AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
AMRI Rensselaer, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
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 October 1, 2021. Such persons may also file a written request for a hearing on the application on or before October 1, 2021.
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 May 31, 2021, 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 substance(s):
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 |
Morphine | 9300 | II |
Fentanyl | 9801 | II |
The company plans to manufacture the above controlled substances as bulk active pharmaceutical ingredients (API) 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 synthetic. No other activities for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-16337 Filed 7-30-21; 8:45 am]
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