[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Page 41517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16337]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-877]


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

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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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):

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