AJNA Biosciences Bulk Manufacturer of Controlled Substances Application
Summary
The Drug Enforcement Administration published notice that AJNA Biosciences applied on March 23, 2026 to be registered as a bulk manufacturer of Schedule I controlled substances psilocybin (drug code 7437) and psilocyn (drug code 7438). The company plans to bulk manufacture psilocybin-containing mushrooms for internal research, clinical trials, and analytical purposes, and to distribute to customers conducting Schedule I clinical research. The public comment period closes June 22, 2026.
What changed
DEA published notice that AJNA Biosciences of Littleton, Colorado applied to be registered as a bulk manufacturer of Schedule I controlled substances psilocybin (7437) and psilocyn (7438) under 21 CFR 1301.33(a). The application covers bulk manufacturing of mushrooms containing these substances for internal research, clinical trials, analytical purposes, and distribution to customers conducting Schedule I clinical research. No other activities are authorized for these drug codes under this registration.
Affected parties including registered bulk manufacturers and applicants may submit electronic comments or written hearing requests on the application through June 22, 2026 via regulations.gov. Competitors in the Schedule I research chemical and psychedelic medicine space should monitor this application, as approval would add a new bulk manufacturer to the supply chain for psilocybin and psilocyn used in clinical research.
Archived snapshot
Apr 21, 2026GovPing 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.
Notice
Bulk Manufacturer of Controlled Substances Application: AJNA Biosciences
A Notice by the Drug Enforcement Administration on 04/21/2026
This document has a comment period that ends in 62 days.
(06/22/2026) View Comment InstructionsPDF
Document Details
Document Dates
- Table of Contents
- Public Comments
- Regulations.gov Data
- Sharing
- Other Formats
- Public Inspection Published Document: 2026-07698 (91 FR 21313) Document Headings ###### Department of Justice
Drug Enforcement Administration
- [Docket No. DEA-1707]
AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
AJNA Biosciences 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 22, 2026. Such persons may also file a written request for a hearing on the application on or before June 22, 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 23, 2026, AJNA Biosciences, 8022 Southpark Circle, Suite 500, Littleton, Colorado 80120-5659, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | I |
The company plans to bulk manufacture mushrooms containing Psilocybin (7437) and Psilocyn (7438) to support internal research, clinical trials, and analytical purposes as well as to distribute to their customers conducting ( printed page 21314) schedule I clinical research. No other activities for these drug codes are authorized for this registration.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-07698 Filed 4-20-26; 8:45 am]
BILLING CODE P
Published Document: 2026-07698 (91 FR 21313)
CFR references
Mentioned entities
Citations
Parties
Related changes
Get daily alerts for FR: Drug Enforcement Administration
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from Justice Department.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FR: Drug Enforcement Administration publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.