DEA Notice: Stepan Company Application for Bulk Controlled Substance Manufacturer

Regs.gov: Drug Enforcement Administration

Published March 12th, 2026

Detected March 15th, 2026

Summary

The DEA has published a notice regarding Stepan Company's application to be registered as a bulk manufacturer of cocaine and ecgonine. Interested parties can submit comments or requests for a hearing by May 12, 2026.

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What changed

The Drug Enforcement Administration (DEA) has issued a notice regarding an application from Stepan Company to be registered as a bulk manufacturer of cocaine (drug code 9041) and ecgonine (drug code 9180), both Schedule II controlled substances. The company intends to produce these substances as internal intermediates or for sale to customers. This notice opens a period for registered bulk manufacturers and other applicants to submit comments or objections.

Regulated entities, particularly other bulk manufacturers of these controlled substances, should review the application details. Comments or requests for a hearing must be submitted electronically through the Federal eRulemaking Portal by May 12, 2026. Failure to comment may result in the DEA proceeding with the registration without further notice.

What to do next

Submit electronic comments or objections to Stepan Company's application by May 12, 2026.
File a written request for a hearing on the application by May 12, 2026.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Stepan Company 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 12, 2026. Such persons may also file a written
request for a hearing on the application on or before May 12, 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 2, 2026, Stepan Company, 100 West Hunter Avenue, Maywood,
New Jersey 07607-1021, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Cocaine | 9041 | II |
| Ecgonine | 9180 | II |
The company plans to bulk manufacture the listed controlled substances for use as internal intermediates or for sale to its
customers. No other activities for these drug codes are authorized for this registration.

Thomas Prevoznik, Deputy Assistant Administrator. [FR Doc. 2026-04969 Filed 3-12-26; 8:45 am] BILLING CODE P