2021-02973. Bulk Manufacturer of Controlled Substances Application: PCI Synthesis

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 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.