Suntree Pharmacy and Suntree Medical Equipment, LLC; 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 Nos. 17-09 and 17-10] I. Procedural History On October 5, 2016, a former Assistant Administrator for Diversion Control of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Suntree Pharmacy (hereinafter, Respondent Pharmacy) and Suntree Medical Equipment LLC (hereinafter, Respondent LLC) (hereinafter collectively, Respondents), of Melbourne, Florida. Administrative Law Judge (hereinafter, ALJ) Exhibit (hereinafter, ALJX) 1, (OSC) at 1. The OSC proposed the revocation of and denial of any pending application to modify or renew Respondents' Certificates of Registration Nos. BS7384174 and FS2194289 “pursuant to 21 U.S.C. 823(f) and 824(a)(4) for the reason that [Respondents'] continued registrations are inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f) .” Id. Specifically, the OSC alleged that “over the course of the seventeen month period from October 2013 through March 2015, [Respondents'] pharmacists filled over 200 controlled substances prescriptions outside the usual course of pharmacy practice in violation of 21 CFR 1306.06 , and in contravention of their `corresponding responsibility' under 21 CFR 1306.04(a) .” OSC, at 2. The OSC further alleged that Respondent Pharmacy's failure to exercise its corresponding responsibility was evidenced by its “repeatedly fill[ing] controlled su…