[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Page 10353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03363]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-788]


Bulk Manufacturer of Controlled Substances Application: Patheon 
API Manufacturing, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Patheon API Manufacturing, Inc., has applied to be registered 
as a bulk manufacturer of basic class(es) of controlled substance(s). 
Refer to Supplemental 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 April 20, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before April 20, 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 November 12, 2020, Patheon API Manufacturing, Inc., 
309 Delaware Street, Greenville, South Carolina 29605, applied to be 
registered as an bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols..................    7370  I
5-Methoxy-N-N-Dimethyltryptamine.......    7431  I
Psilocybin.............................    7437  I
Oxymorphone............................    9652  II
------------------------------------------------------------------------

    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 these 
drugs as synthetic. No other activities for these drug codes are 
authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-03363 Filed 2-18-21; 8:45 am]
BILLING CODE P