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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices
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facie burden of showing that Respondents continued registration would be inconsistent with the public interest. 21 U.S.C. 824a4.
Specifically, I find that the record contains substantial evidence that Respondent violated both Louisiana state law and federal law when she issued thousands of prescriptions for controlled substances in Louisiana during periods when she lacked state authorization to do so. I further find that Respondent failed to provide evidence to rebut the Governments prima facie case.
1. Factors Two and Four The DEA often analyzes Factors Two and Four together. See, e.g., Fred Samimi, M.D., 79 FR 18698, 18709
2014; John V. Scalera, M.D., 78 FR
12092, 12098 2013. Under Factor Two, the DEA analyzes a registrants experience in dispensing controlled substances. 21 U.S.C. 823f2. Factor Two analysis focuses on a registrants acts that are inconsistent with the public interest, rather than on a registrants neutral or positive acts and experience. 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. The Factor Four analysis focuses on violations of state and federal laws and regulations concerning controlled substances.
Volkman v. Drug Enft Admin., 567 F.3d 215, 22324 6th Cir. 2009 citing Gonzales v. Oregon, 546 U.S. 243, 272, 274 2006; Gaudio, 74 FR 1009091.
In this case, Respondent dispensed thousands of prescriptions without a controlled substance license in violation of both state and federal law. Although there are not specific allegations regarding the legitimacy of these prescriptions, I find that dispensing controlled substances without a license constitutes negative dispensing experience and weighs against Respondents continued registration. In fact, during one year, Respondents CDS
had lapsed for 9 monthsthe majority of the year.
Regarding Factor Four, the Government alleged that Respondent repeatedly violated state and federal laws related to controlled substances by issuing thousands of prescriptions for controlled substances in Louisiana during periods when her Louisiana CDS

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license was expired. OSC, at 23 citing La. Stat. 40:967A1a & 40:973; La.
Admin. Code tit. 46, 2705 &
2707B34; 21 U.S.C. 841a1; 21
CFR 1306.03 & 1306.04. According to Louisiana statute, every person who conducts research with, manufactures, distributes, procures, possesses, prescribes, or dispenses any controlled dangerous substance within this state . . . shall obtain a controlled dangerous substance license issued by the Louisiana Board of Pharmacy in accordance with the rules and regulations promulgated by the board prior to engaging in such activity. La.
Stat. Ann. 40:973A1 West 2021.
Moreover, Louisiana law states that a licensee shall not engage in any activity requiring a valid CDS license while his license is expired. 4 La. Admin. Code tit. 46, 2707B3 2021. As for federal law, a prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. 21 CFR 1306.04a. Further, federal law defines an individual practitioner as a physician . . .
licensed, registered, or otherwise permitted by . . . the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. 21 CFR
1300.01b. Additionally, federal law states that a prescription for a controlled substance may be issued only by an individual practitioner who is . . . authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession. 21 CFR 1306.03a1.
Respondent issued thousands of prescriptions for controlled substances in Louisiana during three separate periods when her Louisiana CDS license was expired. Thus, I find that Respondent violated both federal and Louisiana state law related to controlled substances. See Lisa Hamilton, N.P., 84
FR 71465, 71472 2019 finding that prescriptions issued during the lapse of the respondents Massachusetts Controlled Substances Registration violated state and federal law. In this case, given the repeated and extensive nature of Respondents violations of federal and state law related to 4 The Government argues that under state law, the period of expiration during which a Louisiana practitioner cannot prescribe includes the 30 day renewal window because the license has technically expired. See RFAA, at 9. This position is supported by the plain language of the statute and the Louisiana Board of Pharmacys memorandum to DEA, in which it included the initial 30-day window in the listed periods of expiration for Respondents CDS. See RFAAX G2.

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controlled substances, I find that Factors Two and Four weigh against Respondent such that I find Respondents continued registration to be inconsistent with the public interest and, therefore, that a ground for revocation exists under 21 U.S.C.
824a4. Where, as here, the Government has met its prima facie burden of showing that a ground for revocation exists, the burden shifts to the Respondent to show why she can be entrusted with a registration. See Jeffrey Stein, M.D., 84 FR 46968, 46972 2019.
III. Sanction The Government has established grounds to deny a registration; therefore, I will review any evidence and argument the Respondent submitted to determine whether or not the Respondent has presented sufficient mitigating evidence to assure the Administrator that she can be trusted with the responsibility carried by such a registration. Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 2007
quoting Leo R. Miller, M.D., 53 FR
21931, 21932 1988. Moreover, because past performance is the best predictor of future performance, ALRA
Labs, Inc. v. Drug Enft Admin., 54 F.3d 450, 452 7th Cir. 1995, the Agency has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for the registrants actions and demonstrate that registrant will not engage in future misconduct. Jayam Krishna-Iyer, 74 FR 459, 463 2009
quoting Medicine Shoppe, 73 FR 364, 387 2008; see also Samuel S. Jackson, D.D.S., 72 FR 23853; John H. Kennnedy, M.D., 71 FR 35705, 35709 2006; Prince George Daniels, D.D.S., 60 FR 62884, 62887 1995. 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 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.
A. Acceptance of Responsibility As previously discussed, Respondent effectively waived her right to a hearing and therefore there is no credible evidence on the record regarding acceptance of responsibility for me to consider. Even if I could consider the
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