Notices. Notice of application
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/register/2018/02/06/2018-02341A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals ACTION: Notice of application. 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: Controlled substance Drug code Schedule Marihuana 7360 I Tetrahydrocannabinols 7370 I Lisdexamfetamine 1205 II Pentobarbital 2270 II Nabilone 7379 II 4-Anilino-N-phenethyl-4-piperidine
(ANPP)8333 II Remifentanil 9739 II Fentanyl 9801 II 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]
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- 21 CFR 1301
- 28 CFR 0
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