[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-                       9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl.................            9822  I
Amphetamine......................            1100  II
Methamphetamine..................            1105  II
Lisdexamfetamine.................            1205  II
Methylphenidate..................            1724  II
Nabilone.........................            7379  II
4-Anilino-N-phenethyl-4-                     8333  II
 piperidine (ANPP).
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-               9273  II
 dosage forms).
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