82 FR 23066 - Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 96 (May 19, 2017)

Page Range23066-23067
FR Document2017-10230

Federal Register, Volume 82 Issue 96 (Friday, May 19, 2017)
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23066-23067]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10230]


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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 in accordance with 21 CFR 
1301.33(a) on or before July 18, 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

[[Page 23067]]

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 March 
21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, 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 bulk synthetic active 
pharmaceutical ingredients (APIs) for product development and 
distribution to its customers. No other activity for these drug codes 
is authorized for this registration.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10230 Filed 5-18-17; 8:45 am]
BILLING CODE 4410-09-P


Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered 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 July 18, 2017.
FR Citation82 FR 23066 

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