[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33915-33916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11166]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1190]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: United States Pharmacopeial has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
June 26, 2023. Such persons may also file a written request for a
hearing on the application on or before June 26, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on March 23, 2023, United States Pharmacopeial
Convention, 7135 English Muffin Way, Frederick, Maryland 21704, applied
to be registered as an importer of the following basic class(es) of
controlled substance(s):
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Controlled substance Drug code Schedule
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Cathinone........................... 1235 I
Methcathinone....................... 1237 I
Methaqualone........................ 2565 I
Lysergic acid diethylamide.......... 7315 I
4-Methyl-2,5-dimethoxyamphetamine... 7395 I
3,4-Methylenedioxyamphetamine....... 7400 I
4-Methoxyamphetamine................ 7411 I
Codeine-N-oxide..................... 9053 I
Difenoxin........................... 9168 I
Heroin.............................. 9200 I
Morphine-N-oxide.................... 9307 I
Norlevorphanol...................... 9634 I
Methamphetamine..................... 1105 II
Lisdexamfetamine.................... 1205 II
Phenmetrazine....................... 1631 II
Methylphenidate..................... 1724 II
Amobarbital......................... 2125 II
Pentobarbital....................... 2270 II
Secobarbital........................ 2315 II
Glutethimide........................ 2550 II
Phencyclidine....................... 7471 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Phenylacetone....................... 8501 II
Alphaprodine........................ 9010 II
Anileridine......................... 9020 II
Cocaine............................. 9041 II
Dihydrocodeine...................... 9120 II
[[Page 33916]]
Diphenoxylate....................... 9170 II
Levomethorphan...................... 9210 II
Levorphanol......................... 9220 II
Meperidine.......................... 9230 II
Dextropropoxyphene, bulk (non-dosage 9273 II
forms).
Thebaine............................ 9333 II
Oxymorphone......................... 9652 II
Noroxymorphone...................... 9668 II
Alfentanil.......................... 9737 II
Sufentanil.......................... 9740 II
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The company plans to import the bulk control substances for
distribution as analytical reference standards to its customers for
analytical testing of raw materials. No other activities for these drug
codes are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11166 Filed 5-24-23; 8:45 am]
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