Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.

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Federal RegisterDec 28, 2016
81 Fed. Reg. 95647 (Dec. 28, 2016)

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 27, 2017.

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 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 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 September 5, 2016, Johnson Matthey Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid 2010 I
Amphetamine 1100 II
Methylphenidate 1724 II
Codeine 9050 II
Oxycodone 9143 II
Diphenoxylate 9170 II
Hydrocodone 9193 II
Meperidine 9230 II
Methadone 9250 II
Methadone intermediate 9254 II
Morphine 9300 II
Thebaine 9333 II
Opium tincture 9630 II

The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. Thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers.

Dated: December 20, 2016.

Louis J. Milione,

Assistant Administrator.

[FR Doc. 2016-31283 Filed 12-27-16; 8:45 am]

BILLING CODE 4410-09-P