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Bulk Manufacturer of Controlled Substances Application: PCI Synthesis

PCI Synthesis, 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 dru...

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Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-776]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

PCI Synthesis, 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 April 19, 2021. Such persons may also file a written request for a hearing on the application on or before April 19, 2021.

ADDRESS:

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 24, 2020, PCI Synthesis, 9 Opportunity Way, Newburyport, Massachusetts 01950-0195, applied to be registered as a bulk ( printed page 9540) manufacturer of the following basic class(es) of controlled substance(s):

Controlled substance Drug code Schedule
Amphetamine 1100 II
Methamphetamine 1105 II

The company plans to use the listed controlled substances to develop manufacturing processes, and conduct analytical and stability testing. The company has demonstrated and received patent numbers U.S. 9,278,904 and U.S. 9,321,794 from the U.S. Patent Office for the synthesis process for amphetamines.

William T. McDermott,

Assistant Administrator.

[FR Doc. 2021-02973 Filed 2-12-21; 8:45 am]

BILLING CODE P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

86 FR 9539

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Suggested Web Citation

Use this when citing the archival web version of the document.

“Bulk Manufacturer of Controlled Substances Application: PCI Synthesis,” thefederalregister.org (February 16, 2021), https://thefederalregister.org/documents/2021-02973/bulk-manufacturer-of-controlled-substances-application-pci-synthesis.