Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016)
Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)
Notices
Pages 96045-96046
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-31641
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Docket No. DEA-392
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
ACTION: Notice of application.
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DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before February 27, 2017.
ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on September 9, 2016, Janssen Pharmaceutical, Inc., Buildings 1-5 & 7-14, 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
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Controlled substance Drug code Schedule
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Methylphenidate................................... 1724 II
Oxycodone......................................... 9143 II
Hydromorphone..................................... 9150 II
Hydrocodone....................................... 9193 II
Oripavine......................................... 9330 II
Thebaine.......................................... 9333 II
Oxymorphone....................................... 9652 II
Tapentadol........................................ 9780 II
Fentanyl.......................................... 9801 II
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The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers.
Page 96046
Dated: December 21, 2016.
Louis J. Milione,
Assistant Administrator.
FR Doc. 2016-31641 Filed 12-28-16; 8:45 am
BILLING CODE 4410-09-P
