Bulk Manufacturer of Controlled Substances Application: Insys Therapeutics, Inc., 9220 [2016-03855]

Download as PDF 9220 Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices Controlled substance Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Remifentanil (9739) ...................... Fentanyl (9801) ............................ I I II II II The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug code 7360, marihuana, the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinols (7370). No other activity for this drug code is authorized for this registration. Dated: February 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–03853 Filed 2–23–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Chemtos, LLC ACTION: Notice of registration. Chemtos, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Chemtos, LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57389, Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, Texas 78737– 9331 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Chemtos, LLC to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Feb 23, 2016 Jkt 238001 physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Marihuana (7360) ......................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Etorphine HCI (9059) ................... Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Isomethadone (9226) ................... Meperidine (9230) ........................ Meperidine intermediate–A (9232) Meperidine intermediate–B (9233) Meperidine intermediate–C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Dihydroetorphine (9334) ............... Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Racemethorphan (9732) .............. Racemorphan (9733) ................... Schedule I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture small quantities of the listed controlled substances in bulk for distribution to its customers for use as reference standards. Dated: February 16, 2016. Louis J. Milione, Deputy Assistant Administrator. The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA). SUMMARY: 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 April 25, 2016. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated her authority under the Controlled Substances Act to the 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 November 12, 2015, Insys Therapeutics, Inc., 2700 Oakmont, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Schedule I I [FR Doc. 2016–03856 Filed 2–23–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Insys Therapeutics, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug codes 7360, marihuana, and 7370, tetrahydrocannabinols, the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration. Dated: February 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–03855 Filed 2–23–16; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03855]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Insys 
Therapeutics, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: The Attorney General has delegated her authority under the 
Controlled Substances Act to the Administrator of the Drug Enforcement 
Administration (DEA).

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 April 25, 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 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 
November 12, 2015, Insys Therapeutics, Inc., 2700 Oakmont, Round Rock, 
Texas 78665 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers. In reference to 
drug codes 7360, marihuana, and 7370, tetrahydrocannabinols, the 
company plans to bulk manufacture both as synthetic substances. No 
other activity for these drug codes is authorized for this 
registration.

    Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03855 Filed 2-23-16; 8:45 am]
 BILLING CODE 4410-09-P
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