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DEA: SpecGx LLC Bulk Manufacturer Controlled Substances Application Notice

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Summary

The Drug Enforcement Administration (DEA) has issued a notice regarding an application from SpecGx LLC, a bulk manufacturer, to be registered for the production of various controlled substances. The notice provides a list of controlled substances and their schedules for which the company is seeking registration.

Published by DEA on regulations.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The Drug Enforcement Administration (DEA) has published a notice of application for SpecGx LLC, a bulk manufacturer seeking registration to produce a comprehensive list of controlled substances, including Gamma Hydroxybutyric Acid, Tetrahydrocannabinols, Psilocybin, Amphetamine, Methamphetamine, Fentanyl, and others across Schedules I and II. The company intends to manufacture these substances for sale to customers and for internal use in producing non-controlled substances.

Registered bulk manufacturers and other interested parties have until May 26, 2026, to submit electronic comments or objections to the DEA regarding this application, and they may also request a hearing by the same date. Comments must be submitted electronically via the Federal eRulemaking Portal at regulations.gov. Failure to submit comments or requests by the deadline may result in the application proceeding without further objection.

What to do next

  1. Submit electronic comments or objections to the DEA by May 26, 2026.
  2. File a written request for a hearing by May 26, 2026, if desired.

Archived snapshot

Mar 26, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Content

ACTION:

Notice of application.

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 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.

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-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I
Butyryl Fentanyl 9822 I
Fentanyl related compounds as defined in 21 CFR 1308.11(h) 9850 I
Amphetamine 1100 II
Methamphetamine 1105 II
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
Nabilone 7379 II
ANPP (4-Anilino-N-phenethyl-4-piperidine) 8333 II
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 forms) 9273 II
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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CFR references

21 CFR 1301.33(a) 21 CFR 1308.11(h)

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Last updated

Classification

Agency
DEA
Comment period closes
May 26th, 2026 (35 days)
Compliance deadline
May 26th, 2026 (35 days)
Instrument
Notice
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
FR Doc. 2026-05912
Docket
DEA-2026-0463

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled Substances Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Controlled Substances Drug Manufacturing

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