Notice2026-08588
Bulk Manufacturer of Controlled Substances Application: Patheon API Inc.
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
May 4, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Patheon API Inc. 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 91 Issue 85 (Monday, May 4, 2026)</title>
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[Federal Register Volume 91, Number 85 (Monday, May 4, 2026)]
[Notices]
[Page 24008]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08588]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1710]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Patheon API Inc. 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
July 6, 2026. Such persons may also file a written request for a
hearing on the application on or before July 6, 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 <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 February 9, 2026, Patheon API Inc., 6173 East Old
Marion Highway, Florence, South Carolina 29506, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
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Controlled substance Drug code Schedule
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Dimethyltryptamine.................... 7435 I
Psilocybin............................ 7437 I
Psilocyn.............................. 7438 I
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The company plans to bulk manufacture the listed controlled
substances for research and clinical trials. No other activities for
these drug codes are authorized for this registration.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-08588 Filed 5-1-26; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on May 4, 2026.
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