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DEA Notice: Stepan Company Application for Bulk Controlled Substance Manufacturer

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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.

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 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

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

Archived snapshot

Mar 15, 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:

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

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Last updated

Classification

Agency
DEA
Published
March 12th, 2026
Compliance deadline
May 12th, 2026 (21 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers
Geographic scope
National (US) National (US)

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Controlled Substances Manufacturing

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