Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

CourtDrug Enforcement Administration
Citation87 FR 14290
Published date14 March 2022
Record Number2022-05314
Federal Register, Volume 87 Issue 49 (Monday, March 14, 2022)
[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
                [Notices]
                [Page 14290]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [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.
                -----------------------------------------------------------------------
                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 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 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):
                ------------------------------------------------------------------------
                 Drug
                 Controlled substance code Schedule
                ------------------------------------------------------------------------
                Methylphenidate........................ 1724 II
                Hydromorphone.......................... 9150 II
                Hydrocodone............................ 9193 II
                Oripavine.............................. 9330 II
                Thebaine............................... 9333 II
                Tapentadol............................. 9780 II
                ------------------------------------------------------------------------
                 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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