81 FR 63221 - Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 178 (September 14, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 178 (September 14, 2016)
| Page Range | 63221-63221 | |
| FR Document | 2016-22075 |
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)] [Notices] [Page 63221] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22075] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing 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 November 14, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 June 29, 2016, Insys Manufacturing LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I ------------------------------------------------------------------------ The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes are authorized for this registration. Dated: September 7, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-22075 Filed 9-13-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices 63221
Controlled substance Schedule
Tetrahydrocannabinols (7370) ..................................................................................................................................................................... I
4-Methyl-2,5-dimethoxyamphetamine (7395) .............................................................................................................................................. I
3,4-Methylenedioxyamphetamine (7400) .................................................................................................................................................... I
Codeine-N-oxide (9053) .............................................................................................................................................................................. I
Difenoxin (9168) .......................................................................................................................................................................................... I
Heroin (9200) ............................................................................................................................................................................................... I
Morphine-N-oxide (9307) ............................................................................................................................................................................. I
Norlevorphanol (9634) ................................................................................................................................................................................. I
Methamphetamine (1105) ........................................................................................................................................................................... II
Phenmetrazine (1631) ................................................................................................................................................................................. II
Methylphenidate (1724) ............................................................................................................................................................................... II
Amobarbital (2125) ...................................................................................................................................................................................... II
Pentobarbital (2270) .................................................................................................................................................................................... II
Secobarbital (2315) ..................................................................................................................................................................................... II
Glutethimide (2550) ..................................................................................................................................................................................... II
Phencyclidine (7471) ................................................................................................................................................................................... II
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) ..................................................................................................................................... II
Phenylacetone (8501) ................................................................................................................................................................................. II
Alphaprodine (9010) .................................................................................................................................................................................... II
Anileridine (9020) ........................................................................................................................................................................................ II
Cocaine (9041) ............................................................................................................................................................................................ II
Dihydrocodeine (9120) ................................................................................................................................................................................ II
Diphenoxylate (9170) .................................................................................................................................................................................. II
Levomethorphan (9210) .............................................................................................................................................................................. II
Levorphanol (9220) ..................................................................................................................................................................................... II
Meperidine (9230) ....................................................................................................................................................................................... II
Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. II
Thebaine (9333) .......................................................................................................................................................................................... II
Noroxymorphone (9668) .............................................................................................................................................................................. II
Alfentanil (9737) .......................................................................................................................................................................................... II
Sufentanil (9740) ......................................................................................................................................................................................... II
The company plans to import the DEPARTMENT OF JUSTICE substances (other than final orders in
listed controlled substances in bulk connection with suspension, denial, or
powder form from foreign sources for Drug Enforcement Administration revocation of registration) has been
the manufacture of analytical reference [Docket No. DEA–392] redelegated to the Deputy Assistant
standards for sale to their customers. Administrator of the DEA Office of
The company plans to import Bulk Manufacturer of Controlled Diversion Control (‘‘Deputy Assistant
analytical reference standards for Substances Application: Insys Administrator’’) pursuant to section 7 of
Manufacturing LLC 28 CFR part 0, appendix to subpart R.
distribution to its customers for research
and analytical purposes. Placement of ACTION: Notice of application. In accordance with 21 CFR
these drug codes onto the company’s 1301.33(a), this is notice that on June
registration does not translate into DATES: Registered bulk manufacturers of 29, 2016, Insys Manufacturing LLC, 811
automatic approval of subsequent the affected basic classes, and Paloma Drive, Suite C, Round Rock,
permit applications to import controlled applicants therefore, may file written Texas 78665–2402 applied to be
substances. Approval of permit comments on or objections to the registered as a bulk manufacturer the
applications will occur only when the issuance of the proposed registration in following basic classes of controlled
registrant’s business activity is accordance with 21 CFR 1301.33(a) on substances:
consistent with what is authorized or before November 14, 2016.
under to 21 U.S.C. 952(a)(2). ADDRESSES: Written comments should Controlled substance Schedule
Authorization will not extend to the be sent to: Drug Enforcement
Administration, Attention: DEA Federal Marihuana (7360) ......................... I
import of FDA approved or non-
Register Representative/ODW, 8701 Tetrahydrocannabinols (7370) ..... I
approved finished dosage forms for
Morrissette Drive, Springfield, Virginia
commercial sale.
22152. The company plans to manufacture
Dated: September 7, 2016. bulk synthetic active pharmaceutical
SUPPLEMENTARY INFORMATION: The
Louis J. Milione, Attorney General has delegated her ingredients (APIs) for product
Deputy Assistant Administrator. authority under the Controlled development and distribution to its
Substances Act to the Administrator of customers. No other activity for these
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2016–22079 Filed 9–13–16; 8:45 am]
BILLING CODE 4410–09–P the Drug Enforcement Administration drug codes are authorized for this
(DEA), 28 CFR 0.100(b). Authority to registration.
exercise all necessary functions with Dated: September 7, 2016.
respect to the promulgation and
Louis J. Milione,
implementation of 21 CFR part 1301,
incident to the registration of Deputy Assistant Administrator.
manufacturers, distributors, dispensers, [FR Doc. 2016–22075 Filed 9–13–16; 8:45 am]
importers, and exporters of controlled BILLING CODE 4410–09–P
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Document Created: 2016-09-14 02:27:10
Document Modified: 2016-09-14 02:27:10
| 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 November 14, 2016. | |
| FR Citation | 81 FR 63221 |
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