Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2019

[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Page 71474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27952]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-566]

Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc.

ACTION: Notice of application.


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 on or before February 25, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on October 9, 2019, Janssen Pharmaceuticals 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:

Controlled Substance Drug 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.

Dated: December 10, 2019.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2019-27952 Filed 12-26-19; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

Emergency Disaster Relief
National Prescription Drug Take Back Day. Turn in your unused or expired medication for safe disposal here.
RX Abuse Online

U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

DOJ Legal Policies and Disclaimers    |    DOJ Privacy Policy    |    FOIA    |    Section 508 Accessibility