# 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 18, 2025. Such persons may also file a written request for a hearing on the application on or before August 18, 2025.
**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 April 16, 2025, 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 |
| Dihydromorphone | 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 Strait,
Deputy Assistant Administrator.