[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Notices]
[Page 40211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15920]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-867]


Bulk Manufacturer of Controlled Substances Application: Novitium 
Pharma, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Novitium Pharma, LLC 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 September 27, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 27, 2021.

ADDRESS: 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 June 17, 2021, Novitium Pharma, LLC., 70 Lake Drive, 
East Windsor, New Jersey 08520, 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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Psilocybin..............................    7347  I
Psilocyn................................    7348  I
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    The company plans to bulk manufacture the above controlled 
substances to produce Active Pharmaceutical Ingredient (API) and 
finished dosage forms for clinical trial purposes. No other activities 
for these drug codes are authorized for this registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-15920 Filed 7-26-21; 8:45 am]
BILLING CODE 4410-09-P