[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Page 54353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17136]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1242]


Bulk Manufacturer of Controlled Substances Application: Continuus 
Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Continuus Pharmaceuticals 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
October 10, 2023. Such persons may also file a written request for a 
hearing on the application on or before October 10, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for submitting comments. Upon 
submission of your comment, you will receive a Comment Tracking Number. 
Please be aware that submitted comments are not instantaneously 
available for public view on https://www.regulations.gov. If you have 
received a Comment Tracking Number, your comment has been successfully 
submitted and there is no need to resubmit the same comment.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on July 6, 2023, Continuus Pharmaceuticals, 256 West 
Cummings Park, Woburn, Massachusetts 01801, 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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Fentanyl...............................     9801  II
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    The company plans to bulk manufacture the above listed controlled 
substance for research and development purposes only. No other 
activities for these drug codes are 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.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17136 Filed 8-9-23; 8:45 am]
BILLING CODE 4410-09-P