[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
[Pages 42381-42385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17563]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-413F]
Schedules of Controlled Substances: Temporary Placement of Acetyl
Fentanyl Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this final order to temporarily schedule the synthetic opioid,
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), and
its optical, positional, and geometric isomers, salts and salts of
isomers, into schedule I pursuant to the temporary scheduling
provisions of the Controlled Substances Act. This action is based on a
finding by the Administrator that the placement of this opioid
substance into schedule I of the Controlled Substances Act is necessary
to avoid an imminent hazard to the public safety. As a result of this
order, the regulatory controls and administrative, civil, and criminal
sanctions applicable to schedule I controlled substances will be
imposed on persons who handle (manufacture, distribute, import, export,
engage in research, or possess), or propose to handle, acetyl fentanyl.
DATES: This final order is effective on July 17, 2015.
FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of
Diversion Control, Drug Enforcement Administration; Mailing Address:
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202)
598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. Titles II and III are referred to as
the ``Controlled Substances Act'' and the ``Controlled Substances
Import and Export Act,'' respectively, and are collectively referred to
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of
this action. 21 U.S.C. 801-971. The DEA publishes the implementing
regulations for these statutes in title 21 of the Code of Federal
Regulations (CFR), chapter II. The CSA and its implementing regulations
are designed to prevent, detect, and eliminate the diversion of
controlled substances and listed chemicals into the illicit market
while ensuring an adequate supply is available for the legitimate
medical, scientific, research, and industrial needs of the United
States. Controlled substances have the potential for abuse and
dependence and are controlled to protect the public health and safety.
Under the CSA, every controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the drug or other substance may cause. 21 U.S.C. 812. The
initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled
substances is published at 21 CFR part 1308.
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a
[[Page 42382]]
substance into schedule I of the CSA for two years without regard to
the requirements of 21 U.S.C. 811(b) if she finds that such action is
necessary to avoid an imminent hazard to the public safety. 21 U.S.C.
811(h)(1). In addition, if proceedings to control a substance are
initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend
the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has delegated her scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Background
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of the Administrator's intention to temporarily
place a substance into schedule I of the CSA.\1\ The Administrator
transmitted the notice of intent to place acetyl fentanyl into schedule
I on a temporary basis to the Assistant Secretary by letter dated April
7, 2015. The Assistant Secretary responded to this notice by letter
dated April 29, 2015 (received by the DEA on May 05, 2015), and advised
that based on review by the FDA, there are currently no investigational
new drug applications or approved new drug applications for acetyl
fentanyl. The Assistant Secretary also stated that the HHS has no
objection to the temporary placement of acetyl fentanyl into schedule I
of the CSA. The DEA has taken into consideration the Assistant
Secretary's comments as required by 21 U.S.C. 811(h)(4). Acetyl
fentanyl is not currently listed in any schedule under the CSA, and no
exemptions or approvals are in effect for acetyl fentanyl under section
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the scheduling
of acetyl fentanyl in schedule I on a temporary basis is necessary to
avoid an imminent hazard to public safety, and as required by 21 U.S.C.
811(h)(1)(A), a notice of intent to temporarily schedule acetyl
fentanyl was published in the Federal Register on May 21, 2015. 80 FR
29227.
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\1\ Because the Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the authority to make
domestic drug scheduling recommendations, for purposes of this final
order, all subsequent references to ``Secretary'' have been replaced
with ``Assistant Secretary.'' As set forth in a memorandum of
understanding entered into by HHS, the Food and Drug Administration
(FDA), and the National Institute on Drug Abuse (NIDA), the FDA acts
as the lead agency within the HHS in carrying out the Assistant
Secretary's scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
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To find that placing a substance temporarily into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to consider three of the eight factors set
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): the substance's
history and current pattern of abuse; the scope, duration and
significance of abuse; and what, if any, risk there is to the public
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes
actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary
scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1).
Substances in schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1). Available data and information for
acetyl fentanyl, summarized below, indicate that this synthetic opioid
has a high potential for abuse, no currently accepted medical use in
treatment in the United States, and a lack of accepted safety for use
under medical supervision. The DEA analysis is available in its
entirety under the tab ``Supporting and Related Material'' of the
public docket of this action at www.regulations.gov under Docket Number
DEA-413F.
Factor 4. History and Current Pattern of Abuse
Clandestinely produced substances structurally related to the
schedule II opioid analgesic fentanyl were trafficked and abused on the
West Coast in the late 1970s and 1980s. These clandestinely produced
fentanyl-like substances were commonly known as designer drugs, and
recently, there has been a reemergence in the trafficking and abuse of
designer drug substances, including fentanyl-like substances. Alpha-
methylfentanyl, the first fentanyl analogue identified in California,
was placed into schedule I of the CSA in September 1981. Following the
control of alpha-methylfentanyl, the DEA identified several other
fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-methylfentanyl,
beta-hydroxy-3-methylfentanyl, alpha-methylthiofentanyl, thiofentanyl,
beta-hydroxyfentanyl, para-fluorofentanyl and 3-methylfentanyl) in
submissions to forensic laboratories. These substances were temporarily
controlled under schedule I of the CSA after finding that they posed an
imminent hazard to public safety and were subsequently permanently
placed into schedule I of the CSA.
The National Forensic Laboratory Information System (NFLIS) is a
national drug forensic laboratory reporting system that systematically
collects results from drug chemistry analyses conducted by State and
local forensic laboratories across the country. The first laboratory
submission of acetyl fentanyl was recorded in Maine in April 2013
according to NFLIS. NFLIS registered eight reports containing acetyl
fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports
in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio,
Oregon, Pennsylvania, and Virginia.
The System to Retrieve Information from Drug Evidence (STRIDE) is a
database of drug exhibits sent to DEA laboratories for analysis.
Exhibits from this database are from the DEA, other Federal agencies,
and some local law enforcement agencies. Acetyl fentanyl was first
reported to STRIDE in September 2013 from exhibits obtained through a
controlled purchase in Louisiana. In October 2013, an exhibit collected
from a controlled purchase of suspected oxycodone tablets in Rhode
Island contained acetyl fentanyl as the primary substance. In 2014,
STARLiMS (a Web-based, commercial laboratory information management
system that is in transition to replace STRIDE) and STRIDE reported
eight additional seizures in Colorado, Florida, Georgia, and
Washington.
In August 2013, the Centers for Disease Control and Prevention
published an article in its Morbidity and Mortality Weekly Report
documenting a series of 14 fatalities related to acetyl fentanyl that
occurred between March and May 2013. In December 2013, another fatality
associated with acetyl fentanyl was reported in Rhode Island for a
total of 15 fatalities. In February 2014, the North Carolina Department
of Health and Human Services issued a health advisory related to acetyl
fentanyl following at least three deaths related to this synthetic
drug. Toxicologists at the North Carolina Office of the Chief Medical
Examiner detected acetyl fentanyl in specimens associated with deaths
that occurred in January 2014 in Sampson, Person, and
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Transylvania counties. In July and August 2014, four additional
fatalities involving acetyl fentanyl were reported for a total of seven
fatalities in North Carolina. Deaths involving acetyl fentanyl have
also been reported in California (1), Louisiana (14), Oregon (1) and
Pennsylvania (1).
A significant seizure of acetyl fentanyl occurred in April 2013
during a law enforcement investigation in Montreal, Canada.
Approximately three kilograms of acetyl fentanyl in powder form and
approximately 11,000 tablets containing acetyl fentanyl were seized.
Given that a typical dose of acetyl fentanyl is in the microgram range,
a three kilogram quantity could potentially produce millions of dosage
units. In the United States, tablets that mimic pharmaceutical opioid
products have been reported in multiple states, including Colorado,
Florida, Georgia, Rhode Island, and Washington. Recent reports indicate
that acetyl fentanyl in powder form is available over the Internet and
has been imported to addresses within the United States.
Evidence also suggests that the pattern of abuse of fentanyl
analogues, including acetyl fentanyl, parallels that of heroin and
prescription opioid analgesics. For example, seizures of acetyl
fentanyl have been encountered both in powder and in tablet form. It is
also known to have caused many fatal overdoses, in which intravenous
routes of administration and histories of drug abuse are documented.
Factor 5. Scope, Duration and Significance of Abuse
The DEA is currently aware of at least 39 fatalities associated
with acetyl fentanyl. These deaths occurred in 2013 and 2014 from six
states including California, Louisiana, North Carolina, Oregon,
Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases
capturing drug evidence information from DEA forensic laboratories,
have a total of 10 drug reports in which acetyl fentanyl was identified
in six cases for analyzed drugs submitted from January 2010--December
2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and
Washington. It is likely that the prevalence of acetyl fentanyl in
opioid analgesic-related emergency room admissions and deaths is
underreported since standard immunoassays cannot differentiate acetyl
fentanyl from fentanyl.
The population likely to abuse acetyl fentanyl overlaps with the
populations abusing prescription opioid analgesics and heroin. This is
evidenced by the routes of administration and drug use history
documented in acetyl fentanyl fatal overdose cases. Because abusers of
acetyl fentanyl are likely to obtain the drug through illicit sources,
the identity, purity, and quantity is uncertain and inconsistent, thus
posing significant adverse health risks to its abusers. This risk is
particularly heightened by the fact that acetyl fentanyl is a highly
potent opioid (15.7 fold more potent than that of morphine as tested in
mice using an acetic acid writhing method). Thus small changes in the
amount and purity of the substance could potentially lead to overdose
and death.
Factor 6. What, if Any, Risk There Is to the Public Health
Acetyl fentanyl exhibits a pharmacological profile similar to that
of fentanyl and other opioid analgesic compounds, and it is a potent
opioid analgesic reported to be 1/3 as potent as fentanyl and 15.7
times as potent as morphine in mice tested in an acetic acid writhing
method. In addition, studies also showed that the range between the
effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is
narrower than that of morphine and fentanyl, increasing the risk of
fatal overdose. Thus, its abuse is likely to pose quantitatively
greater risks to the public health and safety than abuse of traditional
opioid analgesics such as morphine.
Based on the above pharmacological data, the abuse of acetyl
fentanyl at least leads to the same qualitative public health risks as
heroin, fentanyl, and other opioid analgesic compounds. The public
health risks attendant to the abuse of heroin and opioid analgesics are
well established. The abuse of opioid analgesics has resulted in large
numbers of drug treatment admissions, emergency department visits, and
fatal overdoses.
Acetyl fentanyl has been associated with numerous fatalities. At
least 39 overdose deaths due to acetyl fentanyl abuse have been
reported in six states in 2013 and 2014, California, Louisiana, North
Carolina, Oregon, Pennsylvania, and Rhode Island. This indicates that
acetyl fentanyl poses an imminent hazard to public safety.
Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety
Based on the data and information summarized above, the continued
uncontrolled manufacture, distribution, importation, exportation, and
abuse of acetyl fentanyl poses an imminent hazard to the public safety.
The DEA is not aware of any currently accepted medical uses for this
substance in the United States. A substance meeting the statutory
requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be
placed into schedule I. Substances in schedule I are those that have a
high potential for abuse, no currently accepted medical use in
treatment in the United States, and a lack of accepted safety for use
under medical supervision. Available data and information for acetyl
fentanyl indicate that this substance has a high potential for abuse,
no currently accepted medical use in treatment in the United States,
and a lack of accepted safety for use under medical supervision. As
required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the
Administrator, through a letter dated April 7, 2015, notified the
Assistant Secretary of the DEA's intention to temporarily place this
substance into schedule I.
Conclusion
In accordance with the provisions of section 201(h) of the CSA, 21
U.S.C. 811(h), the Administrator considered available data and
information, herein sets forth the grounds for his determination that
it is necessary to temporarily schedule N-(1-phenethylpiperidin-4-yl)-
N-phenylacetamide (acetyl fentanyl), into schedule I of the CSA, and
finds that placement of this synthetic opioid into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety.
Because the Administrator hereby finds it necessary to temporarily
place this synthetic opioid into schedule I to avoid an imminent hazard
to the public safety, this final order temporarily scheduling acetyl
fentanyl will be effective on the date of publication in the Federal
Register, and will be in effect for a period of two years, with a
possible extension of one additional year, pending completion of the
regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).
The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done ``on the record
after opportunity for a hearing'' conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
of formal rulemaking affords interested parties with appropriate
process and the government with any additional relevant information
needed to make a determination. Final decisions that conclude the
regular scheduling process of formal rulemaking are subject to judicial
review. 21 U.S.C. 877. Temporary
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scheduling orders are not subject to judicial review. 21 U.S.C.
811(h)(6).
Requirements for Handling
Upon the effective date of this final order, acetyl fentanyl will
become subject to the regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
importation, exportation, research, conduct of instructional
activities, and possession of schedule I controlled substances
including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research, conducts instructional
activities with, or possesses), or who desires to handle, acetyl
fentanyl must be registered with the DEA to conduct such activities
pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21
CFR parts 1301 and 1312, as of July 17, 2015. Any person who currently
handles acetyl fentanyl, and is not registered with the DEA, must
submit an application for registration and may not continue to handle
acetyl fentanyl as of July 17, 2015, unless the DEA has approved that
application for registration pursuant to 21 U.S.C. 822, 823, 957, 958,
and in accordance with 21 CFR parts 1301 and 1312. Retail sales of
schedule I controlled substances to the general public are not allowed
under the CSA. Possession of any quantity of this substance in a manner
not authorized by the CSA on or after July 17, 2015 is unlawful and
those in possession of any quantity of this substance may be subject to
prosecution pursuant to the CSA.
2. Security. Acetyl fentanyl is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821,
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of July
17, 2015.
3. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of acetyl fentanyl must be in compliance with 21
U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of
July 17, 2015. Current DEA registrants shall have 30 calendar days from
July 17, 2015, to comply with all labeling and packaging requirements.
4. Inventory. Every DEA registrant who possesses any quantity of
acetyl fentanyl on the effective date of this order must take an
inventory of all stocks of this substance on hand as of July 17, 2015,
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11(a) and (d). Current DEA registrants shall
have 30 calendar days from the effective date of this order to be in
compliance with all inventory requirements. After the initial
inventory, every DEA registrant must take an inventory of all
controlled substances (including acetyl fentanyl) on hand on a biennial
basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
5. Records. All DEA registrants must maintain records with respect
to acetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance
with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. Current DEA
registrants authorized to handle acetyl fentanyl shall have 30 calendar
days from the effective date of this order to be in compliance with all
recordkeeping requirements.
6. Reports. All DEA registrants who manufacture or distribute
acetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015.
7. Order Forms. All DEA registrants who distribute acetyl fentanyl
must comply with order form requirements pursuant to 21 U.S.C. 828 and
in accordance with 21 CFR part 1305 as of July 17, 2015.
8. Importation and Exportation. All importation and exportation of
acetyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957,
958, and in accordance with 21 CFR part 1312 as of July 17, 2015.
9. Quota. Only DEA registered manufacturers may manufacture acetyl
fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826
and in accordance with 21 CFR part 1303 as of July 17, 2015.
10. Liability. Any activity involving acetyl fentanyl not
authorized by, or in violation of the CSA, occurring as of July 17,
2015, is unlawful, and may subject the person to administrative, civil,
and/or criminal sanctions.
Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety. As provided in this
subsection, the Attorney General may, by order, schedule a substance in
schedule I on a temporary basis. Such an order may not be issued before
the expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention to issue such order and the grounds
upon which such order is to be issued, and (2) the date that notice of
the proposed temporary scheduling order is transmitted to the Assistant
Secretary. 21 U.S.C. 811(h)(1).
Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of the Administrative Procedure Act (APA) at 5
U.S.C. 553, do not apply to this temporary scheduling action. In the
alternative, even assuming that this action might be subject to 5
U.S.C. 553, the Administrator finds that there is good cause to forgo
the notice and comment requirements of 5 U.S.C. 553, as any further
delays in the process for issuance of temporary scheduling orders would
be impracticable and contrary to the public interest in view of the
manifest urgency to avoid an imminent hazard to the public safety.
Further, the DEA believes that this temporary scheduling action
final order is not a ``rule'' as defined by 5 U.S.C. 601(2), and,
accordingly, is not subject to the requirements of the Regulatory
Flexibility Act. The requirements for the preparation of an initial
regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable
where, as here, the DEA is not required by the APA or any other law to
publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).
This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
Pursuant to the Congressional Review Act, ``any rule for which an
agency for good cause finds . . . that notice and public procedure
thereon are impracticable, unnecessary, or contrary to the public
interest, shall take effect at such time as the Federal agency
promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the
public interest to schedule these substances immediately because they
pose a public health risk. This temporary scheduling action is taken
pursuant to 21 U.S.C. 811(h), which is specifically designed to enable
the DEA to act in an expeditious manner to avoid an imminent hazard to
the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling
order
[[Page 42385]]
from standard notice and comment rulemaking procedures to ensure that
the process moves swiftly. For the same reasons that underlie 21 U.S.C.
811(h), that is, the DEA's need to move quickly to place this substance
into schedule I because it poses an imminent hazard to public safety,
it would be contrary to the public interest to delay implementation of
the temporary scheduling order. Therefore, in accordance with 5 U.S.C.
808(2), this order shall take effect immediately upon its publication.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, the DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. Amend Sec. 1308.11 by adding paragraph (h)(24) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(24) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its (9821).
optical, positional, and geometric isomers, salts and
salts of isomers (Other names: acetyl fentanyl)...........
* * * * *
Dated: July 13, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-17563 Filed 7-16-15; 8:45 am]
BILLING CODE 4410-09-P