Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials, 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 April 8, 2019.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701
( printed page 2580)
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 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 8, 2018, Johnson Matthey Pharmaceutical Materials, Inc., 25 Patton Road, Devens, Massachusetts 01434 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
Controlled
substances
Drug
code
Schedule
Amphetamine
1100
II
Methylphenidate
1724
II
Nabilone
7379
II
Hydrocodone
9193
II
Levorphanol
9220
II
Alfentanil
9737
II
Remifentanil
9739
II
Sufentanil
9740
II
The company plans to support its other manufacturing facilities located in West Deptford, New Jersey and Conshohocken, Pennsylvania with manufacturing and analytical testing.