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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices Findings as to Allegations The Government alleges that the Respondents COR should be revoked because the Respondent failed to ensure that it only filled prescriptions issued for legitimate medical purposes, and within the course of professional practice, in violation of its corresponding responsibility, and repeatedly filled prescriptions in the face of obvious red flags of diversion, and its registration would be inconsistent with the public interest, as provided in 21 U.S.C. 824a4 and 21
U.S.C. 823f, and in violation of state law under the Florida Administrative Code and state requirements for the minimum standard of care.
In the adjudication of a revocation or suspension of a DEA COR, DEA has the burden of proving that the requirements for such revocation or suspension are satisfied. 21 CFR 1301.44e 2010.
Where the Government has sustained its burden and made its prima facie case, a respondent must both accept responsibility for her actions and demonstrate that she will not engage in future misconduct. Patrick W. Stodola, M.D., 74 FR 20,727, 20,734 2009.
Acceptance of responsibility and remedial measures are assessed in the context of the egregiousness of the violations and the DEAs interest in deterring similar misconduct by the Respondent in the future as well as on the part of others. David A. Ruben, M.D., 78 FR 38,363, 38,364 2013.
Where the Government has sustained its burden, that registrant must present sufficient mitigating evidence to assure the Administrator that he can be entrusted with the responsibility commensurate with such a registration.
Medicine Shoppe-Jonesborough, 73 FR
364, 387 2008.KK
The Agencys conclusion that past performance is the best predictor of future performance has been sustained on review in the courts, Alra Labs., Inc.
v. DEA, 54 F.3d 450, 452 7th Cir. 1995, as has the Agencys consistent policy of strongly weighing whether a registrant who has committed acts inconsistent with the public interest has accepted responsibility and demonstrated that he or she will not engage in future misconduct. Hoxie, 419 F.3d at 48283;
see also Ronald Lynch, M.D., 75 FR
78,745, 78,754 2010 holding that the Respondents attempts to minimize misconduct undermined acceptance of responsibility; George C. Aycock, M.D., 74 FR 17,529, 17,543 2009 finding that much of the respondents testimony undermined his initial acceptance that KK Text
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he was probably at fault for some misconduct; Krishna-Iyer, 74 FR at 463
noting, on remand, that despite the respondents having undertaken measures to reform her practice, revocation had been appropriate because the respondent had refused to acknowledge her responsibility under the law; Med. ShoppeJonesborough, 73 FR at 387 noting that the respondent did not acknowledge recordkeeping problems, let alone more serious violations of federal law, and concluding that revocation was warranted.
The burden of proof at this administrative hearing is a preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91, 10001 1981. The Administrators factual findings will be sustained on review to the extent they are supported by substantial evidence. Hoxie, 419
F.3d at 481. The Supreme Court has defined substantial evidence as such relevant evidence as a reasonable mind might accept as adequate to support a conclusion. Consolidated Edison Co. of New York v. National Labor Relations Board, 305 U.S. 197, 229, 59 S.Ct. 206, 217 1938. While the possibility of drawing two inconsistent conclusions from the evidence does not limit the Administrators ability to find facts on either side of the contested issues in the case, Shatz v. U.S. Dept of Justice, 873
F.2d 1089, 1092 8th Cir. 1989;
Trawick, 861 F.2d at 77, all important aspects of the problem, such as a respondents defense or explanation that runs counter to the Governments evidence, must be considered.
Wedgewood Vill. Pharmacy v. DEA, 509
F.3d 541, 549 D.C. Cir. 2007;
Humphreys v. DEA, 96 F.3d 658, 663
3rd Cir. 1996. The ultimate disposition of the case must be in accordance with the weight of the evidence, not simply supported by enough evidence to justify, if the trial were to a jury, a refusal to direct a verdict when the conclusion sought to be drawn from it is one of fact for the jury. Steadman, 450
U.S. at 99 internal quotation marks omitted.
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported, Morall, 412 F.3d at 183, but mere unevenness in application does not, standing alone, render a particular discretionary action unwarranted. Chein v. DEA, 533 F.3d 828, 835 D.C. Cir. 2008 citing Butz v.
Glover Livestock Commn Co., 411 U.S.
182, 188 1973. It is well-settled that since the Administrative Law Judge has had the opportunity to observe the
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demeanor and conduct of hearing witnesses, the factual findings set forth in this recommended decision are entitled to significant deference, Universal Camera Corp. v. NLRB, 340
U.S. 474, 496 1951, and that this recommended decision constitutes an important part of the record that must be considered in the Administrators decision. Morall, 412 F.3d at 179.
However, any recommendations set forth herein regarding the exercise of discretion are by no means binding on the Administrator and do not limit the exercise of that discretion. 5 U.S.C.
557b 2006; River Forest Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 7th Cir. 1974; Attorney Generals Manual on the Administrative Procedure Act 8
1947.
Red Flags of Diversion The Government has alleged that Pharmacy 4 Less failed to resolve and document red flags of diversion outside the usual course of professional practice 21 CFR 1306.06 and the pharmacys corresponding responsibility 21 CFR 1306.04a and in violation of meeting the Florida minimum standard of care under Florida law.
High Starting Dosages The Government has alleged that Pharmacy 4 Less routinely filled Schedule 2 controlled substances for patients with high starting dosages, including both the dosage being prescribed and the number of tablets being prescribed.
The Government presented evidence by Dr. Hamilton that the initial starting dosages for at least six of the charged patients Patients A.E., B.F., K.E.D., R.R., R.V., and V.W. were too high and potentially fatal to opioid nave patients. Dr. Hamilton gave his opinion that the starting dosages for these charged patients were too high given the nature of the patients medical records and other documents that he had reviewed. Mr. Parrado appeared to agree with Dr. Hamilton that it is necessary to determine whether a patient is opioid nave and that it should be factored into the determination of what a proper starting dosage would be, but disagreed that the starting dosages were necessarily too high. Both experts agreed that in order to determine if a patient is opioid nave, a pharmacist can check EFORCSE, talk to the patient, consult with the prescribing doctor, or take other steps the pharmacist determines to be necessary.
Here, Ms. Mincy testified that she used EFORCSE at the pharmacy to look at patients histories and records before
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