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 October 7, 2019.
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 12 2019, Alcami Wisconsin Corporation, W130N10497 Washington Drive, Germantown, Wisconsin 53022 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
Controlled substance | Drug code | Schedule |
---|---|---|
Marihuana Extract | 7350 | I |
Marihuana | 7360 | I |
Tetrahydrocannabinols | 7370 | I |
5-Methoxy-N-N-dimethyltryptamine | 7431 | I |
Thebaine | 9333 | II |
Alfentanil | 9737 | II |
The company plans to provide bulk active pharmaceutical ingredient to support clinical trials. In reference to drug codes 7350 marihuana extract, 7360 marihuana, and 7360 THC, the company plans to manufacturer these substances synthetically. No other activity for these drug codes is authorized for this registration.
Dated: July 30, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-17002 Filed 8-7-19; 8:45 am]
BILLING CODE 4410-09-P