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 on or before October 25, 2019.
ADDRESS:
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 15, 2019, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rennselaer, New York 12144-2951 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Amphetamine | 1100 | II |
| Lisdexamfetamine | 1205 | II |
| Pentobarbital | 2270 | II |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 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 bulk controlled substances 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.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019-18323 Filed 8-23-19; 8:45 am]
BILLING CODE 4410-09-P