Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC, 60899-60900 [2018-25862]

Download as PDF 60899 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices Company FR Docket Alcami Carolinas Corporation ............................................. 83 FR 46758 ...................................................................... The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic classes of schedule I 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 the company’s 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I controlled substances to the above listed company. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25863 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: GE Healthcare ACTION: Notice of application. 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 December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement amozie on DSK3GDR082PROD with NOTICES1 DATES: Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 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 1301.34(a), this is notice that on September 5, 2018, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004, applied to be registered as an importer of cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of Ioflupane, in the form of three separate analogues of cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. Supplies of this particular controlled substance are not available in the form needed within the current domestic supply of the United States. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25864 Filed 11–26–18; 8:45 am] Published DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC ACTION: Notice of application. 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 January 28, 2019. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 October 4, 2018, Insys Manufacturing, LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P Controlled substance Drug code Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 September 14, 2018. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 7360 7370 Schedule I I 60900 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices 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: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25862 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 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 1301.34(a), this is notice that on September 27, 2018, Fisher Clinical Services, Inc., 700A–C Nestle Way, Breinigsville, Pennsylvania 18031, has applied to be registered as an importer of the below listed basic classes of controlled substances listed in schedule I & II. Controlled substance Drug code Psilocybin ................................................................................................................................................................. Methylphenidate ....................................................................................................................................................... Levorphanol ............................................................................................................................................................. Noroxymorphone ..................................................................................................................................................... Tapentadol ............................................................................................................................................................... The company plans to import the listed controlled substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. DEPARTMENT OF JUSTICE Dated: November 16, 2018. John J. Martin, Assistant Administrator. ACTION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company Notice of application. 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 January 28, 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 DATES: [FR Doc. 2018–25872 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P amozie on DSK3GDR082PROD with NOTICES1 Drug Enforcement Administration Jkt 247001 PO 00000 Frm 00080 Fmt 4703 I II II II II Drug code 3-Fluoro-N-methylcathinone (3–FMC) ....................................................................................................................... Cathinone ................................................................................................................................................................... Methcathinone ............................................................................................................................................................ 4-Fluoro-N-methylcathinone (4–FMC) ....................................................................................................................... 17:45 Nov 26, 2018 7437 1724 9220 9668 9780 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 July 25, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: Controlled substance VerDate Sep<11>2014 Schedule Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 1233 1235 1237 1238 Schedule I I I I

Agencies

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60899-60900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25862]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Insys 
Manufacturing, LLC

ACTION: Notice of application.

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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 on or before January 28, 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 
October 4, 2018, Insys Manufacturing, LLC, 811 Paloma Drive, Suite C, 
Round Rock, Texas 78665, applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Marihuana...............................            7360               I
Tetrahydrocannabinols...................            7370               I
------------------------------------------------------------------------


[[Page 60900]]

    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: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25862 Filed 11-26-18; 8:45 am]
 BILLING CODE 4410-09-P