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Notice

Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC

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Information about this document as published in the Federal Register.

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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.

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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 substanceDrug codeSchedule
Gamma Hydroxybutyric Acid2010I
Tetrahydrocannabinols7370I
Codeine-N-oxide9053I
Dihydromorphine9145I
Difenoxin9168I
Morphine-N-oxide9307I
Normorphine9313I
Norlevorphanol9634I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821I
Butyryl Fentanyl9822I
Amphetamine1100II
Methamphetamine1105II
Lisdexamfetamine1205II
Methylphenidate1724II
Nabilone7379II
4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
Codeine9050II
Dihydrocodeine9120II
Oxycodone9143II
Hydromorphone9150II
Diphenoxylate9170II
Ecgonine9180II
Hydrocodone9193II
Levorphanol9220II
Meperidine9230II
Methadone9250II
Methadone intermediate9254II
Dextropropoxyphene, bulk (non-dosage forms)9273II
Morphine9300II
Oripavine9330II
Thebaine9333II
Opium tincture9630II
Opium, powdered9639II
Oxymorphone9652II
Noroxymorphone9668II
Alfentanil9737II
Remifentanil9739II
Sufentanil9740II
Tapentadol9780II
Fentanyl9801II
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The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.

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Louis J. Milione,

Assistant Administrator.

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[FR Doc. 2017-04645 Filed 3-8-17; 8:45 am]

BILLING CODE 4410-09-P