DEA: SpecGx LLC Controlled Substances Manufacturer Application

FR: Drug Enforcement Administration

Published March 26th, 2026

Detected March 26th, 2026

Summary

The Drug Enforcement Administration (DEA) has published a notice regarding an application from SpecGx LLC to be registered as a bulk manufacturer of various controlled substances, including Schedule I and II drugs. The notice provides a comment period for interested parties to submit objections or requests for a hearing.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice announcing that SpecGx LLC has applied for registration as a bulk manufacturer of controlled substances. The application covers a comprehensive list of Schedule I and II drugs, including Gamma Hydroxybutyric Acid, Tetrahydrocannabinols, Psilocybin, Amphetamine, Methamphetamine, Oxycodone, and Fentanyl-related compounds. This notice serves as a formal publication of the application, allowing for public input.

Interested parties, including existing registered manufacturers and applicants, have until May 26, 2026, to submit electronic comments or written requests for a hearing. Comments must be submitted through the Federal eRulemaking Portal (regulations.gov). Failure to submit comments or requests by the deadline may result in the DEA proceeding with the registration without further consideration of objections or hearing requests.

What to do next

Submit electronic comments or written requests for a hearing by May 26, 2026, if objections exist.
Review the list of controlled substances for which SpecGx LLC is applying for manufacturing registration.

Source document (simplified)

Notice

Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

A Notice by the Drug Enforcement Administration on 03/26/2026

This document has a comment period that ends in 61 days.
(05/26/2026) View Comment Instructions
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Public Inspection Published Document: 2026-05912 (91 FR 14721) Document Headings ###### Department of Justice

Drug Enforcement Administration

[Docket No. DEA-1666]

AGENCY:

Drug Enforcement Administration, Justice.

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 ( printed page 14722) 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.