[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58692-58693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23032]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-911]


Importer 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 an 
importer 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 November 22, 
2021. Such persons may also file a written request for a hearing on the 
application on or before November 22, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn:

[[Page 58693]]

Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 
22152; and (2) Drug Enforcement Administration, Attn: DEA Federal 
Register Representative/DPW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(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 an 
importer of the following basic class(es) of controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Levorphanol.............................   9220  II
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    The company plans to import the listed controlled substance 
Levorphanol to develop the manufacturing process for a drug product 
that will in turn be used to produce a tablet equivalent to the current 
brand product. No other activity for this drug code is authorized for 
this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23032 Filed 10-21-21; 8:45 am]
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