Rules and Regulations. Notice of application

Agency: Drug Enforcement Administration, Justice
Action: Notice of application
Citation: FR Doc. 2020-26912 · Docket No. DEA-747

Summary

Johnson Matthey Inc. has applied to be registered as an importer 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 January 7, 2021. Such persons may also file a written request for a hearing on the application on or before January 7, 2021.

Supplementary Information

In accordance with 21 CFR 1301.34(a), this is notice that on November 2, 2020, Johnson Matthey Inc., 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Schedule Coca Leaves 9040 II Thebaine 9333 II Opium, raw 9600 II Noroxymorphone 9668 II Poppy Straw Concentrate 9670 II Fentanyl 9801 II The company plans to import Coca Leaves (9040), Opium, raw (9600), and Poppy Straw Concentrate (9670) in order to bulk manufacture Active Pharmaceutical Ingredients (API) for distribution to its customers. The company plans to also import Thebaine (9333), Noroxymorphone (9668), and Fentanyl (9801) to use as analytical reference standards, both internally and to be sold to their customers to support testing of Johnson Matthey Inc.'s API's only. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2020-26912 Filed 12-7-20; 8:45 am]