2019-16164. Importer of Controlled Substances Application: Alcami Carolinas Corporation

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 August 29, 2019. Such persons may also file a written request for a hearing on the application on or before August 29, 2019.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on May 8, 2019, Alcami Carolinas Corporation, 1726 North 23rd Street, Wilmington, North Carolina 28405 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substance	Drug code	Schedule
Psilocybin	7437	I
Psilocyn	7438	I
Thebaine	9333	II
Pentobarbital	2270	II

The company plans to import the listed controlled substances in bulk for the manufacturing of capsules/tablets for Phase II clinical trials. Approval of permit applications will occur only when the registrant's activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

Dated: July 16, 2019.

John J. Martin,

Assistant Administrator.