Rules and Regulations. Notice of application
/register/2023/09/15/2023-19989·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Agency: Drug Enforcement Administration, Justice
Action: Notice of application
Citation: FR Doc. 2023-19989 · Docket No. DEA-1248
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 submit electronic comments on or objections to the issuance of the proposed registration on or before November 14, 2023. Such persons may also file a written request for a hearing on the application on or before November 14, 2023.
Supplementary Information
In accordance with 21 CFR 1301.33(a), this is notice that on March 30, 2023, 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 develop manufacturing processes, conduct analytical method validation and conduct bulk product stability studies. No other activities for these drug codes are authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023-19989 Filed 9-14-23; 8:45 am]