Rule2022-25206
Schedules of Controlled Substances: Placement of Zipeprol in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 21, 2022
Effective
December 21, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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
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</html>Indexed from Federal Register on November 21, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.