Notice2022-05314
Bulk Manufacturer 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
March 14, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Janssen Pharmaceuticals Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 87 Issue 49 (Monday, March 14, 2022)</title>
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[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Page 14290]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05314]
[[Page 14290]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-982]
Bulk Manufacturer 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
a bulk manufacturer 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
May 13, 2022. Such persons may also file a written request for a
hearing on the application on or before May 13, 2022.
ADDRESSES: DEA 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.''
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on December 10, 2021, Janssen Pharmaceuticals Inc., 1440
Olympic Drive Athens, Georgia 30601-1645, 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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Methylphenidate........................ 1724 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Oripavine.............................. 9330 II
Thebaine............................... 9333 II
Tapentadol............................. 9780 II
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The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers. No other
activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-05314 Filed 3-11-22; 8:45 am]
BILLING CODE P
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