[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20762]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-896]


Bulk Manufacturer of Controlled Substances Application: PCI 
Synthesis

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: PCI Synthesis 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 November 23, 
2021. Such persons may also file a written request for a hearing on the 
application on or before November 23, 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 30, 2021, PCI Synthesis, 9 Opportunity Way, 
Newburyport, Massachusetts 01950-0195, 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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Amphetamine............................     1100  II
Methamphetamine........................     1105  II
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    The company plans to develop manufacturing processes, conduct 
analytical method validation and conduct bulk product stability 
studies.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-20762 Filed 9-23-21; 8:45 am]
BILLING CODE P