Manufacturers Notice of Application - 2019
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25401]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-529]
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
ACTION: Notice of application.
DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 21, 2020.
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 March 15, 2019, Patheon API Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
, 498 Washington Street, Coventry, Rhode Island 02816 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
|Controlled Substance||Drug Code||Schedule|
|Gamma Hydroxybutyric Acid||2010||I|
The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient for supply to its customers.
Dated: November 5, 2019.
William T. McDermott,
[FR Doc. 2019-25401 Filed 11-21-19; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).