Quiero saber acerca de...

54582

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
there were unexplained discrepancies between Respondents records and the amount of inventory on hand. Such discrepancies provide substantial evidence that Respondent has violated 21 CFR 1304.22c. See e.g., Ester Mark, M.D., 56 FR 16,760, 16,774 2021;
Wayne Pharmacy, 85 FR 63,579, 63,582
2020.
Governments Burden of Proof and Establishment of a Prima Facie Case Based upon my review of each of the allegations by the Government, it is necessary to determine if it has met its prima facie burden of proving the requirements for a sanction pursuant to 21 U.S.C. 824a. At the outset, I find that the Government has demonstrated and met its burden of proof in support of revocation through its case that the Respondent has failed to resolve red flags of diversion and document the resolution of red flags of diversion.
Further, the Government has additionally demonstrated, that Pharmacy 4 Less has violated certain recordkeeping requirements of the Code of Federal Regulations. Inasmuch as the Government has established by a preponderance of the evidence that the Respondent acted outside of the usual course of professional practice and beneath the applicable standard of care in the state of Florida, and violated federal laws relating to controlled substances on numerous occasions,KKK
it has met its prima facie burden of proving that the requirements for a sanction pursuant to 21 U.S.C. 824a are satisfied.
Public Interest Determination: The Standard Pursuant to 21 U.S.C. 823f 2006 &
Supp. III 2010, the Administrator 65
may revoke a DEA Certificate of Registration if persuaded that the maintaining such registration would be inconsistent with the public interest.
Evaluation of the following factors have been mandated by Congress in determining whether maintaining such registration would be inconsistent with the the public interest:
1 The recommendation of the appropriate State licensing board or professional disciplinary authority.
2 The registrants experience in dispensing, or conducting research with respect to controlled substances.
3 The registrants conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
KKK Omitted
text for clarity.
authority has been delegated pursuant to 28 CFR 0.100b and 0.104 2008.
65 This
VerDate Sep<11>2014

20:19 Sep 30, 2021

Jkt 256001

4 Compliance with applicable State, Federal, or local laws relating to controlled substances.
5 Such other conduct which may threaten the public health and safety.
21 U.S.C. 823f.
These factors are . . . considered in the disjunctive. Robert A. Leslie, M.D., 68 FR 15,227, 15,230 2003. Any one or a combination of factors may be relied upon, and when exercising authority as an impartial adjudicator, the Agency may properly give each factor whatever weight it deems appropriate in determining whether a registrants registration should be revoked. Id.
citation omitted; David H. Gillis, M.D., 58 FR 37,507, 37,508 1993; see also Morall v. DEA, 412 F.3d 165, 17374
D.C. Cir. 2005; Henry J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424 1989.
Moreover, the Agency is not required to make findings as to all of the factors, Hoxie v. DEA, 419 F.3d 477, 482 6th Cir. 2005; see also Morall, 412 F.3d at 173, and is not required to discuss consideration of each factor in equal detail, or even every factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 4th Cir. 1988 holding that the Administrators obligation to explain the decision rationale may be satisfied even if only minimal consideration is given to the relevant factors, and that remand is required only when it is unclear whether the relevant factors were considered at all. The balancing of the public interest factors is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest . . . . Jayam Krishna-Iyer, M.D., 74 FR 459, 462
2009.
Factors 2 and 4: Experience in Dispensing, and Compliance With Applicable State, Federal, or Local Laws Relating to Controlled Substances The Governments case invoking the public interest factors of 21 U.S.C. 823f seeks the revocation of the Respondents COR based primarily on conduct most aptly considered under Public Interest Factors 2 and 4.66 LLL 67 68 69
66 21 U.S.C. 823f2, 4. There is nothing in the record to suggest that a state licensing board made any recommendation regarding the disposition of the Respondents DEA COR Factor 1. Likewise, the record contains no evidence that the Respondent has been convicted of or charged with a crime related to controlled substances Factor 3.
LLL For brevity and keeping with recent cases, I
have removed the legal standard used originally by the ALJ throughout this section to analyze Factors 2 and 4 and have replaced it with this text.
67 Omitted text where footnote was included.

PO 00000

Frm 00034

Fmt 4701

Sfmt 4703

Factors Two and Four are often analyzed together. See, e.g., Fred Samimi, M.D., 79 FR 18,698, 18,709
2014; John V. Scalera, M.D., 78 FR
12,092, 12,098 2013. Under Factor Two, the DEA analyzes a registrants experience in dispensing . . .
controlled substances. 21 U.S.C.
823f2. Factor Two analysis focuses on an applicants acts that are inconsistent with the public interest, rather than on an applicants neutral or positive acts and experience.MMM Randall L. Wolff, M.D., 77 FR 5106, 5121 n.25 2012
explaining that every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of the registrants professional career quoting Jayam Krishna-Iyer, M.D., 74
FR 459, 463 2009. Similarly, under Factor Four, the DEA analyzes an applicants compliance with federal and state controlled substance laws. 21
U.S.C. 823f4. Factor Four analysis focuses on violations of state and federal laws and regulations. Volkman v. DEA, 567 F.3d 215, 22324 6th Cir. 2009
citing Gonzales v. Oregon, 546 U.S.
243, 272, 274 2006; see Joseph Gaudio, M.D., 74 FR 10,083, 10,09091
2009.
Here, Pharmacy 4 Less provided evidence of its compliance with state and federal law through the introduction of two Florida Department of Health Inspection reports.70 RX 14, 15. One of the reports, dated February 28, 2017, occurred before the June 6, 2017 on-site inspection by the DEA. RX
15. The report appears to show that Pharmacy 4 Less was in compliance with all applicable portions of the state inspectors report, which not only cites to Florida administrative regulations, but also to federal regulations. While the thoroughness and thus full significance of the Florida state inspections cannot be gleaned from the inspection reports, and the Florida inspector cannot be held to determine compliance with federal regulations in the same manner as DEA
DIs, it is sufficient evidence to show that the Florida inspector not only determined at least some sufficient maintenance of required standards under federal regulations, but particularly with Florida administrative regulations under Florida state law. This gives indication that Pharmacy 4 Less was in compliance with, at a minimum, 68 Omitted
text where footnote was included.
text where footnote was included.
MMM As it is not relevant, I have removed the ALJs analysis regarding the history of Pharmacy 4
Less and its impact on the local community which, according to the ALJ, was based on very little evidence in the record.
70 Omitted text where footnote was included.
69 Omitted
E:FRFM01OCN2.SGM

01OCN2