[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Page 5275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
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Drug
Controlled substance code Schedule
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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