Importer of Controlled Substances Application: Cambrex Charles City

Primary source

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Published

November 29, 2024

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Cambrex Charles City 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.

Full Text

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<title>Federal Register, Volume 89 Issue 230 (Friday, November 29, 2024)</title>
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[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Page 94763]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28064]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1460]


Importer of Controlled Substances Application: Cambrex Charles 
City

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Cambrex Charles City 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 
December 30, 2024. Such persons may also file a written request for a 
hearing on the application on or before December 30, 2024.

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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 June 18, 2024, Cambrex Charles City, 1205 11th 
Street, Charles City, Iowa 50616-3466, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
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Psilocybin..............................    7437  I
4-Anilino-N-phenethyl-4-piperidine          8333  II
 (ANPP).
Phenylacetone...........................    8501  II
Coca Leaves.............................    9040  II
Opium Raw...............................    9600  II
Poppy Straw Concentrate.................    9670  II
------------------------------------------------------------------------

    The company plans to import psilocybin for formulation development 
and clinical trial support for their customers. The remaining listed 
controlled substances will be imported to support the manufacture into 
other controlled substances which will be distributed to their 
customers. 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. 2024-28064 Filed 11-27-24; 8:45 am]
BILLING CODE P


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