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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices Loss of Trust Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, 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. Here, Pharmacy 4 Less has failed to establish that it can be entrusted with maintaining its registration.SSS
The CSA authorizes the Attorney General to promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter. 21
U.S.C. 871b. In efficiently executing the revocation and suspension authority delegated to me under the CSA for the aforementioned purposes, I review the evidence and argument Respondents submitted to determine whether or not they have presented sufficient mitigating evidence to assure the Administrator that they can be trusted with the responsibility carried by such a registration. Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 2007
quoting Leo R. Miller, M.D., 53 FR
21,931, 21,932 1988. The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent; therefore, the Agency looks at factors, such as the related to remedial measures taken by the Respondent. See Tr. 702; 1047. As I find that the Respondent has failed to accept any responsibility, I find that RX 1837 should not be considered by the Administrator towards remedial measures taken by the Respondent. See Ajay S. Ahuja, 84 FR 5479, 5498 n.33 2019 A registrant does not accept responsibility for its actions simply by taking remedial measures. Holiday CVS, L.L.C., d/b/a CVS/
Pharmacy Nos. 219 & 5195, 77 FR 62,316, 62,346
2012. Further, 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 79,188, 79,20203
2016.
SSS For brevity and keeping with recent cases, I
have modified the legal standard used originally by the ALJ regarding loss of trust and have replaced it with this text.

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acceptance of responsibility and the credibility of that acceptance as it relates to the probability of repeat violations or behavior and the nature of the misconduct that forms the basis for sanction, while also considering the Agencys interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 2016.
Regarding all of these matters, there is nothing in the record establishing that Respondent Pharmacy has accepted responsibility for its actions. The Respondents only fact witness, Ms.
Mincy, conveyed that she was resentful at the Agencys intervention at the pharmacy. She seemed to maintain a confrontational attitude with DI1, suggesting he was harassing the Respondent and that he was lying during testimony. The closest Respondent came to accepting responsibility was in its Exceptions, in which Respondent admitted that it was filling too many c2 Schedule II
prescriptions in the past. Resp Exceptions, at 5. Even if this admission were part of the evidentiary record, the entirety of the record lacks the unequivocal acceptance of responsibility necessary to establish Respondent trustworthiness with a registration.
The egregiousness of Respondent Pharmacys conduct and the interests of specific and general deterrence support a sanction of revocation. RD, at 99.
Respondent Pharmacy filled many prescriptions over multiple years for these patients without resolving numerous red flags. There is nothing in the record that lends support to the proposition that Respondent Pharmacys future behavior will deviate in any positive respect from its past behavior.
Due to the fact that Respondent Pharmacy has accepted no responsibility nor offered any remedial measures,TTT it has given me no reassurance that I can entrust it with a
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registration and no evidence that it will not repeat its egregious behavior.
Regarding general deterrence, the Agency bears the responsibility to deter similar misconduct on the part of others for the protection of the public at large.
David A. Ruben, 78 FR at 38,385. Based on the number and egregiousness of the established violations in this case, a sanction less than revocation would send a message to the regulated community that compliance with the law is not a condition precedent to maintaining registration.
A balancing of the statutory public interest factors, coupled with consideration of Respondent Pharmacys failure to accept responsibility, the absence of any evidence of remedial measures to guard against recurrence, and the Agencys interest in deterrence, support the conclusion that Respondent Pharmacy should not continue to be entrusted with a registration.
As such, I find from the course of these proceedings that Pharmacy 4 Less has lost a significant amount of trust and has failed to prove to the Agency that it can be entrusted to maintain its COR in lawful fashion.
Recommendation Considering the entire record before me, the conduct of the hearing, and observation of the testimony of the witnesses presented, I find that the Government has met its burden of proof and has established a prima facie case for revocation. Further, I find that the Respondent has not accepted responsibility, or presented sufficient evidence demonstrating that the Agency can entrust it to maintain its COR.
Therefore, I recommend the Respondents DEA COR FP5459082
should be revoked and any pending applications for renewal or modification of such registration be denied.
Signed: May 22, 2019.

TTT I

have already addressed that Respondent Pharmacy presented factual assertions related to remedial measures for the first time in Respondents Exceptions, but most of those facts are not supported by the record and were not under oath or subject to cross examination.

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Mark M. Dowd, U.S. Administrative Law Judge.
FR Doc. 202121429 Filed 93021; 8:45 am BILLING CODE 441009P

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