| Page Range | 13136-13137 | |
| FR Document | 2017-04645 |
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)] [Notices] [Pages 13136-13137] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04645] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC 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 May 8, 2017. 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 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 14, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 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 Tetrahydrocannabinols............ 7370 I Codeine-N-oxide.................. 9053 I Dihydromorphine.................. 9145 I Difenoxin........................ 9168 I Morphine-N-oxide................. 9307 I Normorphine...................... 9313 I Norlevorphanol................... 9634 I Acetyl Fentanyl (N-(1- 9821 I phenethylpiperidin-4-yl)-N- phenylacetamide). Butyryl Fentanyl................. 9822 I Amphetamine...................... 1100 II Methamphetamine.................. 1105 II Lisdexamfetamine................. 1205 II Methylphenidate.................. 1724 II Nabilone......................... 7379 II 4-Anilino-N-phenethyl-4- 8333 II piperidine (ANPP). Codeine.......................... 9050 II Dihydrocodeine................... 9120 II Oxycodone........................ 9143 II Hydromorphone.................... 9150 II Diphenoxylate.................... 9170 II Ecgonine......................... 9180 II Hydrocodone...................... 9193 II Levorphanol...................... 9220 II Meperidine....................... 9230 II Methadone........................ 9250 II Methadone intermediate........... 9254 II Dextropropoxyphene, bulk (non- 9273 II dosage forms). Morphine......................... 9300 II Oripavine........................ 9330 II Thebaine......................... 9333 II Opium tincture................... 9630 II Opium, powdered.................. 9639 II Oxymorphone...................... 9652 II Noroxymorphone................... 9668 II Alfentanil....................... 9737 II Remifentanil..................... 9739 II Sufentanil....................... 9740 II Tapentadol....................... 9780 II Fentanyl......................... 9801 II ------------------------------------------------------------------------ [[Page 13137]] The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers. Louis J. Milione, Assistant Administrator. [FR Doc. 2017-04645 Filed 3-8-17; 8:45 am] BILLING CODE 4410-09-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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 May 8, 2017. | |
| FR Citation | 82 FR 13136 |