Notice2021-16337
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 2, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 145 (Monday, August 2, 2021)</title>
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[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Page 41517]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]
BILLING CODE P
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</html>Indexed from Federal Register on August 2, 2021.
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