[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Page 46906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11821]
[[Page 46906]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1369]
Importer of Controlled Substances Application: Veranova, L.P.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Veranova, L.P. has applied to be registered as an importer 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
July 1, 2024. Such persons may also file a written request for a
hearing on the application on or before July 1, 2024.
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. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: 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. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on April 8, 2024, Veranova, L.P., 2003 Nolte Drive, West
Deptford, New Jersey 08066-1727, 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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Coca Leaves............................. 9040 II
Thebaine................................ 9333 II
Opium, raw.............................. 9600 II
Noroxymorphone.......................... 9668 II
Poppy Straw Concentrate................. 9670 II
Fentanyl................................ 9801 II
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The company plans to import Coca Leaves (9040), Opium, raw (9600),
and Poppy Straw Concentrate (9670) in order to bulk manufacture Active
Pharmaceutical Ingredients (API) for distribution to its customers. The
company plans to also import Thebaine (9333), Noroxymorphone (9668),
and Fentanyl (9801) to use as analytical reference standards, both
internally and to be sold to their customers to support testing of
Veranova, L.P. APIs 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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-11821 Filed 5-29-24; 8:45 am]
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