[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Rules and Regulations]
[Pages 5188-5192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02319]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-476]


Schedules of Controlled Substances: Temporary Placement of 
Fentanyl-Related Substances in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary amendment; temporary scheduling order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to schedule fentanyl-related 
substances that are not currently listed in any schedule of the 
Controlled Substances Act (CSA) and their isomers, esters, ethers, 
salts and salts of isomers, esters, and ethers in schedule I. This 
action is based on a finding by the Administrator that the placement of 
these synthetic opioids in schedule I 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, reverse distribute, import, export, 
engage in research, conduct instructional activities or chemical 
analysis, or possess), or propose to handle fentanyl-related 
substances.

DATES: This temporary scheduling order is effective February 6, 2018, 
until February 6, 2020. If this order is extended or made permanent, 
the DEA will publish a document in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, 
provides the Attorney General with the authority to temporarily place a 
substance in schedule I of the CSA for two years without regard to the 
requirements of 21 U.S.C. 811(b) if he 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 
permanently are initiated under 21 U.S.C. 811(a)(1) while the substance 
is temporarily controlled under section 811(h), the Attorney General 
may extend the temporary scheduling \1\ for up to one year. 21 U.S.C. 
811(h)(2).
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notification adheres 
to the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
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    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 (FD&C Act), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

The Nature of the Problem and DEA's Approach to Correct It

    It is well known that deaths associated with the abuse of 
substances structurally related to fentanyl \2\ in the United States 
are on the rise and have already reached alarming levels. While a 
number of factors appear to be contributing to this public health 
crisis, chief among the causes is the sharp increase in recent years in 
the availability of illicitly produced, potent substances structurally 
related to fentanyl. Fentanyl is approximately 100 times more potent 
than morphine, and the substances structurally related to fentanyl that 
DEA is temporarily controlling also tend to be potent substances. 
Typically, these substances are manufactured outside the United States 
by clandestine manufacturers and then smuggled into the United States.
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    \2\ As explained further below, in this document, the term 
``fentanyl-related substances'' is defined to include substances 
structurally related to fentanyl but which are not controlled under 
a separate scheduling action (listed under another Administration 
Controlled Substance Code Number). Thus, all ``fentanyl-related 
substances'' are structurally related to fentanyl, but some 
fentanyl-related substances are controlled under separate scheduling 
actions.
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    Fentanyl is often mixed with heroin and other substances (such as 
cocaine and methamphetamine) or used in counterfeit pharmaceutical 
prescription drugs. As a consequence, users who buy these substances on 
the illicit market are often unaware of the specific substance they are 
actually consuming and the associated risk. According to the Centers 
for Disease Control and Prevention (CDC), drug overdose deaths 
involving synthetic opioids (excluding methadone), such as fentanyl and 
tramadol, increased from 5,544 in 2014 to 9,580 in 2015. According to 
provisional data released in August 2017 by the CDC, National Center 
for Health Statistics, an estimated 55 Americans are dying every day 
from overdoses of synthetic opioids (excluding methadone).\3\ Drug 
overdose deaths involving synthetic opioids excluding methadone for the 
12-month period ending in January of 2017 (20,145 deaths) more than 
doubled from the corresponding data for the period ending in January of 
2016 (9,945 deaths).
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    \3\ Provisional synthetic opioid death overdose counts are based 
on CDC data available for analysis as of August 6, 2017, based on 
the 12-month reporting period ending January 2017. See https://www.cdc.gov/nchs/data/health_policy/monthly-drug-overdose-death-estimates.pdf accessed 09-06-2017.
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    DEA has responded to this crisis by issuing eight temporary 
scheduling

[[Page 5189]]

orders to control seventeen substances structurally related to fentanyl 
since 2015. However, this approach has not been completely effective in 
preventing the emergence of new substances structurally related to 
fentanyl. This is because when DEA temporarily controls a given 
substance structurally related to fentanyl, illicit manufacturers 
located abroad begin producing new such substances through other 
structural modifications. Those new nonscheduled substances then are 
smuggled into the United States, where they are distributed by 
traffickers in this country as a purportedly ``noncontrolled'' 
substance.\4\ In this way, traffickers are effectively circumventing 
the temporary control mechanism that Congress established under 21 
U.S.C. 811(h) to combat newly emerging dangerous drugs. Post mortem 
toxicology and medical examiner reports collected by the DEA show 
mortality connected to substances structurally related to fentanyl. 
Control of these substances is necessary to avoid an imminent hazard to 
the public safety.
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    \4\ Such trafficking is actually illegal as persons who do so 
can be prosecuted using the controlled substance analogue provisions 
of the CSA. 21 U.S.C. 802(32), 813. However, prosecution under the 
analogue provisions requires proof of additional elements not 
required for prosecuting trafficking in scheduled substances.
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    Given the gravity of the ongoing fentanyl-related overdose crisis 
in the United States, protection of the public safety demands the 
utilization of 21 U.S.C. 811(h) in a manner that cannot be readily 
circumvented by drug traffickers. Specifically, in issuing this 
temporary scheduling order, DEA exercises its authority to avoid an 
imminent hazard to the public safety by placing fentanyl-related 
substances, as defined later in this document, in schedule I. As 
explained below, these fentanyl-related substances--including those 
that have not yet been introduced by traffickers into the U.S. market--
present a significant risk to the public health and safety and need to 
be controlled under section 811(h) to avoid an imminent hazard to the 
public safety. It should also be noted that none of the substances that 
is being temporarily controlled has a currently accepted medical use in 
treatment in the United States; nor is any of the substances the 
subject of an exemption or approval under section 505 of the FD&C Act. 
In accordance with section 811(h), if any exemption or approval is in 
effect under section 505 of the FD&C Act with respect to a substance 
that falls within the definition of a fentanyl-related substance set 
forth in this document, such substance is excluded from the temporary 
scheduling order.

What Is Controlled Under This Temporary Scheduling Order

    On December 29, 2017, as required by 21 U.S.C. 811(h)(A), the DEA 
Administrator published a notice of intent to issue an order 
temporarily placing fentanyl-related substances in schedule I. 82 FR 
61700. This temporary order places fentanyl-related substances in 
schedule I of the CSA for two years. DEA may extend the temporary 
scheduling for an additional year (a total of three years) if 
proceedings to permanently schedule the substances are pending. As 
defined in the notice of intent, as well as in this temporary order, 
fentanyl-related substances includes any substance not otherwise 
controlled in any schedule (i.e., not included under any other 
Administration Controlled Substance Code Number) that is structurally 
related to fentanyl by one or more of the following modifications:
    (A) Replacement of the phenyl portion of the phenethyl group by any 
monocycle, whether or not further substituted in or on the monocycle;
    (B) substitution in or on the phenethyl group with alkyl, alkenyl, 
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
    (C) substitution in or on the piperidine ring with alkyl, alkenyl, 
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro 
groups;
    (D) replacement of the aniline ring with any aromatic monocycle 
whether or not further substituted in or on the aromatic monocycle; 
and/or
    (E) replacement of the N-propionyl group by another acyl group.

How DEA Will Identify Individual Fentanyl-Related Substances That Fall 
Within This Temporary Scheduling Order

    As indicated, the temporary scheduling order includes all 
substances that fall within the above definition--even if such 
substances have not yet emerged on the illicit market in the United 
States. As a result, DEA cannot currently specify the chemical name of 
every potential substance that might fall under this new definition. 
However, because the definition of fentanyl-related substance describes 
a unique chemical structure, DEA has the authority to under 21 U.S.C. 
811(h) to temporarily schedule this category of substance. In the 
future, if and when DEA identifies a specific new substance that falls 
under the definition, the agency will publish in the Federal Register, 
and on the agency website, the chemical name of such substance. Thus, 
the text of the definition of fentanyl-related substance includes 
language indicating that it ``includes, but is not limited to, the 
following substances:'' It bears emphasis, however, that even in the 
absence of a future publication by DEA specifically identifying such a 
substance, the substance is controlled by virtue of this temporary 
scheduling order if it falls within the definition of fentanyl-related 
substance.

Notification to the Secretary of Health and Human Services

    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 his intention to temporarily place a substance 
in schedule I of the CSA.\5\ On November 6, 2017, the Administrator 
transmitted notice by letter to the Assistant Secretary for Health of 
HHS of his intent to place fentanyl-related substances, unless listed 
in another schedule, in schedule I on a temporary basis. The Assistant 
Secretary responded by letter dated November 29, 2017, and advised that 
based on a review by the Food and Drug Administration (FDA), they are 
not aware of any investigational new drug applications or approved new 
drug applications for fentanyl-related substances as defined above 
under section 505 of the FD&C Act, 21 U.S.C. 355, and that HHS has no 
objection to the temporary placement of these substances in schedule I 
of the CSA. As indicated, in accordance with section 811(h), fentanyl-
related substances are defined under this temporary scheduling order to 
exclude any substance for which an exemption or approval is in effect 
under section 505 of the FD&C Act.
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    \5\ As discussed in a memorandum of understanding entered into 
by 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 Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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Grounds for Temporary Scheduling Order

    To find that placing a substance temporarily in 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 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,

[[Page 5190]]

risk there is to the public health. 21 U.S.C. 811(h)(3). These factors 
include, but are not limited to, actual abuse, diversion from 
legitimate channels, and clandestine importation, manufacture, or 
distribution. Id. DEA has considered these factors for fentanyl-related 
substances, as defined above, and finds that the information is 
consistent across this class of substances. The DEA's three-factor 
analysis is available in its entirety under ``Supporting and Related 
Material'' of the public docket for this action at www.regulations.gov 
under Docket Number DEA-476.
    Substances that are included in the above-listed structural 
modifications and any combination of these structural modifications 
have been found to cause pharmacological effects that are similar to 
those of fentanyl. It therefore is reasonable to expect that all such 
substances, even if they have yet to appear on the illicit market in 
the United States, share the dangerous and potentially lethal 
properties that have caused the recent spike in fentanyl-related 
overdose deaths in the United States. While these substances may not 
yet have appeared in the domestic illicit market, with 21 U.S.C. 
811(h), Congress empowered DEA to act proactively to ``avoid an 
imminent hazard to the public safety'' by scheduling dangerous 
substances on a temporary basis before they adversely impact the public 
safety. Thus, where, as here, DEA has evidence indicating that certain 
substances, due to their chemical structure and resulting 
pharmacological properties, as well as observed patterns of production 
and trafficking of closely related substances, will pose an imminent 
hazard to the public safety in the absence of control in schedule I 
(having considered the relevant factors under 21 U.S.C. 811(h)(3)), DEA 
may issue a temporary order under 21 U.S.C. 811(h). By temporarily 
placing these fentanyl-related substances in schedule I, it is DEA's 
intention to deter the production and introduction of these substances 
into the United States that traffickers might be considering--before 
such activity even begins--thereby avoiding an imminent hazard to the 
public safety. The alternative approach, of only temporarily 
controlling substances that have already appeared in the illicit U.S. 
market, is beneficial but has not eliminated the danger these newly 
created substances pose and is not as effective in preventing future 
deaths and serious injuries associated with these substances. In 
addition, by controlling fentanyl-related substances, the temporary 
scheduling order will facilitate the development of international, 
national, and local prevention strategies that decrease morbidity and 
mortality from overdoses caused by or associated with fentanyl-related 
substances.
    For these reasons, DEA has concluded that issuing a temporary 
scheduling order is necessary to avoid an imminent hazard to the public 
safety.

Schedule I Classification

    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in 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).
    As indicated, DEA finds that the fentanyl-related substances that 
are temporarily controlled by virtue of this order have a high 
potential for abuse. Information provided by the Assistant Secretary of 
HHS indicates that these fentanyl-related substances, as defined, have 
no currently accepted medical use in treatment in the United States and 
lack accepted safety for use under medical supervision.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Administrator issues this temporary scheduling order 
to place fentanyl-related substances in schedule I of the CSA. Because 
the Administrator hereby finds that it is necessary to temporarily 
place fentanyl-related substances in schedule I to avoid an imminent 
hazard to the public safety, this temporary order scheduling these 
substances is effective on the date the order is published in the 
Federal Register, and is in effect for a period of two years. DEA may 
extend the temporary scheduling for an additional year (a total of 
three years) if proceedings to permanently schedule the substances are 
pending. 21 U.S.C. 811(h)(1) and (2).

Requirements for Handling

    Upon the effective date of this temporary order, fentanyl-related 
substances will be subject to the regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, reverse distribution, importation, 
exportation, engagement in research, and conduct of instructional 
activities or chemical analysis with, and possession of schedule I 
controlled substances including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, fentanyl-related substances 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 
February 6, 2018. Any person who currently handles fentanyl-related 
substances, and is not registered with the DEA, must submit an 
application for registration and may not continue to handle fentanyl-
related substances as of February 6, 2018, 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 these substances in a 
manner not authorized by the CSA on or after February 6, 2018 is 
unlawful and those in possession of any quantity of these substances 
may be subject to prosecution pursuant to the CSA.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle fentanyl-related 
substances must surrender all currently held quantities of fentanyl-
related substances.
    3. Security. Fentanyl-related substances are 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 February 6, 2018.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of fentanyl-related substances must be in 
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR 
part 1302. Current DEA registrants shall have 30 calendar days from 
February 6, 2018, to comply with all labeling and packaging 
requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
fentanyl-related substances on the effective date of this order must 
take an inventory of all stocks of these substances on hand, pursuant 
to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 
1304.04, and 1304.11. 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

[[Page 5191]]

substances (including fentanyl-related substances) 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.
    6. Records. All DEA registrants must maintain records with respect 
to fentanyl-related substances pursuant to 21 U.S.C. 827 and 958, and 
in accordance with 21 CFR parts 1304, 1312, and 1317. Current DEA 
registrants shall have 30 calendar days from the effective date of this 
order to be in compliance with all recordkeeping requirements.
    7. Reports. All DEA registrants who manufacture or distribute 
fentanyl-related substances must submit reports pursuant to 21 U.S.C. 
827 and in accordance with 21 CFR parts 1304 and 1312 as of February 6, 
2018.
    8. Order Forms. All DEA registrants who distribute fentanyl-related 
substances must comply with order form requirements pursuant to 21 
U.S.C. 828 and in accordance with 21 CFR part 1305 as of February 6, 
2018.
    9. Importation and Exportation. All importation and exportation of 
fentanyl-related substances must be in compliance with 21 U.S.C. 952, 
953, 957, 958, and in accordance with 21 CFR part 1312 as of February 
6, 2018.
    10. Quota. Only DEA registered manufacturers may manufacture 
fentanyl-related substances in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of 
February 6, 2018.
    11. Liability. Any activity involving fentanyl-related substances 
not authorized by, or in violation of, the CSA, occurring as of 
February 6, 2018, 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 a 
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 of HHS. 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 notice-and-comment requirements 
of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, 
do not apply to this temporary order. In the alternative, even if this 
order were subject to section 553 of the APA, the Administrator would 
find that there is good cause to forgo the notice-and-comment 
requirements of section 553, as any further delays in the process for 
issuance of temporary scheduling orders would be contrary to the public 
interest in view of the urgent need to control fentanyl-related 
substances to avoid an imminent hazard to the public safety.
    Since this temporary scheduling action is not a ``rule'' as defined 
by 5 U.S.C. 601(2), it is not subject to the requirements of the 
Regulatory Flexibility Act (RFA). 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 section 553 
of 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.
    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.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act is inapplicable, as it applies only to 
rules. However, if this were a rule, 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 to 
avoid an imminent hazard to the public safety. 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 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 these substances in schedule I because they pose 
an imminent hazard to the public safety, it would be contrary to the 
public interest to delay implementation of the temporary scheduling 
order. Therefore, this order shall take effect immediately upon its 
publication. The DEA has submitted a copy of this temporary order to 
both Houses of Congress and to the Comptroller General, although such 
filing is not required under the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 
because, as noted above, this action is an order, not a rule.

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), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11, add paragraph (h)(30) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

 
 
 
(30) Fentanyl-related substances, their isomers, esters,            9850
 ethers, salts and salts of isomers, esters and ethers..
 

    (i) Fentanyl-related substance means any substance not otherwise 
listed under another Administration Controlled Substance Code Number, 
and for which no exemption or approval is in effect under section 505 
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is 
structurally

[[Page 5192]]

related to fentanyl by one or more of the following modifications:
    (A) Replacement of the phenyl portion of the phenethyl group by any 
monocycle, whether or not further substituted in or on the monocycle;
    (B) Substitution in or on the phenethyl group with alkyl, alkenyl, 
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
    (C) Substitution in or on the piperidine ring with alkyl, alkenyl, 
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro 
groups;
    (D) Replacement of the aniline ring with any aromatic monocycle 
whether or not further substituted in or on the aromatic monocycle; 
and/or
    (E) Replacement of the N-propionyl group by another acyl group.
    (ii) This definition includes, but is not limited to, the following 
substances:
    (A) [Reserved]
    (B) [Reserved]

    Dated: February 1, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-02319 Filed 2-5-18; 8:45 am]
 BILLING CODE 4410-09-P