Notice2023-27707
Bulk Manufacturer of Controlled Substances Application: AJNA BioSciences
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 18, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 241 (Monday, December 18, 2023)</title>
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[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87459]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27707]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1306]
Bulk Manufacturer of Controlled Substances Application: AJNA
BioSciences
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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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
February 16, 2024. Such persons may also file a written request for a
hearing on the application on or before February 16, 2024.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 September 20, 2023, 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):
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Drug
Controlled substance code Schedule
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Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
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The company plans to bulk manufacture by cultivating research Good
Manufacturing Practices whole plant 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-27707 Filed 12-15-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on December 18, 2023.
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