Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
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...
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 September 21, 2026. Such persons may also file a written request for a hearing on the application on or before September 21, 2026.
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 June 18, 2026, 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
( printed page 46483)
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 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug code as synthetic. No other activities for these drug codes are authorized for this registration.