[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Notices]
[Page 39867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13026]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1219]


Importer of Controlled Substances Application: Alcami Carolinas 
Corporation

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Alcami Carolinas Corporation has applied to be registered as 
an importer of basic class(es) of controlled substance(s). Refer to 
SUPPLEMENTARY INFORMATION listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
July 20, 2023. Such persons may also file a written request for a 
hearing on the application on or before July 20, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for submitting comments. Upon 
submission of your comment, you will receive a Comment Tracking Number. 
Please be aware that submitted comments are not instantaneously 
available for public view on https://www.regulations.gov. If you have 
received a Comment Tracking Number, your comment has been successfully 
submitted and there is no need to resubmit the same comment. All 
requests for a hearing must 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. All requests for a hearing should also be 
sent to: Drug Enforcement Administration, Attn: Administrator, 8701 
Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on May 22, 2023, Alcami Carolinas Corporation, 1519 
North 23rd Street, Wilmington, North Carolina 28405-1827, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

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          Controlled substance               Drug code       Schedule
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Psilocybin..............................            7437               I
Psilocin................................            7438               I
Pentobarbital...........................            2270              II
Thebaine................................            9333              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. The company plans to import derivatives of Thebaine that have 
been determined by DEA to be captured under drug code (9333) Thebaine. 
No other activities for these drug codes are authorized for this 
registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2).
    Authorization will not extend to the import of Food and Drug 
Administration-approved or non-approved finished dosage forms for 
commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-13026 Filed 6-16-23; 8:45 am]
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