Suntree Pharmacy, et al. v. Drug Enforcement Administration

On February 14, 2022, a three-judge panel of the Eleventh Circuit upheld the DEA Administrator’s decision to revoke Suntree Pharmacy’s DEA registration interpreting 21 C.F.R. § 1306.04(a) to not require evidence of a prescription’s illegitimacy before deciding it was dispensed in violation of the regulation. This vague regulation is fraught with misconceptions. In Gonzales, the Attorney General thought he could interpret “legitimate medical purpose” under § 1306.04(a). Gonzales v. Oregon, 546 U.S. 243 (2006). The Court explained, however, he exceeded his limited authority under the Act. Id. More recently, a circuit split as to whether “knowingly” applied to “except as authorized” under the CSA brought the regulation back before the Court. Ruan v. United States, 597 U.S. ___ (2022) (slip op.). This Petition raises a third misconception. In ignoring Gonzales, the DEA has interpreted “legitimate medical purpose” so that a pharmacy violates its corresponding responsibility whether or not there is evidence of a prescription’s illegitimacy. Holiday CVS, Fed. Reg. 62316 (2012). This ultra vires authority has allowed the DEA to discipline pharmacists for failing to resolve “red flags” before filling a prescription. See Id. Sadly, when challenged in court, the DEA hides behind the great deference awarded to administrative agencies. This Petition seeks to fight this harmful deference and asks the Court: Whether a pharmacy violates its corresponding responsibility under 21 C.F.R. § 1306.04(a) and knowingly fills a prescription for a controlled substance not issued for a legitimate medical purpose where the prescription’s legitimacy remains undetermined?