83 FR 5275 - Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 25 (February 6, 2018)

[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Page 5275]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02341]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cedarburg 
Pharmaceuticals

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 April 9, 2018.

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 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 
29, 2017, Cedarburg Pharmaceuticals, Inc., A Division of Albany 
Molecular Research Inc. (AMRI), 870 Badger Circle, Grafton, Wisconsin 
53024 applied to be registered as a bulk manufacturer the following 
basic classes of controlled substances:

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Marihuana..............................    7360  I
Tetrahydrocannabinols..................    7370  I
Lisdexamfetamine.......................    1205  II
Pentobarbital..........................    2270  II
Nabilone...............................    7379  II
4-Anilino-N-phenethyl-4-piperidine         8333  II
 (ANPP).
Remifentanil...........................    9739  II
Fentanyl...............................    9801  II
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    The company plans to manufacture the above listed controlled 
substances in bulk for distribution to its customers. In reference to 
drug codes 7360 marihuana, the company plans to bulk manufacture 
cannabidiol as a synthetic intermediate. The company plans to 
manufacture bulk active pharmaceutical ingredients (API) for 
distribution to its customers. 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: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02341 Filed 2-5-18; 8:45 am]
 BILLING CODE 4410-09-P