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 [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN
THE FEDERAL REGISTER]. Such persons may also file a written request for a hearing on
the application on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION
IN THE FEDERAL REGISTER].
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
Gamma Hydroxybutyric Acid
Ibogaine
Lysergic acid diethylamide
Tetrahydrocannabinols
Dimethyltryptamine
1-[1-(2-Thienyl)cyclohexyl]piperidine
Noroxymorphone
Heroin
Normorphine
Amphetamine
Methamphetamine
Amobarbital
Phencyclidine
Phenylacetone
Cocaine
Codeine
Dihydrocodeine
Oxycodone
Hydromorphone
Ecgonine
Hydrocodone
Meperidine
Metazocine
Methadone
Dextropropoxyphene, bulk (non-dosage forms)
Morphine
Oripavine
Thebaine
Oxymorphone
Phenazocine
Carfentanil
Fentanyl

Drug Code
2010
7260
7315
7370
7435
7470
9145
9200
9313
1100
1105
2125
7471
8501
9041
9050
9120
9143
9150
9180
9193
9230
9240
9250
9273
9300
9330
9333
9652
9715
9743
Schedule
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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: 6/6/2024 8:45 am; Publication Date: 6/7/2024]