85 FR 76 pg. 21890 - Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Type: NOTICEVolume: 85Number: 76Page: 21890
Page: 21890Docket number: [Docket No. DEA-622]
FR document: [FR Doc. 2020-08330 Filed 4-17-20; 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-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