Notice2022-03897
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
February 24, 2022
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 Supplemental Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 87 Issue 37 (Thursday, February 24, 2022)</title>
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[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10388-10389]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03897]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-953]
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 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 April 25, 2022.
Such persons may also file a written request for a hearing on the
application on or before April 25, 2022.
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 November 16, 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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Controlled substance Drug code Schedule
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Tetrahydrocannabinols.............. 7370 I
3,4-Methylenedioxyamphetamine...... 7400 I
3,4-Methylenedioxymethamphetamine.. 7405 I
5-Methoxy-N-N-dimethyltryptamine... 7431 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
5-Methoxy-N,N-diisopropyltryptamine 7439 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 code 7370 (Tetrahydrocannabinols), the company plans
to bulk manufacture this drug as a synthetic. No other activities for
these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03897 Filed 2-23-22; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on February 24, 2022.
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