[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Rules and Regulations]
[Pages 70717-70721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25206]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-477]


Schedules of Controlled Substances: Placement of Zipeprol in 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places zipeprol (chemical name: 1-methoxy-3-[4-(2-
methoxy-2-phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol), including 
its isomers, esters, ethers, salts, and salts of isomers, esters and 
ethers, whenever the existence of such isomers, esters, ethers and 
salts is possible within the specific chemical designation, in schedule 
I of the Controlled Substances Act. This action is being taken to 
enable the United States to meet its obligations under the 1971 
Convention on Psychotropic Substances. This action imposes the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule I controlled substances on persons who handle 
(manufacture, distribute, import, export, engage in research, conduct 
instructional activities or chemical analysis with, or possess), or 
propose to handle zipeprol.

DATES: Effective December 21, 2022.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and 
Chemical Evaluation Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The United States is a party to the 1971 United Nations Convention 
on Psychotropic Substances (1971 Convention), February 21, 1971, 32 
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting 
changes in drug schedules under the 1971 Convention are governed 
domestically by 21 U.S.C. 811(d)(2)-(4). When the United States 
receives notification of a scheduling decision pursuant to Article 2 of 
the 1971 Convention adding a drug or other substance to a specific 
schedule, the Secretary of the Department of Health and Human Services 
(HHS),\1\ after consultation with the Attorney General, shall first 
determine whether existing legal controls under subchapter I of the 
Controlled Substances Act (CSA) and the Federal Food, Drug, and 
Cosmetic Act meet the requirements of the schedule specified in the 
notification with respect to the specific drug or substance.\2\ Based 
on those

[[Page 70718]]

determinations, as appropriate, the Secretary of HHS (Secretary) shall 
recommend to the Attorney General that he initiate proceedings for 
scheduling the drug or substance pursuant to 21 U.S.C. 811(a) and 
(b).\3\ The CSA also stipulates that in certain circumstances where the 
permanent section 811(a) scheduling will not be completed in time as 
required by the 1971 Convention, the Attorney General shall, after 
satisfying other specified conditions, issue a temporary order 
controlling the drug or substance under schedule IV or V, whichever is 
most appropriate to carry out the minimum United States obligations 
under the 1971 Convention.\4\
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in 
carrying out the Secretary's scheduling responsibilities under the 
CSA, with the concurrence of NIDA. 50 FR 9518 (March 8, 1985). The 
Secretary of HHS has delegated to the Assistant Secretary for Health 
of HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460 (July 1, 1993).
    \2\ 21 U.S.C. 811(d)(3).
    \3\ Id.
    \4\ 21 U.S.C. 811(d)(4)(A).
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    In the event that the Secretary did not so consult with the 
Attorney General to make a determination about the existing legal 
controls, and the Attorney General did not issue a temporary order, the 
procedures for permanent scheduling are set forth in 21 U.S.C. 811(a) 
and (b). Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by 
rule, add to such a schedule or transfer between such schedules any 
drug or other substance, if he finds that such drug or other substance 
has a potential for abuse, and makes with respect to such drug or other 
substance the findings prescribed by 21 U.S.C. 812(b) for the schedule 
in which such drug or other substance is to be placed. The Attorney 
General has delegated this scheduling authority to the Administrator of 
the Drug Enforcement Administration (Administrator).\5\
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    \5\ 28 CFR 0.100.
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Background

    Zipeprol (chemical name: 1-methoxy-3-[4-(2-methoxy-2-
phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol) is pharmacologically 
an opioid drug with some hallucinogenic properties that has no approved 
medical use in the United States.
    In March 1995, the United Nations Commission on Narcotic Drugs, on 
the advice of the Director-General of the World Health Organization, 
placed zipeprol in Schedule II of the 1971 Convention, thus notifying 
all parties to the 1971 Convention.

DEA and HHS Eight Factor Analyses

    On May 20, 2013, in accordance with 21 U.S.C. 811(b), and in 
response to the Drug Enforcement Administration's (DEA) August 3, 2009 
request, HHS provided to DEA a scientific and medical evaluation and a 
scheduling recommendation for zipeprol. DEA subsequently reviewed HHS' 
evaluation and recommendation for schedule I placement and all other 
relevant data, and conducted its own analysis under the eight factors 
stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 812(b)(1), 
that this substance warrants control in schedule I. Both DEA and HHS 
analyses are available in their entirety under ``Supporting and Related 
Material'' of the public docket for this rule at http://www.regulations.gov under docket number DEA-477.

Notice of Proposed Rulemaking To Schedule Zipeprol

    On May 14, 2020, DEA published a notice of proposed rulemaking 
(NPRM) entitled ``Schedules of Controlled Substances: Placement of 
zipeprol in schedule I.'' \6\ The NPRM provided an opportunity for 
interested persons to file a request for a hearing in accordance with 
DEA regulations on or before June 15, 2020. No requests for such a 
hearing were received by DEA. The NPRM also provided an opportunity for 
interested persons to submit comments on the proposed rule on or before 
July 13, 2020.
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    \6\ 85 FR 28899.
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Comments Received

    DEA received eight comments on the proposed rule to control 
zipeprol in schedule I of the CSA.

Support for Rulemaking

    Comments: Three commenters recognized zipeprol's high potential for 
abuse and adverse health effects, including reports of hallucinations, 
seizures, overdoses, and deaths. Thus, these commenters supported the 
placement of zipeprol in schedule I.
    DEA Response: DEA appreciates these comments in support of this 
rulemaking.

Dissent for Rulemaking

    Five commenters opposed the placement of zipeprol in schedule I, 
and provided various reasons as discussed below.
    Comment: One commenter contended that it is not appropriate for DEA 
to schedule zipeprol as health experts, not law enforcement, should 
regulate and oversee all schedules I through III substances, and 
specifically that the Secretary of HHS is responsible for adding new 
substance to the CSA schedules.
    DEA Response: DEA disagrees. Congress through the enactment of the 
CSA provided specific roles and procedures for both law enforcement 
(DEA) and the medical community (HHS) in controlled drugs with 
potential for abuse.\7\ These procedures were followed in promulgating 
this final rule.
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    \7\ 21 U.S.C. 811(a) and (b).
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    Comment: One commenter stated that all drugs need to be deregulated 
and decriminalized, and the focus of the law enforcement should be 
directed towards addressing social and non-drug related public health 
matters such as violent crime, unsolved murders, and control of 
obesity.
    DEA Response: This comment is outside the scope of this rule 
insofar as it addresses drugs other than zipeprol. Regarding zipeprol, 
however, DEA maintains that control of zipeprol is needed and is 
appropriate. As stated in the background section, zipeprol is an opioid 
drug with some hallucinogenic properties that has no approved medical 
use in the United States.
    In March 1995, the United Nations Commission on Narcotic Drugs, on 
the advice of the Director-General of the World Health Organization, 
placed zipeprol in Schedule II of the 1971 Convention, thus notifying 
all parties to the 1971 Convention. As a party to the 1971 Convention, 
the United States is taking action to place appropriate controls on 
zipeprol by scheduling it under the CSA.
    Comment: One of two commenters mistakenly believe that zipeprol is 
a schedule II controlled substance under the CSA and that the proposed 
rule would reclassify zipeprol from schedule II to schedule I. The 
first commenter stated that reclassifying zipeprol to schedule I 
control does not warrant priority as it is not currently being used in 
the United States nor is it being actively manufactured or used in 
other countries, and there is a need for reclassification of many other 
drugs. This commenter added that marijuana needs to be reclassified 
from its current schedule I control.
    DEA Response: DEA emphasizes to these commenters that zipeprol is 
not currently scheduled under the CSA. Perhaps the commenters are 
thinking of zipeprol's control status under the 1971 Convention. As 
noted in the background section, the Committee on Narcotic Drugs added 
zipeprol to Schedule II of the 1971 Convention in March 1995. DEA 
further notes that classification of a drug under the 1971 Convention, 
and its relevant schedules, is different from that of the CSA.\8\
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    \8\ The CSA has five schedules (schedules I-V) with specific 
criteria set forth for each schedule. Schedule I is the only 
possible schedule in which a drug or other substance may be placed 
if it has high potential for abuse and no currently accepted medical 
use in treatment in the United States. See 21 U.S.C. 812(b). In 
contrast, the 1971 Convention has four schedules (Schedules I-IV) 
but does not have specific criteria for each schedule. The 1971 
Convention simply defines its four schedules, in Article 1, to mean 
the correspondingly numbered lists of psychotropic substances 
annexed to the Convention, and altered in accordance with Article 2.

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[[Page 70719]]

    Regarding the comment about reclassifying marijuana, this current 
rulemaking pertains only to the scheduling of zipeprol. Therefore, this 
comment is outside the scope of this rule.
    Comment: A commenter noted that zipeprol and dextromethorphan (DXM, 
unscheduled under the CSA) are both cough suppressants with potential 
for abuse; however, adding control of DXM should take priority over 
reclassifying control of zipeprol as DXM is available and ``wildly 
abused'' in the United States.
    DEA Response: This current rulemaking pertains only to the 
scheduling of zipeprol. Therefore, this comment is outside the scope of 
this rule.
    Comment: One commenter recognized zipeprol's high potential for 
abuse and dependence but expressed that zipeprol has an accepted 
medical use as a cough suppressant. The commenter noted that schedule 
I, by definition, is only for drugs with both no accepted medical use 
and a high potential for abuse. Therefore, the commenter contends that 
zipeprol should instead be placed in schedule II.
    DEA Response: DEA does not agree. While zipeprol was previously 
marketed and used in other countries in the 1980s and 1990s as a cough 
suppressant (antitussive), hallucinations, convulsions, and opioid-like 
tolerance, along with both a psychological and physical dependence, 
have been reported following its ingestion. As discussed in HHS's 
eight-factor analysis, zipeprol is not approved by the Food and Drug 
Administration for use in the United States. As explained in the NPRM, 
the medical and scientific evaluation and scheduling recommendation 
issued by the Assistant Secretary for Health of HHS (Assistant 
Secretary for HHS) concludes that zipeprol has no currently accepted 
medical use in treatment in the United States, has high potential for 
abuse, and lacks accepted safety for use under medical supervision. 
Following DEA's proposed determination to place zipeprol in schedule I, 
as outlined in the NPRM, the Administrator maintains the 
appropriateness of that schedule placement and concludes that zipeprol 
warrants control in schedule I of the CSA.\9\ Further, regarding the 
appropriateness of placing zipeprol in schedule I of the CSA, DEA notes 
that Article 2, paragraph 7(b), of the 1971 Convention sets forth the 
minimum requirements that the United States must meet when a substance 
has been added to Schedule II of the 1971 Convention. As a party to the 
1971 Convention, the United States is taking action to place 
appropriate controls on zipeprol by scheduling it under the CSA.
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    \9\ 21 U.S.C. 812(b)(1).
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    DEA conducted an eight-factor analysis pursuant to 21 U.S.C. 811(c) 
and based its scheduling determination on a comprehensive evaluation of 
all available data. As stated in the NPRM, after careful review of all 
relevant data, DEA concurred with HHS' assessment that zipeprol has a 
high potential for abuse with no currently accepted medical use in 
treatment the United States and lacks accepted safety for use under 
medical supervision. Congress established only one schedule, schedule 
I, for drugs of abuse with ``no currently accepted medical use in 
treatment in the United States'' and ``lack of accepted safety for use 
under medical supervision.'' \10\ The other four schedules require the 
drug or other substance to have a currently accepted medical use in 
treatment in the United States or a currently accepted medical use with 
severe restrictions (schedule II) or a currently accepted medical use 
in treatment in the United States (schedules III through V).\11\ DEA is 
therefore promulgating this final rule placing zipeprol in schedule I 
under the CSA.
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    \10\ 21 U.S.C. 812(b).
    \11\ Id.
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Scheduling Conclusion

    After consideration of the public comments, the scientific and 
medical evaluation and accompanying recommendation of HHS, and 
conducting an independent eight-factor analysis, DEA finds substantial 
evidence of potential for abuse of zipeprol. As such, DEA is 
permanently scheduling zipeprol as a controlled substance under the 
CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V.\12\ The CSA also outlines the 
findings required to place a drug or other substance in any particular 
schedule.\13\ After consideration of the analysis and recommendation of 
the Assistant Secretary for HHS and review of all other available data, 
the Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds 
that:
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    \12\ 21 U.S.C. 812(a).
    \13\ 21 U.S.C. 812(b).
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    (1) Zipeprol has a high potential for abuse. This potential is 
comparable to certain schedule II substances (e.g., morphine);
    (2) Zipeprol has no currently accepted medical use in treatment in 
the United States; \14\ and
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    \14\ Although there is no evidence suggesting that zipeprol has 
a currently accepted medical use in treatment in the United States, 
it bears noting that a drug cannot be found to have such medical use 
unless DEA concludes that it satisfies a five-part test. 
Specifically, with respect to a drug that has not been approved by 
FDA, to have a currently accepted medical use in treatment in the 
United States, all of the following must be demonstrated: i. the 
drug's chemistry must be known and reproducible; ii. there must be 
adequate safety studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug must be accepted 
by qualified experts; and v. the scientific evidence must be widely 
available. 57 FR 10499 (1992), pet. for rev. denied, Alliance for 
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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    (3) There is a lack of accepted safety for use of zipeprol under 
medical supervision.
    Based on these findings, the Administrator concludes that zipeprol, 
including its isomers, esters, ethers, salts, and salts of isomers, 
esters and ethers, whenever the existence of such isomers, esters, 
ethers and salts is possible within the specific chemical designation, 
warrants control in schedule I of the CSA.\15\
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    \15\ 21 U.S.C. 812(b)(1).
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Requirements for Handling Zipeprol

    Effective as of December 21, 2022, zipeprol will be subject to the 
CSA's schedule I regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, 
dispensing, importing, exporting, research, and conduct of 
instructional activities, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, or conducts instructional 
activities or chemical analysis with, or possesses) zipeprol, or who 
desires to handle zipeprol, must be registered with 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. Any person who handles 
zipeprol and is not registered with DEA must submit an application for 
registration and may not continue to handle zipeprol after the 
effective date of this rule, unless DEA has approved that application, 
pursuant to 21 U.S.C.

[[Page 70720]]

822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 
1312.
    2. Disposal of stocks. Any person unwilling or unable to obtain a 
schedule I registration must surrender all quantities of zipeprol as of 
the effective date of this rule, or may transfer all such quantities of 
currently held zipeprol to a person registered with DEA. Zipeprol is 
required to be disposed of in accordance with 21 CFR part 1317, in 
addition to all other applicable Federal, State, local, and tribal 
laws.
    3. Security. Zipeprol is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821 
and 823 and in accordance with 21 CFR parts 1301.71-1301.76. Non-
practitioners handling zipeprol must also comply with the employee 
screening requirements of 21 CFR parts 1301.90-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of zipeprol must comply with 21 U.S.C. 825, and 
be in accordance with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture zipeprol in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303.
    6. Inventory. Every DEA registrant who possesses any quantity of 
zipeprol must take an inventory of zipeprol on hand pursuant to 21 
U.S.C. 827 and in accordance with 21 CFR parts 1304.03, 1304.04, and 
1304.11(a) and (d).
    Any person who registers with DEA must take an initial inventory of 
all stocks of controlled substances (including zipeprol) on hand on the 
date the registrant first engages in the handling of controlled 
substances, pursuant to 21 U.S.C. 827, 958, and in accordance with 21 
CFR parts 1304.03, 1304.04, and 1304.11(a) and (b).
    After the initial inventory, every DEA registrant must take an 
inventory of all controlled substances (including zipeprol) on hand 
every two years, pursuant to 21 U.S.C. 827, and in accordance with 21 
CFR parts 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to zipeprol, pursuant to 21 U.S.C. 827, 
and in accordance with 21 CFR 1301.74(b) and (c), 1301.76(b), and parts 
1304, 1312, and 1317. Manufacturers and distributors must submit 
reports regarding zipeprol to the Automation of Reports and 
Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance 
with 21 CFR parts 1304 and 1312.
    8. Order Forms. Every DEA registrant who distributes or orders 
zipeprol must comply with the order form requirements, pursuant to 21 
U.S.C. 828 and in accordance with 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
zipeprol must comply with 21 U.S.C. 952, 953, 957, and 958, and in 
accordance with 21 CFR part 1312.
    10. Liability. Any activity involving zipeprol not authorized by, 
or in violation of, the CSA or its implementing regulations, is 
unlawful, and may subject the person to administrative, civil, and/or 
criminal sanctions.

Regulatory Analyses

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    In accordance with 21 U.S.C. 811(a), this final scheduling action 
is subject to formal rulemaking procedures performed ``on the record 
after opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget (OMB) pursuant to section 
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed 
in E.O. 13563.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The rule does not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act, 5 U.S.C. 601-612, has reviewed this final rule and by approving it 
certifies that it will not have a significant economic impact on a 
substantial number of small entities.
    DEA is placing the substance zipeprol, including its isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, 
whenever the existence of such isomers, esters, ethers and salts is 
possible within the specific chemical designation, in schedule I of the 
CSA. This action is being taken to enable the United States to meet its 
obligations under the 1971 Convention. This action imposes the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule I controlled substances on persons who handle 
(manufacture, distribute, reverse distribute, import, export, engage in 
research, conduct instructional activities or chemical analysis with, 
or possess), or propose to handle zipeprol.
    Based on the review of HHS' scientific and medical evaluation and 
all other relevant data, DEA determined that zipeprol has a high 
potential for abuse, has no currently accepted medical use in treatment 
in the United States, and lacks accepted safety for use under medical 
supervision. DEA's research confirms that there is no legitimate 
commercial market for zipeprol in the United States. Therefore, DEA 
estimates that no United States entity currently handles zipeprol and 
does not expect any United States entity to handle zipeprol in the 
foreseeable future. DEA concludes that no legitimate United States 
entity would be affected by this rule. As such, this rule will not have 
a significant effect on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
action would not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any 1 year * * *.'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of this final rule to both Houses of Congress and to 
the Comptroller General.

[[Page 70721]]

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 14, 2022, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

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, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. Amend Sec.  1308.11 by adding paragraph (b)(92) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *

 
 
 
(92) Zipeprol (1-methoxy-3-[4-(2-methoxy-2-                         9873
 phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol)..........
 

* * * * *

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-25206 Filed 11-18-22; 8:45 am]
BILLING CODE 4410-09-P