Justice Department, Drug Enforcement Administration
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Justice Drug Enforcement Administration [Docket No. 08-6] On November 15, 2012, I, the Administrator of the Drug Enforcement Administration, issued a Declaratory Order in the above-captioned matter. [ 1 ] Therein, I held that Lannett Company, Incorporated's (hereinafter, Lannett) proposed importation of synthetic dronabinol (THC) in finished dosage form, a schedule I controlled substance, for the purpose of conducting stability and bioequivalency studies to support an Abbreviated New Drug Application (ANDA), constitutes “scientific, analytical, or research uses” and is therefore a permissible importation under 21 U.S.C. 952(a)(2)(C) . Declaratory Order, at 36. However, I further held that Lannett had not justified that the quantities of the proposed importations (300,000 dosage units) were “limited quantities” as required by section 952(a)(2)(C). Id. at 35-36. I therefore ordered Lannett to provide justification for the quantities it sought to import. Id. at 40. I also held that upon Lannett's “providing adequate justification for the quantit[ies] of the [proposed] importation[s],” its “registration would be consistent with ( printed page 62699) the public interest.” Id. (citing 21 U.S.C. 823(a) ). [ 2 ] In response, Lannett filed a new application, seeking to import 10,000 dosage units for each of the three dosage strengths for which it intends to file an ANDA. [ 3 ] See Lannett Company, Inc.'s Response To The Adm…
Citation: 78 FR 62698
