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

Manufacturers Notice of Application - 2021

[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Page 2457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00351]


Drug Enforcement Administration

[Docket No. DEA-756]

Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

SUMMARY: Cedarburg Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental 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 March 15, 2021. Such persons may also file a written request for a hearing on the application on or before March 15, 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 October 16, 2020, Cedarburg Pharmaceuticals 870 Badger Circle, Grafton, Wisconsin 53024, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled Substance Drug Code Schedule
Tetrahydrocannabinols 7370 I
3, 4-Methylenedioxymethamphetamine 7405 I
Dimethyltryptamine 7435 I
Psilocybin 7437 I
Methylphenidate 1724 II
Nabilone 7379 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II
Fentanyl 9801 II

The company plans to manufacture bulk active pharmaceutical ingredients (API) for distribution to its customers. In reference to the drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture as synthetic. No other activity for this drug code is authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2021-00351 Filed 1-11-21; 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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