Importer of Controlled Substances Application: SpecGX LLC

Primary source

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Published

April 28, 2022

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

SpecGX, LLC 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 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25303-25304]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09033]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-993]


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 Supplemental 
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 
May 31, 2022. Such persons may also file a written request for a 
hearing on the application on or before May 31, 2022.

ADDRESSES: The Drug Enforcement Administration (DEA) 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 January 26, 2022, SpecGX LLC, 3600 North 2nd Street, 
Saint Louis, Missouri 63147, 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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Marihuana..............................    7360  I
Phenylacetone..........................    8501  II
Coca Leaves............................    9040  II
Thebaine...............................    9333  II
Opium, Raw.............................    9600  II
Poppy Straw Concentrate................    9670  II
Tapentadol.............................    9780  II
------------------------------------------------------------------------

    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. In reference to drug code 7360 
(Marihuana), the company plans to import synthetic cannabinol. No other 
activity for this drug is authorized for this registration. Placement 
of these codes onto the company's registration

[[Page 25304]]

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.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-09033 Filed 4-27-22; 8:45 am]
BILLING CODE P


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