4 OTC, Inc.; Decision and Order

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. 10-51] On September 22, 2011, Administrative Law Judge (ALJ) Gail A. Randall issued the attached Recommended Decision. Therein, the ALJ recommended that I deny Respondent's application for a Certificate of Registration as an importer of ephedrine, a list I chemical. Neither party filed exceptions to the decision. [ 1 ] Having considered the record as a whole, including the parties' briefs, I have decided to adopt the ALJ's findings of fact and conclusions of law except as explained below. Because I agree with the ALJ's conclusion that Respondent has failed to prove that the proposed importation of its combination ephedrine products is “necessary to provide for medical, scientific, or other legitimate purposes” and thus, it is not entitled to the issuance of a rule under 21 U.S.C. 952(a)(1) authorizing the importation of such products, this alone is reason to adopt the ALJ's recommendation. ALJ at 54-57. I further agree with the ALJ's ultimate conclusion that Respondent's registration would be “inconsistent with the public interest.” 21 U.S.C. 958(c)(2)(A) ; ALJ at 80-81. Accordingly, Respondent's application will be denied. The Section 952 Analysis As the ALJ noted, in 2006, Congress enacted the Combat Methamphetamine Epidemic Act of 2005 (CMEA), Public Law 109-177 , 120 Stat. 256. Among the CMEA's provisions was section 715, 120 Stat. 264-65, which amended 21 U.S.C. 952(a) by adding the…