[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