Notice2023-01202
Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 23, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Janssen Pharmaceuticals Inc. 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.
Full Text
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<title>Federal Register, Volume 88 Issue 14 (Monday, January 23, 2023)</title>
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[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Page 4021]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01202]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1130]
Importer of Controlled Substances Application: Janssen
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Janssen Pharmaceuticals Inc. 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
February 22, 2023. Such persons may also file a written request for a
hearing on the application on or before February 22, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 December 1, 2022, Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645,
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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Methylphenidate........................ 1724 II
Thebaine............................... 9333 II
Poppy Straw Concentrate................ 9670 II
Tapentadol............................. 9780 II
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The company plans to import intermediates classified under
Tapentadol (9780) and Thebaine (9333) for further manufacturing to the
controlled substances Tapentadol and Buprenorpine, respectively, prior
to distribution to customers. The company plans to import Poppy Straw
Concentrate (9670) to bulk manufacture other controlled substances. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01202 Filed 1-20-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on January 23, 2023.
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