Royal Emerald Pharmaceuticals Bulk Manufacturer Registration Application

Regs.gov: Drug Enforcement Administration

Published March 31st, 2026

Detected April 2nd, 2026

Summary

The DEA published notice that Royal Emerald Pharmaceuticals applied to be registered as a bulk manufacturer of Schedule I controlled substances including Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370). The company, located in Desert Hot Springs, California, plans to provide cannabis botanical raw material and API to DEA-registered researchers and manufacturers. Comments and objections on the application are due June 1, 2026.

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What changed

The DEA published notice of Royal Emerald Pharmaceuticals' application to become a bulk manufacturer of three Schedule I controlled substances related to cannabis. The application, filed March 3, 2026, covers Marihuana Extract (drug code 7350), Marihuana (7360), and Tetrahydrocannabinols (7370). No other activities are authorized for this registration. The notice is issued pursuant to 21 CFR 1301.33(a).

Registered bulk manufacturers and applicants may submit electronic comments or objections to the proposed registration on or before June 1, 2026. Interested parties may also file a written request for a hearing by that date. All comments must be submitted through regulations.gov. This notice does not impose new compliance obligations on third parties but provides an opportunity for public input on the application.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Royal Emerald Pharmaceuticals 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 June 1, 2026. Such persons may also file a written
request for a hearing on the application on or before June 1, 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 March 03, 2026, Royal Emerald Pharmaceuticals, 14011 Palm Drive,
Building B, Desert Hot Springs, California 92240-6845, applied to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Marihuana Extract | 7350 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
The company plans to bulk manufacture the listed controlled substance(s) to provide Marihuana (Cannabis) as botanical raw
material and/or active pharmaceutical ingredients (API) to Drug Enforcement Administration-registered researchers and manufacturers.
No other activities for these drug codes are authorized for this registration.

Thomas Prevoznik, Deputy Assistant Administrator. [FR Doc. 2026-06256 Filed 3-31-26; 8:45 am] BILLING CODE P