[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Page 16498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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]
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