Changeflow GovPing Healthcare & Life Sciences AJNA Biosciences applies for DEA bulk manufactu...
Routine Notice Added

AJNA Biosciences applies for DEA bulk manufacturer registration

Email

Summary

AJNA Biosciences applies for DEA bulk manufacturer registration

Published by DEA on regulations.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

Archived snapshot

Apr 22, 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:

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

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

Download File

Download

Get daily alerts for Regs.gov: Drug Enforcement Administration

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from DEA.

What's AI-generated?

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.

Last updated

Classification

Agency
DEA
Instrument
Notice

Get alerts for this source

We'll email you when Regs.gov: Drug Enforcement Administration publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!