83 FR 46758 - Importer of Controlled Substances Application: Alcami Carolinas Corporation

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 179 (September 14, 2018)

[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46758-46759]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20001]


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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 October 15, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before October 15, 2018.

[[Page 46759]]


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

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on July 
2, 2018, Alcami Carolinas Corporation, 1726 North 23rd Street, 
Wilmington, North Carolina 28405-1822 applied to be registered as an 
importer of the following basic classes of controlled substances:

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                                           Drug
          Controlled substance             code          Schedule
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Psilocybin.............................     7437  I
Psilocyn...............................     7438  I
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    The company plans to import the listed controlled substances in 
bulk form 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: September 5, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-20001 Filed 9-13-18; 8:45 am]
 BILLING CODE 4410-09-P