, March/April 2011.
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Paperwork Reduction Act
Pursuant to Section 3507(d) of the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.), DEA has identified the following
collections of information related to this proposed rule on the
disposal of controlled substances and has submitted these collection
requests to the Office of Management and Budget (OMB) for review and
approval. This proposed rule implements the Secure and Responsible Drug
Disposal Act of 2010
[[Page 75806]]
(Disposal Act), in addition to reorganizing and consolidating existing
regulations on disposal into a comprehensive regulatory framework for
the destruction of controlled substances. In accordance with the
Controlled Substances Act (CSA), which establishes a closed system of
distribution for all controlled substances, DEA registrants are
required to make a biennial inventory and maintain, on a current basis,
a complete and accurate record of each controlled substance
manufactured, received, sold, delivered, or otherwise disposed of. 21
U.S.C. 827(a). These records must be in accordance with and contain
such relevant information as may be required by regulations promulgated
by DEA. 21 U.S.C. 827(b)(1). In this rule, DEA proposes to revise
existing and add a minimum amount of new registrant recordkeeping
requirements, which are consistent with those requirements that are
already required by statute and the proposed new part on disposal that
creates a comprehensive regulatory framework for the destruction of
controlled substances.
Title: Implementation of Registrant Recordkeeping Requirements Pursuant
to the Controlled Substances Act, 21 U.S.C. 827
The recordkeeping requirements that DEA registrants are required to
maintain pursuant to law are a vital component of DEA's enforcement and
control responsibilities--such records alert DEA to problems of
diversion and ensure that the system of controlled substances
distribution is open only to legitimate handlers of such substances.
As discussed in the section on reverse distributors above, DEA is
proposing to revise the information that registered reverse
distributors are currently required to record consistent with previous
requirements as well as a minimum amount of requirements under the
proposed new comprehensive regulatory framework for the destruction of
controlled substances. As discussed in more detail above, DEA proposes
to modify the existing information that reverse distributors are
required to record for clarity and consistency. In addition, DEA
proposes that for all controlled substance records, reverse
distributors will be required to maintain their existing business
records so that the record of receipt is maintained with the
corresponding record of return or destruction. By maintaining all
relevant business records together, DEA will be able to trace each
substance received by a reverse distributor from its acquisition to its
disposition, whether by destruction or return to the manufacturer.
DEA estimates that there will be 60 respondents to this information
collection and that their estimated frequency of response will vary.
DEA estimates that the frequency of response will vary, because in
accordance with 21 U.S.C. 827(a), registrants make an initial and
biennial inventory and maintain, on a current basis, a complete and
accurate record of each controlled substance manufactured, received,
sold, delivered, or otherwise disposed of. Because DEA is proposing
recordkeeping requirements that registered reverse distributors are
already required to maintain in accordance with 21 U.S.C. 827(a) and
(b), DEA anticipates that the annual hour burden will not be increased
by the proposed rule.
DEA is also proposing revised information that registrants are
required to record in the return and recall process. DEA proposes to
delete the existing rule on return and recall, 21 CFR 1307.12, and to
implement separate rules on the return and recall of controlled
substances for registrants and non-registrants. The return and recall
recordkeeping requirements have been revised to reflect these changes.
DEA estimates that the universe of potential respondents to this
information collection will be 68,344 respondents (Distributors--828,
Reverse Distributors--60, Manufacturers--522, Retail Pharmacies--
66,934). DEA estimates that the frequency of response will vary,
because in accordance with 21 U.S.C. 827(a), registrants make an
initial and biennial inventory and maintain, on a current basis, a
complete and accurate record of each controlled substance manufactured,
received, sold, delivered, or otherwise disposed of. Because DEA is
proposing recordkeeping requirements that registrants are already
required to maintain in accordance with 21 U.S.C. 827(a) and (b), DEA
anticipates that the annual hour burden will not be increased by the
proposed rule.
DEA is proposing new recordkeeping requirements for registrants
that collect controlled substances from ultimate users and other non-
registrants in accordance with the new authority provided in the
Disposal Act. To implement the Disposal Act, DEA is proposing to
provide ultimate users, long term care facilities, and other non-
registrants safe and convenient options to transfer controlled
substances for purposes of disposal: Take-back events, mail-back
programs, and collection receptacle locations. In the proposed rule,
registered manufacturers, distributors, reverse distributors, and
retail pharmacies may obtain authorization from DEA to be a collector.
A collector is a registered person authorized to receive a controlled
substance for the purpose of disposal from non-registrants in lawful
possession of controlled substances. DEA is proposing information that
collectors must record based on the particular ultimate user collection
method utilized (i.e., mail-back program or collection receptacle).
DEA estimates that the universe of potential participants to this
information collection will be 68,344 respondents (Distributors--828,
Reverse Distributors--60, Manufacturers--522, Retail Pharmacies--
66,934).\47\ DEA estimates that the frequency of response will vary,
because in accordance with 21 U.S.C. 827(a), registrants make an
initial and biennial inventory and maintain, on a current basis, a
complete and accurate record of each controlled substance manufactured,
received, sold, delivered, or otherwise disposed of. DEA notes,
however, that the option to become an authorized collector is voluntary
and no entity is required to establish or operate a disposal program as
an authorized collector. The authorization to collect is a new activity
and DEA has no criterion to determine the level of participation. As a
result, the number of respondents is based on the current number of
registrants which may request authorization to become a collector and
the annual hour burden cannot be determined at this time. DEA will
continue to monitor and analyze the potential burden of the new
requirements imposed by this proposed rule and will review all comments
submitted in response to this proposed rule and information collection
request.
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\47\ The universe of potential participants includes all
registrants that could potentially become authorized collectors. It
is likely that this estimate will be adjusted downward once DEA
obtains more information.
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DEA is also proposing to authorize registered reverse distributors
and distributors to acquire controlled substances from authorized law
enforcement agencies and certain collectors that have acquired
controlled substances from ultimate users and other non-registrants.
DEA proposes to require these registered reverse distributors and
distributors to maintain complete and accurate records of controlled
substances received, delivered, or otherwise transferred for the
purpose of destruction.
DEA estimates that the universe of potential respondents to this
information collection will be 888 respondents (Distributors--828,
Reverse
[[Page 75807]]
Distributors--60). DEA estimates that the frequency of response will
vary, because in accordance with 21 U.S.C. 827(a), registrants make an
initial and biennial inventory and maintain, on a current basis, a
complete and accurate record of each controlled substance manufactured,
received, sold, delivered, or otherwise disposed of. The authorization
for reverse distributors and distributors to acquire controlled
substances collected by law enforcement agencies and authorized
collectors is new. As a result, DEA presently has no criterion to
determine the level of participation and the annual hour burden cannot
be determined at this time. DEA will continue to analyze the potential
burden of the new requirements imposed by this proposed rule and review
all comments submitted in response to this proposed rule and
information collection request.
Title: Registrant Record of Controlled Substances Destroyed--DEA Form
41
OMB Control Number: 1117-0007.
Form Number: DEA Form 41.
The recordkeeping requirements that DEA registrants are required to
maintain pursuant to law are a vital component of DEA's enforcement and
control responsibilities--such records alert DEA to problems of
diversion and ensure that the system of controlled substances
distribution is open only to legitimate handlers of such substances.
DEA is proposing information that registrants involved in the
destruction of controlled substances must record. The record of
destruction must include the signature of the two authorized employees
of the registrant that witnessed the destruction, in addition to other
information about the controlled substance disposed of and the method
of destruction utilized. DEA proposes to modify existing DEA Form 41 to
reflect the proposed record of destruction for controlled substances
that remain in the closed system of distribution and to account for
registrant destruction of controlled substances collected from ultimate
users and other non-registrants outside the closed system pursuant to
the Disposal Act. DEA Form 41 has previously been approved by OMB and
assigned OMB control number 1117-0007.
In accordance with the current 21 CFR 1307.21, a DEA registrant
that desires to dispose of a controlled substance must submit three
copies of DEA Form 41 to the Special Agent in Charge (SAC) in their
area. DEA is proposing to delete 21 CFR 1307.21 and replace it with a
comprehensive part 1317 on disposal. In an effort to minimize the
burden on registrants and in accordance with the proposed comprehensive
regulatory framework for disposal, registrants that destroy controlled
substances and utilize DEA Form 41 will no longer be required to submit
three copies of DEA Form 41 to the SAC in their area. Rather, in
accordance with the CSA, such registrants will be required to keep and
make available the information in the specified format, for at least
two years, for inspection and copying by officers or employees of the
United States authorized by the Attorney General. 21 U.S.C. 827(b).
DEA estimates that there will be 68,344 respondents (Distributors--
828, Reverse Distributors--60, Manufacturers--522, Retail Pharmacies--
66,934) to this information collection. The number of respondents
(68,344) represents the total number of registrants in business
activities that are most likely to destroy controlled substances. DEA
estimates that the frequency of response will vary, because in
accordance with 21 U.S.C. 827(a), registrants maintain, on a current
basis, a complete and accurate record of each controlled substance
manufactured, received, sold, delivered, or otherwise disposed of and
as a result will make a record of destruction each time they destroy a
controlled substance. DEA estimates that the average time per response
will be 30 minutes and that the total annual burden will be 34,172
hours.
Request for Comments Regarding the Proposed Information Collection
All estimates include the time for reviewing instructions;
searching existing data sources; gathering or maintaining the needed
data; and reviewing the information. DEA solicits comments concerning:
Whether these information collection requirements are necessary for the
proper performance of the functions of DEA, including whether the
information has practical utility; the accuracy of DEA's estimates of
the burden of the information collection requirements; the quality,
utility, and clarity of the information to be collected; and whether
the burden of collection of information on those who are to respond,
including through the use of automated collection techniques or other
forms of information technology, may be minimized. For information or a
copy of the paperwork package submitted to OMB, contact John W.
Partridge, Executive Assistant, Office of Diversion Control, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (202) 307-4654.
Organizations and individuals desiring to submit comments on the
collection of information requirements should direct them to Drug
Enforcement Administration, Attention: Office of Diversion Control (OD/
DX), 8701 Morrissette Drive, Springfield, Virginia 22152.
OMB is required to make a decision concerning the collection of
information requirements contained in this proposed rule between 30 and
60 days after its publication in the Federal Register. Therefore, a
comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication. The final rule will respond
to any OMB or public comments on the information collection
requirements contained in this proposal.
DEA is not authorized to impose a penalty on persons for violating
information collection requirements which do not display a current OMB
control number, if required. DEA intends to obtain current OMB control
numbers for any new information collection requirements resulting from
this rulemaking action prior to the effective date of the final rule.
The OMB control number, when assigned, will be announced by separate
notice in the Federal Register.
Executive Order 12988
This proposed regulation meets the applicable standards set forth
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law, impose enforcement responsibilities on any state or diminish the
power of any state to enforce its own laws. Accordingly, this
rulemaking does not have federalism implications warranting the
application of Executive Order 13132.
National Environmental Policy Act (NEPA)
This proposed rule provides options for the collection of
controlled substances by registrants and non-registrants consistent
with DEA regulations and federal, state, tribal, and local laws and
regulations. Provision of these options is intended to result in
increased collection and destruction of unused controlled substances
and thereby prevent diversion of such unused substances to illicit uses
and result in collection and destruction of larger quantities in
economical and
[[Page 75808]]
environmentally sound manners. This proposed rule establishes the legal
requirements for the handling of controlled substances. Destruction of
controlled substances must be consistent with federal, state, tribal
and local laws and regulations.
DEA and the regulated community have disposed of controlled
substances since passage of the CSA. DEA has published a categorical
exclusion from further NEPA analysis for the storage and destruction of
controlled substances. This proposed rule would not authorize any new
methods of storage, transportation, or destruction of controlled
substances, but is limited to the logistics and documentation of the
collection of controlled substances for destruction. Accordingly, this
proposed rule does not significantly affect the quality of the human
environment. DEA has, therefore, determined that this proposed rule
does not have significant individual or cumulative effects on the human
environment and is excluded from detailed analysis pursuant to 28 CFR
part 61, Appendix B.
Unfunded Mandates Reform Act
This proposed rule will not result in the expenditure by state,
local, and tribal governments, in the aggregate, or by the private
sector, of $136,000,000 or more (adjusted for inflation) in any one
year, and will not significantly or uniquely affect small governments.
Therefore, no actions were deemed necessary under the provisions of the
Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.
Executive Order 13175
This proposed rule is required by statute, will not have tribal
implications and will not impose substantial direct compliance costs on
Indian tribal governments.
List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1305
Drug traffic control.
21 CFR Part 1307
Drug traffic control.
21 CFR Part 1317
Drug traffic control, Reporting and recordkeeping requirements,
Security measures.
For the reasons set forth above, DEA proposes to amend 21 CFR parts
1300, 1301, 1304, 1305, 1307, and 1317 as follows:
PART 1300--DEFINITIONS
1. The authority citation for part 1300 is revised to read as
follows:
Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
2. Amend Sec. 1300.01, in paragraph (b) by:
a. Alphabetically adding a definition of "collection";
b. Revising the third sentence of the definition of "freight
forwarding facility";
c. Alphabetically adding definitions of "non-retrievable" and
"reverse distribute"; and
d. Revising the definition of "reverse distributor".
The additions and revisions read as follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
(b) * * *
Collection means to receive a controlled substance for the purpose
of destruction from an ultimate user, a person lawfully entitled to
dispose of ultimate user decedent's property, or a long term care
facility on behalf of an ultimate user that resides or has resided at
that facility. The term collector means a registered manufacturer,
distributor, reverse distributor, or retail pharmacy that is authorized
under this chapter to so receive a controlled substance for the purpose
of destruction.
* * * * *
Freight forwarding facility * * * For purposes of this definition,
a distributing registrant is a person who is registered with the
Administration as a manufacturer, distributor (excluding reverse
distributor), and/or importer.
* * * * *
Non-retrievable means, for the purpose of destruction, the
condition or state to which a controlled substance shall be rendered
following a process that permanently alters that controlled substance's
physical and/or chemical condition or state through irreversible means
and thereby renders the controlled substance unavailable and unusable
for all practical purposes. The process to achieve a non-retrievable
condition or state may be unique to a substance's chemical and/or
physical properties. A controlled substance is considered "non-
retrievable" when it cannot be transformed to a physical and/or
chemical condition or state as a controlled substance or controlled
substance analogue. The purpose of destruction is to render the
controlled substance(s) to a non-retrievable state and thus prevent
diversion of any such substance to illicit purposes.
* * * * *
Reverse distribute means to acquire controlled substances from
another DEA registrant or a law enforcement agency for the purpose of:
(1) Return to the registered manufacturer or another registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf; or
(2) Destruction.
Reverse distributor means a person who reverse distributes a
controlled substance.
* * *
* * * * *
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
3. The authority citation for part 1301 continues to read as
follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 953, 956, 957, 958.
4. Amend Sec. 1301.13 by revising paragraph (e)(1)(i) to read as
follows:
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
* * * * *
(e) * * *
(1)
[[Page 75809]]
Business activity |
Controlled
substances |
DEA application
forms |
Application fee
($) |
Registration
period
(years) |
Coincident activities allowed |
(i) Manufacturing |
Schedules I–V |
New—225
Renewal—225a |
3,047
3,047 |
1 |
Schedules I–V: May distribute that substance
or class for which registration
was issued; may not distribute any
substance or class for which not registered.
Schedules II–V: May conduct chemical
analysis and preclinical research (including
quality control analysis) with
substances listed in those schedules
for which authorization as a mfg. was
issued. |
* * * * *
5. Amend Sec. 1301.25 by revising paragraph (i) to read as
follows:
Sec. 1301.25 Registration regarding ocean vessels, aircraft, and
other entities.
* * * * *
(i) Controlled substances acquired and possessed in accordance with
this section shall be distributed only to persons under the general
supervision of the medical officer employed by the owner or operator of
the vessel, aircraft, or other entity, except in accordance with part
1317 of this chapter.
6. Revise Sec. 1301.51 to read as follows:
Sec. 1301.51 Modification in registration.
(a) Any registrant may apply to modify his/her registration to
authorize the handling of additional controlled substances, to change
his/her name or address, or in the case of retail pharmacies,
manufacturers, distributors, and reverse distributors, to authorize
such registrant to be a collector, by submitting a letter of request to
the Registration Unit, Drug Enforcement Administration. See the Table
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
(1) The letter shall contain:
(i) The registrant's name, address, and registration number as
printed on the certificate of registration;
(ii) The substances and/or schedules to be added to the
registration, a request for authorization to collect and the type(s) of
collection the registrant intends to conduct (collection receptacle or
mail-back program), or the new name or address; and
(iii) A signature in accordance with Sec. 1301.13(j) of this part.
(2) If the registrant is seeking to handle additional controlled
substances listed in Schedule I for the purpose of research or
instructional activities, the registrant shall attach three copies of a
research protocol describing each research project involving the
additional substances, or two copies of a statement describing the
nature, extent, and duration of such instructional activities, as
appropriate.
(3) If a registered retail pharmacy is applying for a modification
in registration to authorize such registrant to be a collector and
maintain a collection receptacle at a long term care facility in
accordance with Sec. 1317.80 of this chapter, the registrant shall
include the physical location of each long term care facility at which
the registered pharmacy intends to operate a collection receptacle.
(b) No fee shall be required to be paid for modifications. The
request for modification shall be handled in the same manner as an
application for registration. If the modification in registration is
approved, the Administrator shall issue a new certificate of
registration (DEA Form 223) to the registrant, who shall maintain it
with the old certificate of registration until expiration.
7. Amend Sec. 1301.52 by revising paragraph (c) to read as
follows:
Sec. 1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.
* * * * *
(c) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substances (without
transferring such business activities to another person) shall return
for cancellation his/her certificate of registration, and any
unexecuted order forms in his/her possession, to the Registration Unit,
Drug Enforcement Administration. See the Table of DEA Mailing Addresses
in Sec. 1321.01 of this chapter for current mailing address. Any
controlled substances in his/her possession may be disposed of in
accordance with part 1317 of this chapter.
* * * * *
8. Amend 1301.72 by revising paragraph (a) introductory text to
read as follows:
Sec. 1301.72 Physical security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic treatment
programs; storage areas.
(a) Schedules I and II. Raw material, bulk materials awaiting
further processing, and finished products which are controlled
substances listed in Schedule I or II (except GHB that is manufactured
or distributed in accordance with an exemption under section 505(i) of
the FFDCA which shall be subject to the requirements of paragraph (b)
of this section), in addition to sealed mail-back packages and inner
liners collected in accordance with part 1317 of this chapter, shall be
stored in one of the following secured areas:
* * * * *
9. Amend Sec. 1301.75 by revising paragraph (b) to read as
follows:
Sec. 1301.75 Physical security controls for practitioners.
* * * * *
(b) Controlled substances listed in Schedules II, III, IV, and V,
in addition to sealed mail-back packages and inner liners collected in
accordance with part 1317 of this chapter, shall be stored in a
securely locked, substantially constructed cabinet. However, pharmacies
and institutional practitioners may disperse such substances, excluding
sealed mail-back packages and collection receptacle inner liners,
throughout the stock of non-controlled substances in such a manner as
to obstruct the theft or diversion of the controlled substances.
* * * * *
10. Amend Sec. 1301.76 by revising paragraph (c) to read as
follows:
Sec. 1301.76 Other security controls for practitioners.
* * * * *
[[Page 75810]]
(c) Whenever the registrant distributes a controlled substance (as
permitted in Sec. Sec. 1301.13(e)(1), 1307.11, 1317.05, and 1317.10 of
this chapter), he/she shall comply with the requirements imposed on
non-practitioners in Sec. 1301.74(a), (b), and (e).
* * * * *
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
11. The authority citation for part 1304 is revised to read as
follows:
Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(f) and (g), and
965, unless otherwise noted.
12. Amend Sec. 1304.03 by revising the first two sentences of
paragraph (a) to read as follows:
Sec. 1304.03 Persons required to keep records and file reports.
(a) Each registrant shall maintain the records and inventories and
shall file the reports required by this part and part 1317 of this
chapter, except as exempted by this section. Any registrant who is
authorized to conduct other activities without being registered to
conduct those activities, pursuant to Sec. Sec. 1301.22(b), 1307.11,
or 1307.13 of this chapter, shall maintain the records and inventories
and shall file the reports required by this part for persons registered
to conduct such activities. * * *
* * * * *
13. Amend Sec. 1304.04 by revising paragraph (a) introductory text
to read as follows:
Sec. 1304.04 Maintenance of records and inventories.
(a) Except as provided in paragraphs (a)(1) and (2) of this
section, every inventory and other records required to be kept under
this part and part 1317 of this chapter must be kept by the registrant
and be available, for at least 2 years from the date of such inventory
or records, for inspection and copying by authorized employees of the
Administration.
* * * * *
14. Amend Sec. 1304.11 by revising paragraph (e) introductory
text, paragraph (e)(2), and paragraph (e)(3) introductory text to read
as follows:
Sec. 1304.11 Inventory requirements.
* * * * *
(e) Inventories of manufacturers, distributors, dispensers,
researchers, importers, exporters and chemical analysts. Each person
registered or authorized (by Sec. Sec. 1301.13, 1307.11, or 1307.13 of
this chapter) to manufacture, distribute, dispense, import, export,
conduct research or chemical analysis with controlled substances and
required to keep records pursuant to Sec. 1304.03 shall include in the
inventory the information listed below.
* * * * *
(2) Inventories of distributors. Except for reverse distributors
covered by Sec. 1317.25 of this chapter, each person registered or
authorized to distribute controlled substances shall include in the
inventory the same information required of manufacturers pursuant to
paragraphs (e)(1)(iii) and (iv) of this section.
(3) Inventories of dispensers and researchers. Each person
registered or authorized to dispense or conduct research with
controlled substances shall include in the inventory the same
information required of manufacturers pursuant to paragraphs
(e)(1)(iii) and (iv) of this section. In determining the number of
units of each finished form of a controlled substance in a commercial
container that has been opened, the dispenser or researcher shall do as
follows:
* * * * *
15. Amend Sec. 1304.22 by revising the introductory text,
paragraph (b), and removing paragraph (e).
The revisions read as follows:
Sec. 1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers and exporters.
Each person registered or authorized (by Sec. Sec. 1301.13(e),
1307.11, or 1307.13 of this chapter) to manufacture, distribute,
dispense, import, export, or conduct research with controlled
substances shall maintain records with the information listed below.
* * * * *
(b) Records for distributors. Except for reverse distributors
covered by Sec. Sec. 1317.25 and 1317.55 of this chapter, each person
registered or authorized to distribute controlled substances shall
maintain records with the same information required of manufacturers
pursuant to paragraphs (a)(2)(i), (ii), (iv), (v), (vii), (viii), and
(ix) of this section or, when applicable, Sec. 1317.55 of this
chapter.
* * * * *
16. Amend Sec. 1304.25 by revising paragraphs (a)(9) and (b)(9) to
read as follows:
Sec. 1304.25 Records for treatment programs which compound narcotics
for treatment programs and other locations.
* * * * *
(a) * * *
(9) The quantity disposed of by destruction, including the reason,
date and manner of destruction. All other destruction of narcotic
controlled substances shall comply with part 1317 of this chapter.
(b) * * *
(9) The number of units of finished forms and/or commercial
containers destroyed in any manner by the registrant, including the
reason, the date and manner of destruction. All other destruction of
narcotic controlled substances shall comply with part 1317 of this
chapter.
PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
17. The authority citation for part 1305 continues to read as
follows:
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
18. Amend Sec. 1305.03 by adding paragraph (e) to read as follows:
Sec. 1305.03 Distributions requiring a Form 222 or a digitally signed
electronic order.
* * * * *
(e) Deliveries to an authorized DEA registrant pursuant to part
1317 of this chapter by an ultimate user, a long-term care facility on
behalf of an ultimate user that resides or has resided at that
facility, or a person authorized to dispose of the ultimate user
decedent's property.
PART 1307--MISCELLANEOUS
19. The authority citation for part 1307 continues to read as
follows:
Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise
noted.
Sec. 1307.11 [Amended]
20. In Sec. 1307.11, remove and reserve paragraph (a)(2).
Sec. 1307.12 [Removed]
21. Remove Sec. 1307.12.
22. Revise Sec. 1307.13 to read as follows:
Sec. 1307.13 Incidental manufacture of controlled substances.
Any registered manufacturer who, incidentally but necessarily,
manufactures a controlled substance as a result of the manufacture of a
controlled substance or basic class of controlled substance for which
he is registered and has been issued an individual manufacturing quota
pursuant to part 1303 of this chapter (if such substance or class is
listed in Schedule I or II) shall be exempt from the requirement of
registration pursuant to part 1301 of this chapter and, if such
incidentally manufactured substance is listed in Schedule I or II,
shall be exempt from the requirement of an individual manufacturing
quota
[[Page 75811]]
pursuant to part 1303 of this chapter, if such substances are disposed
of in accordance with part 1317 of this chapter.
Sec. 1307.21 [Removed]
23. Remove Sec. 1307.21
24. Revise Sec. 1307.22 to read as follows:
Sec. 1307.22 Delivery of surrendered and forfeited controlled
substances.
Any controlled substance surrendered by delivery to the
Administration under part 1317 of this chapter or forfeited pursuant to
section 511 of the Act (21 U.S.C. 881) may be delivered to any
department, bureau, or other agency of the United States or of any
state upon proper application addressed to the Office of Diversion
Control, Drug Enforcement Administration. See the Table of DEA Mailing
Addresses in Sec. 1321.01 of this chapter for the current mailing
address. The application shall show the name, address, and official
title of the person or agency to whom the controlled drugs are to be
delivered, including the name and quantity of the substances desired
and the purpose for which intended. The delivery of such controlled
drugs shall be ordered by the Administrator, if, in his opinion, there
exists a medical or scientific need therefor.
25. Add part 1317 to read as follows:
PART 1317--DISPOSAL
Sec.
1317.01 Scope.
1317.02 Definitions.
Subpart A--Disposal of Controlled Substances by Registrants
1317.05 Registrant disposal.
1317.10 Registrant return or recall recordkeeping and order form
requirements.
1317.15 Reverse distributor registration requirements and authorized
activities.
1317.20 Reverse distributor employee security requirement.
1317.25 Reverse distributor inventory, recordkeeping, reporting, and
order form requirements.
Subpart B--Disposal of Controlled Substances by Ultimate Users and
Other Non-Registrants
1317.30 Authorization to collect from non-registrants.
1317.35 Collection by law enforcement agencies.
1317.40 Registrants authorized to collect and authorized collection
activities.
1317.45 Collector security requirements.
1317.50 Collector inventory, recordkeeping, reporting, and order
form requirements.
1317.55 Registered reverse distributor and distributor acquisition
of controlled substances from law enforcement agencies or authorized
collectors.
1317.60 Inner liner requirements.
1317.65 Take-back events.
1317.70 Mail-back programs.
1317.75 Collection receptacles.
1317.80 Collection receptacles at long term care facilities.
1317.85 Ultimate user delivery for the purpose of recall or
investigational use of drugs.
Subpart C--Destruction of Controlled Substances
1317.90 Methods of destruction.
1317.95 Destruction procedures.
1317.100 Recordkeeping requirements.
Authority: 21 U.S.C. 821; 822; 823; 827; 828; 871(b); and 958.
Sec. 1317.01 Scope.
This part prescribes the process and procedures for the delivery,
collection, and destruction of damaged, expired, recalled, unused, or
otherwise unwanted controlled substances that are lawfully possessed by
DEA registrants (Subpart A) and non-registrants (Subpart B). The
purpose of such procedures is to provide prompt, safe, and effective
disposal methods while providing effective controls against the
diversion of controlled substances.
Sec. 1317.02 Definitions.
(a) As used in this part, the following terms shall have the
meaning specified:
Authorized Employee means an individual employed full time by the
registrant, who has not been convicted of a felony offense related to
controlled substances and has not, at any time, had an application for
registration with DEA denied, had a DEA registration revoked or
suspended, or surrendered a DEA registration for cause.
For cause means in lieu of, or as a consequence of, any federal or
state administrative, civil, or criminal action resulting from an
investigation of the individual's handling of controlled substances.
Inner liner means a liner that meets the specifications listed in
Sec. 1317.60 of this chapter and is used in the collection of
controlled substances.
Law enforcement officer means a person that is:
(i) Employed full time by a law enforcement agency;
(ii) Under the direction and control of a federal, state, tribal,
or local government;
(iii) Acting in the course of their official duty; and
(iv) Duly sworn and given the authority by any federal, state,
tribal, or local government to carry firearms, execute and serve
warrants, make arrests without warrant, and make seizures of property.
(b) Any other term contained in this part and not defined in
paragraph (a) of this section shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
Subpart A--Disposal of Controlled Substances by Registrants
Sec. 1317.05 Registrant disposal.
(a) Practitioner Inventory. Any DEA registered practitioner in
lawful possession of a controlled substance in its inventory who
desires to dispose of that substance shall do so in one of the
following ways:
(1) Promptly destroy that controlled substance in accordance with
subpart C of this part using an on-site method of destruction;
(2) Promptly deliver that controlled substance to a reverse
distributor's registered location by common or contract carrier or by
reverse distributor pick-up at the registrant's registered location;
(3) For the purpose of return or recall, promptly deliver that
controlled substance by common or contract carrier or pick-up at the
registrant's registered location to: The registered person from whom it
was obtained, the registered manufacturer of the substance, or another
registrant authorized by the manufacturer to accept returns or recalls
on the manufacturer's behalf; or
(4) Request assistance from the Special Agent in Charge of the
Administration in the area in which the practitioner is located.
(i) The request shall be made by submitting one copy of DEA Form 41
to the Special Agent in Charge in the practitioner's area. The DEA Form
41 shall list the controlled substance or substances which the
registrant desires to dispose.
(ii) The Special Agent in Charge shall instruct the applicant to
dispose of the controlled substance in one of the following manners:
(A) By transfer to a person registered under the Act and authorized
to transport or destroy the substance;
(B) By delivery to an agent of the Administration or to the nearest
office of the Administration; or
(C) By destruction in the presence of an agent of the
Administration or other authorized person.
(iii) In the event that a practitioner is required regularly to
dispose of controlled substances, the Special Agent in Charge may
authorize the practitioner to dispose of such substances, in accordance
with subparagraph (a)(2) of this section, without prior application in
each instance, on the condition that the practitioner keep records of
such disposals and file periodic reports with the Special Agent in
Charge
[[Page 75812]]
summarizing the disposals. The Special Agent in Charge may place such
conditions as she/he deems proper on practitioner procedures regarding
the disposal of controlled substances.
(b) Non-practitioner inventory. Any DEA registrant who is a non-
practitioner in lawful possession of a controlled substance in its
inventory who desires to dispose of that substance shall do so in one
of the following ways:
(1) Promptly destroy that controlled substance in accordance with
Subpart C of this part using an on-site method of destruction;
(2) Promptly deliver that controlled substance to a reverse
distributor's registered location by common or contract carrier or by
reverse distributor pick-up at the registrant's registered location;
(3) For the purpose of return or recall, promptly deliver that
controlled substance by common or contract carrier or pick-up at the
registrant's registered location to: The registered person from whom it
was obtained, the registered manufacturer of the substance, or another
registrant authorized by the manufacturer to accept returns or recalls
on the manufacturer's behalf; or
(4) Promptly transport that controlled substance by its own means
to the registered location of a reverse distributor, the location of
destruction, or the registered location of any person authorized to
receive that controlled substance for the purpose of return or recall
as described in paragraph (b)(3) of this section.
(i) If a non-practitioner transports controlled substances by its
own means to the location of destruction, the non-practitioner shall
follow the procedures set forth at Sec. 1317.95(b).
(ii) If a non-practitioner transports controlled substances by its
own means to a registered location for any other authorized purpose
described in this paragraph (b)(4), transportation shall be directly to
the authorized registered location and two authorized employees of the
transporting non-practitioner shall accompany the controlled substances
to the destination registered location.
(c) Collected Controlled Substances. Any authorized collector in
lawful possession of a controlled substance acquired by collection from
an ultimate user or other authorized non-registrant person shall
dispose of that substance in the following ways:
(1) Mail-Back Program. Upon receipt of a sealed mail-back package,
the authorized collector shall promptly:
(i) Destroy the package in accordance with Subpart C of this part
using an on-site method of destruction; or
(ii) Securely store the package in a manner consistent with the
security requirements for Schedule II controlled substances until
prompt on-site destruction can occur or, with regard to the receipt of
unauthorized packages, until instructions from the Administration are
received.
(2) Collection Receptacles. Upon removal from the permanent outer
shell, the authorized collector shall promptly:
(i) Destroy the inner liner and its contents; or
(ii) Store the inner liner and its contents at the collector's
registered location in a manner consistent with the security
requirements for Schedule II controlled substances until prompt
destruction can occur.
(iii) Practitioner Methods of Destruction. Authorized collectors
who are registered practitioners shall dispose of sealed inner liners
and their contents by utilizing any method in Sec. 1317.05(a)(1),
(a)(2), or (a)(4), or by delivering sealed inner liners and their
contents to a distributor's registered location by common or contract
carrier or by distributor pick-up at the collector's authorized
collection location for destruction.
(iv) Non-Practitioner Methods of Destruction. Authorized collectors
who are non-practitioners shall dispose of sealed inner liners and
their contents utilizing any method in Sec. 1317.05(b)(1), (b)(2), or
(b)(4), or by delivering sealed inner liners and their contents to a
distributor's registered location by common or contract carrier or by
distributor pick-up at the collector's authorized collection location
for destruction. Except distributing registrants shall not utilize
freight forwarding facilities to transfer sealed inner liners and their
contents.
Sec. 1317.10 Registrant return or recall recordkeeping and order form
requirements.
(a) Each registrant shall maintain a record of each return or
recall transaction in accordance with part 1304 of this chapter.
(1) Each registrant that delivers a controlled substance to another
registrant for the purpose of return or recall shall maintain a record
pursuant to Sec. 1304.22(b).
(2) Each registrant that receives a controlled substance for the
purpose of return or recall shall maintain a record that includes the
following information: the date of the transaction; the name, form, and
quantity of each controlled substance received; and the name, address,
and registration number of the delivering registrant from whom the
substance was received.
(b) Each registrant that delivers a controlled substance in
Schedule I or II for the purpose of return or recall shall use an order
form in the manner prescribed in part 1305 of this chapter.
(c) Deliveries for the purpose of return or recall may be made
through a freight forwarding facility operated by the person to whom
the controlled substance is being returned provided that advance notice
of the return is provided and delivery is directly to an agent or
employee of the person to whom the controlled substance is being
returned.
Sec. 1317.15 Reverse distributor registration requirements and
authorized activities.
(a) Any person that reverse distributes a controlled substance
shall be registered with DEA as a reverse distributor, unless exempted
by law or otherwise authorized pursuant to this chapter.
(b) A registered reverse distributor shall acquire controlled
substances from a DEA registrant pursuant to Sec. Sec. 1317.05 and
1317.55(a) in the following manner:
(1) The registered reverse distributor may pick-up controlled
substances from a DEA registrant at the DEA registrant's registered
location; or
(2) The registered reverse distributor may receive controlled
substances delivered by common or contract carrier or delivered
directly by a registrant who is a non-practitioner.
(i) Delivery to the registered reverse distributor by an authorized
DEA registrant directly or by common or contract carrier may only be
made to the reverse distributor at the reverse distributor's registered
location. Once en route, such deliveries may not be re-routed to any
other location or person, regardless of registration status.
(ii) All controlled substance deliveries to a registered reverse
distributor shall be personally received by an authorized employee of
the reverse distributor at the registered location.
(c) Upon acquisition of a controlled substance by pick-up or
delivery, a registered reverse distributor shall:
(1) Immediately and securely store the controlled substance at the
reverse distributor's registered location, or immediately transfer the
controlled substance to the reverse distributor's registered location
for secure storage until timely destruction or timely return of the
substance to the registered manufacturer or other registrant authorized
by the manufacturer to accept returns or recalls on the manufacturer's
behalf;
(2) Immediately deliver the controlled substance to the registered
manufacturer or another registrant authorized by the
[[Page 75813]]
manufacturer to accept returns or recalls on the manufacturer's behalf;
(3) Timely destroy the controlled substance in a manner prescribed
in Subpart C of this part; or
(4) Immediately deliver the controlled substance to the location of
destruction for timely destruction pursuant to paragraph (d) of this
section.
(d) A registered reverse distributor shall destroy or cause the
destruction of any controlled substance received for the purpose of
destruction as soon as practicable but no later than fourteen calendar
days of receipt.
Sec. 1317.20 Reverse distributor employee security requirement.
A registered reverse distributor shall not employ, as an agent or
employee who has access to or influence over controlled substances, any
person who has been convicted of any felony offense relating to
controlled substances or who, at any time, had an application for
registration with DEA denied, had a DEA registration revoked or
suspended, or has surrendered a DEA registration for cause.
Sec. 1317.25 Reverse distributor inventory, recordkeeping, reporting,
and order form requirements.
(a) A registered reverse distributor that acquires controlled
substances from a registrant shall maintain the records, reports, and
order forms described in this section and part 1304 of this chapter,
except that a reverse distributor that acquires controlled substances
from law enforcement agencies or authorized collectors pursuant to
subpart B of this part shall follow Sec. 1317.55(d) through (f) of
this chapter.
(b) Inventory requirements. Each person registered as a reverse
distributor shall include the following information in the inventory
records required by Sec. 1304.11 of this chapter:
(1) The name of the substance; and
(2) The total quantity of the substance:
(i) For controlled substances in bulk form, to the nearest metric
unit weight consistent with unit size;
(ii) For each controlled substance in finished form: Each finished
form of the substance (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter); the number of units or
volume of each finished form in each commercial container (e.g., 100-
tablet bottle or 3-milliliter vial); and the number of commercial
containers of each such finished form (e.g. four 100-tablet bottles or
six 3-milliliter vials); and
(iii) For controlled substances in a commercial container, carton,
crate, drum, or other receptacle that has been opened: If the substance
is listed in Schedule I or II, make an exact count or measure of the
contents; or if the substance is listed in Schedule III, IV or V, make
an estimated count or measure of the contents, unless the container
holds more than 1,000 tablets or capsules in which case an exact count
of the contents shall be made.
(c) Record requirements. Each person registered as a reverse
distributor shall maintain records with the following information
required by Sec. 1304.21 of this chapter:
(1) For return or recall to manufacturers:
(i) The date of receipt; the name and quantity of each controlled
substance received; the name, address, and DEA number of the person
from whom the substance was received; and the reason for return (e.g.,
recall or return); and
(ii) The date of return to the manufacturer or other registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf; the name and quantity of each controlled substance returned;
the name, address, and DEA number of the person from whom the substance
was received; the name, address, and DEA number of the registrant to
whom the substance was returned; and the method of return (e.g., common
or contract carrier).
(2) For destruction:
(i) The date of receipt; the name and quantity of each controlled
substance received; and the name, address, and DEA number of the person
from whom the substance was received; and
(ii) The date of destruction; the method of destruction; the name
and quantity of each controlled substance destroyed; the name, address,
and DEA number of the person from whom the substance was received; the
place of destruction; and the name and signature of the two authorized
employees of the registered reverse distributor that witnessed the
destruction.
(3) The total quantity of each controlled substance shall be
recorded in accordance with the following:
(i) For controlled substances in bulk form: To the nearest metric
unit weight or volume consistent with unit size;
(ii) For controlled substances in finished form: Each finished form
(e.g., 10-milligram tablet or 10-milligram concentration per fluid
ounce or milliliter); the number of units or volume of finished form in
each commercial container (e.g., 100-tablet bottle or 3-milliliter
vial); and the number of commercial containers of each such finished
form (e.g., four 100-tablet bottles or six 3-milliliter vials); and
(iii) For controlled substances in a commercial container, carton,
crate, drum, or other receptacle that has been opened: If the substance
is listed in Schedule I or II make an exact count or measure of the
contents; or if the substance is listed in Schedule III, IV or V, make
an estimated count or measure of the contents, unless the container
holds more than 1,000 tablets or capsules in which case an exact count
of the contents shall be made.
(4) For all records, the record of receipt shall be maintained
together with the corresponding record of return or destruction.
(d) Reports to ARCOS. Registered reverse distributors shall report
acquisition/distribution transactions pursuant to Sec. 1304.33 of this
chapter.
(e) Order forms. Each person registered to reverse distribute
controlled substances in Schedules I or II shall comply with the
requirements in part 1305 of this chapter.
Subpart B--Disposal of Controlled Substances by Ultimate Users and
Other Non-Registrants
Sec. 1317.30 Authorization to collect from non-registrants.
(a) The following persons are authorized to collect controlled
substances from ultimate users and other non-registrants for
destruction in compliance with this chapter:
(1) Any registrant authorized by DEA to be a collector pursuant to
Sec. 1317.40 of this chapter; and
(2) Any federal, state, tribal, or local law enforcement agency or
any law enforcement officer employed thereby acting in the course of
that person's official duties and pursuant to Sec. 1317.35 of this
chapter.
(b) The following non-registrant persons in lawful possession of a
controlled substance in Schedules II, III, IV, or V may transfer that
substance to the authorized persons listed in paragraph (a) of this
section, and in a manner authorized by this part, for the purpose of
disposal:
(1) An ultimate user in lawful possession of a controlled
substance;
(2) Any person lawfully entitled to dispose of a decedent's
property if that decedent was an ultimate user that died while in
lawful possession of a controlled substance; and
(3) A long term care facility on behalf of an ultimate user who
resides or resided at such long term care facility and is/was in lawful
possession of a controlled substance in accordance with Sec. 1317.80
of this chapter only.
[[Page 75814]]
Sec. 1317.35 Collection by law enforcement agencies.
(a) A Federal, state, tribal, or local law enforcement agency may
collect controlled substances from ultimate users and persons lawfully
entitled to dispose of an ultimate user decedent's property using the
following collection methods:
(1) Take-back events in accordance with Sec. 1317.65 of this
chapter;
(2) Mail-back programs in accordance with Sec. 1317.70 of this
chapter; or
(3) Collection receptacles located at the law enforcement agency's
physical address and in accordance with Sec. 1317.75 of this chapter.
(b) A law enforcement agency that conducts a take-back event or a
mail-back program or maintains a collection receptacle should maintain
any records of removal, storage, or destruction of the controlled
substances collected in a manner that is consistent with that agency's
recordkeeping requirements for illicit controlled substances evidence.
(c) Any controlled substances collected by a law enforcement agency
through a take-back event, mail-back program, or collection receptacle
should be stored in a manner that prevents the diversion of controlled
substances and is consistent with that agency's standard procedures for
storing illicit controlled substances.
(d) Any controlled substances collected by a law enforcement agency
through a take-back event, mail-back program, or collection receptacle
should be transferred to a destruction location in a manner that
prevents diversion.
(e) A law enforcement agency that transfers controlled substances
collected from ultimate users pursuant to this part to a reverse
distributor for destruction should maintain a record that contains the
following information: if an inner liner as described in Sec. 1317.60
of this chapter is used, the unique identification number of the inner
liner transferred, the size of the inner liner transferred (e.g., 5
gallon, 10 gallon, etc.); if a mail-back package as described in Sec.
1317.70 is used, the unique identification number of each package; the
date of the transfer; and the name, address, and DEA registration
number of the reverse distributor to whom the controlled substances
were transferred.
Sec. 1317.40 Registrants authorized to collect and authorized
collection activities.
(a) Manufacturers, distributors, reverse distributors, and retail
pharmacies may apply to modify their registration to obtain
authorization to be a collector in accordance with Sec. 1301.51 of
this chapter. Authorization to be a collector is subject to renewal. If
a registrant who is authorized to collect ceases activities as a
collector, such registrant shall apply to modify its registration in
accordance with Sec. 1301.51 of this chapter to indicate that the
registrant no longer collects.
(b) Collection by registrants shall occur only at the following
locations:
(1) Those registered locations of manufacturers, distributors,
reverse distributors, and retail pharmacies that are authorized for
collection; and
(2) Long term care facilities at which registered retail pharmacies
are authorized to maintain collection receptacles.
(c) Authorized collectors may conduct the following activities:
(1) Receive mail-back packages at a registered location that has an
on-site method of destruction pursuant to Sec. 1317.70 of this
chapter;
(2) Install, manage, and maintain collection receptacles located at
their authorized collection location(s); and
(3) Promptly dispose of sealed inner liners and their contents as
provided for in Sec. 1317.05(c)(2).
Sec. 1317.45 Collector security requirements.
An authorized collector shall not employ, as an agent or employee
who has access to or influence over controlled substances acquired by
collection, any person who has been convicted of any felony offense
relating to controlled substances or who, at any time, had an
application for registration with DEA denied, had a DEA registration
revoked or suspended, or has surrendered a DEA registration for cause.
Sec. 1317.50 Collector inventory, recordkeeping, reporting, and order
form requirements.
(a) Inventory record requirements. Each authorized collector shall
maintain the following information in the inventory:
(1) For registrants authorized to collect through a mail-back
program, the record shall include the following information about each
unused mail-back package and each returned mail-back package on hand
awaiting destruction:
(i) The date of the inventory;
(ii) The number of mail-back packages; and
(iii) The unique identification number of each package on hand,
whether unused or awaiting destruction.
(2) For registrants authorized to collect through a collection
receptacle, the record shall include the following information about
each unused inner liner on hand and each inner liner on hand awaiting
destruction:
(i) The date of the inventory;
(ii) The number of inner liners;
(iii) The unique identification number of each inner liner; and
(iv) The size (e.g., 5 gallon, 10 gallon, etc.) of each inner
liner.
(b) Continuing record requirements. Each authorized collector shall
maintain the following records:
(1) For registrants authorized to collect through a mail-back
program, the record shall include the following:
(i) For those unused packages that the collector makes available to
ultimate users and other authorized non-registrants at the authorized
collector's registered address: The date made available, the number of
packages, and the unique identification number of each package;
(ii) For those unused packages provided to a third party to make
available to ultimate users and other authorized non-registrants (e.g.,
a pharmacy, grocery store, etc.): The name of the third party and
physical address of the location receiving the unused packages, date
sent, and the number of unused packages sent with the corresponding
unique identification numbers;
(iii) Upon receipt of a sealed package: The date of receipt and the
unique identification number on the individual package; and
(iv) Upon destruction of a sealed package pursuant to Subpart C of
this chapter: In accordance with the recordkeeping requirements in
Sec. 1317.100 of this chapter.
(2) For registrants authorized to collect through a collection
receptacle, the record shall include the following:
(i) Upon acquisition of each inner liner: The date the inner liner
is acquired, the corresponding unique identification number of each
inner liner, and the size (e.g., 5 gallon, 10 gallon, etc.) of each
inner liner.
(ii) Upon installation of each inner liner in a collection
receptacle: The date of installation, the address and DEA registration
number of the location of the collection receptacle where the inner
liner is installed, the unique identification number of the inner
liner, the size of the inner liner (e.g., 5 gallon, 10 gallon, etc.),
and the name of two authorized employees who witnessed the
installation;
(iii) Upon removal of the inner liner: The date of removal, the
address and DEA registration number of the collection location, the
unique identification number of the inner liner, the size of the inner
liner (e.g., 5 gallon, 10 gallon, etc.), and the name of two authorized
employees who witnessed the removal;
[[Page 75815]]
(iv) Upon secure storage of a sealed inner liner: The date of the
transfer to storage, the unique identification number of the inner
liner stored, the size of the inner liner stored (e.g., 5 gallon, 10
gallon, etc.), and the name of two authorized employees who transferred
the inner liner to secure storage;
(v) Upon transfer of a sealed inner liner to a reverse distributor
or distributor: The date of the transfer, the address and DEA
registration number of the reverse distributor or distributor to whom
the inner liner was transferred, the unique identification number of
the inner liner transferred, the size of the inner liner transferred
(e.g., 5 gallon, 10 gallon, etc.), and the name of the two authorized
employees who transferred the inner liner to the reverse distributor or
distributor; and
(vi) Upon destruction pursuant to subpart C of this chapter: In
accordance with the recordkeeping requirements in Sec. 1317.100 of
this chapter.
(c) Reports to ARCOS. Authorized collectors are exempt from the
ARCOS reporting requirements in Sec. 1304.33 of this chapter for
controlled substances collected through mail-back programs and
collection receptacles for the purpose of disposal.
(d) Order forms. Authorized collectors are exempt from the
requirements in part 1305 of this chapter for controlled substances
collected through mail-back programs and collection receptacles for the
purpose of disposal.
Sec. 1317.55 Registered reverse distributor and distributor
acquisition of controlled substances from law enforcement agencies or
authorized collectors.
(a) A registered reverse distributor is authorized to acquire
controlled substances from law enforcement agencies that collect
controlled substances from ultimate users. A registered reverse
distributor is authorized to acquire controlled substances from
authorized collectors that collect controlled substances through a
collection receptacle in accordance with Sec. Sec. 1317.75 and 1317.80
of this chapter.
(b) A registered distributor is authorized to acquire controlled
substances from authorized collectors that collect controlled
substances through a collection receptacle pursuant to Sec. Sec.
1317.75 and 1317.80 of this chapter.
(c) A registered reverse distributor or a registered distributor
that acquires controlled substances in accordance with paragraphs (a)
or (b) of this section shall:
(1) Acquire the controlled substances in the manner prescribed in
Sec. 1317.15(b) of this part;
(2) Dispose of the controlled substances in the following manner:
(i) Immediately and securely store the controlled substance at the
reverse distributor's registered location, or immediately transfer the
controlled substances to the reverse distributor's registered location
for secure storage, until timely destruction; or
(ii) Immediately deliver the controlled substance to the location
of destruction for timely destruction.
(iii) Destroy, or cause the controlled substances to be destroyed,
as soon as practicable but no later than fourteen calendar days of
receipt.
(iv) Destruction shall be in accordance with Subpart C of this
part.
(3) Secure storage of the controlled substances shall be in a
manner consistent with the security requirements for Schedule II
controlled substances until timely destruction can occur.
(d) Record requirements. A registered reverse distributor or a
registered distributor that acquires controlled substances pursuant to
paragraphs (a) or (b) of this section shall maintain the following
records:
(1) Upon receipt: The date of receipt; the name and address of the
law enforcement agency or the name, address, and DEA registration
number of the authorized collector from whom the inner liner (or mail-
back package if from a law enforcement agency) was received; the unique
identification number of the inner liner (or mail-back package if from
a law enforcement agency) received; and the size of the inner liner
received (e.g., 5 gallon, 10 gallon, etc.);
(2) Upon transfer to secure storage: The date of storage; the
address and DEA number of the storage location; the unique
identification number of the inner liner or mail-back package stored
(if available in the case of a law enforcement agency); and the size of
the inner liner stored (e.g., 5 gallon, 10 gallon, etc.);
(e) Reports to ARCOS. Reverse distributors and distributors that
acquire controlled substances pursuant to paragraphs (a) or (b) of this
section are exempt from the ARCOS reporting requirements in Sec.
1304.33 of this chapter with regard to any controlled substances
acquired pursuant to paragraphs (a) or (b) of this section.
(f) Order forms. Reverse distributors and distributors that acquire
controlled substances pursuant to paragraphs (a) or (b) of this section
are exempt from the requirements in part 1305 of this chapter with
regard to any controlled substances acquired pursuant to paragraphs (a)
or (b) of this section.
Sec. 1317.60 Inner liner requirements.
For the purpose of part 1317 of this chapter, an inner liner shall
fulfill the following requirements:
(a) The inner liner shall be waterproof, tamper-evident, and tear-
resistant;
(b) The inner liner shall be removable and sealable immediately
upon removal without emptying or touching the contents;
(c) The contents of the inner liner shall not be viewable from the
outside when sealed;
(d) The size of the inner liner shall be clearly marked on the
outside of the liner (e.g., 5 gallon, 10 gallon, etc.); and
(e) The inner liner shall bear a permanent, unique identification
number that enables the liner to be tracked.
Sec. 1317.65 Take-back events.
(a) Any Federal, state, tribal, or local law enforcement agency may
conduct a take-back event and collect controlled substances from
ultimate users and persons lawfully entitled to dispose of an ultimate
user decedent's property in accordance with this section. Any person
may partner with a law enforcement agency to hold a collection take-
back event in accordance with this section.
(b) The law enforcement agency shall appoint a law enforcement
officer employed full time by the agency to oversee the collection. Law
enforcement officers employed and authorized by the law enforcement
agency conducting a take-back event shall maintain control and custody
of the collected substances from the time the substances are collected
from the ultimate user or person authorized to dispose of the ultimate
user decedent's property until secure transfer, storage, or destruction
of the controlled substance has occurred.
(c) Each take-back event should have at least one receptacle for
the collection of permitted substances. The collection receptacle
should be a securely locked, substantially constructed container with
an outer shell and a removable inner liner as specified in Sec.
1317.60 of this chapter. The outer shell should include a small opening
that allows contents to be added to the inner liner, but that does not
allow removal of the inner liner's contents.
(d) Only those controlled substances listed in Schedule II, III,
IV, or V that are lawfully possessed by an ultimate user or person
entitled to dispose of an ultimate user decedent's property may
[[Page 75816]]
be collected. Controlled and non-controlled substances may be collected
together and be comingled.
(e) Only ultimate users and persons entitled to dispose of an
ultimate user decedent's property in lawful possession of a controlled
substance in Schedule II, III, IV, or V may transfer such substances to
the law enforcement agency during the take-back event. No other person
may handle the controlled substances at any time.
Sec. 1317.70 Mail-back programs.
(a) A mail-back program may be conducted by any federal, state,
tribal, or local law enforcement agency or any authorized collector. An
authorized collector conducting a mail-back program shall have and
utilize at their registered location a method of destruction consistent
with Sec. 1317.90 of this chapter.
(b) Only those controlled substances listed in Schedule II, III,
IV, or V that are lawfully possessed by an ultimate user or person
lawfully entitled to dispose of an ultimate user decedent's property
may be collected. Controlled and non-controlled substances may be
collected together and be comingled.
(c) A law enforcement agency or authorized collector that conducts
a mail-back program shall make packages available (for sale or for
free) as specified in this paragraph to ultimate users and persons
lawfully entitled to dispose of an ultimate user decedent's property,
for the collection of controlled substances by mail. Any person may
partner with an authorized collector or law enforcement agency to make
such packages available in accordance with this section. The packages
made available shall meet the following specifications:
(1) The package shall be nondescript and shall not include any
markings or other information that might indicate that the package
contains controlled substances;
(2) The package shall be water- and spill-proof; tamper-evident,
tear-resistant, and sealable;
(3) The package shall be preaddressed with and delivered to the
authorized collector's registered address or the participating law
enforcement agency's physical address;
(4) The cost of shipping the package shall be postage paid;
(5) The package shall have a unique identification number that
enables the package to be tracked; and
(6) The package shall include instructions for the user that
indicate the process for mailing back the package, the permitted
substances that can be sent, and notice that only packages provided by
the authorized collector will be accepted for destruction.
(d) Ultimate users and persons lawfully entitled to dispose of an
ultimate user decedent's property shall not be required to provide any
personally identifiable information when mailing back controlled
substances to an authorized collector. The authorized collector or law
enforcement agency may implement a system that allows ultimate users or
persons lawfully entitled to dispose of an ultimate user decedent's
property to notify the collector or agency that they are sending one of
the designated packages by giving the unique identification number on
the package.
(e) An authorized collector that conducts a mail-back program
pursuant to paragraph (a) shall:
(1) Accept only those controlled substances contained within
packages that the collector made available for the collection of
controlled substances by mail.
(2) Within three business days of receipt, notify the Field
Division Office of the Administration in their area of the receipt of a
package that likely contains controlled substances and that the
authorized collector did not make available for the collection of
controlled substances by mail.
(f) Only law enforcement officers employed by the law enforcement
agency and authorized employees of the collector shall handle packages
received through an authorized mail-back program. Upon receipt of a
mail-back package by an authorized collector conducting a mail-back
program, the package shall not be opened, x-rayed, analyzed, or
otherwise penetrated.
Sec. 1317.75 Collection receptacles.
(a) Any federal, state, tribal, or local law enforcement agency or
authorized collector may manage, maintain, and empty collection
receptacles for disposal.
(b) Only those controlled substances listed in Schedule II, III,
IV, or V that are lawfully possessed by an ultimate user or other
authorized non-registrant person may be collected. Controlled and non-
controlled substances may be collected together and be comingled.
(c) Only ultimate users and other authorized non-registrant persons
in lawful possession of a controlled substance in Schedule II, III, IV,
or V may put such substances in a collection receptacle at a registered
location (e.g., ultimate user cannot transfer such substance to
pharmacy staff to put into a collection receptacle).
(d) Collection receptacles shall be securely placed and maintained:
(1) At an authorized collector's registered location, which shall
have proper building security in accordance with Sec. Sec. 1301.71 to
1301.77 of this chapter;
(2) At a long term care facility in accordance with Sec. 1317.80
of this chapter; or
(3) At a law enforcement agency's physical location.
(e) For authorized collectors, a controlled substance collection
receptacle shall:
(1) Be securely fastened to a permanent structure so that it cannot
be removed;
(2) At a registered location, be located in the immediate proximity
of a designated area where controlled substances are stored and at
which an authorized employee is present (e.g., can be seen from the
pharmacy counter); or at a long term care facility pursuant to Sec.
1317.80, be located in a secured area regularly monitored by personnel
of that long term care facility;
(3) Meet the following design specifications:
(i) A securely locked, substantially constructed container with a
permanent outer shell and a removable inner liner as specified in Sec.
1317.60 of this chapter.
(ii) The outer container shall include a small opening that allows
contents to be added to the inner liner, but does not allow removal of
the inner liner's contents;
(iii) The outer container shall prominently display a sign
indicating that only non-controlled drugs and Schedule II, III, IV, or
V controlled substances are acceptable (Schedule I controlled
substances, controlled substances that are not lawfully possessed by
the ultimate user, and other illicit or dangerous substances are not
permitted); and
(iv) Access to the inner liner shall be restricted to authorized
employees of the authorized collector.
(f) At a registered location, the small opening in the outer
container of the collection receptacle shall be locked or made
otherwise inaccessible to the public when an authorized employee is not
present (e.g., when the pharmacy is closed).
(g) The installation and removal of the inner liner of the
collection receptacle shall be performed by or under the supervision of
at least two authorized employees of the authorized collector. The
inner liner shall be sealed immediately upon removal from the permanent
outer shell and the sealed inner liner shall not be opened, x-rayed,
analyzed, or otherwise penetrated.
[[Page 75817]]
Sec. 1317.80 Collection receptacles at long term care facilities.
(a) A long term care facility may dispose of controlled substances
in Schedules II, III, IV, and V on behalf of an ultimate user who
resides or resided at such long term care facility when such disposal
occurs immediately, but no longer than three business days after the
discontinuation of use by the ultimate user. A long term care facility
shall dispose of such controlled substances only by transferring those
controlled substances into an authorized collection receptacle located
at that long term care facility.
(b) Only a registered retail pharmacy authorized to collect at the
long term care facility may manage and maintain collection receptacles
at that long term care facility and remove or supervise the removal of
the inner liner of the collection receptacles at that long term care
facility in accordance with Sec. 1317.75(g) of this chapter. The
registered retail pharmacy shall comply with all other requirements in
Sec. 1317.75 of this chapter.
(c) A registered retail pharmacy that intends to operate a
collection receptacle at a long term care facility shall apply to
modify its registration in accordance with Sec. 1301.51 of this
chapter and shall include in the application for modification in
registration the physical location of each long term care facility at
which the registered pharmacy intends to operate a collection
receptacle.
Sec. 1317.85 Ultimate user delivery for the purpose of recall or
investigational use of drugs.
(a) In the event of a product recall, an ultimate user in lawful
possession of a controlled substance listed in Schedule II, III, IV, or
V may deliver the recalled substance to the manufacturer of the
substance or another registrant authorized by the manufacturer to
accept recalled controlled substances on the manufacturer's behalf.
(1) Continuing record requirements. Such registrant accepting
recalled controlled substances shall maintain a record of each recalled
controlled substance received from an ultimate user, to include the
following information: The date of receipt, and the name, form, and
quantity of each controlled substance received.
(2) Order forms. Such registrant accepting recalled controlled
substances is exempt from the requirements in part 1305 of this chapter
for the receipt of recalled controlled substances from ultimate users.
(3) Reports to ARCOS. Such registrant accepting recalled controlled
substances may report as a single transaction all recalled controlled
substances of the same name and finished form (e.g., all 10-milligram
tablets or all 5-milligram concentration per fluid ounce or milliliter)
received from ultimate users for the purpose of reporting acquisition
transactions pursuant to Sec. 1304.33 of this chapter.
(b) An ultimate user that is participating in an investigational
use of drugs pursuant to 21 U.S.C. 355(i) and 360b(j) and wishes to
deliver any unused controlled substances received as part of that
research to the registered dispenser from which the ultimate user
obtained those substances may do so in accordance with regulations
promulgated by the Secretary of Health and Human Services pursuant to
21 U.S.C. 355(i) and 360b(j).
Subpart C--Destruction of Controlled Substances
Sec. 1317.90 Methods of destruction.
(a) All controlled substances to be destroyed shall be destroyed in
compliance with applicable federal, state, tribal, and local laws and
regulations and shall be rendered non-retrievable.
(b) Where multiple controlled substances are comingled, the method
of destruction shall be sufficient to render all such controlled
substances non-retrievable. When the actual substances collected for
destruction are unknown but may reasonably include controlled
substances, the method of destruction shall be sufficient to render
non-retrievable any controlled substance likely to be present.
(c) The method of destruction shall be consistent with the purpose
of rendering all controlled substances to a non-retrievable state in
order to prevent diversion of any such substance to illicit purposes
and to protect the public health and safety.
Sec. 1317.95 Destruction procedures.
The destruction of any controlled substance shall be in accordance
with the following requirements:
(a) If the controlled substances are transferred to a person
registered under the Act and authorized to accept the controlled
substances for purposes of disposal, two authorized employees of the
transferring registrant shall load and unload or observe the loading
and unloading of any controlled substances until transfer is complete.
(b) If the controlled substances are transported by a registrant to
the location of destruction, the following procedures shall be
followed:
(1) Transportation shall be directly to the destruction location;
(2) Two authorized employees of the transporting registrant shall
accompany the controlled substances to the destruction location;
(3) Two authorized employees of the transporting registrant shall
load and unload or observe the loading and unloading of the controlled
substances;
(4) Two authorized employees of the transporting registrant shall
handle or observe the handling of any controlled substance until the
substance is rendered non-retrievable; and
(5) Two authorized employees of the transporting registrant shall
personally witness the destruction of the controlled substance until it
is rendered non-retrievable.
(c) If the controlled substances are destroyed at a registrant's
registered location utilizing an on-site method of destruction, the
following procedures shall be followed:
(1) Two authorized employees of the registrant shall handle or
observe the handling of any controlled substance until the substance is
rendered non-retrievable; and
(2) Two authorized employees of the registrant shall personally
witness the destruction of the controlled substance until it is
rendered non-retrievable.
Sec. 1317.100 Recordkeeping requirements.
(a) In addition to any other recordkeeping requirements, any
registered person that destroys or causes the destruction of a
controlled substance shall maintain a record of destruction on a form
issued by DEA that includes the following information: The date of
destruction; the method of destruction; the name and address of the
place of destruction; the name and quantity of the controlled
substances destroyed or the unique identification number of the inner
liner or mail-back package destroyed; the size of the inner liner
destroyed (e.g., 5 gallon, 10 gallon, etc.); and the name and signature
of the two authorized employees who witnessed the destruction.
(b) If the controlled substances destroyed were received from
another registrant, the registrant destroying the controlled substances
shall maintain a copy of the record transferring the substances or a
copy of the DEA Form 222.
Dated: December 17, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-30699 Filed 12-20-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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