Notice2026-05353
Importer of Controlled Substances Application: SpecGx LLC
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 19, 2026
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 Supplementary Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 91 Issue 53 (Thursday, March 19, 2026)</title>
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[Federal Register Volume 91, Number 53 (Thursday, March 19, 2026)]
[Notices]
[Page 13336]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05353]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1683]
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 20, 2026. Such persons may also file a written request for a
hearing on the application on or before April 20, 2026.
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 February 3, 2026, 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 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 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.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-05353 Filed 3-18-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on March 19, 2026.
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