[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Proposed Rules]
[Page 3480-3487]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja09-31]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, 1305, and 1307
[Docket No. DEA-316A]
RIN 1117-AB18
Disposal of Controlled Substances by Persons Not Registered With
the Drug Enforcement Administration
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: In response to concerns raised by individuals, public and
private organizations, the healthcare industry, and the law enforcement
community, the Drug Enforcement Administration (DEA) is soliciting
information on the disposal of controlled substances dispensed to
individual patients, also defined as ultimate users, as well as long
term care facilities. DEA is seeking options for the safe and
responsible disposal of dispensed controlled substances in a manner
consistent with the Controlled Substances Act and its implementing
regulations.
DATES: Written comments must be postmarked on or before March 23, 2009,
and electronic comments must be sent on or before midnight Eastern time
March 23, 2009.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-316'' on all written and electronic correspondence.
Written comments being sent via regular or express mail should be sent
to the Drug Enforcement Administration, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
Comments may be sent to DEA by sending an electronic message to
dea.diversion.policy@usdoj.gov. Comments may also be sent
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. DEA will
accept attachments to electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept
any file formats other than those specifically listed here.
Please note that DEA is requesting that electronic comments be
submitted before midnight Eastern time on the day the comment period
closes because http://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern time on the day the
comment period closes. Commenters in time zones other than Eastern time
may want to consider this so that their electronic comments are
received. All comments sent via regular or express mail will be
considered timely if postmarked on the day the comment period closes.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152,
Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
If you want 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 want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the
[[Page 3481]]
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 Drug Enforcement Administration'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.
Legal Authority
The Drug Enforcement Administration (DEA) enforces the
Comprehensive Drug Abuse Prevention and Control Act of 1970, often
referred to as the Controlled Substances Act (CSA) and the Controlled
Substances Import and Export Act (21 U.S.C. 801-971) as amended. DEA
regulations implementing these statutes are published in Title 21 of
the Code of Federal Regulations (CFR), Parts 1300 to 1399. These
regulations are designed to establish a framework for the legal
distribution of controlled substances to deter their diversion to
illegal purposes and to ensure that there is a sufficient supply of
these drugs for legitimate medical, scientific, research, industrial,
and other purposes. Controlled substances are those substances listed
in the schedules of the CSA and 21 CFR 1308.11-1308.15, and generally
include narcotics, stimulants, depressants, and hallucinogens that have
a potential for abuse and physical and psychological dependence, as
well as anabolic steroids.
The CSA and DEA's regulations require that persons involved in the
manufacture, distribution, research, dispensing, import, and export of
controlled substances register with DEA (unless exempt), keep track of
all stocks of controlled substances, and maintain records to account
for all controlled substances received, distributed, or otherwise
disposed of.
Background
Under the CSA, Congress established a ``closed system'' of
distribution designed to prevent the diversion of controlled
substances.\1\ As part of this closed system, all persons who lawfully
handle controlled substances must be registered with DEA or exempt from
registration by the CSA or DEA regulations. Another central element of
this closed system is that DEA registrants must maintain strict records
of all transactions in controlled substances. Consistent with the CSA
requirements, current DEA regulations employ a system to account for
all controlled substances received, stored, distributed, dispensed, or
otherwise disposed of. Under this system, all controlled substances
used in legitimate commerce may be transferred only between persons or
entities who are DEA registrants or who are exempted from the
requirement of registration, until they are dispensed to the ultimate
user. Thus, for example, a controlled substance, after being
manufactured by a DEA-registered manufacturer, may be transferred to a
DEA-registered distributor for subsequent distribution to a DEA-
registered retail pharmacy. After a DEA-registered practitioner, such
as a physician or a dentist, issues a prescription for a controlled
substance to a patient (i.e., the ultimate user), that patient can fill
that prescription at a retail pharmacy to obtain that controlled
substance. In this system, the manufacturer, the distributor, the
practitioner, and the retail pharmacy are all required to be DEA
registrants, or to be exempted from the requirement of registration, to
participate in the process.
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\1\ H.R. Rep. No. 91-1444 at 3 (1970).
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As set forth in the CSA, an ultimate user is exempt from the
requirement of registration--but only to the extent the ultimate user
possesses a controlled substance that has been lawfully obtained for
his own use or 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. 822(c)(3),
802(27)). Beyond such circumstances, the CSA and its implementing
regulations do not currently contemplate a situation in which an
ultimate user would distribute a controlled substance. Thus, such
distribution, regardless of the purpose, is illegal.
Under the Controlled Substances Act, specifically 21 U.S.C.
802(27), the term ``ultimate user'' means 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. Ultimate users are not required to
register with DEA to possess controlled substances.
Every person who manufactures or distributes any controlled
substance or List I chemical, or who proposes to engage in the
manufacture or distribution of any controlled substance or List I
chemical, shall obtain annually a registration issued by the Attorney
General in accordance with the rules and regulations promulgated by him
(21 U.S.C. 822(a)). ``The term `distribute' means to deliver (other
than by administering or dispensing) a controlled substance or a listed
chemical'' (21 U.S.C. 802(11)). ``The terms `deliver' or `delivery'
mean the actual, constructive, or attempted transfer of a controlled
substance or a listed chemical, whether or not there exists an agency
relationship.'' (21 U.S.C. 802(8)). Thus, because the terms deliver and
distribute, as defined in the CSA, encompass all methods of delivery
and distribution of controlled substances, and because the CSA allows
ultimate users to obtain and possess controlled substances solely for
purposes of use, under current law, an ultimate user may not deliver or
distribute controlled substances for purposes of disposal (unless the
ultimate user is also a DEA registrant).
DEA issues registrations to certain business firms, called reverse
distributors, to authorize them to take controlled substances that are
expired or otherwise unwanted from other DEA registrants for subsequent
disposal or distribution back to the manufacturer. Reverse distributors
are the only DEA registrants permitted to receive controlled substances
from other registrants expressly for the purpose of disposal; other
registrants, e.g., pharmacies, may dispose of controlled substances
already in their possession that have expired, been damaged, or
contaminated, but may not accept controlled substances from another
person solely for the purpose of disposal. Under 21 CFR 1300.01(b)(41):
The term ``reverse distributor'' means a registrant who receives
controlled substances acquired from another DEA registrant for the
purpose of--
(i) Returning unwanted, unusable, or outdated controlled
substances to the manufacturer or the manufacturer's agent; or
(ii) Where necessary, processing such substances or arranging
for processing such substances for disposal.
DEA issues these firms registrations as reverse distributors and
they must adhere to certain security and recordkeeping requirements to
ensure that unwanted controlled substances are accounted for and
disposed of in accordance with all relevant State and
[[Page 3482]]
Federal laws and regulations. In addition, reverse distributors must
adhere to any local, county, State, and/or Federal environmental
regulations when they dispose of the unwanted controlled substances.
While a reverse distributor is registered by DEA at a specific location
and is permitted to store controlled substances at that location, it is
important to note that the reverse distributor is not required to
dispose of the controlled substances at its registered location.
Opportunities for large scale disposal (including by reverse
distributors) of unused or expired controlled substances have been
complicated by existing statutory requirements under the Controlled
Substances Act and Federal and State waste disposal laws.
By regulation, a reverse distributor cannot take unwanted
controlled substances from non-DEA registrants. For example, as stated
previously, once a controlled substance has been dispensed to a patient
as the ultimate user, either by prescription or through other means,
the ultimate user cannot give the controlled substance to a reverse
distributor. Such furnishing of a controlled substance by the ultimate
user would be a distribution, which an ultimate user is not permitted
to make without being registered. Further, the reverse distributor
cannot currently take custody of the controlled substance because
reverse distributors are only permitted to receive controlled
substances from other DEA registrants. Members of the public have told
DEA that the inability to use a reverse distributor in the disposal
process is one of the reasons that ultimate users have difficulty
safely disposing of unwanted medications, especially controlled
substances.
Aside from ultimate users not being permitted to distribute
controlled substances for purposes of disposal without being separately
registered and reverse distributors not being permitted to receive
controlled substances from non-registered ultimate users, recordkeeping
requirements also apply to the disposal of controlled substances. The
CSA requires every registrant who manufactures, distributes, or
dispenses a controlled substance or substances to maintain, on a
current basis, a complete and accurate record of each such substance
manufactured, received, sold, delivered, or otherwise disposed of by
the registrant (21 U.S.C. 827(a)(3)). Records must contain such
information as the Attorney General requires to be kept by regulation
(21 U.S.C. 827(b)(1)). For reverse distributors, these records include,
for each controlled substance in finished form, the following:
(i) The name of the substance.
(ii) Each finished form (e.g., 10-milligram tablet or 10-
milligram concentration per fluid ounce or milliliter) and the
number of units or volume of finished form in each commercial
container (e.g., 100-tablet bottle or 3-milliliter vial).
(iii) The number of commercial containers of each such finished
form received from other persons, including the date of and number
of containers in each receipt and the name, address, and
registration number of the person from whom the containers were
received.
(iv) The number of commercial containers of each such finished
form distributed back to the original manufacturer of the substance
or manufacturer's agent, including the date of and number of
containers in each such distribution and the name, address, and
registration number of the manufacturer or manufacturer's agent to
whom the containers were distributed.
(v) The number of units or volume of finished forms and/or
commercial containers disposed of including the date and manner of
disposal, the quantity of the substance in finished form disposed,
and the signatures of two responsible employees of the registrant
who witnessed the disposal.
(21 CFR 1304.22(e)(2))
Based on current law and DEA regulations, if ultimate users were
otherwise permitted to provide their unwanted controlled substances to
reverse distributors then the above recordkeeping requirements would
continue to apply to the reverse distributors, unless an exemption is
granted by regulation pursuant to 21 U.S.C. 827(c)(3).
Redistribution or Reuse
As discussed below, nonregistrants may dispose of controlled
substances upon instruction by DEA Special Agents in Charge. However,
no provisions in the CSA or DEA regulations allow a DEA registrant to
routinely acquire controlled substances from a non-registrant (i.e.
individual patient). Hence, patients are currently prohibited from
furnishing controlled substances to reverse distributors for disposal
and from returning controlled substances to a registrant for the
purpose of redistribution or reuse. According to the National
Conference of State Legislatures, in 2007, 10 States passed laws
allowing or encouraging the donation of unused pharmaceutical drugs.
Many of these programs involve health care facilities, nursing homes or
other pharmacies. However, the CSA and current DEA regulations prohibit
ultimate users from delivering or distributing controlled substances--
even if such distribution takes the form of a donation to a DEA
registrant participating in one of these State authorized programs--and
prohibit registrants from accepting such donations from ultimate users.
Consequently, these State laws do not provide a mechanism consistent
with Federal law for donation, return, or reuse of controlled
substances.
The Food and Drug Administration (FDA) does not generally permit
the redistribution of medications, except under limited circumstances.
The FDA Compliance Policy Guides Manual, Chapter 4, Human Drugs,
Section 460.300 reads as follows:
Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (CPG
7132.09)
POLICY:
A pharmacist should not return drugs [sic] products to his stock
once they have been out of his possession. It could be a dangerous
practice for pharmacists to accept and return to stock the unused
portions of prescriptions that are returned by patrons, because he
would no longer have any assurance of the strength, quality, purity
or identity of the articles.
Many state boards of pharmacy have issued regulations
specifically forbidding the practice. We endorse the actions of
these State boards as being in the interest of public health.
The pharmacist or doctor dispensing a drug is legally
responsible for all hazards of contamination or adulteration that
may arise, should he mix returned portions of drugs to his shelf
stocks. Some of our investigations in the past have shown that drugs
returned by patrons and subsequently resold by the pharmacist were
responsible for injuries.\2\
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\2\ Food and Drug Administration, Compliance Guides Policy
Manual Section 460.300, Return of Unused Prescription Drugs to
Pharmacy Stock (CPG 7132.09). October 1, 1980. http://www.fda.gov/
ora/compliance_ref/cpg/cpgdrg/cpg460-300.html.
DEA shares similar concerns regarding the redistribution of
controlled substances. This practice is not addressed by the CSA or its
implementing regulations.
Disposal of Unused or Unwanted Medications by Ultimate Users
As stated previously, the CSA and its implementing regulations do
not contemplate a situation in which an ultimate user would distribute
controlled substances. However, 21 CFR 1307.21 provides the procedure
for disposing of controlled substances by persons who are not
registrants. This procedure involves the nonregistrant submitting a
letter to the local DEA Special Agent in Charge. The letter must
include the name and address of the person; the name and quantity of
each controlled substance to be disposed of; how the applicant obtained
the controlled substance, if known; and the name, address, and
registration number, if known, of the person who possessed
[[Page 3483]]
the controlled substances prior to the applicant, if known (21 CFR
1307.21(a)(2)). Provided such disposal is permissible under the CSA,
the Special Agent in Charge shall authorize and instruct the applicant
to dispose of the controlled substance through any of the following
methods: Transfer of the substance to a person registered under the CSA
and authorized to possess the substance; delivery to an agent of the
Administration or to the nearest office of the Administration; by
destruction in the presence of an agent of the Administration or other
authorized person; or, by such other means as the Special Agent in
Charge may determine to ensure that the substance does not become
available to unauthorized persons (21 CFR 1307.21(b)). Though this is
an option currently available to ultimate users, it is used in
extremely limited circumstances.
Another option available for the disposal of unwanted controlled
substances dispensed to ultimate users is through take-back programs
that comply with applicable Federal and state law. Take-back programs
are organized collection events designed to reduce the amount of
unwanted or unused pharmaceuticals that may pose a risk to public
health and safety, may be accessible to diversion, or that otherwise
may be disposed of in a manner that does not comply with State or
Federal laws or regulations. As previously stated, the distribution of
a controlled substance by an ultimate user for the purpose of disposal
is a scenario not contemplated by the CSA and its closed system of
distribution. However, as indicated above, ultimate users, and other
DEA nonregistrants, in possession of controlled substances may dispose
of those substances by receiving permission from the local DEA Special
Agent in Charge, provided such disposal takes place in a manner
consistent with the structure of the CSA.
In the absence of regulations expressly addressing the disposal of
controlled substances dispensed to ultimate users, DEA has recently
granted temporary permission to law enforcement agencies who have
requested authorization to accept for disposal controlled substances
that have been dispensed to ultimate users. In granting such temporary
authorization, DEA has imposed certain conditions to ensure that the
controlled substances do not become available to unauthorized persons,
consistent with 21 CFR 1307.21, and to promote consistency with the
structure of the CSA. Thus, the only take-back programs for which DEA
has recently granted temporary allowances are those in which law
enforcement officials directly receive the controlled substances from
the ultimate users. Recognizing that there might be additional
appropriate methods of allowing for the disposal of controlled
substances dispensed to ultimate users, DEA is seeking information to
provide more accessible ways to safely and responsibly dispose of
dispensed controlled substances in a manner consistent with the CSA.
Disposal of Unused Medications by Long Term Care Facilities (LTCFs)
The term ``long term care facility'' (LTCF) is defined to mean ``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)(25)). Most LTCFs are not DEA registered entities.
When patients residing at LTCFs require controlled substances their
practitioner issues a prescription which is usually dispensed for the
full amount by a registered pharmacy. The LTCF holds the prescribed
drugs in a custodial manner for the patient and dispenses the
medications on the schedule the practitioner orders. As a result of
these dispensing practices, when patients die, leave the facility, or
their medication is discontinued or changed, the LTCF may be left with
excess controlled substances that must be disposed of to avoid
diversion.
DEA has been acutely aware of the problems surrounding the disposal
of dispensed controlled substances at LTCFs for some time, and has
worked to reduce the accumulation of controlled substances at LTCFs
through a number of regulatory actions. Prescribing practitioners are
required by regulation to specify the quantity prescribed on the
prescriptions. However, DEA recognized that LTCF patients are a unique
part of society, and may often need the Schedule II controlled
substances medications they are prescribed changed on short notice
based on their rapidly changing health conditions. Consequently,
patients might not need the full quantity of the Schedule II controlled
substance that the practitioner had initially prescribed. To reduce the
potential excess amounts of dispensed controlled substances,
practitioners prescribing Schedule II controlled substances for LTCF
patients needed the ability to prescribe smaller quantities of those
substances more frequently than would be necessary for other patients.
Practitioners are required to manually sign prescriptions for Schedule
II controlled substances for the prescription to be valid (21 CFR
1306.05(a)), and the dispensing pharmacy is unable to dispense the
needed controlled substance until it receives a valid prescription (21
CFR 1306.11(a)). It became evident that this requirement made it more
difficult for prescribing practitioners to be responsive to the
immediate and changing needs of LTCF patients. To address this
circumstance, DEA promulgated regulations that permit the facsimile
transmission of written, manually signed Schedule II prescriptions for
residents of LTCFs by the practitioner or the practitioner's agent to
the dispensing pharmacy (21 CFR 1306.11(f)). The facsimile serves as
the original prescription for the dispensing pharmacy's records. DEA
has also permitted the facsimile transmission of written, manually
signed Schedule II controlled substance prescriptions for patients
enrolled in hospice care programs certified and/or paid for by Medicare
under Title XVIII of the United States Code, or hospice programs
licensed by the State (21 CFR 1306.11(g)).
DEA has also established partial dispensing provisions for
Schedules II-V prescriptions (including unit-dose dispensing, if
desired), to limit the quantity of controlled substances dispensed at
one time and avoid waste if the treatment was changed or discontinued.
These regulations include specific provisions for residents of LTCFs or
patients with medical diagnoses documenting a terminal illness (21 CFR
1306.13(b), 1306.23). According to the pharmacy industry, however,
dispensing fees, reimbursement practices, and difficulties in educating
practitioners regarding the need to prescribe controlled substances in
anticipation of a patient's actual need for the controlled substance
have, for the most part, precluded using that approach.
To further prevent the accumulation of controlled substances at
LTCFs, DEA has permitted retail pharmacies to install and operate
automated dispensing systems (ADS) at LTCFs (21 CFR 1301.27). ADS are
conceptually similar to a vending machine. A pharmacy stores bulk
controlled substances in the ADS in separate bins or containers and
programs and controls the ADS remotely. Only authorized staff at the
LTCF has access to the ADS's contents, which are dispensed on a single-
dose basis at the time of administration pursuant to a prescription.
The ADS electronically records each dispensing, thus maintaining
dispensing records for the pharmacy. Because the controlled substances
are not considered dispensed until the system provides them,
[[Page 3484]]
controlled substances in the ADS are pharmacy stock, not waste.
Despite DEA's efforts to reduce the accumulation of dispensed
controlled substances at LTCFs, accumulation continues to be a concern.
LTCFs that are not DEA registrants may not transfer the controlled
substances to either the pharmacy that supplied them or to a reverse
distributor for disposal.
Purpose of Advance Notice of Proposed Rulemaking
On February 20, 2007, in recognition of the advice being provided
by environmental organizations to the public to dispose of medications
in household trash (as opposed to flushing them into the waste-water
system), the U.S. Office of National Drug Control Policy (ONDCP)
announced guidelines for the disposal of ultimate user medications,
including dispensed controlled substances. The guidelines were
published by ONDCP in conjunction with the Department of Health and
Human Services (HHS), and the EPA.\3\ The guidelines advise the public
to flush medications only if the prescription label or accompanying
patient information specifically states to do so. Instead of flushing,
ONDCP recommends that, after performing a minimal deactivation
procedure, the medications be disposed of in common household trash or
at community pharmaceutical ``take-back'' programs. The press release
announcing the guidelines stated:
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\3\ Office of National Drug Control Policy, Executive Office of
the President. Proper Disposal of Prescription Drugs. February 2007.
http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_
disposal.pdf.
The new Federal guidelines are a balance between public health
concerns and potential environmental concerns. ``While EPA continues
to research the effects of pharmaceuticals in water sources, one
thing is clear: Improper drug disposal is a prescription for
environmental and societal concern,'' said EPA Administrator Stephen
L. Johnson. ``Following these new guidelines will protect our
Nation's waterways and keep pharmaceuticals out of the hands of
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potential abusers.''
In addition to environmental concerns, there are safety concerns
that medications, especially controlled substances, could be either
intentionally or unintentionally abused. Children may retrieve a
medication from the trash and ingest it without the specific intention
of abusing it. For these reasons, some medications include flushing
disposal instructions to make them less available and to mitigate
safety risks.
The illicit use of prescription medication is a growing problem
among young adults. According to the 2007 National Survey on Drug Use
and Health, more persons age 12 and above are engaged in the non-
medical use of psychotherapeutic drugs than those abusing cocaine,
heroin, and methamphetamine combined. Prescription drug abuse is second
only to marijuana use.\4\ The 2005 Partnership Attitude Tracking Study
(PATS) reported that 62 percent of teens say prescription pain
relievers are easy to get from parents' medicine cabinets.\5\
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\4\ Office of National Drug Control Policy, Executive Office of
the President. Prescription for Danger, A Report on the Troubling
Trend of Prescription and Over-the-Counter Drug Abuse Among the
Nation's Teens. January 2008.
\5\ Partnership for a Drug-Free America, The Partnership
Attitude Tracking Study (PATS): Teens in grades 7 through 12 (2005).
May 16, 2006.
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DEA is seeking options for the disposal of controlled substances
dispensed to DEA nonregistrants that protect public health and safety,
minimize the possibility of diversion, are consistent with the CSA and
DEA regulations, and provide sound environmental solutions.
Request for Information
DEA seeks comments regarding the promulgation of regulations to
permit the disposal of controlled substances by ultimate users and long
term care facilities consistent with the Controlled Substances Act and
its implementing regulations. DEA seeks comments regarding how various
entities would address the issue of the disposal of dispensed
controlled substances held by DEA nonregistrants in light of the
current restrictions that are in place. Commenters are encouraged to
include the question number enumerated below in their response.
Although all comments are welcome, DEA is particularly interested in
comments regarding the questions listed below. These questions are
separated into groups by area of interest. The groups are:
Ultimate Users
State and Local Law Enforcement Agencies & Publicly Owned
Treatment Works
Concerned Interest Groups
Long Term Care Facilities
Hospices and In-Home Care Groups
Pharmacies
Narcotic Treatment Programs
Reverse Distributors
State Regulatory Agencies
All Interested Parties
For Ultimate Users (Patients or Family Members of Patients Who Possess
Controlled Substances Which Have Been Legally Dispensed)
1. Can you distinguish a controlled substance from a non-controlled
substance?
2. Why do you have unwanted or outdated controlled substances in
your possession?
3. What method, if any, do you currently use to dispose of your
unwanted or outdated pharmaceuticals, including controlled substances?
4. Are you willing to seek locations outside of your home to
dispose of unwanted pharmaceuticals?
5. Does your community, county, or State have laws, regulations, or
policies in place that prohibit medications, including controlled
substances, from being flushed or placed in the garbage?
6. Does your community have take-back programs during which you can
provide pharmaceuticals to an entity for disposal? If so, do you know
whether these programs accept controlled substances?
7. If your community has take-back programs, who sponsors the
program?
8. If you participated in a take-back program, please describe how
the program worked.
9. If you participated in a take-back program, was a law
enforcement agency involved?
10. If you participated in a take-back program, did you encounter
any problems? Please explain.
11. What do you believe is the best method of disposing of unwanted
or outdated pharmaceuticals, including controlled substances dispensed
to ultimate users?
12. Would you be willing to pay a fee to have your medication
disposed of in a manner that minimizes the possibility of the diversion
of legally obtained controlled substance medications for illegal
purposes and is environmentally safe? If so, how much would you be
willing to pay?
13. Would you consider using a postage paid mailing container to
dispose of unwanted medications?
14. Where would you be willing to go to obtain such a postage paid
mailing container (e.g., local pharmacy, police department, take-back
event)?
15. Would you be willing to pay the postage on a mailing container
used to ship controlled substances and other pharmaceuticals to another
location for disposal? If so, how much would you be willing to pay?
16. Would you consider the use of a mailing container more
convenient or less convenient than taking unwanted
[[Page 3485]]
controlled substances to a pharmacy or to a take-back event?
17. What other means of disposal would you consider convenient?
For State and Local Law Enforcement Agencies and Publicly Owned
Treatment Works
18. Is the disposal of unwanted or outdated pharmaceuticals a
problem in your area?
19. Do individuals bring their unwanted or outdated
pharmaceuticals, including controlled substances which have been
legally obtained, to your department for disposal?
20. Does your department encourage or discourage such activity?
Please explain.
21. If individuals bring their unwanted or outdated
pharmaceuticals, including controlled substances which have been
legally obtained, to your department for your department to dispose of,
how does that process work? Do individuals drop the pharmaceuticals in
a container, hand them to a department employee, or hand them to a law
enforcement officer?
22. Have you ever had any challenges or difficulties with taking
individuals' unwanted or outdated pharmaceuticals, including controlled
substances, for disposal? If so, please explain.
23. Does your department/facility participate in take-back
programs?
24. If your department/facility participates in take-back programs,
what is the nature of your participation?
25. Have you ever encountered any challenges or difficulties when
participating in such programs? Please explain.
26. If your department/facility does not participate in take-back
programs, what, if anything, prevents such participation?
27. Does your department/facility have the staffing and resources
to participate in take-back programs?
28. Is your department aware of any cases of diversion involving
take-back programs? If so, did the diversion result in the arrest or
prosecution of any individuals?
29. Regardless of how you receive the medications (e.g., take-back
program, individual drop off) for disposal, do you differentiate
between controlled substances and noncontrolled substances? If so, how?
30. Regardless of how you receive the medications for disposal,
what would you estimate to be the percentage, quantity, or other
measurable unit of controlled substances as compared to noncontrolled
substances?
31. Regardless of how you receive the medications for disposal,
prior to disposal, where do you store these pharmaceuticals and under
what security?
32. How do you dispose of the controlled substances that you
receive?
33. What records do you generate regarding what you receive and
what you dispose of?
34. How far must you travel to dispose of pharmaceuticals,
including controlled substances?
35. What do you do if the landfill or incinerator you plan to use
is closed, nonoperational, or otherwise unavailable?
36. How much money has your participation in pharmaceutical
disposal cost your department/facility in the previous year?
37. How many man-hours has your participation in drug disposal cost
your department/facility in the previous year?
38. If you are receiving unwanted or outdated pharmaceuticals for
disposal, are you doing so as a result of local or State policy, law,
or regulation?
39. If your department does not currently receive pharmaceuticals
for disposal, would it be interested in receiving them?
40. Would your department/facility be willing to make available
postage paid envelopes to be used by the public to mail pharmaceuticals
to a reverse distributor or a law enforcement agency for disposal?
41. What do you believe is the best method of safely disposing of
unwanted or outdated controlled substances held by DEA nonregistrants?
For Concerned Interest Groups
42. What prompted you to get involved in the issue of drug
disposal?
43. What is your group doing to address this issue?
44. What have been your successes?
45. What challenges or difficulties have you encountered?
46. If you accept medications for disposal, what records do you
maintain, if any?
47. If you accept medications for disposal, how do you store and
secure these medications prior to disposal?
48. If you accept medications for disposal, do you differentiate
between controlled substances and noncontrolled substances? If so, how?
49. What has been law enforcement's involvement in the disposal of
these medications, if any?
50. What would you estimate to be the percentage, quantity, or
other measurable unit of controlled substances as compared to
noncontrolled substances that your disposal programs received?
51. If you have a pharmaceutical disposal program in place, how is
it funded?
52. There is concern that residue from pharmaceuticals is being
found in drinking water. What is your understanding of the percentage
of this problem that is due to ultimate users flushing their unused or
unwanted medications?
For Long Term Care Facilities
53. Is the issue of unwanted or unused pharmaceuticals, including
controlled substances, a concern at your facility?
54. What are the reasons why your facility is in possession of
unwanted or outdated pharmaceuticals, including controlled substances?
55. At the end of each month is your facility in possession of a
significant amount of unwanted or outdated pharmaceuticals? How much?
Of those pharmaceuticals, what would you estimate the percentage of
controlled substances to be?
56. How do you normally dispose of these pharmaceuticals, including
controlled substances?
57. Does law enforcement, or some other State agency, assist you in
disposing of controlled substances?
58. Are you mandated by any local or State law or regulation to
dispose of these medications, including controlled substances, in a
specific manner? If so, how?
59. Does your facility take unwanted or outdated pharmaceuticals to
local take-back programs?
60. Are you aware of automated dispensing systems? If so, does your
facility use them? Have they reduced the amount of excess medications
at the facility?
61. Has the ability of a pharmacy to receive faxed schedule II
prescriptions for patients in long term care facilities helped to
reduce the amount of excess medications at your facility?
62. How do you believe the accumulation of unwanted or outdated
pharmaceuticals at long term care facilities can be better addressed?
63. What do you believe is the best method for disposing of these
pharmaceuticals?
For Hospices and In-Home Care Groups
64. Is the accumulation of unwanted or outdated controlled
substances a problem for your business?
65. If you dispose of unwanted or outdated pharmaceuticals, what
methods do you currently use to dispose of such pharmaceuticals,
including controlled substances?
[[Page 3486]]
66. If you dispose of pharmaceuticals, including controlled
substances, what have been your successes?
67. If you dispose of pharmaceuticals, including controlled
substances, what challenges or difficulties have you encountered?
68. What do you believe is the best method of disposing of these
unwanted or outdated pharmaceuticals, including controlled substances?
69. Has the ability of a pharmacy to receive faxed schedule II
prescriptions for patients enrolled in hospice programs helped to
reduce the amount of excess medications?
70. How do you believe the accumulation of unwanted or outdated
pharmaceuticals by patients enrolled in hospice programs can be better
addressed?
For Pharmacies
71. Is the disposal of unwanted or outdated pharmaceuticals by
ultimate users a problem in your area?
72. Does your State permit your pharmacy to take unwanted or
outdated pharmaceuticals, including dispensed controlled substances,
from ultimate users?
73. Does your State permit your pharmacy to place unwanted or
outdated pharmaceuticals obtained from ultimate users, including
dispensed controlled substances, back into stock?
74. If you provide pharmaceuticals, including controlled
substances, to long term care facilities, does your State permit your
pharmacy to take back unwanted, unused, or outdated medications from
those facilities?
75. Does your State permit your pharmacy to place unwanted or
outdated pharmaceuticals obtained from long term care facilities,
including dispensed controlled substances, back into stock?
76. Does your pharmacy participate in any pharmaceutical take-back
programs? If so, please describe.
77. If your pharmacy participates in pharmaceutical take-back
programs, what have been the successes?
78. If your pharmacy participates in pharmaceutical take-back
programs, what challenges or difficulties have you encountered?
79. Would your pharmacy be willing to make available postage paid
envelopes to be used by the public to mail unwanted or outdated
pharmaceuticals to a reverse distributor or law enforcement agency for
disposal? Would your pharmacy consider paying for any costs associated
with this activity? If so, how much would your pharmacy be willing to
pay?
80. Would your individual pharmacy or chain consider contributing
financially to offset the expense of a pharmaceutical disposal program?
If so, what type of program is your pharmacy interested in?
81. What do you believe is the best method to dispose of unwanted
or outdated pharmaceuticals obtained from ultimate users, including
dispensed controlled substances?
82. Has the ability of a pharmacy to receive faxed schedule II
prescriptions for patients enrolled in hospice programs or residing at
long term care facilities helped to reduce the amount of excess
medications?
83. How can the accumulation of unwanted or outdated
pharmaceuticals, including controlled substances, at long term care
facilities and hospice programs be better addressed?
For Narcotic Treatment Programs
84. What are the concerns of narcotic treatment programs regarding
the disposal of controlled substances used in maintenance or
detoxification treatment?
85. Would your narcotic treatment program consider contributing
financially to offset the expense of a pharmaceutical disposal program?
If so, what type of program would best meet your needs?
86. What do you believe is the best method to dispose of unwanted
or outdated dispensed controlled substances?
87. What are the reasons why NTPs are in possession of controlled
substances that require disposal?
88. Have controlled substances awaiting disposal been a source of
diversion for your NTP?
For Reverse Distributors
89. Have you been approached by any group or any law enforcement
agency requesting that you participate in the disposal of
pharmaceuticals, including controlled substances dispensed to ultimate
users?
90. Do you currently accept pharmaceuticals, including dispensed
controlled substances, from ultimate users for disposal? If so, how?
91. Are your competitors accepting pharmaceuticals, including
dispensed controlled substances, from ultimate users for disposal?
92. If you accept pharmaceuticals, including dispensed controlled
substances, from ultimate users for disposal, what have your successes
been?
93. If you accept pharmaceuticals, including dispensed controlled
substances, from ultimate users for disposal, what challenges or
difficulties have you encountered?
94. If you were able to accept pharmaceuticals, including dispensed
controlled substances, from ultimate users for disposal, would your
facility be able to handle this added volume?
95. What does it cost to dispose of controlled substances?
96. What do you estimate it would cost to dispose of controlled
substances dispensed to ultimate users? On what basis are costs
calculated (e.g., per pound disposed of)?
97. Do you currently accept pharmaceuticals from long term care
facilities (LTCFs) for disposal? If so, how?
98. Are your competitors accepting pharmaceuticals from LTCFs for
disposal?
99. If you accept pharmaceuticals from long term care facilities
for disposal, what have your successes been?
100. If you accept pharmaceuticals from long term care facilities
for disposal, what challenges or difficulties have you encountered?
101. If you were able to accept pharmaceuticals, including
dispensed controlled substances, from long term care facilities for
disposal, would your facility be able to handle this added volume?
102. What do you estimate it would cost to dispose of dispensed
controlled substances obtained from long term care facilities? On what
basis are costs calculated (e.g., per pound disposed of)?
103. What do you believe is the best method of disposing of
unwanted or outdated pharmaceuticals, including controlled substances
dispensed to DEA nonregistrants?
104. Would you accept for disposal controlled substances that have
been dispensed to ultimate users directly from ultimate users by means
of individual mailing containers?
105. Do you perceive any problems with reverse distributors
accepting dispensed controlled substances directly from ultimate users
by means of individual mailing containers?
106. Would your company be interested in contributing financially
to offset the expense of a disposal program for ultimate users that
would be instituted at your company?
107. If reverse distributors were permitted to accept controlled
substances dispensed to ultimate users for disposal, how do you believe
the unwanted or outdated controlled substances should be provided by
the ultimate user to the reverse distributor?
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For State Regulatory Agencies
108. What current laws or regulations does your State have
regarding the disposal of dispensed controlled substances and
noncontrolled substances by ultimate users?
109. What laws or regulations, if any, is your State considering
regarding the disposal of dispensed controlled or noncontrolled
substances by ultimate users?
110. Does your State agency participate in any initiatives (e.g.,
take-back or mail-back programs) regarding the disposal of dispensed
controlled and noncontrolled substances by ultimate users at this time?
If so, please describe.
111. Is your State agency aware of any cases of diversion regarding
take-back programs? If so, did the diversion result in the arrest or
prosecution of any individuals?
112. If your State agency does not participate in any initiatives
regarding the disposal of dispensed controlled or noncontrolled
substances by ultimate users, why not?
113. If your State agency participates in any initiatives regarding
the disposal of dispensed controlled and noncontrolled substances by
ultimate users, what would you estimate to be the percentage, quantity,
or other measurable unit of controlled substances as compared to
noncontrolled substances received?
114. If your State agency participates in any initiatives regarding
the disposal of dispensed controlled and noncontrolled substances by
ultimate users, does your agency fund all or part of the initiative? If
other funding is received, who provides the other funding?
115. If your State agency participates in any initiatives regarding
the disposal of dispensed controlled and noncontrolled substances by
ultimate users, what successes have you seen regarding these
initiatives?
116. If your State agency participates in any initiatives regarding
the disposal of dispensed controlled and noncontrolled substances by
ultimate users, what challenges or difficulties have you encountered?
For All Interested Parties
117. DEA also seeks comment from all interested parties regarding
the funding of the disposal of unwanted or outdated controlled
substances held by DEA nonregistrants.
Regulatory Certifications
This action is an Advance Notice of Proposed Rulemaking (ANPRM).
Accordingly, the requirement of Executive Order 12866 to assess the
costs and benefits of this action does not apply. Rather, among the
purposes DEA has in publishing this ANPRM is to seek information from
the public on the costs, benefits, and other impacts pertaining to the
disposal of controlled substances dispensed to ultimate users and long
term care facilities. Similarly, the requirements of section 603 of the
Regulatory Flexibility Act do not apply to this action since, at this
stage, it is an ANPRM and not a ``rule'' as defined in section 601 of
the Regulatory Flexibility Act. Following review of the comments
received to this ANPRM, if DEA promulgates a Notice or Notices of
Proposed Rulemaking regarding this issue, DEA will conduct all analyses
required by the Regulatory Flexibility Act, Executive Order 12866, and
any other statutes or Executive Orders relevant to those rules and in
effect at the time of promulgation.
Dated: January 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E9-1056 Filed 1-16-09; 8:45 am]
BILLING CODE 4410-09-P