80 FR 235 pg. 76311 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, Inc.
Type: NOTICEVolume: 80Number: 235Page: 76311
Page: 76311Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2015-30811 Filed 12-7-15; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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 in accordance with 21 CFR 1301.33(a) on or before February 8, 2016.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/OD/D, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearing should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control ("Deputy 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 October 26, 2015, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434 applied to be registered as a bulk manufacturer of the following basic classes controlled substances:
| Controlled substance | Schedule |
|---|---|
| Amphetamine (1100) | II |
| Methylphenidate (1724) | II |
| Nabilone (7379) | II |
| Hydrocodone (9193) | 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 and to conduct analytical testing in support of the company's primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to its customers.
Dated: November 30, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30811 Filed 12-7-15; 8:45 am]
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