Notice2021-20762
Bulk Manufacturer of Controlled Substances Application: PCI Synthesis
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
September 24, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 183 (Friday, September 24, 2021)</title>
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[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53117]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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