85 FR 155 pgs. 48562-48563 - Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
Type: NOTICEVolume: 85Number: 155Pages: 48562 - 48563
Pages: 48562, 48563Docket number: [Docket No. DEA-698]
FR document: [FR Doc. 2020-17434 Filed 8-10-20; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-698]
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
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.
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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