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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
2016 multiple customers presenting prescriptions written by the same prescriber for the same drugs in the same quantities; customers with the same last name and street address presenting similar prescriptions on the same day; long distances; drug cocktails; The Medicine Shoppe, 79 FR
59504, 59507, 5951213 2014
unusually large quantity of a controlled substance; pattern prescribing; irregular dosing instructions; drug cocktails;
Holiday CVS, 77 FR 62316, 6231722
2012 long distances; multiple customers presenting prescriptions written by the same prescriber for the same drugs in the same quantities;
customers with the same last name and street address presenting virtually the same prescriptions within a short time span; payment by cash; East Main Street Pharmacy, 75 FR 66149, 66163
65 2010 long distances; lack of individualized therapy or dosing; drug cocktails; early fills/refills; other pharmacies refusals to fill the prescriptions. Here, the Government established the presence of red flags on the prescriptions that Respondent Pharmacy filled.
Further, under Florida law, which is supportive of the applicable standard of care in Florida, a pharmacist is required to conduct a prospective drug use review before filling or refilling any prescription for controlled substances.
Fla. Admin. Code r. 64B1627.810.
Florida also requires that pharmacists question prescriptions that may not be valid and only fill the prescriptions if the pharmacist is able to validate the prescription. Fla. Admin. Code r.
64B1627.831.OOO
This leads me to the conclusion that Pharmacy 4 Less PPP has operated outside the usual course of professional practice in violation of 21 CFR 1306.06
and in violation of its corresponding responsibility in violation of 21 CFR
1306.04a. Further, as the Florida laws and regulations provide for the standards of practice for pharmacists and pharmacies, including requiring certain standards of review and documentation, I find that the charged regulations bear a substantial relationship to the CSAs purposes of drug abuse and diversion. As such, I
find that Pharmacy 4 Less has failed to meet the standard of care as provided OOO Omitted, for brevity, text regarding the legal standard requiring a nexus between the state law that has been violated and the CSAs purpose of preventing drug abuse and diversion. I find that, here, Florida law was used to support determination of the standard of care, but that the Government did not allege independent violations of state law.
PPP Omitted finding of a violation of Florida law.

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for under Florida law and regulations and as I have found above.
In light of the record as to this factor, I find that the favorable evidence introduced through the Respondent is overwhelmed by the evidence introduced through the Government that the Respondent has failed to comply with federal omitted law and has violated its corresponding responsibility. Therefore, I find factors 2 and 4 significantly favor revoking the Respondents registration.
Due Process Right of the Respondent Omitted. The Government asserts in its Posthearing Brief that Pharmacy 4
Less has been disingenuous during the course of this matter and should be penalized for its decision to file a motion to suppress, and to withhold subpoenaed records from the Government when it asserted HIPAA
privacy issues and was preparing to contest the DEAs administrative subpoena in United States District Court. Govt Posthearing, at 44.
Omitted. The ALJ found that the Respondents decision to contest the DEAs administrative subpoena should not be held against the Respondent as either an adverse inference or as an independent violation. I decline to make any findings regarding the Governments argument and have omitted the analysis accordingly.
Acceptance of Responsibility The Governments prima facie burden having been met, the Respondent must present sufficient mitigating evidence to assure the Administrator that he can be entrusted with the responsibility incumbent with such registration.
Medicine Shoppe-Jonesborough, 73 FR
364, 387 2008, Samuel S. Jackson, 72
FR 23,848, 23,853 2007.QQQ This feature of the Agencys interpretation of its statutory mandate on the exercise of its discretionary function under the CSA
has been sustained on review. MacKay, 664 F.3d at 822. As, past performance is the best predictor of future performance, DEA has repeatedly held that where an applicant has committed acts inconsistent with the public interest, the applicant must accept responsibility for his actions and demonstrate that he will not engage in future misconduct. ALRA
Labs, Inc. v. DEA, 54 F.3d 450, 452 7th Cir.1995; Medicine Shoppe, 73 FR 387;
see also Hoxie, 419 F.3d at 483
admitting fault is properly considered by DEA to be an important factor in the public interest determination. So too, in
making the public interest determination, this Agency places great weight on an applicants candor, both during an investigation and in a subsequent proceeding. Robert F.
Hunt, 75 FR 49,995, 50,004 2010;
Hoxie, 419 F.3d at 483.
While an applicant must accept responsibility and demonstrate that he will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction.
See, e.g., Joseph Gaudio, 74 FR 10,083, 10,094 2009; Southwood Pharmaceuticals, Inc., 72 FR 36,487, 36,504 2007. The egregiousness and extent of an applicants misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19,386, 19,38788 2011
explaining that a respondent can argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation; Paul H.
Volkman, 73 FR 30,630, 30,644 2008;
see also Gregory D. Owens, 74 FR
36,751, 36,757 n.22 2009. Likewise, DEA considers its interest in deterring future misconduct by both the registrant as well as other registrants. Ruben, 78
FR at 38,364. RRR
The Respondent argued during the hearing that it had accepted responsibility by virtue of its submission of a corrective action plan which the DEA rejected, modification of its behavior, a reduction in the number of patients they see and for whom it fills prescriptions, as well as the implementation of a number of other remedial changes. Tr. 30. However, no one from Pharmacy for Less has admitted any wrongdoing regarding the vast majority of infractions I found.
I find that Ms. Mincy, the only fact witness for the Respondent, did not accept responsibility for either her actions or on behalf of Pharmacy 4 Less.
Additionally, I find that Ms. Mincy was sometimes a less than reliable witness.
Although correcting violative behavior and practices is very important to establish acceptance of responsibility, conceding wrongdoing is critical to reestablishing trust with the Agency.
Holiday CVS, L.L.C., 77 FR 62,316, 62,346 2012, Daniel A. Glick, D.D.S., 80 FR 74,800, 74,801 2015. As such, I
find that Pharmacy 4 Less has failed to unequivocally accept any responsibility in this matter.71
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this proceeding, this Tribunal conditionally admitted RX 1837 as potentially 71 During
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