[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Page 36941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16164]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Alcami Carolinas 
Corporation

ACTION: Notice of application.

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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:

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         Controlled substance           Drug code         Schedule
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Psilocybin............................       7437  I
Psilocyn..............................       7438  I
Thebaine..............................       9333  II
Pentobarbital.........................       2270  II
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    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.
[FR Doc. 2019-16164 Filed 7-29-19; 8:45 am]
 BILLING CODE 4410-09-P