Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, Inc.

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Federal RegisterFeb 7, 2019
84 Fed. Reg. 2579 (Feb. 7, 2019)

ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 8, 2019.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.33(a), this is notice that on November 8, 2018, Johnson Matthey Pharmaceutical Materials, Inc., 25 Patton Road, Devens, Massachusetts 01434 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substances Drug code Schedule
Amphetamine 1100 II
Methylphenidate 1724 II
Nabilone 7379 II
Hydrocodone 9193 II
Levorphanol 9220 II
Alfentanil 9737 II
Remifentanil 9739 II
Sufentanil 9740 II

The company plans to support its other manufacturing facilities located in West Deptford, New Jersey and Conshohocken, Pennsylvania with manufacturing and analytical testing.

Dated: December 21, 2018.

John J. Martin,

Assistant Administrator.

[FR Doc. 2019-01507 Filed 2-6-19; 8:45 am]

BILLING CODE 4410-09-P