Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.

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Federal RegisterDec 28, 2016
81 Fed. Reg. 95639 (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 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 September 26, 2016, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substance Drug code Schedule
Codeine 9050 II
Oxycodone 9143 II
Hydromorphone 9150 II
Hydrocodone 9193 II
Morphine 9300 II

The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers.

Dated: December 20, 2016.

Louis J. Milione,

Assistant Administrator.

[FR Doc. 2016-31284 Filed 12-27-16; 8:45 am]

BILLING CODE 4410-09-P