Notice2021-18234
Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics 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 25, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Benuvia Therapeutics Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Full Text
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<title>Federal Register, Volume 86 Issue 162 (Wednesday, August 25, 2021)</title>
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[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Page 47521]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18234]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-872]
Bulk Manufacturer of Controlled Substances Application: Benuvia
Therapeutics Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Benuvia Therapeutics Inc., has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to SUPPLEMENTARY 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 25,
2021. Such persons may also file a written request for a hearing on the
application on or before October 25, 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 July 1, 2021, Benuvia Therapeutics Inc., 2700 Oakmont
Drive, Round Rock, Texas 78665, 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
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The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. The company plans to manufacture the above-listed controlled
substances in bulk to produce finished dosage forms and conduct
research to develop new drug products and for clinical studies. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-18234 Filed 8-24-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on August 25, 2021.
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