Jones Total Health Care Pharmacy, LLC v. Drug Enforcement Administration

881 F.3d 823
CourtCourt of Appeals for the Eleventh Circuit
DecidedJanuary 29, 2018
Docket16-17346 Non-Argument Calendar
StatusPublished
Cited by9 cases

This text of 881 F.3d 823 (Jones Total Health Care Pharmacy, LLC v. Drug Enforcement Administration) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eleventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Jones Total Health Care Pharmacy, LLC v. Drug Enforcement Administration, 881 F.3d 823 (11th Cir. 2018).

Opinion

PER CURIAM:

Before this Court is a petition for review of a final order of the United States Drug Enforcement Administration (“DEA”) revoking Jones Total Health Care Pharmacy, LLC’s (“Jones Pharmacy”) certifícate of registration under the Controlled Substances Act (“CSA”) to dispense controlled substances and denying SND Healthcare, LLC’s (“SND Healthcare”) application for a certificate of registration to dispense controlled substances. The DEA Acting Administrator revoked Jones Pharmacy’s registration after determining that it unlawfully dispensed controlled substances and that Cherese Jones, the pharmacy’s owner and operator,, failed to accept full responsibility for the misconduct. Because Jones also owned and operated SND Healthcare, the Acting Administrator denied SND Healthcare’s pending application for the same reasons. Jones Pharmacy and SND Healthcare (“Petitioners”) then filed this petition for review, arguing that the DEA’s decision is arbitrary and capricious. We disagree, so we deny.the petition for review.

I.

Jones Pharmacy-is a community pharmacy started by Jones in Fort Lauderdale. Jones graduated from Texas A & M University with a Doctor of Pharmacy degree in 2000 and worked in clinical and retail pharmacy positions before opening Jones Pharmacy in February 2010.

Jones Pharmacy was registered with the DEA to dispense substances controlled by the CSA, 21 U.S.C. § 801, et seq. In 2013, Jones sought to open SND Healthcare and submitted an application for registration to dispensé controlled substances through that entity.

The CSA creates “a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.” See Gonzales v. Raich, 545 U.S. 1, 13, 125 S.Ct. 2195, 162 L.Ed.2d 1 (2005). Pharmacies that dispense prescription medications that are controlled substances are required to obtain proper registration from the Attorney General. See 21 U.S.C. §§ 822(a), 823(f); Gonzales v. Oregon, 546 U.S. 243, 250-51, 126 S.Ct. 904, 163 L.Ed.2d 748 (2006). Under the CSA, the responsibility for the proper prescribing and dispensing of. controlled substances, which must be for “a legitimate medical purpose,” is on the prescribing practitioner, “but a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 C.F.R. § 1306.04(a). Thus, pharmacists have a “corresponding responsibility” to refuse to fill prescriptions that are not issued for a legitimate, medical purpose. See id.

The Attorney General has the authority to deny, revoke, or suspend registrations. See 21 U.S.C. §§ 823(f), 824(a). The Attorney General has delegated this authority to the DEA. See United States v. Lippner, 676 F.2d 456, 460 (11th Cir, 1982) (holding that the functions vested in the Attorney General by the Comprehensive Drug Abuse Prevention Act were properly delegated to the DEA). When an existing registration is proposed for revocation, the DEA must serve an “order to show cause” on the registrant and give the registrant an opportunity for a hearing before an Administrative Law Judge (“ALJ”) in order to contest the proposed action. See 21 U.S.C. § 824(c).

' On October 6, 2014, the DEA issued an order to show cause proposing to revoke Jones Pharmacy’s existing registration and to deny SND Héalthcare’s application for registration.- In the order,‘the DEA alleged that, from February 2010 to July 2012, Jones Pharmacy “repeatedly failed to ensure that it filled only prescriptions issued for legitimate medical purposes within the usual course of professional practice.” Jones Pharmacy, according to the order, repeatedly ignored “obvious and unresolvable red flags of diversion.” The order also alleged record-keeping violations. According to the order, Jones Pharmacy’s practices warranted denial of SND Healthcare’s application because Jones was the owner and operator of both entities and they were one integrated enterprise.

Petitioners requested a hearing, which was held before an ALJ in March 2015. At the hearing, the ALJ heard testimony from several persons, including Domingo Gonzales (a DEA diversion investigator), Mary, Crane (a Pharmacy Inspector for the Florida Department of Health), Dr. Tracy Gordon (the government’s expert), Donna Horn (Jones Pharmacy’s expert), and Jones. . . -

After the hearing,- the ALJ issued her findings of fact, conclusions of law, and recommendations that the DEA Acting Administrator revoke Jones Pharmacy’s registration and- deny SND Healthcare’s application for registration. The ALJ credited the testimony of Gordon, who reviewed over one-hundred prescriptions filled by- Jones Pharmacy between February 2010 -and July 2012 and found that they had one or more “red flags”—indicia that the prescriptions were not issued for a legitimate medical purpose—and should not have been filled. According to Gordon, these red flags included the following: (1) individuals traveling long distances to fill prescriptions; (2) prescriptions for drug “cocktails,” known for their abuse potential, such as oxycodone and Xanax; (3) individuals who arrived together with identical or nearly identical prescriptions; (4) purported pain patients with prescriptions for immediate-release rather than long-acting narcotics; (5) cash purchases; and (6) doctors prescribing outside the scope of their usual practice. The ALJ credited Gordon’s testimony that many of these red flags could not have been resolved by the pharmacists. Accordingly, the ALJ determined that Jones Pharmacy violated its “corresponding responsibility” by filling controlled-substances prescriptions with unresolved red flags.

Crediting Gonzales’s testimony and other evidence submitted by the government, the ALJ also found additional indicators that Jones Pharmacy dispensed controlled substances unlawfully. The ALJ cited statistics showing that, from February 2010 to July 2012, Jones Pharmacy’s business was based primarily on sales of controlled substances. In addition, of the more than 3,000 controlled-substance prescriptions filled, 99% were for immediate-release drugs, 89% were for “cocktail” drugs, and ■ 93% were paid for in cash. The ALJ noted that these statistics were “unusually high compared to national averages.” For instance, according to a report from the IMS Institute of Healthcare Informatics, the national average for cash sales between 2007 and 2011 was 6%.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
881 F.3d 823, Counsel Stack Legal Research, https://law.counselstack.com/opinion/jones-total-health-care-pharmacy-llc-v-drug-enforcement-administration-ca11-2018.