DEA: SpecGx LLC Bulk Manufacturer Controlled Substances Application Notice

Regs.gov: Drug Enforcement Administration

Detected March 26th, 2026

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.

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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

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

Source document (simplified)

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.