Skip to Content

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Help' button on the bottom right of each page!

Notice

Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals

This document has a comment period that ends in 25 days. (10/13/2020) Submit a formal comment

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start 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.

End Preamble Start Supplemental Information

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 substanceDrug codeSchedule
Tetrahydrocannabinols7370I
Methylphenidate1724II
Nabilone7379II
4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
Fentanyl9801II

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.

Start Signature

William T. McDermott,

Assistant Administrator.

End Signature End Supplemental Information

[FR Doc. 2020-17434 Filed 8-10-20; 8:45 am]

BILLING CODE 4410-09-P