DEA Bulk Manufacturer Application for Controlled Substances

Regs.gov: Drug Enforcement Administration

Published March 18th, 2026

Detected March 19th, 2026

Summary

The DEA has published a notice regarding an application from Sterling Wisconsin, LLC to be registered as a bulk manufacturer of Schedule I and II controlled substances, including Lysergic Acid Diethylamide, Marihuana Extract, and Oliceridine. Registered manufacturers and applicants can submit comments or hearing requests by May 18, 2026.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice concerning an application from Sterling Wisconsin, LLC for registration as a bulk manufacturer of specific controlled substances, including Lysergic Acid Diethylamide, Marihuana Extract, and Oliceridine. The application details the controlled substances and their schedules, with the company intending to manufacture these for commercial sale. This notice serves as an opportunity for existing registered bulk manufacturers and other applicants to review the application.

Interested parties, including registered bulk manufacturers and other applicants, have until May 18, 2026, to submit electronic comments or objections to the proposed registration, or to file a written request for a hearing. All comments must be submitted electronically through the Federal eRulemaking Portal at regulations.gov. Failure to submit comments or requests by the deadline may result in the application proceeding without further input from these parties.

What to do next

Review Sterling Wisconsin, LLC's application for bulk manufacturing of controlled substances.
Submit electronic comments or objections to the proposed registration by May 18, 2026.
File a written request for a hearing by May 18, 2026, if applicable.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Sterling Wisconsin, 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 18, 2026. Such persons may also file a written
request for a hearing on the application on or before May 18, 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 January 27, 2026, Sterling Wisconsin, LLC, W130N10497 Washington
Drive, Germantown, Wisconsin 53022-4448, applied to be registered as a bulk manufacturer of the following basic class(es)
of controlled substance(s):

| Controlled substance | Drug
code | Schedule |
| --- | --- | --- |
| Lysergic Acid Diethylamide | 7315 | I |
| Marihuana Extract | 7350 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Mescaline | 7381 | I |
| 5-Methoxy-N-N-Dimethyltryptamine | 7431 | I |
| Psilocybin | 7437 | I |
| Oliceridine | 9245 | II |
| Thebaine | 9333 | II |
| Alfentanil | 9737 | II |
The company plans to bulk manufacture the listed controlled substances for commercial sale to its customers. In reference
to drug codes 7350 (Marihuana Extract), 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture
these drugs as synthetic. No other activities for these drug codes are authorized for this registration.

Thomas Prevoznik, Deputy Assistant Administrator. [FR Doc. 2026-05357 Filed 3-18-26; 8:45 am] BILLING CODE P