Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC, 54611 [2018-23696]

Download as PDF Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices Dated: October 11, 2018. John J. Martin, Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2018–23684 Filed 10–29–18; 8:45 am] 54611 Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23696 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–392] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration ACTION: Notice of application. [Docket No. DEA–392] [Docket No. DEA–392] ACTION: Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as bulk manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUMMARY: Company khammond on DSK30JT082PROD with NOTICES Johnson Matthey Pharmaceutical Materials Inc. Alcami Wisconsin Corporation. FR docket Published 83 FR 27632. June 13, 2018. 83 FR 27628. June 13, 2018. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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 each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed companies. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23698 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 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 31, 2018. DATES: Bulk Manufacturer of Controlled Substances Registration 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 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 August 22, 2018, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665–1019 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Marihuana ......... Tetrahydrocannabinols. 7360 7370 Schedule I 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. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Importer of Controlled Substances Application: United States Pharmacopeial Convention 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 November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 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 August 17, 2018, United States Pharmacopeial DATES: E:\FR\FM\30OCN1.SGM 30OCN1

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[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Page 54611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23696]


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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 December 31, 2018.

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 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 August 
22, 2018, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, 
Texas 78665-1019 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
------------------------------------------------------------------------

    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: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23696 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P