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

Manufacturers Notice of Application - 2017

[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13136-13137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04645]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC

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 in accordance with 21 CFR 1301.33(a) on or before May 8, 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 his 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 November 14, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled Substance Drug Code Schedule
Gamma Hydroxybutyric Acid 2010 I
Tetrahydrocannabinols 7370 I
Codeine-N-oxide 9053 I
Dihydromorphine 9145 I
Difenoxin 9168 I
Morphine-N-oxide 9307 I
Normorphine 9313 I
Norlevorphanol 9634 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I
Butyryl Fentanyl 9822 I
Amphetamine 1100 II
Methamphetamine 1105 II
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
Nabilone 7379 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II
Codeine 9050 II
Dihydrocodeine 9120 II
Oxycodone 9143 II
Hydromorphone 9150 II
Diphenoxylate 9170 II
Ecgonine 9180 II
Hydrocodone 9193 II
Levorphanol 9220 II
Meperidine 9230 II
Methadone 9250 II
Methadone intermediate 9254 II
Dextropropoxyphene, bulk (non-dosage forms) 9273 II
Morphine 9300 II
Oripavine 9330 II
Thebaine 9333 II
Opium tincture 9630 II
Opium, powdered 9639 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Alfentanil 9737 II
Remifentanil 9739 II
Sufentanil 9740 II
Tapentadol 9780 II
Fentanyl 9801 II

[[Page 13137]]

The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.

Louis J. Milione,
Assistant Administrator.

[FR Doc. 2017-04645 Filed 3-8-17; 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 Printing Office (GPO).

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

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