Manufacturers Notice of Application - 2020
[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10601]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-610]
Bulk Manufacturer of Controlled Substances Application: SpecGx LLC
ACTION: Notice of application.
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 July 17, 2025.
ADDRESSES: Written comments should be sent to: Drug Enforcement Administration (DEA), 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 January 29, 2020, SpecGx LLC, 3600 North Second Street, Saint Louis, Missouri 63147-3457 applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
|Controlled Substance||Drug Code||Schedule|
|Gamma Hydroxybutyric Acid||2010||I|
|Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)||9821||I|
|Fentanyl related-substances as defined in 21 CFR 1308.11(h)||9850||I|
|Dextropropoxyphene, bulk (non-dosage forms)||9273||II|
The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for this drug code is authorized for this registration.
William T. McDermott,
[FR Doc. 2020-10601 Filed 5-15-20; 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).