Skip to Content

Notice

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

This document has a comment period that ends in 6 days. (09/25/2017) Submit a formal comment

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 September 25, 2017.

ADDRESSES:

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

End Preamble Start Supplemental Information

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 March 30, 2017, 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 substanceDrug codeSchedule
Marihuana7360I
Tetrahydrocannabinols7370I
Amphetamine1100II
Lisdexamfetamine1205II
Methylphenidate1724II
Pentobarbital2270II
4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
Codeine9050II
Oxycodone9143II
Hydromorphone9150II
Hydrocodone9193II
Meperidine9230II
Morphine9300II
Fentanyl9801II

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

In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

Start Signature

Dated: July 19, 2017.

Demetra Ashley,

Acting Assistant Administrator.

End Signature End Supplemental Information

[FR Doc. 2017-15688 Filed 7-25-17; 8:45 am]

BILLING CODE 4410-09-P