[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Page 59199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23282]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-916]


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 December 27, 
2021. Such persons may also file a written request for a hearing on the 
application on or before December 27, 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 September 8, 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..............................    7437  I
Psilocyn................................    7438  I
Levorphanol.............................    9220  II
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    The company plans to bulk manufacture drug codes 7438 and 7437 to 
produce Active Pharmaceutical Ingredient (API) and finished dosage 
forms for use in clinical trial studies only. In reference to drug code 
9220, the company plans to bulk manufacture this drug code to support 
commercial drug product manufacturing and drug development purposes. No 
other activities for these drug codes are authorized for this 
registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23282 Filed 10-25-21; 8:45 am]
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