[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Page 20699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06181]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1343]


Importer of Controlled Substances Application: SpecGx LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: SpecGx LLC 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 
April 24, 2024. Such persons may also file a written request for a 
hearing on the application on or before April 24, 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 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 January 24, 2024, SpecGx LLC, 3600 North 2nd Street, 
Saint Louis, Missouri 63147-3457, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Phenylacetone...........................    8501  II
Coca Leaves.............................    9040  II
Thebaine................................    9333  II
Opium, raw..............................    9600  II
Poppy Straw Concentrate.................    9670  II
Tapentadol..............................    9780  II
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    The company plans to import the listed controlled substances for 
bulk manufacture into Active Pharmaceutical Ingredients (API) for 
distribution to its customers. In reference to Tapentadol (9780) and 
Thebaine (9333), the company plans to import intermediate forms of 
these controlled substances for further manufacturing prior to 
distribution to its customers. No other activity for these drugs is 
authorized for this registration. Placement of these codes onto the 
company's registration does not translate into automatic approval of 
subsequent permit applications to import controlled substances.
    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.

Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-06181 Filed 3-22-24; 8:45 am]
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