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

Manufacturers Notice of Application - 2021

[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Page 40211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15920]


Drug Enforcement Administration

[Docket No. DEA-867]

Bulk Manufacturer of Controlled Substances Application: Novitium Pharma, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

SUMMARY: Novitium Pharma, LLC 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 September 27, 2021. Such persons may also file a written request for a hearing on the application on or before September 27, 2021.

ADDRESS: 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 June 17, 2021, Novitium Pharma, LLC, 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled Substance Drug Code Schedule
Psilocybin 7437 I
Psilocyn 7438 I

The company plans to bulk manufacture the above controlled substances to produce Active Pharmaceutical Ingredient (API) and finished dosage forms for clinical trial purposes. No other activities for these drug codes are authorized for this registration.

Brian S. Besser,
Acting Assistant Administrator.

[FR Doc. 2021-15920 Filed 7-26-21; 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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