Notice2024-12567
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
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
June 7, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
American Radiolabeled Chem has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 89 Issue 111 (Friday, June 7, 2024)</title>
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[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48689-48690]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12567]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1382]
Bulk Manufacturer of Controlled Substances Application: American
Radiolabeled Chem
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: American Radiolabeled Chem has applied to be registered as a
bulk manufacturer 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
August 6, 2024. Such persons may also file a written request for a
hearing on the application on or before August 6, 2024.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on May 8, 2024, American Radiolabeled Chem, 101 Arc
Drive, Saint Louis, Missouri 63146-3502, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
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Controlled substance Drug code Schedule
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Gamma Hydroxybutyric Acid............ 2010 I
Ibogaine............................. 7260 I
Lysergic acid diethylamide........... 7315 I
Tetrahydrocannabinols................ 7370 I
Dimethyltryptamine................... 7435 I
1-[1-(2-Thienyl)cyclohexyl]piperidine 7470 I
Noroxymorphone....................... 9145 I
Heroin............................... 9200 I
Normorphine.......................... 9313 I
Amphetamine.......................... 1100 II
Methamphetamine...................... 1105 II
Amobarbital.......................... 2125 II
Phencyclidine........................ 7471 II
Phenylacetone........................ 8501 II
Cocaine.............................. 9041 II
Codeine.............................. 9050 II
Dihydrocodeine....................... 9120 II
Oxycodone............................ 9143 II
Hydromorphone........................ 9150 II
Ecgonine............................. 9180 II
Hydrocodone.......................... 9193 II
Meperidine........................... 9230 II
Metazocine........................... 9240 II
Methadone............................ 9250 II
Dextropropoxyphene, bulk (non-dosage 9273 II
forms).
[[Page 48690]]
Morphine............................. 9300 II
Oripavine............................ 9330 II
Thebaine............................. 9333 II
Oxymorphone.......................... 9652 II
Phenazocine.......................... 9715 II
Carfentanil.......................... 9743 II
Fentanyl............................. 9801 II
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The company plans to bulk manufacture the listed controlled
substances for internal use as intermediates or for sale to its
customers. The company plans to manufacture small quantities of the
above listed controlled substances as radiolabeled compounds for
biochemical research. In reference to drug code 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-12567 Filed 6-6-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on June 7, 2024.
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