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 in accordance with 21 CFR 1301.33(a) on or before May 8, 2017.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
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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 November 14, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
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|Controlled substance||Drug code||Schedule|
|Gamma Hydroxybutyric Acid||2010||I|
|Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)||9821||I|
|Dextropropoxyphene, bulk (non-dosage forms)||9273||II|
The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.
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Louis J. Milione,
[FR Doc. 2017-04645 Filed 3-8-17; 8:45 am]
BILLING CODE 4410-09-P