Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2020

[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Page 21890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08330]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-622]

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

ACTION: Notice of application.


DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before June 19, 2020.

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

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on March 9, 2020, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144-2951, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:

Controlled Substance Drug Code Schedule
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Amphetamine 1100 II
Lisdexamfetamine 1205 II
Pentobarbital 2270 II
ANPP (4-Anilino-N-phenethyl-4-piperidine) 8333 II
Codeine 9050 II
Oxycodone 9143 II
Hydromorphone 9150 II
Hydrocodone 9193 II
Meperidine 9230 II
Morphine 9300 II
Fentanyl 9801 II

The company plans to manufacture the above controlled substances as bulk active pharmaceutical ingredients (APIs) for use in product development and for distribution to its customers. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2020-08330 Filed 4-17-20; 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 Publishing Office (GPO).

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