Importer of Controlled Substances Application: Alcami Carolinas Corporation

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Published

July 8, 2021

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

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

Full Text

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<title>Federal Register, Volume 86 Issue 128 (Thursday, July 8, 2021)</title>
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[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Page 36160]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14533]



[[Page 36160]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-863]


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 
Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before August 9, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before August 9, 2021.

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 18, 2021, Alcami Carolinas Corporation, 1726 
North 23rd Street, Wilmington, North Carolina 28405-1822, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

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

    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 activity for these drug code is 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-14533 Filed 7-7-21; 8:45 am]
BILLING CODE P


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