[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10388-10389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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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[[Page 10389]]

    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]
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