Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

Primary source

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Published

March 26, 2026

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

SpecGx LLC has applied to be registered as a bulk manufacturer 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 58 (Thursday, March 26, 2026)</title>
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[Federal Register Volume 91, Number 58 (Thursday, March 26, 2026)]
[Notices]
[Pages 14721-14722]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05912]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1666]


Bulk Manufacturer 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 a bulk manufacturer 
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 
May 26, 2026. Such persons may also file a written request for a 
hearing on the application on or before May 26, 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

[[Page 14722]]

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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on February 4, 2026, SpecGx, LLC, 3600 North Second 
Street, Saint Louis, Missouri 63147-3457, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............         2010  I
Tetrahydrocannabinols................         7370  I
Psilocybin...........................         7437  I
Codeine-N-oxide......................         9053  I
Dihydromorphine......................         9145  I
Difenoxin............................         9168  I
Morphine-N-oxide.....................         9307  I
Normorphine..........................         9313  I
Alphamethadol........................         9605  I
Betamethadol.........................         9609  I
Norlevorphanol.......................         9634  I
Acetyl Fentanyl (N-(1-                        9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl.....................         9822  I
Fentanyl related compounds as defined         9850  I
 in 21 CFR 1308.11(h).
Amphetamine..........................         1100  II
Methamphetamine......................         1105  II
Lisdexamfetamine.....................         1205  II
Methylphenidate......................         1724  II
Nabilone.............................         7379  II
ANPP (4-Anilino-N-phenethyl-4-                8333  II
 piperidine).
Phenylacetone........................         8501  II
Codeine..............................         9050  II
Dihydrocodeine.......................         9120  II
Oxycodone............................         9143  II
Hydromorphone........................         9150  II
Diphenoxylate........................         9170  II
Ecgonine.............................         9180  II
Hydrocodone..........................         9193  II
Levorphanol..........................         9220  II
Isomethadone.........................         9226  II
Meperidine...........................         9230  II
Meperidine intermediate-A............         9232  II
Meperidine intermediate-B............         9233  II
Meperidine intermediate-C............         9234  II
Methadone............................         9250  II
Methadone intermediate...............         9254  II
Dextropropoxyphene, bulk (non-dosage          9273  II
 forms).
Morphine.............................         9300  II
Oripavine............................         9330  II
Thebaine.............................         9333  II
Opium tincture.......................         9630  II
Opium, powdered......................         9639  II
Oxymorphone..........................         9652  II
Noroxymorphone.......................         9668  II
Alfentanil...........................         9737  II
Remifentanil.........................         9739  II
Sufentanil...........................         9740  II
Tapentadol...........................         9780  II
Fentanyl.............................         9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for sale to its customers and for internal use to produce 
non-controlled substances. In reference to drug code 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture this 
drug code as synthetic. No other activities for these drug codes are 
authorized for this registration.

Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-05912 Filed 3-25-26; 8:45 am]
BILLING CODE P


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