Notice2022-06167
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, 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
March 23, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Patheon API Manufacturing, 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 87 Issue 56 (Wednesday, March 23, 2022)</title>
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[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Page 16498]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06167]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-987]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Patheon API Manufacturing, 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
May 23, 2022. Such persons may also file a written request for a
hearing on the application on or before May 23, 2022.
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 March 2, 2022, Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South Carolina 29605-5420, 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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Gamma Hydroxybutyric Acid.............. 2010 I
Tetrahydrocannabinols.................. 7370 I
5-Methoxy-N-N-Dimethyltryptamine....... 7431 I
Alpha-Methyltryptamine................. 7432 I
Dimethyltryptamine..................... 7435 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
Thebaine............................... 9333 II
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
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The company plans to bulk manufacture the listed controlled
substances as an Active Pharmaceutical Ingredient (API) for
distribution to its customers. In reference to dug code 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture this
drug as synthetic. No other activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-06167 Filed 3-22-22; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on March 23, 2022.
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