Bulk Manufacturer of Controlled Substances Application: Navinta LLC
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 22, 2019.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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 delegated 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 September 13, 2018, Navinta, LLC., 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
Controlled substance
Drug code
Schedule
Pentobarbital
2270
II
4-Anilino-N-phenethyl-4-piperidine (ANPP)
8333
II
Levorphanol
9220
II
Remifentanil
9739
II
Fentanyl
9801
II
The company plans to manufacture the listed controlled substances in bulk for sale to its customers.