Notice of application.
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.
Written comments should be sent to: Drug Enforcement Administration (DEA), Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
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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|
|Start Printed Page 29742|
|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.
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William T. McDermott,
[FR Doc. 2020-10601 Filed 5-15-20; 8:45 am]
BILLING CODE 4410-09-P