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

Manufacturers Notice of Application - 2018

[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Page 7221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03293]


Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.

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 April 23, 2018.

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 Deputy Assistant Administrator of the DEA Office of Diversion Control ("Deputy 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 09, 2017, Johnson Matthey Inc., 2003 Nolte Drive, West Deptford, NJ 08066, 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
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Dihydromorphine 9145 I
Difenoxin 9168 I
Propiram 9649 I
Amphetamine 1100 II
Methamphetamine 1105 II
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
Nabilone 7379 II
Cocaine 9041 II
Codeine 9050 II
Dihydrocodeine 9120 II
Oxycodone 9143 II
Hydromorphone 9150 II
Diphenoxylate 9170 II
Ecgonine 9180 II
Hydrocodone 9193 II
Meperidine 9230 II
Methadone 9250 II
Methadone intermediate 9254 II
Morphine 9300 II
Thebaine 9333 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 manufacture the above-listed controlled substances in bulk for sale to its customers. Thebaine (9333) will be used to manufacture other controlled substances for sale in bulk 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.

Dated: February 6, 2018.

Susan A. Gibson,
Deputy Assistant Administrator.

[FR Doc. 2018-03293 Filed 2-16-18; 8:45 am]



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