Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2021

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Pages 26070-26071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09988]


Drug Enforcement Administration

[Docket No. DEA-826]

Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

SUMMARY: Patheon API Manufacturing, Inc., 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 file written comments on or objections to the issuance of the proposed registration on or before July 12, 2021. Such persons may also file a written request for a hearing on the application on or before July 12, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on March 18, 2021, Patheon API Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605-5420, 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
Tetrahydrocannabinols 7370 I
5-Methoxy-N-N-Dimethyltryptamine 7431 I
a-Methyltryptamine 7432 I
Psilocybin 7437 I
Thebaine 9333 II
Oxymorphone 9652 II
Noroxymorphone 9668 II

[[Page 26071]]

The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. In reference to dug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2021-09988 Filed 5-11-21; 8:45 am]


NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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