Manufacturers Notice of Application - 2021
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13252]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-857]
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
SUMMARY: Cambrex Charles City 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 August 23, 2021. Such persons may also file a written request for a hearing on the application on or before August 23, 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 May 6, 2021, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
|Controlled Substance||Drug Code||Schedule|
|Gamma Hydroxybutyric Acid||2010||I|
|Opium fluid extract||9620||II|
The company plans to manufacture the above-listed controlled substances in bulk for conversion to other controlled substances and sales to its customers for dosage form development, clinical trials and use in stability qualification studies. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration.
William T. McDermott,
[FR Doc. 2021-13252 Filed 6-23-21; 8:45 am]
BILLING CODE P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).