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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices supported by the record and were not under oath or subject to cross examination when they were presented for the first time in Respondents Exceptions. Moreover, where a registrant has not accepted responsibility it is not necessary to consider evidence of the registrants remedial measures. Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79188, 7920203
2016. As Respondent Pharmacy has failed to unequivocally accept responsibility for its actions, the purported remedial measures offered by Respondent in its Exceptions, even if they were part of the evidentiary record, would have no impact on my decision in this case.
Similarly, the Respondents Exceptions contained a number of factual assertions regarding Owner Richard Sprys purported work with law enforcement bodies to report illegal pharmacy operations and provide testimony, seemingly for the DEA in one instance, to hold those pharmacies accountable. Id. at 3. None of these facts were given under oath and none were subject to cross-examination; therefore, they are simply not part of the evidentiary record. Even if Respondents assertions had been appropriately submitted through testimonial evidence, they could only have been relevant in assessing whether Respondent Pharmacy could be entrusted with a registration. Here, as Respondent Pharmacy has failed to unequivocally accept responsibility for its actions, such assertions would have had no impact on my decision.
The remainder of the Respondents Exceptions are addressed in their relevant sections of the Recommended Decision as footnoted below.
The decision below is based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of both parties. I adopt the ALJs Recommended Decision with noted modifications.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge The Assistant Administrator, Drug Enforcement Administration DEA, issued an Order to Show Cause,1 dated July 5, 2018, seeking to deny the Respondents Certificate of Registration, number FP5459082, on the ground that the Respondents registration would be inconsistent with the public interest, that Patient A.V. was successfully taken off of opioids. Resp Exceptions, at 23.
1 ALJ Ex. 1.

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pursuant to 21 U.S.C. 824a4, and as defined in 21 U.S.C. 823f. The Respondent requested a hearing on August 2, 2018,2 and prehearing proceedings were initiated.3 A hearing was conducted in this matter on November 57, 2018, in Orlando, Florida, and resumed on February 25, 2019, at the DEA Hearing Facility in Arlington, Virginia.
The issue ultimately to be adjudicated by the Administrator,F with the assistance of this Recommended Decision, is whether the record as a whole establishes by a preponderance of the evidence that the Respondents subject registration with the DEA should be revoked pursuant to 21 U.S.C.
824a4.
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I
have set forth my recommended findings of fact and conclusions of law below.
The Allegations In the OSC, the Government contends that the DEA should revoke the Respondents DEA COR because it failed to comply with 21 U.S.C. 824a4 and its registration is inconsistent with the public interest, see 21 U.S.C. 823f.
Specifically, the Government alleges the following:
1. The Respondent failed to ensure that it only filled prescriptions issued for legitimate medical purposes and repeatedly filled prescriptions in the face of obvious red flags of diversion, in violation of both federal and state law including 21 CFR 1306.06, 1306.04a;
Wheatland Pharmacy, 78 FR 69411, 69445 2013; Fla. Admin. Code r.
64B1627.810, 64B1627.831 4, specifically from at least October 27, 2015 to at least June 19, 2017, to at least ten different patients. ALJ Ex. 1 at 2
4.
2. The Respondent routinely filled Schedule II controlled substances without resolving the red flag of patients with very high starting dosages, both with respect to the individual dose being prescribed and with respect to the number of tablets being prescribed, which is potentially fatal for a patient. ALJ Ex. 1 at 5.
3. The Respondent routinely filled controlled substance prescriptions 2 ALJ

Ex. 2.
Ex. 3.
F All references to Acting Administrator have been changed to Administrator.
4 It was noted that there was a scriveners error by the Government citing to r. 64B1627.821. The Government later corrected the cite to reflect the correct citation to r. 64B1627.831.
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without resolving the red flag of immediate release pain medication over long periods of time. A chronic pain patient should be moved to a long acting medication. ALJ Ex. 1 at 6.
4. The Respondent routinely filled controlled substance prescriptions without resolving the red flag of extremely high cash prices. ALJ Ex. 1 at 7.
5. The Respondent routinely filled prescriptions without resolving the red flag for patients who traveled long distances to visit the Respondents pharmacy. ALJ Ex. 1 at 8.
6. The Respondent would fill prescriptions without resolving the red flag for drug combinations that needed to be questioned, such as the combination of buprenorphine and oxycodone. ALJ Ex. 1 at 9.
Treatment of Patients Patient A.E.
From November 19, 2015, to at least June 1, 2017, the Respondent filled at least 21 prescriptions for hydromorphone for A.E. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04a.
Specifically:
a. A.E.s prescriptions were for 84
tablets of hydromorphone 8 mg, which is a large amount of tablets at the highest dosage strength.
b. A.E. filled his prescriptions for short acting hydromorphone since at least November 19, 2015, even though hydromorphone is not prescribed for long-term use or chronic conditions.
c. A.E. paid cash for his prescriptions at inflated prices, paying $500.00 for 84
tablets of hydromorphone 8 mg, approximately $5.95 per pill, at a time when legitimate pharmacies were charging approximately $1.50.
Patient A.R.
From March 17, 2016, to at least June 7, 2017, the Respondent filled at least 17
prescriptions for oxycodone for A.R.
outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04a.
Specifically:
a. A.R. filled his prescriptions for immediate release oxycodone since at least March 17, 2016, even though oxycodone is not prescribed for longterm use or chronic conditions.
b. A.R. drove extremely long distances to fill oxycodone prescriptions. A.R.
drove approximately 37 miles southwest to visit the prescribing doctor, an additional 17.9 miles further southwest
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