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Routine Notice Added Final

Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals

Favicon for www.federalregister.gov FR: Drug Enforcement Administration
Published April 1st, 2026
Detected April 1st, 2026
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Summary

The DEA published a notice that Royal Emerald Pharmaceuticals applied to register as a bulk manufacturer of Schedule I controlled substances including Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370) at its facility in Desert Hot Springs, California. The company proposes to provide cannabis botanical raw material and active pharmaceutical ingredients (API) to DEA-registered researchers and manufacturers. Public comments on the application are due June 1, 2026.

What changed

The DEA published notice of Royal Emerald Pharmaceuticals' application to register as a bulk manufacturer of Schedule I controlled substances listed in 21 CFR 1301.33(a). The application covers Marihuana Extract (drug code 7350), Marihuana (7360), and Tetrahydrocannabinols (7370). The company intends to supply cannabis botanical raw material and API to DEA-registered researchers and manufacturers. Docket No. DEA-1694.

This is a routine notice inviting electronic comments or written hearing requests from interested parties. No compliance deadline applies to third parties. Those wishing to object to the registration may submit comments through regulations.gov on or before June 1, 2026. No other parties need to take action unless they wish to oppose the application.

Source document (simplified)

Notice

Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals

A Notice by the Drug Enforcement Administration on 04/01/2026

  • This document has a comment period that ends in 61 days.
    (06/01/2026) View Comment Instructions

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  • Public Inspection Published Document: 2026-06256 (91 FR 16243) Document Headings ###### Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-1694]

AGENCY:

Drug Enforcement Administration, Justice.

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

Published Document: 2026-06256 (91 FR 16243)

CFR references

21 CFR 1301.33(a)

Classification

Agency
Justice Department
Published
April 1st, 2026
Comment period closes
June 1st, 2026 (61 days)
Compliance deadline
June 1st, 2026 (61 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
91 FR 16243 / Docket No. DEA-1694
Docket
Docket No. DEA-1694

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled Substances Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Cannabis
Operational domain
Compliance, Legal
Topics
Pharmaceuticals Healthcare

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