Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration, 3480-3487 [E9-1056]
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the proposal, that ‘‘the Commission
believes DCMs benefit from endeavoring
to recruit their public directors from a
broad and culturally diverse pool of
qualified candidates.’’ The purpose of
the acceptable practices is to ‘‘ensure
that there is adequate independence
within [exchange] board[s] to insulate
[their] regulatory functions from the
interests of the exchange’s management,
members and other business interests of
the market itself.’’ 71 FR 38740 (July 7,
2006). It is not clear to me how
recruiting directors from a culturally
diverse pool of candidates advances that
goal, nor is it a given that seating a wellqualified board that is culturally diverse
is something that may be practicably
accomplished. My primary objection,
however, is based on the fact that we
have no legal authority to issue
pronouncements on the subject. We are
not a commission of general
jurisdiction. Our authority and oversight
responsibilities are specifically limited
by statute and do not include the
promotion of equal employment
opportunity. Moreover, to the extent the
Commission may be suggesting that
exchanges consider factors such as race,
gender, national origin, or religion in
selecting public directors, we may be
encouraging activity that could
potentially violate Title VII of the Civil
Rights Act of 1964.
Concurring Statement of Commissioner
Bart Chilton Regarding the Withdrawal
of Previously Proposed Amendments to
the Acceptable Practices for Core
Principle 15 and Solicitation of Public
Comments on New Proposed
Amendments
I concur in the Commission’s issuance
of the above-referenced action. I write
separately, however, to comment on
certain aspects of the proposal of
particular interest to me.
First, I am gratified to see language in
the proposal relating to my longstanding
request that we note to designated
contract markets the benefits of
diversity in recruiting public directors.
While this is, as stated, not a
requirement under the acceptable
practices, it is quite obviously a
laudable and attainable goal, and one
that should be encouraged.
Second, I would ask commenters to
respond specifically as to whether the
Commission has included within the
proposal all appropriate decisionmaking bodies at designated contract
markets, or whether the class should be
broadened to include entities other than
boards of directors, executive
committees or similarly empowered
bodies, regulatory oversight committees,
and disciplinary panels.
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Lastly, I note with some concern the
timeline of this proposal. In November
2007, the Commission stayed the ‘‘final’’
acceptable practices that had been
issued in February 2007. This was a
necessary action, although unfortunate
in that it created further delay in an
already protracted and flawed process.
Even more unfortunate, swift action was
promised on this proposal in December
2007, yet it has taken more than a full
year to see any progress. As public
servants, we can and should do better to
serve American consumers and
businesses.
[FR Doc. E9–891 Filed 1–16–09; 8:45 am]
BILLING CODE 6351–01–P
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.
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
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be sent to DEA by sending an electronic
message to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
https://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
https://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 https://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
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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
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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.
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
1 H.R.
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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
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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:
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(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 nonregistrant (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
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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
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
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. https://www.fda.gov/ora/
compliance_ref/cpg/cpgdrg/cpg460-300.html.
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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
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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
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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,
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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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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 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.
3 Office of National Drug Control Policy,
Executive Office of the President. Proper Disposal
of Prescription Drugs. February 2007. https://
www.whitehousedrugpolicy.gov/publications/pdf/
prescrip_disposal.pdf.
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16:26 Jan 16, 2009
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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
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
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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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 takeback 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
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mstockstill on PROD1PC66 with PROPOSALS
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
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16:26 Jan 16, 2009
Jkt 217001
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?
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3485
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?
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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules
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?
mstockstill on PROD1PC66 with PROPOSALS
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?
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16:26 Jan 16, 2009
Jkt 217001
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
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Fmt 4702
Sfmt 4702
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., takeback 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?
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
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Part 180
Office of the Secretary
49 CFR Part 80
Federal Railroad Administration
49 CFR Part 261
Federal Transit Administration
49 CFR Part 640
Maritime Administration
49 CFR Part 1700
[Docket No. DOT–OST–2009–0004]
mstockstill on PROD1PC66 with PROPOSALS
For All Interested Parties
RIN 2105–AD70
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.
Credit Assistance for Surface
Transportation Projects
Regulatory Certifications
This action is an Advance Notice of
Proposed Rulemaking (ANPRM).
Accordingly, the requirement of
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16:26 Jan 16, 2009
Jkt 217001
AGENCIES: Federal Highway
Administration (FHWA), Federal
Railroad Administration (FRA), Federal
Transit Administration (FTA), Maritime
Administration (MARAD), Office of the
Secretary of Transportation (OST),
Department of Transportation (DOT).
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3487
ACTION: Notice of proposed rulemaking
(NPRM); request for comments.
SUMMARY: Recent changes to the
Transportation Infrastructure Finance
and Innovation Act (TIFIA) statute
require changes in the TIFIA rule. In
addition, the DOT has gained
substantial administrative experience
since the TIFIA rule was last amended
in 2000. The DOT proposes to amend
the TIFIA rule to implement the recent
statutory changes and to incorporate
certain other changes to the rule that it
considers will improve the efficiency of
the program and its usefulness to
borrowers. In addition, the DOT seeks
comment on policy issues with
potentially significant impact on the
TIFIA project selection process.
DATES: Comments must be received on
or before March 23, 2009.
ADDRESSES: Mail or hand deliver
comments to the U.S. Department of
Transportation, Dockets Management
Facility, Room W12–140, 1200 New
Jersey Avenue, SE., Washington, DC
20590, or submit comments
electronically at https://
www.regulations.gov, or fax comments
to (202) 493–2251. Alternatively,
comments may be submitted via the
Federal eRulemaking Portal at https://
www.regulations.gov (follow the on-line
instructions for submitting comments).
All comments should include the
docket number that appears in the
heading of this document. All
comments received will be available for
examination and copying at the above
address from 9 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal
holidays. Those desiring notification of
receipt of comments must include a selfaddressed, stamped postcard or you
may print the acknowledgment page
that appears after submitting comments
electronically. All comments received
into any docket may be searched in
electronic format by the name of the
individual submitting the comment (or
signing the comment, if submitted on
behalf of an association, business, labor
union, etc.). Persons making comments
may review DOT’s complete Privacy Act
Statement in the Federal Register
published on April 11, 2000 (Volume
65, Number 70, Pages 19477–78), or you
may view the statement at https://
dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
Mark Sullivan, TIFIA Joint Program
Office (202) 366–5785, or Mr. Steven
Rochlis, Office of the Chief Counsel
(202) 366–1395, Federal Highway
Administration; Mr. Michael Bouril,
Office of Budget (202) 366–4587, Mr.
Jacob Falk, Office of Policy (202) 366–
E:\FR\FM\21JAP1.SGM
21JAP1
]]>Agencies
[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Proposed Rules]
[Pages 3480-3487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1056]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document
is also available at the https://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 https://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 https://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.
---------------------------------------------------------------------------
\1\ H.R. Rep. No. 91-1444 at 3 (1970).
---------------------------------------------------------------------------
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. https://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:
---------------------------------------------------------------------------
\3\ Office of National Drug Control Policy, Executive Office of
the President. Proper Disposal of Prescription Drugs. February 2007.
https://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
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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
