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DEA Notice of Application for Bulk Controlled Substance Manufacturer Registration

Favicon for www.regulations.gov Regs.gov: Drug Enforcement Administration
Published March 18th, 2026
Detected March 19th, 2026
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Summary

The DEA has published a notice regarding an application from Siegfried Grafton, Inc. to be registered as a bulk manufacturer of various controlled substances, including Schedule I and II drugs. Interested parties can submit comments or requests for a hearing by May 18, 2026.

What changed

The Drug Enforcement Administration (DEA) has issued a notice regarding an application from Siegfried Grafton, Inc. (located in Grafton, Wisconsin) to be registered as a bulk manufacturer of a comprehensive list of controlled substances. These include Schedule I substances such as Lysergic acid diethylamide, Marihuana Extract, Marihuana, Tetrahydrocannabinols, and various phenethylamines, as well as Schedule II substances like Lisdexamfetamine, Methylphenidate, Amobarbital, Nabilone, and several opioid-related compounds. The company intends to produce these substances for analytical reference standards or for sale to customers, with specific plans for synthetic production of Marihuana and Tetrahydrocannabinols.

Registered bulk manufacturers and other interested parties have until May 18, 2026, to submit electronic comments or objections to the proposed registration, or to file a written request 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 opportunity for input. This notice is critical for existing manufacturers in the affected classes of controlled substances and for any entity that may be impacted by the new registration.

What to do next

  1. Review the list of controlled substances for which Siegfried Grafton, Inc. has applied for bulk manufacturing registration.
  2. Submit electronic comments or objections to the DEA via regulations.gov by May 18, 2026, if applicable.
  3. File a written request for a hearing by May 18, 2026, if desired.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Siegfried Grafton, Inc. 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 February 25, 2026, Siegfried Grafton, Inc., 870 Badger Circle,
Grafton, Wisconsin 53024-0000, 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 |
| 4-Bromo-2,5-dimethoxy- phenethylamine | 7392 | I |
| 3,4-Methylenedioxy- amphetamine | 7400 | I |
| 3,4-Methylenedioxy- methamphetamine | 7405 | I |
| 5-Methoxy-N-N-dimethyltryptamine | 7431 | I |
| Dimethyltryptamine | 7435 | I |
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | I |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| Amobarbital | 2125 | II |
| Nabilone | 7379 | II |
| ANPP (4-Anilino-N-phenethyl-4-piperidine) | 8333 | II |
| Hydrocodone | 9193 | II |
| Opium extracts | 9610 | II |
| Opium, powdered | 9639 | II |
| Opium, granulated | 9640 | II |
| Opium poppy | 9650 | II |
| Noroxymorphone | 9668 | II |
| Remifentanil | 9739 | II |
| Fentanyl | 9801 | II |
The company plans to bulk manufacture the listed controlled substances for purpose of analytical reference standards or for
sale to its customers. In reference to drug codes 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. 2026-05358 Filed 3-18-26; 8:45 am] BILLING CODE 4410-09-P

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Classification

Agency
DEA
Published
March 18th, 2026
Compliance deadline
May 18th, 2026 (60 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers
Geographic scope
National (US)

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Controlled Substances Drug Manufacturing Regulatory Compliance

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