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Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals

Cedarburg Pharmaceuticals applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Tetrahydrocannabinol, Methylphenidate, Nabil...

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Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-698]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Cedarburg Pharmaceuticals applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Tetrahydrocannabinol, Methylphenidate, Nabilone, 4-Anilino-N-phenethyl-4-piperidine (ANPP), and Fentanyl.

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 October 13, 2020.

( printed page 48563)

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 June 24, 2020, Cedarburg Pharmaceuticals, 870 Badger Circle, Grafton, Wisconsin 53024-0000, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:

Controlled substance Drug code Schedule
Tetrahydrocannabinols 7370 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 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. 2020-17434 Filed 8-10-20; 8:45 am]

BILLING CODE 4410-09-P

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85 FR 48562

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“Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals,” thefederalregister.org (August 11, 2020), https://thefederalregister.org/documents/2020-17434/bulk-manufacturer-of-controlled-substances-application-cedarburg-pharmaceuticals.