Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem

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Published

June 30, 2022

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 87 Issue 125 (Thursday, June 30, 2022)</title>
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[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Notices]
[Page 39127]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14040]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1031]


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 29, 2022. Such persons may also file a written request for a 
hearing on the application on or before August 29, 2022.

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 24, 2022, 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):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
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).
Morphine...............................     9300  II
Oripavine..............................     9330  II
Thebaine...............................     9333  II
Oxymorphone............................     9652  II
Phenazocine............................     9715  II
Carfentanil............................     9743  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for the internal use 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. No other activities for these drug codes are 
authorized for this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-14040 Filed 6-29-22; 8:45 am]
BILLING CODE 4410-09-P


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