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Manufacturers Notice of Application - 2018

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Page 27632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12685]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

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

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 August 13, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 January 1, 2018, Johnson Matthey Pharmaceutical Materials Inc., 25 Patton Road, Devens, MA 01434 applied to be registered as a bulk manufacturer for the basic classes of controlled substances:

Controlled Substance 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 utilize this facility to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers as well as to conduct analytical testing in support of the company's primary manufacturing facility in West Deptford, New Jersey.

Dated: June 6, 2018.

John J. Martin,
Assistant Administrator.

[FR Doc. 2018-12685 Filed 6-12-18; 8:45 am]

BILLING CODE 4410-09-P

 

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

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