[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Page 8245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03357]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Mallinckrodt, 
LLC

ACTION: Notice of registration.

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SUMMARY: Mallinckrodt, LLC applied to be registered as a manufacturer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants Mallinckrodt, LLC registration as a 
manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and 
published in the Federal Register on September 23, 2015, 80 FR 57388, 
Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 
63147 applied to be registered as a manufacturer of certain basic 
classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Mallinckrodt, LLC to manufacture 
the basic classes of controlled substances is consistent with the 
public interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. The DEA 
investigated the company's maintenance of effective controls against 
diversion by inspecting and testing the company's physical security 
systems, verifying the company's compliance with state and local laws, 
and reviewing the company's background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the following basic classes of controlled substances:

 
------------------------------------------------------------------------
            Controlled substance                       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-  I
 yl)-N-phenylacetamide) (9821).
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
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)  II
 (9273).
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
------------------------------------------------------------------------

    The company plans to manufacturer bulk active pharmaceutical 
ingredients (API) for distribution to its customers.

    Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03357 Filed 2-17-16; 8:45 am]
 BILLING CODE 4410-09-P