Notices. Notice of application
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/register/2024/06/07/2024-12567·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 7020-02-P 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. 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 *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. 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): Controlled substance Drug 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 forms) 9273 II 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 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]
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