[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26070-26071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09988]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-826]


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 file written comments on or objections to 
the issuance of the proposed registration on or before July 12, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before July 12, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on March 18, 2021, 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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        Controlled substance            Drug code          Schedule
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Gamma Hydroxybutyric Acid..........            2010  I
Tetrahydrocannabinols..............            7370  I
5-Methoxy-N-N-Dimethyltryptamine...            7431  I
a-Methyltryptamine.................            7432  I
Psilocybin.........................            7437  I
Thebaine...........................            9333  II
Oxymorphone........................            9652  II
Noroxymorphone.....................            9668  II
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[[Page 26071]]

    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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-09988 Filed 5-11-21; 8:45 am]
BILLING CODE P