Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Department of Justice Drug Enforcement Administration [Docket No. DEA-392] ACTION: Notice of application. DATES: Registered bulk manufacturers of the affected basic classes, and...
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 on or before March 19, 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 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 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on November 10, 2017, Johnson Matthey Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428 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
Amphetamine
1100
II
Methylphenidate
1724
II
Codeine
9050
II
Oxycodone
9143
II
Diphenoxylate
9170
II
Hydrocodone
9193
II
Meperidine
9230
II
Methadone
9250
II
Methadone intermediate
9254
II
Morphine
9300
II
Thebaine
9333
II
Opium tincture
9630
II
( printed page 2216)
The company plans to manufacture the listed controlled substances in bulk for either internal use or for sale to its customers. Thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers.