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Notice

Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.

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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 December 19, 2016.

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 her 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 Office of Diversion Control (“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 September 5, 2016, Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742 applied to be registered as a bulk manufacturer the following basic classes of controlled substances:

Controlled SubstanceDrug codeSchedule
Gamma Hydroxybutyric Acid2010I
Marihuana7360I
Tetrahydrocannabinols7370I
Dihydromorphine9145I
Difenoxin9168I
Propiram9649I
Amphetamine1100II
Methamphetamine1105II
Lisdexamfetamine1205II
Methylphenidate1724II
Nabilone7379II
Cocaine9041II
Codeine9050II
Dihydrocodeine9120II
Oxycodone9143II
Hydromorphone9150II
Diphenoxylate9170II
Ecgonine9180II
Hydrocodone9193II
Meperidine9230II
Methadone9250II
Methadone intermediate9254II
Morphine9300II
Thebaine9333II
Oxymorphone9652II
Noroxymorphone9668II
Alfentanil9737II
Remifentanil9739II
Sufentanil9740II
Tapentadol9780II
Fentanyl9801II

The company plans to manufacture the listed controlled substances in bulk for sale to its customers.

In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

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Dated: October 11, 2016.

Louis J. Milione,

Assistant Administrator.

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[FR Doc. 2016-25133 Filed 10-17-16; 8:45 am]

BILLING CODE 4410-09-P