On February 6, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Grace S. Joanita, N.P., of Cincinnati, Ohio (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, Attachment (Attach.) F, at 1, 4. The OSC proposed the revocation of Registrant's DEA registration, No. MJ5209677, alleging that Registrant materially falsified her December 7, 2021 renewal application for registration. Id. at 2 (citing 21 U.S.C. 824(a)(1)). 1

On July 5, 2023, the Government submitted an RFAA to the Administrator requesting that the Agency issue a default final order revoking Registrant's registration. RFAA, at 1-3. After carefully reviewing the entire record and conducting the analysis as set forth in detail below, the Agency finds that Registrant is in default and finds that Registrant materially falsified her renewal application. Accordingly, the Agency grants the Government's RFAA and revokes Registrant's registration.

Under 21 CFR 1301.43, a registrant entitled to a hearing who fails to file a timely hearing request “within 30 days after the date of receipt of the [OSC] . . . shall be deemed to have waived their right to a hearing and to be in default” unless “good cause” is established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence of a demonstration of good cause, a registrant who fails to timely file an answer also is “deemed to have waived their right to a hearing and to be in default.” 21 CFR 1301.43(c)(2).

The OSC notified Registrant of her right to file a written request for a hearing and an answer, and that if she failed to file such a request and answer, she would be deemed to have waived her right to a hearing and be in default. 2 RFAAX 1, Attach. F, at 2-3 (citing 21 CFR 1301.43). Registrant did not request a hearing, file an answer, or respond to the OSC in any way. RFAA, at 1-3. Accordingly, Registrant is in default. 21 CFR 1301.43(c)(1); RFAA, at 1-3.

“A default, unless excused, shall be deemed to constitute a waiver of the [registrant's] right to a hearing and an admission of the factual allegations of the [OSC].” 21 CFR 1301.43(e). Because Registrant is in default and has not moved to excuse the default, the Agency finds that Registrant has admitted to the factual allegations in the OSC. 21 CFR 1301.43(c)(1), (e), (f)(1).

Further, “[i]n the event that [a registrant] . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] 1316.67.” 21 CFR 1301.43(f)(1). Here, the Government has requested final agency action based on Registrant's default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 1-3; see also 21 CFR 1316.67.

The Agency finds that, in light of Registrant's default, the factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e). Accordingly, Registrant is deemed to have admitted to each of the following facts. 3 On or about December 7, 2021, Registrant submitted a timely renewal application for her DEA registration, No. MJ5209677. RFAAX 1, Attach. F, at 1. The renewal application requested information regarding Registrant's fee exemption status. Id. at 1-2. Specifically, the application requested the name, title, phone number, and email address of a certifying official, and the name of a fee exempt institution. Id. at 2. Registrant responded to the fee exemption prompts, and provided the name of a certifying official for whom she had not worked since November 20, 2019. Id. Based on the information Registrant provided in response to the fee exemption prompts, her registration was granted “fee exempt” status and she therefore did not pay the required fee to renew her registration. Id. In December 2021, January 2022, and August 2022, DEA provided Registrant opportunities to pay the required registration fee and fill out a Change of DEA Fee Exemption Status form. Id. At the time the OSC was issued, Registrant had not paid the required fee or filled out the Change of DEA Fee Exemption Status form. Id.

A DEA registration may be denied, suspended, or revoked upon a finding that the applicant or registrant materially falsified any application filed pursuant to or required by the Controlled Substances Act (CSA). 21 U.S.C. 824(a)(1). 4 To present a prima facie case for material falsification, the Government's record evidence must show (1) the submission of an application, (2) containing a false statement and/or omitting information that the application requires, (3) when the submitter knew or should have known that the statement is false and/or that the omitted information existed and the application required its disclosure, and (4) the false statement and/or required but omitted information is material, that is, it “connect[s] to at least one of [the section 823] factors that, according to the CSA, [the Administrator] `shall' consider” when analyzing “whether issuing a registration `would be inconsistent with the public interest.' ” Frank Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21 U.S.C. 823 and Kungys, 485 U.S. at 771); see also Sasha Melissa Ikramelahai, 90 FR 32017, 32019 (2025); Michael Bouknight, 90 FR 31247, 31249 (2025).

Regarding materiality, Kungys holds that a statement is material if it is “predictably capable of affecting, i.e., had a natural tendency to affect, the [Agency's] official decision,” or stated differently, “had a natural tendency to influence the decision.” Kungys, 485 U.S. at 771-72. As already discussed, materiality, for the purposes of the CSA, is tied to the factors that the Administrator “shall” consider when determining whether issuance of a registration “would be inconsistent with the public interest.” 21 U.S.C. 823; Kungys, 485 U.S. at 771-72; Stirlacci, 85 FR at 45234, 45238.

The Government has the burden of proof in this proceeding. 21 CFR 1301.44. The Government must establish material falsification with record evidence that is clear, unequivocal, and convincing. Kungys, 485 U.S. at 772; Stirlacci, 85 FR at 45230-39. Here, the Agency finds that the Government's clear, unequivocal, and convincing record evidence presents a prima facie case that Registrant submitted a materially false application. 21 U.S.C. 823, 824(a)(1).

As the Agency finds above, Registrant submitted a renewal application for DEA registration and the application requested information regarding exemption from paying the required fee. RFAAX 1, Attach. F, at 2; see also 21 CFR 1301.13(e) (setting forth the fee schedule); 21 CFR 1301.21 (setting forth the conditions for fee exemption). Registrant responded to the fee exemption prompts and provided employment information—specifically, the name of a certifying official—that was false at the time she submitted her renewal application, because she had not worked for that certifying official in over two years. RFAAX 1, Attach. F, at 2. By responding to the fee exemption prompts, Registrant falsely represented that she was entitled to fee exemption. Id. In other words, on her renewal application, Registrant claimed to meet the regulatory requirements for a fee exemption by representing that she worked for a certifying official for whom she did not work for at the time, and she knew or should have known that she did not work for the certifying official when she submitted her application. Id.; see also Ikramelahai, 90 FR at 32020 (finding registrant created the false impression that she possessed a state license when, in fact, it belonged to a different practitioner). Thus, Registrant's renewal application contained false statements.

In addition, the false statements were material. Specifically, Registrant's falsities are connected to public interest factor D, under which DEA considers an applicant's compliance or non-compliance with Federal laws relating to controlled substances. 21 U.S.C. 823(g)(1)(D). DEA's registration and renewal process are governed by the CSA and its implementing regulations—in other words, Federal laws which relate to controlled substances. In applying for a DEA registration or renewing a DEA registration, an applicant or registrant must comply with Federal laws that govern the issuance and renewal of controlled substance registrations. See, e.g., 21 U.S.C. 821 (authorizing the Attorney General to promulgate regulations and charge fees relating to the registration and dispensing of controlled substances); 21 U.S.C. 822(a)(2) (“Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him.”); 21 U.S.C. 823(g)(1) (setting forth the factors that the Attorney General must consider when determining whether to grant or deny a registration); 21 CFR 1301.13 (establishing application requirements, including registration fees tied to specific regulated activities); 21 CFR 1301.21 (setting forth conditions for fee exemption); Gonzales v. Raich, 545 U.S. 1, 14 (2005) (“The CSA and its implementing regulations set forth strict requirements regarding registration . . . .”). Thus, evaluating an applicant's or registrant's compliance with the Federal laws that govern registration and renewal, including DEA's fee schedule and fee exemptions, is appropriately considered under factor D. 5 21 U.S.C. 823(g)(1)(D).

Accordingly, making a false statement regarding entitlement to fee exemption has a natural tendency to influence the Agency's decision regarding whether issuance of a registration “would be inconsistent with the public interest.” 21 U.S.C. 823; Kungys, 485 U.S. at 771-72; Stirlacci, 85 FR at 45234, 45238; RFAAX 1, Attach. F, at 1-2. Therefore, the falsities in Registrant's application were “predictably capable of affecting” DEA's decision to renew her registration, and therefore the Agency finds that they were material. Kungys, 485 U.S. at 771-72.

In sum, the Agency finds clear, unequivocal, and convincing record evidence, based on Registrant's admissions, that she submitted a materially false renewal application for registration. 21 U.S.C. 824(a)(1); 21 CFR 1301.43(e).

As a result of this established violation, the Agency finds that the Government has established a prima facie case for sanction, that Registrant did not rebut that prima facie case, and that there is clear, unequivocal, and convincing record evidence supporting the revocation of Registrant's registration. 21 U.S.C. 824(a)(1).

Where, as here, the Government has presented a prima facie case showing that Registrant submitted a materially false application for registration renewal, the burden shifts to Registrant to show why she can be trusted with a registration. Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018). The issue of trust is a fact-dependent determination based on the circumstances presented by the individual practitioner. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Historically, the Agency has considered acceptance of responsibility, egregiousness, and deterrence when making this assessment.

Specifically, the Agency requires the practitioner to accept responsibility for his or her violation. Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). Acceptance of responsibility must be unequivocal. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024); Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31.

In addition, the Agency considers the egregiousness and extent of the misconduct in determining the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the need to deter similar acts by Registrant, by current registrants, and by future applicants for registration. Stein, 84 FR at 46972-73.

Here, Registrant did not timely request a hearing, or timely or properly answer the allegations, and was therefore deemed to be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA, at 1-3. To date, Registrant has not filed a motion with the Office of the Administrator to excuse the default. 21 CFR 1301.43(c)(1). Registrant has thus failed to answer the allegations contained in the OSC and has not otherwise availed herself of the opportunity to refute the Government's case. As such, Registrant has not accepted responsibility for the proven violations, has made no representations regarding her future compliance with the CSA, and has not made any demonstration that she can be trusted with registration.

Moreover, the evidence presented by the Government shows that Registrant provided false information regarding her fee exempt status. Providing false information as part of an application process for controlled substance privileges governed by Federal law calls into question Registrant's honesty, trustworthiness, and ability or willingness to comply with the laws governing controlled substances. To permit Registrant to maintain a registration under these circumstances would send a dangerous message that DEA does not expect compliance with its registration requirements and that the registration fees required by statute and regulation can be circumvented without consequence by making false statements. Registrant and the regulated community must be on notice that DEA's registration and renewal process, to include the required fees, is governed by Federal law, that DEA will strictly enforce those Federal laws, and that DEA expects applicants and registrants to adhere to those Federal laws.

Accordingly, the Agency will order the revocation of Registrant's registration.

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. MJ5209677 issued to Grace S. Joanita, N.P. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Grace S. Joanita, N.P., to renew or modify this registration, as well as any other pending application of Grace S. Joanita, N.P., for additional registration in Ohio. This Order is effective November 17, 2025.

This document of the Drug Enforcement Administration was signed on October 1, 2025, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

On October 20, 2021, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Hovic Pharmacy of Houston, Texas (Respondent). Request for Final Agency Action (RFAA), at 1801. 1 The OSC proposes the revocation of Respondent's DEA registration No. FH5569112 (registration), pursuant to 21 U.S.C. 824(a)(4) “because . . . [Respondent's] continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. [823(g)(1)].”  2 Id. According to the OSC, “Respondent's pharmacists filled many controlled substance prescriptions outside the usual course of pharmacy practice . . . and in contravention of their `corresponding responsibility.' ” Id. at 1802, citing 21 CFR 1306.06 and 1306.04(a).

The OSC more specifically alleges that, according to an “independent pharmacy expert” retained by DEA who “reviewed . . . prescription data” referenced in the OSC, the “data present[ ] multiple red flags that were highly indicative of abuse and diversion.” Id. at 1806. With respect to the “controlled substances purchased by and distributed to” a recruiter (Recruiter), the expert opined that the “red flags inherent in those prescriptions could not have been resolved by a pharmacist acting in the usual course of professional practice, and, therefore, each prescription was filled outside the standard of care of pharmacy practice in Texas.”  3 Id. As for the prescriptions whose red flags “could potentially be resolved, the expert concluded that, based on documentation provided by . . . [Respondent, Respondent] made no effort to resolve the red flags and therefore, those prescriptions were also filled outside the standard of care of pharmacy practice in Texas.” Id.

Respondent initially requested a hearing, but submitted a Waiver of Hearing on February 10, 2022, days before the hearing scheduled for February 14 through February 17 was to begin. 4 Id. at 1807-08; infra section III.A. The Chief ALJ issued his Order Terminating Proceedings on February 11, 2022. RFAA, at 1809. The Government filed its RFAA, and served Respondent, on October 30, 2023. Id. at 21.

Having thoroughly analyzed the record and applicable law, the Agency summarizes its findings and conclusions: (1) the OSC includes multiple, specific allegations that Respondent violated the Controlled Substances Act (CSA), the CSA's implementing rules, and Texas law, (2) Respondent requested a hearing, participated during most of the pre-hearing stage, and simply withdrew its hearing request, without explanation or elaboration of any kind, days before the four-day scheduled hearing was to begin, (3) the Government's RFAA presents a prima facie case as to all but three of the apparent OSC allegations, and (4) the record includes substantial record evidence, indeed unequivocal and uncontroverted record evidence, that Respondent violated federal and Texas law, thus unlawfully releasing about 13,135 controlled substance tablets, and about a 3,478 days' supply of promethazine with codeine (Schedule V), into the community in a period of about eighteen months. 5 6 Accordingly, the Agency will revoke Respondent's registration. Infra, Order.

The main objectives of the CSA, according to the Supreme Court, are to “conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.” Gonzales v. Raich, 545 U.S. 1, at 12 (2005). Given these objectives, the Supreme Court states, particular congressional concerns included “the need to prevent the diversion of drugs from legitimate to illicit channels.” Id. at 12-13. Further, according to the Supreme Court, to accomplish the CSA's objectives, “Congress devised a closed regulatory system making it unlawful to . . . dispense[ ] or possess any controlled substance except in a manner authorized by” the statute. 7 Id. at 13.

According to the CSA's implementing rules, a lawful controlled substance order or prescription is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). As the Supreme Court explained, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . . [and] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”  8 Gonzales v. Oregon, 546 U.S. 243, 274 (2006), see also United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), cert. denied, 444 U.S. 866 (1979) (pharmacist's failed challenge to his federal corresponding responsibility).

While the “responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, . . . a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR 1306.04(a).

The OSC is addressed to Respondent at its registered address in Texas. Therefore, the Agency also evaluates Respondent's actions according to Texas law, including the applicable Texas pharmacist professional responsibilities. Gonzales v. Oregon, 546 U.S. at 269-71.

During the period alleged in the OSC, Texas law specifically addressed pharmacists' professional responsibilities. First, according to Texas law, “[a] pharmacist may not dispense . . . a controlled substance . . . except under a valid prescription and in the course of professional practice.” Tex. Health & Safety Code § 481.074(a) (2017, 2019). Second, pharmacists “shall make every reasonable effort to ensure that any prescription drug order . . . has been issued for a legitimate medical purpose by a practitioner in the course of medical practice.” 22 Tex. Admin. Code § 291.29(b) (2018). Further, according to Texas law, a “pharmacist shall make every reasonable effort to prevent inappropriate dispensing due to fraudulent, forged, invalid, or medically inappropriate prescriptions in violation of a pharmacist's corresponding responsibility.” Id. § 291.29(f). Texas law specifically identifies “red flag factors” that are “relevant to preventing the non-therapeutic dispensing of controlled substances” that “shall be considered by evaluating the totality of the circumstances rather than any single factor.” Id. Several of those red flag factors are relevant to the adjudication of the OSC.

According to Texas law, a “reasonably discernible pattern of substantially identical prescriptions for the same controlled substances, potentially paired with other drugs, for numerous persons, indicating a lack of individual drug therapy in prescriptions issued by the practitioner” is a red flag factor. Id. § 291.29(f)(1). Likewise, under Texas law, “prescriptions by a prescriber . . . [that] are routinely for controlled substances commonly known to be abused drugs, including opioids, benzodiazepines, muscle relaxants, psychostimulants containing codeine, or any combination of these drugs” is a red flag factor. Id. § 291.29(f)(3). Another red flag factor is “prescriptions for controlled substances . . . [that] are commonly for the highest strength of the drug and/or for large quantities ( e.g., monthly supply), indicating a lack of individual drug therapy in prescriptions issued by the practitioner.” Id. § 291.29(f)(5). Two other red flag factors are “multiple persons with the same address [who] present substantially similar controlled substance prescriptions from the same practitioner,” and “persons [who] consistently pay for controlled substance prescriptions with cash or cash equivalents more often than through insurance.” Id. §§ 291.29(f)(11) and (12).

The Texas Administrative Code clearly sets out the operational standard for a pharmacy to follow when it is presented with a controlled substance prescription exhibiting a “red flag factor”: “Prior to dispensing, any questions regarding a prescription drug order must be resolved with the prescriber and written documentation of these discussions made and maintained as specified in subparagraph (C) of this paragraph.”  9 Id. § 291.33(c)(2)(A)(iv) (2018-2023). This Texas documentation requirement preludes a post hoc oral statement that identification and resolution of a “red flag factor” actually took place absent the existence of documentation compliant with Section 291.33(c)(2)(C).

In sum, the Government charges Respondent with filling controlled substance prescriptions outside the usual course of Texas pharmacy practice in contravention of its corresponding responsibility over the course of many years: (1) Respondent filled controlled substance prescriptions for Recruiter and Recruiter's recruits, knowing that the controlled substances were destined for resale on the street, a clearly illegitimate purpose, and (2) Respondent filled controlled substance prescriptions beneath the applicable standard of care and outside the usual course of professional practice. RFAA, at 1802, 1804-1806.

The RFAA is more than 1,800 pages, mostly documentary evidence, and includes three sworn, under penalty of perjury, Declarations: one by a (now-retired) Diversion Investigator (DI), one by Recruiter, and one by the Government's expert, Dr. Diane Ginsburg, a Registered Pharmacist. Id. at 1810-50.

The DI's Declaration states that its content is based on “personal knowledge and/or information gained in the course of . . . official duties.” Id. at 1813. Its content includes background about DEA's investigation of Respondent and others, information supporting the OSC's allegations, and material that is consistent with portions of Recruiter's Declaration. 11 Id. at 1813-20. The Agency finds that DI's Declaration is internally consistent and supports the Government's request to revoke Respondent's registration. Id. The Agency affords DI's Declaration full credibility, due to its internal consistency and its having been sworn to under penalty of perjury.

Recruiter's declaration, dated February 17, 2022, is sworn to and signed by Recruiter. Id. at 1810-12. According to the Declaration, Recruiter is “currently incarcerated” in federal prison “serving a 60-month sentence as a result of pleading guilty to the charge of conspiracy to dispense and distribute hydrocodone.” Id. at 1810. Recruiter's Declaration describes a conspiracy in which Recruiter and Recruiter's recruits unlawfully obtained controlled substance prescriptions. Recruiter then presented the prescriptions to Respondent, and Respondent's pharmacists filled them even though the pharmacists knew or had reason to know that the prescriptions were unlawfully obtained. Recruiter then sold the unlawfully obtained controlled substances on the street. Id. at 1810-12.

Based on the admissions in Recruiter's Declaration, the Agency finds that Recruiter, “[f]rom at least 2017 through 2020 . . .[,] participated in a scheme to obtain prescriptions for controlled substances from practitioners and those prescriptions were filled at . . . [Respondent].”  12 Id. The Agency further finds unequivocal and uncontroverted record evidence that Recruiter “recruit[ed] individuals to pose as patients (recruits) who would obtain prescriptions for controlled substances from two different practitioners,” that Respondent would fill the controlled substance prescriptions, including prescriptions for hydrocodone-acetaminophen 10-325 (Schedule II), promethazine with codeine, carisoprodol (Schedule IV), and alprazolam (Schedule IV), and that Recruiter “would then purchase these prescriptions with cash, pick up the drugs[,] and sell the drugs to street level customers.”  13 Id. at 1810. In sum, given the self-incriminating nature of Recruiter's Declaration, the corroboration of its content by DI's Declaration, its internal consistency, and its having been sworn to under penalty of perjury, the Agency affords Recruiter's Declaration credibility. 14

The Agency finds unequivocal and uncontroverted record evidence that Recruiter “developed a relationship with the employees” of Respondent who “rarely questioned” the controlled substance prescriptions that Recruiter dropped off for about eleven individuals approximately three times a week for several years.”  15 Id. at 1810-11; see also id. at 1812 (“Though I firmly believe . . . [Respondent Pharmacist Two] knew or had reason to know that the prescriptions I purchased and picked up from . . . [Respondent] were not issued for a legitimate medical purpose, . . . [Respondent Pharmacist One] was also aware that I was regularly picking up prescriptions for controlled substances that had been prescribed to others.”).

The Agency also finds unequivocal and uncontroverted record evidence that Respondent Pharmacist Two “instructed” Recruiter about how to do business with Respondent. Id. at 1811. For example, Respondent Pharmacist Two told Recruiter not to bring the recruits to the store to pick up and purchase the controlled substances. Id. Instead, she instructed Recruiter “to come in and pick up the prescriptions,” and either to forge the recruits' names on the signature log or to sign Recruiter's own name. Id.; id. at 31-89 (Respondent's signature logs, GX 4, that Recruiter annotated with a circle or a circle with a check mark to signify when Recruiter forged the recruit's name (circle only) and when Recruiter signed Recruiter's own name (circle and check mark)); id. at 171-237 (Respondent's Dispensed Drug Report for the Period of January 3, 2020, through March 29, 2021, GX 8, showing about twenty-seven prescription number matches between the signature log prescription numbers that Recruiter signed, forging the recruit's name, and controlled substances, such as promethazine with codeine, hydrocodone-acetaminophen 10-325, and carisoprodol 350, that Respondent filled and sold to Recruiter from January 23, 2020, to March 23, 2020). 16

In sum, the Agency finds unequivocal and uncontroverted record evidence that Respondent did not question, address, prevent, or otherwise take any action when Recruiter asked for, signed the signature log for, paid for, and left Respondent's store with filled controlled substance prescriptions issued for persons other than Recruiter. Id. at 1811 (“At no time did anyone at . . . [Respondent] question the fact that I was picking up controlled substances for others. At no time did anyone at . . . [Respondent] refuse to provide me with a prescription that was issued to someone else even though I signed the person's name instead of my own. I was also never asked to provide any proof that I had authority to pick up prescriptions for anyone other than myself.”).

Further, the Agency finds unequivocal and uncontroverted record evidence that at least one of Respondent's pharmacists knew, and even conversed “often” with Recruiter, about Recruiter's street resale of the controlled substances that Respondent filled for Recruiter and Recruiter's recruits. Id. at 1811-12. For example, Recruiter and at least Respondent Pharmacist Two “often” discussed Recruiter's specific controlled substance brand preferences, the brands with a “higher resale value” on the street. Id. at 1811 (Recruiter's Declaration identifying specific brands of promethazine with codeine and of hydrocodone products). Further, Respondent “often required [Recruiter] to pay more than the cash price that was listed on the prescription itself.” Id. at 1812. Regarding promethazine with codeine, for example, Recruiter “would pay approximately $240 for 8 ounces . . . [t]hough this arrangement seemed unfair, . . . [but Recruiter] accepted it because . . . [Recruiter] was able to sell the controlled substances on the street for more.”  17 Id.

The Agency further finds unequivocal and uncontroverted record evidence that Recruiter was not the only recruiter for whom Respondent filled controlled substance prescriptions. Id. at 1811. The record evidence is that Respondent Pharmacist Two interacted with another recruiter, and even catered to him by instructing Recruiter to frequent Respondent “at approximately 4 p.m. each day to pick up prescriptions, so . . . [Recruiter] would not be seen by” the other recruiter who did not want Recruiter to “use” Respondent “to fill prescriptions.” Id.

Further, the Agency finds unequivocal and uncontroverted record evidence that one of Respondent's pharmacists even lent Recruiter money to pay for the recruits' doctor visits with the understanding that Recruiter would re-pay the money after selling on the street the controlled substances that Respondent provided. Id. at 1811-12. Further, the Agency finds undisputed record evidence that one of Respondent's pharmacists lent Recruiter as much as $800 for this purpose. Id. at 1812.

In sum, the Agency finds unequivocal and uncontroverted record evidence that, “[f]rom at least 2017 through 2020,” Respondent, by its pharmacists, filled controlled substance prescriptions for Recruiter, and for at least one other recruiter, with knowledge that those controlled substances would be diverted. E.g., id. at 1810.

The Agency finds that Dr. Ginsburg qualifies as an expert in pharmaceutical controlled substance dispensing in Texas, and accepts her as such in this adjudication. 18 Id. at 1725-84 (sixty-page curriculum vitae of Dr. Ginsburg, a Texas Registered Pharmacist, listing her accomplishments; education; publications on a broad variety of pharmacy-related topics; invited papers and presentations on the national, international, state, and local levels with a primary focus on pharmacy- and pharmacist-related topics; professional affiliations; honors and awards, and her work experience as a pharmacist and educator). The Agency recognizes Dr. Ginsburg as an expert in pharmaceutical controlled substance dispensing in Texas. 19 Id. at 1725-84, 1821-50. The Agency, because Dr. Ginsberg is an expert in pharmaceutical controlled substance dispensing in Texas, because her Declaration accurately states Respondent's legal responsibilities according to relevant federal and Texas law, because her Declaration is sworn to under penalty of perjury, and because her Declaration asserts that she reviewed Government exhibits 4 through 36, affords Dr. Ginsburg's Declaration full credibility. 20 Id. at 31-1724, 1822-23, 1825.

Based on Dr. Ginsburg's Declaration and the entirety of the record evidence before the Agency, the Agency finds unequivocal and uncontroverted record evidence that Respondent's “pharmacists failed to carry out their corresponding responsibility when they dispensed controlled substances to . . . customers, in that they ignored red flags indicating a risk of diversion and failed to ensure that the prescriptions dispensed were issued for a legitimate medical purpose in the usual course of professional practice.” Id. at 1823 (Dr. Ginsburg's Declaration is based on the record evidence she reviewed); see also id. (Dr. Ginsburg's Declaration stating that “all minimally competent pharmacists can and should be able to recognize `red flags' related to prescriptions, and they are required to do so in the usual course of pharmacy practice in Texas.”); id. at 1823-24 (Dr. Ginsburg's Declaration stating that “a `red flag' is anything about a prescription that would cause the pharmacist to be concerned that the prescription was not issued for a legitimate medical purpose in the usual course of professional practice.”); id. at 1824 (Dr. Ginsburg's Declaration stating that, “When confronted with a red flag or red flags concerning a prescription for controlled substances, a pharmacist must try to resolve the red flags to determine whether or not the prescription is legitimate. A pharmacist must resolve the red flag(s) prior to filling the prescription. Depending on the type of red flag, there are different steps that the pharmacist can take to determine whether or not the prescription is legitimate. These steps involve obtaining more information from the physician or the patient, or both.”); id. at 1825; infra (Dr. Ginsberg's Declaration explaining “unresolvable” red flags, offering the example of Recruiter's picking up controlled substance prescriptions issued to others, and concluding that both Respondent Pharmacists filled controlled substance prescriptions in the face of unresolvable red flags).

According to the OSC's allegations, controlled substance “cocktail prescriptions” are controlled substance prescriptions including “various combinations of the highly abused hydrocodone, carisoprodol, alprazolam . . . [,] and promethazine with codeine.” RFAA, at 1804-05. Based on Dr. Ginsburg's Declaration and the entirety of the record evidence before the Agency, the Agency finds unequivocal and uncontroverted record evidence that “hydrocodone, promethazine with codeine, carisoprodol, and alprazolam . . . [are] highly abused controlled substances,” and that these types of combination controlled substance “cocktail prescriptions have long been recognized as a red flag for abuse and/or diversion in Texas and significantly increase a patient's risk of morbidity and overdose.” Id. at 1832; see also id. at 1823 (Dr. Ginsburg's Declaration stating that “[h]ydrocodone, alprazolam, promethazine with codeine, and carisoprodol are several of the more commonly diverted and abused drugs in Texas.”). Based on Dr. Ginsburg's Declaration and the Agency's careful analysis of the evidence before it, the Agency further finds that “[t]here is nothing in any of the [record] documents [that Dr. Ginsburg reviewed] to show that . . . [Respondent] recognized these cocktail prescriptions as a red flag for abuse and/or diversion, and nothing to indicate that . . . [Respondent] took any steps to resolve the red flags prior to dispensing” them. Id. at 1832; id. at 1825-32.

Accordingly, based on these expert-based, undisputed findings and opinions, the Agency finds unequivocal and uncontroverted record evidence that, from July 17, 2019, to July 10, 2020, Respondent filled about 138 controlled substance cocktail prescriptions involving five individuals without resolving those red flags of abuse and/or diversion. Id. at 106-237, 425-616, 1824-32. By failing to exercise its corresponding responsibility and filling these controlled substance prescriptions, Respondent released into the community about 3143 hydrocodone-acetaminophen 10-325 mg tablets, about 2680 carisoprodol 350 mg tablets, about 1326 days' supply (or more than three and a half years' supply) of promethazine with codeine, about 190 alprazolam 1 mg tablets, and about 90 alprazolam 2 mg tablets. Id. at 106-237, 425-616.

According to the OSC's allegations, Respondent filled monthly prescriptions for promethazine with codeine to three individuals from March 4, 2019, to June 18, 2020. Id. at 1804. Based on Dr. Ginsburg's Declaration and the entirety of the record evidence before the Agency, the Agency finds unequivocal and uncontroverted record evidence that Respondent failed to exercise its corresponding responsibility and filled “[r]epeated and continuous” prescriptions for promethazine with codeine to three individuals from March 4, 2019, to June 18, 2020, approximately monthly. 21 Id. at 1832 (describing the promethazine with codeine prescriptions for the three individuals as “monthly prescriptions,” “continuous prescriptions,” and “continuous prescriptions,” respectively). Based on Dr. Ginsburg's Declaration and the entirety of the record evidence before the Agency, the Agency finds unequivocal and uncontroverted record evidence that promethazine with codeine is a “highly abused cough suppressant normally prescribed for short term use,” and that its “repeated prescribing . . . has long been recognized in Texas as a red flag for abuse and/or diversion.” Id. at 1834; see also id. at 1824. Based on Dr. Ginsburg's Declaration and the Agency's careful analysis of the evidence before it, the Agency further finds that Respondent failed to exercise its corresponding responsibility as “[t]here is nothing . . . [in the record] to show that . . . [Respondent] recognized these prescriptions as a red flag for abuse and/or diversion, and nothing to indicate that . . . [Respondent] took any steps to resolve the red flag prior to dispensing.” Id. at 1834.

Accordingly, consistent with the expert's undisputed Declaration, the Agency finds unequivocal and uncontroverted record evidence that, from March 4, 2019, to June 18, 2020, Respondent released about 1,089 days' (or almost 3 years') worth supply of promethazine with codeine into the community by its “[r]epeated and continuous” failures to exercise its corresponding responsibility and filling three individuals' almost monthly illegitimate controlled substance prescriptions. Id. at 294-324, 425-93, 1610-1714, 1832-34. Taking into account overlap with the promethazine with codeine involved in the cocktail calculations, Respondent, violating its corresponding responsibility, released about an additional 285 days' worth supply of promethazine with codeine into the community by its “[r]epeated and continuous” filling of three individuals' prolonged, and almost monthly, promethazine with codeine controlled substance prescriptions. Id. at 294-324, 425-93, 1610-1714.

According to the OSC's allegations, “pattern prescribing” is “when a practitioner prescribes the same controlled substances in identical or substantially similar dosages and quantities, thus indicating a lack of individualized care.” Id. at 1805. According to Dr. Ginsburg's Declaration, “pattern prescribing” is a prescriber's employment of a “ `one size fits all' approach to prescribing potentially dangerous narcotics, usually by prescribing the narcotics in identical or nearly identical quantities to each patient regardless of the patient's individualized medical condition.” Id. at 1824. Based on Dr. Ginsburg's Declaration and the Agency's careful analysis of the evidence before it, the Agency finds unequivocal and uncontroverted record evidence that two physicians engaged in “pattern prescribing,” that both doctors' pattern prescribing involved their issuing controlled substance prescriptions for hydrocodone-acetaminophen 10-325 mg, carisoprodol 350 mg, and promethazine with codeine, and that they issued these controlled substance prescriptions to at least seven individuals. Based on Dr. Ginsburg's Declaration and the Agency's careful analysis of the evidence before it, the Agency further finds that “[t]here is nothing . . . [in the record] to show that . . . [Respondent] recognized these prescriptions as a red flag for abuse and/or diversion, and nothing to indicate that . . . [Respondent] took any steps to resolve the red flag prior to dispensing.” Id. at 1843, see also id. at 1834-43.

In sum, according to evidence that is unequivocal and uncontroverted, from March 8, 2019, to July 3, 2020, Respondent released about 1,456 days' (or almost a 4 years') worth supply of promethazine with codeine 240 mL, about 303 days' (or about two months shy of one year) worth supply of promethazine with codeine 180 mL, about an additional 2,666 tablets of carisoprodol 350 mg, and about an additional 3,328 tablets of hydrocodone-acetaminophen 10-325 into the community by filling controlled substances prescriptions without resolving the red flag of pattern prescribing. 22 Id. at 325-424, 617-804, 1610-1714, 1834-43.

The OSC states that “pharmacy shopping” is when an individual “fill[s] prescriptions for controlled substances at multiple pharmacies.” Id. at 1805. Dr. Ginsburg's Declaration states that “pharmacy shopping” may indicate that a customer is trying to avoid being suspected of abuse and/or diversion while obtaining controlled substances. Id. at 1847; see also id. at 1824, 1843-47. The Ginsburg Declaration further states that “[p]harmacy shopping has long been recognized as a red flag for abuse and/or diversion in Texas because it may indicate the customer is attempting to obtain prescriptions and avoid suspicion.”  23 Id. at 1847. Based on Dr. Ginsburg's Declaration and the entirety of the record evidence before the Agency, the Agency finds unequivocal and uncontroverted record evidence that controlled substance prescriptions for three individuals, including for Recruiter, were filled by “pharmacy shopping,” that is, by filling one of three controlled substance prescriptions issued at, or at about, the same time (including hydrocodone-acetaminophen 10-325 in all but one case) at a different pharmacy from where they filled the other two, typically at Respondent. Id. at 1843-47. Based on Dr. Ginsburg's Declaration and the Agency's careful analysis of the evidence before it, the Agency further finds that “[t]here is nothing . . . [in the record evidence] to show that . . . [Respondent] recognized these prescriptions as a red flag for abuse and/or diversion,” and that there is “nothing [in the record evidence] to indicate that . . . [Respondent] took any steps to resolve the red flag prior to dispensing.” Id. at 1847.

Accordingly, based on these expert-based, undisputed findings, the Agency finds unequivocal and uncontroverted evidence that, from December 17, 2018, to May 22, 2020, Respondent released about an additional 1,038 tablets of carisoprodol 350 mg and about an additional 456 days' (or over one year's) worth supply of promethazine with codeine 240 mL into the community by filling controlled substance prescriptions issued to individuals who engaged in “pharmacy shopping” without resolving that red flag. Id. at 1594-1609, 1843-47.

In sum, based on Dr. Ginsburg's Declaration and the entirety of the record evidence before the Agency, the Agency finds unequivocal and uncontroverted record evidence that Respondent's pharmacists failed to recognize and resolve red flags of abuse and/or diversion, “failed to carry out their corresponding responsibility,” and “failed to ensure that the dispensed prescriptions were issued for a legitimate medical purpose in the usual course of professional practice.” Id. at 1823.

As already discussed, the Agency finds that the evidence the Government submitted with the RFAA, in conjunction with Respondent's not having submitted any evidence, is unequivocal and uncontroverted record evidence that Recruiter, “[f]rom at least 2017 through 2020,” participated in a scheme to obtain illegitimate controlled substance prescriptions, to present them to Respondent to fill, and to sell the Respondent-filled controlled substances on the street. Supra section III.A.2. As already discussed, the Agency also finds unequivocal and uncontroverted record evidence that Respondent Pharmacists One and Two knowingly participated in the scheme by filling the illegitimate controlled substance prescriptions without identifying, let alone resolving, those prescriptions' red flags. Supra sections III.A.2, III.A.3. For example, as already discussed, Respondent Pharmacist Two instructed Recruiter on how to carry out parts of the scheme, lent Recruiter money to enable accomplishment of the scheme's goals, and charged inflated costs for fills. Supra section III.A.2. Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent violated federal and Texas law because, at least in 2019 and 2020, Respondent's employees knowingly participated in a scheme to distribute controlled substances to a known street dealer. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074(a) (2017, 2019); 22 Tex. Admin. Code §§ 291.29(b) and (f) (2018), 291.33(c)(2)(A)(iv) and (C) (2018-2023); supra section II.

As already discussed, the Agency finds unequivocal and uncontroverted record evidence that Recruiter, “[f]rom at least 2017 through 2020,” participated in a scheme to obtain illegitimate controlled substance prescriptions, to present them to Respondent to fill, and to sell the Respondent-filled controlled substances on the street. Supra section III.A.2. For example, as the Agency already found, Respondent Pharmacist Two told Recruiter not to bring the recruits to the store to pick up and purchase the controlled substance prescriptions. Id. Instead, Respondent Pharmacist Two instructed Recruiter “to come in and pick up the prescriptions,” and either to forge the recruits' names on the signature log or to sign Recruiter's own name. Id. By way of further examples, as the Agency already found, Respondent Pharmacist Two and Recruiter “often” discussed Recruiter's specific controlled substance brand preferences, the brands with a “higher resale value” on the street; a Respondent pharmacist helped Recruiter buy the specific brand of a controlled substance that brought the higher street resale value; and one of Respondent's pharmacists even lent Recruiter money to pay for the recruits' doctor visits with the understanding that Recruiter would re-pay the money after selling on the street the controlled substances that Respondent provided. Id. Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent violated federal and Texas law between at least September 16, 2019, and March 23, 2020. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074(a) (2017, 2019); 22 Tex. Admin. Code §§ 291.29(b) and (f) (2018), 291.33(c)(2)(A)(iv) and (C) (2018-2023); supra section II.

As already discussed, the Agency finds unequivocal and uncontroverted record evidence that, monthly from March to December of 2019, and from February to June of 2020, Respondent filled prescriptions for promethazine with codeine for two individuals. Supra section III.A.3.; n.21. Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent violated federal and Texas law, monthly, as to the two individuals' monthly, or more frequently than monthly, prescriptions for promethazine with codeine. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074 (2017, 2019); 22 Tex. Admin. Code §§ 291.29 (2018), 291.33 (2018-2023). Supra section II.

As already discussed, the Agency finds unequivocal and uncontroverted record evidence that Respondent filled about 138 controlled substance cocktail prescriptions involving five individuals without resolving those red flags of abuse and/or diversion from July 17, 2019, to July 10, 2020. Supra section III.A.3. Also as already discussed, the Agency finds unequivocal and uncontroverted record evidence that these cocktail prescriptions involved various combinations of hydrocodone-acetaminophen 10-325 mg, carisoprodol 350 mg, alprazolam 1 mg, alprazolam 2 mg, and promethazine with codeine. Supra section III.A.3. Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent violated federal and Texas law by filling controlled substance cocktail prescriptions involving five individuals without resolving those red flags of abuse and/or diversion from July 17, 2019, to July 10, 2020. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074 (2017, 2019); 22 Tex. Admin. Code §§ 291.29 (2018), 291.33 (2018-2023); supra section II.

As already discussed, the Agency finds unequivocal and uncontroverted record evidence that, between March 8, 2019, and July 3, 2020, Respondent filled controlled substance prescriptions issued by two practitioners to at least seven individuals without resolving the prescriptions' pattern prescribing red flags. Supra section III.A.3. Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent violated federal and Texas law, between March 8, 2019, and July 3, 2020, by filling controlled substance prescriptions without identifying and resolving those prescriptions' pattern prescribing red flags of abuse and/or diversion. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074 (2017, 2019); 22 Tex. Admin. Code §§ 291.29 (2018), 291.33 (2018-2023); supra section II.

As already discussed, the Agency finds unequivocal and uncontroverted record evidence that Respondent filled controlled substance prescriptions for three individuals without identifying and resolving their pharmacy shopping red flags from December 17, 2018, to May 22, 2020. Supra section III.A.3. Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent violated federal and Texas law. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074 (2017, 2019); 22 Tex. Admin. Code §§ 291.29 (2018), 291.33 (2018-2023); supra section II.

Under Section 304 of the CSA, “[a] registration . . . to . . . distribute[ ] or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under . . . [21 U.S.C. 823] inconsistent with the public interest as determined by such section.” 21 U.S.C. 824(a)(4). In the case of a “practitioner,” which is defined in 21 U.S.C. 802(21) to include a “pharmacy,” Congress directed the Attorney General to consider five factors in making the public interest determination. 21 U.S.C. 823(g)(1)(A-E). 24

The five factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (“It is well established that these factors are to be considered in the disjunctive” (quoting In re Arora, 60 FR 4447, 4448 (1995))); Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). The Agency may give each factor the weight it deems appropriate. Gonzales v. Oregon, 546 U.S. at 293 (Scalia, J., dissenting) (quoting In re Arora, 60 FR 4447, 4448 (1995)), e.g., Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007) (importer); Morall v. Drug Enf't Admin., 412 F.3d 165, 174 (D.C. Cir. 2005) (practitioner), quoting Henry J. Schwarz, Jr., Denial of Application, 54 FR 16422, 16424 (Apr. 24, 1989).

The Agency “may properly rely on any one or a combination of factors.” Gonzales v. Oregon, 546 U.S. at 293 (Scalia, J. dissenting) (quoting In re Arora, 60 FR 4447, 4448 (1995)); Morall, 412 F.3d at 185 n.2 (Henderson, J. concurring and referring to pages 173-74 of the majority opinion); see also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018) ( citing Akhtar-Zaidi v. Drug Enf't Admin., 841 F.3d 707, 711 (6th Cir. 2016)); Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while the Agency is required to consider each of the factors, it “need not make explicit findings as to each one.” MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (the Agency “must consider each of these factors” but “need not make explicit findings as to each one”) (quoting Volkman, quoting Hoxie, and citing Morall ). “In short, . . . 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; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009) (on remand). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.

The Government has the burden of proof in this proceeding. 21 CFR 1301.44(e); see also Morall, 412 F.3d. at 174.

While the Agency considered all of the 21 U.S.C. 823(g)(1) factors in this matter, the Agency finds that the Government's prima facie case is confined to factors B and D. The Agency finds that the Agency-found facts regarding Respondent's conduct with respect to factors B and D, its unlawful conduct under applicable federal and Texas law, constitute a prima facie showing that Respondent's continued registration would be inconsistent with the public interest. 21 CFR 1306.04(a); Tex. Health & Safety Code § 481.074(a) (2017, 2019); 22 Tex. Admin. Code §§ 291.29(b) and (f) (2018), 291.33(c)(2)(A)(iv) and (C) (2018-2023); MacKay, 664 F.3d at 819; supra section II.

Accordingly, the Government has satisfied its prima facie burden of showing that Registrant's continued registration would be “inconsistent with the public interest.” 21 U.S.C. 824(a)(4) in conjunction with 823(g)(1); supra sections II, III.A.1. III.A.2., III.A.3., III.B., III.C., III.D., III.E., III.F., III.G. Respondent, who chose not to submit any evidence for the Agency's consideration, also did not attempt to rebut the Government's prima facie case.

Where, as here, the Government has met its prima facie burden of showing that Respondent's continued registration would be inconsistent with the public interest due to its experience dispensing controlled substances and its failure to comply with applicable laws relating to controlled substances, the burden shifts to Respondent to show why the Agency should continue to entrust it with a registration. Morall, 412 F.3d. at 174; Jones Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D., 83 FR 18882 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833.

Moreover, as past performance is the best predictor of future performance, DEA Administrators have required that a registrant who has committed acts inconsistent with the public interest must accept responsibility for those acts and demonstrate that it will not engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833 (citing authority including Alra Labs., Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995) (“An agency rationally may conclude that past performance is the best predictor of future performance.”). “[T]hat consideration is vital to whether continued registration is in the public interest.” MacKay, 664 F.3d at 820. A registrant's acceptance of responsibility must be unequivocal. Jones Total Health Care Pharmacy, 881 F.3d at 830-31.

Further, DEA Administrators have found that the egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction. Id. at 834 and n.4. DEA Administrators have also considered the need to deter similar acts by the respondent and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.

Here, Respondent chose to withdraw its request for a hearing just days before the hearing was scheduled to begin. Supra section I. As such, the record includes no evidence submitted by Respondent. Nor did Respondent attempt to convince the Agency that it understands that its issuance of controlled substances fell short of the applicable legal standards, and that this substandard controlled substance issuance has serious negative ramifications for the health, safety, and medical care of individuals who come to it with controlled substance prescriptions to be filled. E.g., Jones Total Health Care Pharmacy, 881 F.3d at 834 and n.4; Garrett Howard Smith, M.D., 83 FR at 18910 (collecting cases) (“The egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction.”). As such, it is not reasonable to believe that Respondent's future issuance of controlled substances will comply with legal requirements.

The unequivocal and uncontroverted record evidence is the Respondent's founded violations resulted in the release of about 13,135 controlled substance tablets, and about a 3478 days' supply of promethazine with codeine into the community in a period of about eighteen months. Supra sections I, III.A.3., III.B., III.C., III.D., III.E., III.F., III.G. The controlled substances unlawfully released into the community were hydrocodone-acetaminophen 10-325 mg tablets, carisoprodol 350 mg tablets, alprazolam tablets, and promethazine with codeine, controlled substances known to be abused and diverted. Id.

There is no record evidence that Respondent takes responsibility, let alone unequivocal responsibility, for the founded violations.

There is no record evidence from which the Agency may reasonably conclude that Respondent's future controlled substance-related actions will comply with legal requirements. Accordingly, Respondent did not convince the Agency that it should continue to entrust Respondent with a registration.

The interests of specific and general deterrence weigh in favor of revocation. Further, given the foundational nature and vast number of Respondent's violations, a sanction less than revocation would send a message to the existing and prospective registrant community that compliance with the law is not essential to maintaining a registration.

Accordingly, I shall order the sanction the Government requested, as contained in the Order below.

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a)(4) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate of Registration No. FH5569112 issued to Hovic Pharmacy. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending application of Hovic Pharmacy to renew or modify this registration, as well as any other pending application of Hovic Pharmacy for registration in Texas. This Order is effective November 17, 2025.

This document of the Drug Enforcement Administration was signed on October 1, 2025, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

On August 13, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Shannon Wagner, D.O., of Green Bay, Wisconsin (Respondent). OSC, at 1, 3. The OSC proposed the denial of Respondent's application for a DEA Certificate of Registration (registration), Control No. W23130415C, alleging that Respondent has been mandatorily excluded from participation in Medicare, Medicaid, and all Federal health care programs pursuant to 42 U.S.C. 1320a-7(a). Id. at 1-2 (citing 21 U.S.C. 824(a)(5)).

A hearing was held before DEA Administrative Law Judge (ALJ) Teresa A. Wallbaum who, on February 21, 2025, issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (RD). The RD recommended that Respondent's application be granted. RD, at 20. The Government filed exceptions to the RD. Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the entirety of the ALJ's rulings, credibility findings, 1 findings of fact, conclusions of law, sanctions analysis, and recommended sanction in the RD, and summarizes, and expands upon portions thereof herein.

Pursuant to 21 U.S.C. 824(a)(5), the Attorney General is authorized to suspend or revoke a registration upon finding that the registrant “has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42.” The Agency has consistently held that it may also deny an application upon finding that an applicant has been excluded from a federal health care program. See Arvinder Singh, M.D., 81 FR 8247, 8248 n.3 (2016) (“ `[W]here a registration can be revoked under [21 U.S.C.] 824, it can, a fortiori, be denied under [21 U.S.C.] 823 since the law would not require an agency to indulge in the useless act of granting a license on one day only to withdraw it on the next.' ” (quoting Kwan Bo Jin, M.D., 77 FR 35021, 35021 n.2 (2012)).

On August 21, 2014, in the United States District Court for the Western District of Michigan, Respondent pleaded guilty to one count of conspiracy to pay and receive health care kickbacks, in violation of 42 U.S.C. 1320a-7b(b) and 18 U.S.C. 371; and one count of filing a false tax return, in violation of 26 U.S.C. 7206(1). 2 RD, at 3; Government Exhibit (GX) 3. On November 28, 2014, the U.S. Department of Health and Human Services, Office of Inspector General (HHS/OIG), mandatorily excluded Respondent from participation in Medicare, Medicaid, and all federal health care programs pursuant to 42 U.S.C. 1320a-7(a) for a period of thirteen years. RD, at 3; GX 7. The exclusion became effective on December 18, 2014, and imposed an exclusion for a minimum period of thirteen years. 3 Id. Accordingly, the Agency finds substantial record evidence that Respondent has been, and continues to be, excluded from participation in federal health care programs. 4

The Agency agrees with the ALJ and finds substantial record evidence that Respondent has been, and remains, mandatorily excluded from federal health care programs pursuant to 42 U.S.C. 1320a-7(a), 5 and Respondent has admitted to the same. RD, at 3, 18; GX 7. Accordingly, the Agency finds that substantial record evidence establishes the Government's prima facie case for denying Respondent's application under 21 U.S.C. 824(a)(5). See also 21 U.S.C. 823(g)(1).

Where, as here, the Government has met its prima facie burden of showing that Respondent's application for a registration should be denied, the burden shifts to Respondent to show why she can be entrusted with a registration. Morall v. Drug Enf't Admin., 412 F.3d. 165, 174 (D.C. Cir. 2005); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the best predictor of future performance, DEA Administrators have required that a respondent who has committed acts inconsistent with the public interest must accept responsibility for those acts and demonstrate that he or she will not engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833. A respondent's acceptance of responsibility must be unequivocal. Id. at 830-31. In addition, a respondent's candor during the investigation and hearing has been an important factor in determining acceptance of responsibility and the appropriate sanction. Id. Further, DEA Administrators have found that the egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction. Id. at 834 & n.4. DEA Administrators have also considered the need to deter similar acts by the respondent and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.

Here, the Agency agrees with the ALJ that Respondent unequivocally accepted responsibility for her conduct. Respondent acknowledged at every opportunity that her conduct was wrong. RD, at 12. Respondent testified directly and credibly that she had committed the charged crimes and that, in doing so, she made a significant mistake that had harmed her patients. Id. at 13. Respondent addressed, and accepted responsibility, for all her misconduct, including the illegal kickback conspiracy, the tax evasion, and her failure to take action to stop her husband. Id. Respondent testified credibly that she had learned to never allow anyone or anything to come between her and her patients. Id. Respondent directly and unequivocally acknowledged her crimes and her responsibility for her crimes during cross-examination and questioning from the ALJ. Id. Respondent acknowledged her fault and provided credible, persuasive clarifications as to other statements she had made. Id.

Having found that Respondent has unequivocally accepted responsibility for her conduct, the Agency considers whether Respondent has implemented sufficient remedial measures to demonstrate that she will not engage in future misconduct and can be trusted with a registration. 6 The Agency considers the fact that Respondent is no longer married to her co-conspirator, a significant remedial measure. 7 Tr. 39. Since Respondent's conviction and loss of license, Respondent has taken concrete steps to reestablish trust and rebuild her practice. RD, at 17.

According to Respondent, her time in prison affected how she viewed medicine and her own past actions. Tr. 46-48; RD, at 6. Respondent testified that she saw multiple inmates receive inadequate medical care for serious conditions, and she herself was refused treatment. Id. Respondent testified that these experiences made her a better doctor and made her think more about health care in general in that there are segments of the population that are completely neglected. Id. Respondent candidly and credibly testified that her time in prison changed her and made her realize that medical care involved not just treatment, but all administrative duties. RD, at 13.

After Respondent's release from prison in 2016, she did not immediately return to the practice of medicine. RD, at 7. Respondent worked a variety of jobs such as food delivery, waitressing, trucking, and cleaning. Id.; Tr. 55-56. On multiple occasions, she had to wait on former colleagues and other doctors that she knew. Id. Respondent testified that working these positions humbled her and made her aware of how valuable her license was and what an honor it was to have it. Id. Respondent eventually secured a medical license in Wisconsin, for which she disclosed her criminal convictions and exclusion from federal health care programs. Tr. 56. To do so, she was required to work under a limited license for a year, with quarterly reports from a supervisor to the Wisconsin Medical Board. Id. After one year, she applied for and received a full medical license in Wisconsin. Tr. 57. Respondent obtained employment at a clinic in Wisconsin. Tr. 62-64. Respondent is seeking a DEA registration because she plans to work with incarcerated people and a DEA registration is required for a position within the corrections system. RD, at 7. Respondent has also taken approximately 240 hours of continuing medical education credits. 8 Tr. 61. Finally, in terms of mitigation and remedial measures, Respondent has paid, and continues to pay, the ordered restitution of $270,000. 9 RD, at 17. The Agency agrees with the ALJ that Respondent has taken “significant, concrete remedial steps” to ensure the misconduct will not reoccur. Id. at 18.

Regarding egregiousness, there is no dispute that the conduct that led to Respondent's conviction and subsequent exclusion from all federal health care programs was egregious. In a case brought under 21 U.S.C. 824(a)(5), the length of the exclusion, the nature of the misconduct, and the period of incarceration are relevant considerations in determining egregiousness. George Roussis, M.D., 86 FR 61316, 61322-23 (2021) (citing Michael Jones, M.D., 86 FR 20728, 20732 (2021)). In the instant case, Respondent has been excluded for 13 years, with that exclusion ending in 2027. RD, at 18. As for the underlying conviction, Respondent pleaded guilty to a seven-year conspiracy, to commit health care fraud and filed a false tax return. Id. The egregious nature of Respondent's lengthy exclusion from federal health care programs and the egregious nature of the criminal conduct underlying the conviction would typically weigh in favor of denial of her application. Id. However, the conspiracy ended in April 2011, and the tax offense occurred in March 2012. GX 3, at 3. Thus, Respondent's criminal conduct ended over 13 years ago. RD, at 18, and Respondent has taken significant remedial measures during that time. Id.

In addition to acceptance of responsibility, the Agency considers both specific and general deterrence when determining an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 (2015). Because these administrative proceedings are intended to be remedial, rather than punitive, the Agency has previously found that, under appropriate circumstances, “criminal convictions and sanctions by state licensing authorities can sufficiently deter physicians from engaging in misconduct, making the denial of an application . . . unnecessary to achieve the goal of general deterrence.” Gilbert Y. Kim, D.D.S., 87 FR 21139, 21145 (2022) (citing Kansky J. Delisma, M.D., 85 FR 23845, 23854 (2020)). The Agency has also held that, sometimes, “such punitive measures can suffice to deter the registrant or applicant from future misconduct, making revocation or denial of an application unnecessary to achieve specific deterrence.” Id.

Here, the Agency does not find that imposing further sanction is necessary to deter Respondent from engaging in future misconduct. Respondent received significant criminal punishment for her criminal conduct. RD, at 19. Respondent's plea agreement imposed a significant price for her crimes, 24 months of imprisonment, the forfeiture of thirteen real properties and cash, and detailed obligations for cooperation in her case. Id. Respondent served 17 months of her 24-month prison sentence, successfully completed supervised release, forfeited two clinics along with other properties, and continues to pay restitution for her crimes of conviction. Thus, the Agency finds that the punitive, remedial, and personal consequences that Respondent suffered are sufficient to deter her from engaging in future misconduct. The Agency also finds that the significant consequences that Respondent has faced are sufficient to deter the general registrant community from committing similar misconduct.

Ultimately, the determination of the appropriate sanction turns on whether the Agency can trust Respondent with a registration and that Respondent will not repeat her misconduct. See Heavenly Care Pharmacy, 85 FR 53402, 53420 (2020). Respondent testified candidly, unequivocally accepted responsibility, and demonstrated genuine insight into the nature and scope of her criminal misconduct. RD, at 19. In sum, Respondent's candid, genuine testimony, coupled with her concrete remedial actions, convince the Agency that she can be trusted with a registration. Therefore, the Agency will grant her application.

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823 and 824, I hereby dismiss the Order to Show Cause issued to Shannon Wagner, D.O., and grant the pending application for a DEA Certificate of Registration, Control No. W23130415C, submitted by Shannon Wagner, D.O. This Order is effective immediately.

This document of the Drug Enforcement Administration was signed on October 1, 2025, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

On August 16, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to David S. Pecora, P.A., of Bemidji, Minnesota (Applicant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 15. The OSC proposed the denial of Applicant's application for DEA registration, Control Number W23054133M, alleging that he materially falsified multiple applications for registration and that his registration would be inconsistent with the public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1), 824(a)(1)). 1

On September 30, 2024, the Government submitted a RFAA to the Administrator requesting that the Agency issue a default final order denying Applicant's application. RFAA, at 1, 3-4. After carefully reviewing the entire record and conducting the analysis as set forth in detail below, the Agency grants the Government's request for final agency action and denies Applicant's application. As a preliminary matter, this Decision addresses whether or not Applicant is in default and finds that he is. Thereafter, this Decision makes specific factual findings on the alleged violations as set forth in the OSC. Specifically, this Decision considers whether Applicant submitted a materially false application and finds that he did. Additionally, this Decision considers whether Applicant's registration would be inconsistent with the public interest and finds that it would be. Lastly, this Decision determines that the appropriate sanction is denial of Applicant's application.

Under 21 CFR 1301.43, a registrant or applicant entitled to a hearing who fails to file a timely hearing request “within 30 days after the date of receipt of the [OSC] . . . shall be deemed to have waived their right to a hearing and to be in default” unless “good cause” is established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence of a demonstration of good cause, a registrant or applicant who fails to timely file an answer also is “deemed to have waived their right to a hearing and to be in default.” 21 CFR 1301.43(c)(2).

The OSC notified Applicant of his right to file a written request for a hearing and an answer, and that if he failed to file such a request and answer, he would be deemed to have waived his right to a hearing and be in default. 2 RFAAX 1, at 14 (citing 21 CFR 1301.43). Here, Applicant did not request a hearing, file an answer, or respond to the OSC in any way. RFAA, at 1-3. Accordingly, Applicant is in default. 21 CFR 1301.43(c)(1).

“A default, unless excused, shall be deemed to constitute a waiver of the [applicant's] right to a hearing and an admission of the factual allegations of the [OSC].” 21 CFR 1301.43(e). Because Applicant is in default and has not moved to excuse the default, the Agency finds that Applicant has admitted to the factual allegations in the OSC. 21 CFR 1301.43(c)(1), (e), (f)(1).

Further, “[i]n the event that [an applicant] . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] 1316.67.” 21 CFR 1301.43(f)(1). Here, the Government has requested final agency action based on Applicant's default pursuant to 21 CFR 1301.43(c)(1), (f)(1). RFAA, at 1-3; see also 21 CFR 1316.67.

The Agency finds that, in light of Applicant's default, the factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e). Accordingly, Applicant is deemed to have admitted to each of the following facts. 3

On January 6, 2012, Applicant submitted an application for DEA registration, which was assigned control number W12001098M. RFAAX 1, at 9.

The application's Liability Question 3 asked: “Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?” Id.

Applicant answered “no” to Liability Question 3. Id. In doing so, Applicant failed to disclose that: (a) in July 2007, Applicant's West Virginia registered nursing license, number 53904, was suspended; and (b) in October 2008, Applicant's Florida registered nursing license, number RN9221251, was suspended. Id. Applicant's January 2012 application was approved and assigned DEA registration number MP2562432. Id.

On October 12, 2013, Applicant submitted an application for DEA registration, which was assigned control number W13085169M. RFAAX 1, at 9.

The application's Liability Question 3 asked: “Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?” Id.

Applicant answered “no” to Liability Question 3. Id. In doing so, Applicant failed to disclose that: (a) in July 2007, Applicant's West Virginia registered nursing license, number 53904, was suspended; (b) in October 2008, Applicant's Florida registered nursing license, number RN9221251, was suspended; and (c) in July 2012, Applicant's application for a physician assistant license in North Dakota was denied. Id. at 9-10. Applicant's October 2013 application was approved and assigned DEA registration number MP3221417. Id.

On January 21, 2016, Applicant submitted an application for DEA registration, which was assigned control number W16005281M. RFAAX 1, at 10.

The application's Liability Question 2 asked: “Has the applicant ever surrendered (for cause) or had a federal controlled substances registration revoked, suspended, restricted, or denied, or is any such action pending?” Id.

Applicant answered “yes” to Liability Question 2. Id. In response to the application's direction to provide the date and location of the incident that prompted the affirmative answer, Applicant stated: “January 30, 2015,” and “BEMIDJI, MINNESOTA.” Id.

In response to the application's direction to provide the nature of the incident, Applicant stated: “ON 10/01/2014, I MISTAKENLY TOOK TABLETS OF SOMA. 4 DURING MY PREVIOUS ABUSE OF SOMA, I HAD PLACED SOME SOMA TABLETS IN THE SAME CONTAINER AS MY ASPIRIN. ON 10/01/2014, I DEVELOPED A HEADACHE AND WENT INTO MY BATHROOM WITHOUT TURNING ON THE LIGHT (AS LIGHT INCREASES MY HEADACHES). I TOOK OUT THE BOTTLE OF ASPIRIN AND POURED THEM INTO MY HAND. I TOOK TWO TABLETS. THIS WAS AN UNINTENTIONAL INJECTION OF SOMA.” Id.

In response to the application's direction to provide the result of the incident, Applicant stated: “I WAS BEING MOUNTED BY MINNESOTA HEALTH PROFESSIONALS SERVICES PROGRAM. I DID A UA THE NEXT DAY. IT WAS POSITIVE FOR SOMA. AFTER AN INVESTIGATION BY MINNESOTA BOARD OF MEDICAL PRACTICE, THEY DETERMINED TREATMENT WAS NOT NECESSARY. FLORIDA PROFESSIONALS RESOURCE NETWORK BEGAN MONITORING ME (I ALSO HAVE A FLORIDA PA LICENSE). FLORIDA DID MANDATE TREATMENT. I WENT TO HAZELDEN BETTY FORD IN CENTER CITY, MN. I WAS THERE FOR 60 DAYS OF IN-PATIENT TREATMENT IN THE HEALTH CARE PROFESSIONALS SEC.” Id.

These descriptions most closely resemble circumstances relating to DEA registration number MP3221417, which Applicant surrendered for cause on January 30, 2015. Id.

The application's Liability Question 3 asked: “Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?” Id. at 11.

Applicant answered “yes” to Liability Question 3. Id. In response to the application's direction to provide the date and location of the incident that prompted the affirmative answer, Applicant stated: “September 15, 2013,” and “MINNEAPOLIS, MN.” Id.

In response to the application's direction to provide the nature of the incident, Applicant stated: “SOMETIME DURING THE FALL OF 2013, AND AFTER I COMPLETED 90-DAYS OF IN-PATIENT TREATMENT AT TALBOTT RECOVERY CAMPUS, I MEET WITH JACK HENDERSON & ANDY BIRD WITH THE MINNESOTA DEA AND SURRENDERED MY DEA LICENSE.” Id.

In response to the application's direction to provide the result of the incident, Applicant stated: “MY DEA LICENSE WAS RE-ISSUED TO ME ABOUT A YEAR LATER.” Id.

These descriptions most closely resemble circumstances relating to DEA registration number MP2562432, which Applicant surrendered for cause on June 4, 2013, and not any state professional license or state controlled substance registration. Id.

While Applicant made some disclosures in response to Liability Question 3, Applicant failed to disclose that: (a) in July 2007, Applicant's West Virginia registered nursing license, number 53904, was suspended; (b) in October 2008, Applicant's Florida registered nursing license, number RN9221251, was suspended; (c) in July 2012, Applicant's application for a physician assistant license in North Dakota was denied; (d) in January 2014, Applicant's Minnesota physician assistant license, number 10593, was suspended and the suspension was stayed; (e) in November 2014, Applicant's Minnesota physician assistant license, number 10593, was suspended; (f) in January 2015, Applicant's Minnesota physician assistant license, number 10593, was indefinitely suspended; and (g) in November 2015, Applicant's Minnesota physician assistant license, number 10593, was reinstated, suspended, and the suspension was stayed. Id. Applicant's January 2016 application was approved and assigned DEA registration number MP4140478. Id.

On February 11, 2020, Applicant submitted an application to renew DEA registration number MP4140478. RFAAX 1, at 12. The application's Liability Question 3 asked: “Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?” Id. Applicant answered “yes” to Liability Question 3. Id.

In response to the application's direction to provide the date and location of the incident that prompted the affirmative answer, Applicant stated: “February 11, 2020,” and “NOTHING NEW TO REPORT.” Id. In response to the application's direction to provide the nature of the incident, Applicant stated: “NOTHING NEW TO REPORT SINCE LAST REGISTRATION.” Id. In response to the application's direction to provide the result of the incident, Applicant stated: “NOTHING NEW TO REPORT.” Id.

Applicant's follow-up responses to Liability Question 3 were false because Applicant again failed to disclose the incidents in West Virginia, Florida, North Dakota, and Minnesota that made his application, number W16005281M, false. Id. Applicant's February 2020 renewal application for registration number MP4140478 was approved. Id.

On May 2, 2023, Applicant submitted an application for DEA registration, which was assigned control number W23054133M. RFAAX 1, at 12.

The application's Liability Question 2 asked: “Has the applicant ever surrendered (for cause) or had a federal controlled substances registration revoked, suspended, restricted, or denied, or is any such action pending?” Id. Applicant answered “yes” to Liability Question 2. Id. In response to the application's direction to provide the date and location of the incident that prompted the affirmative answer, Applicant stated: “February 10, 2022,” and “MINNESOTA.” Id.

In response to the application's direction to provide the nature of the incident, Applicant stated: “MY MN PHYSICIAN ASSISTANT LICENSE WAS SUSPENDED DUE TO MY DIVERSION OF PROPOFOL FOR SELF USE. I THEN HAD TO SURRENDER MY MN DEA REGISTRATION DUE TO MY MN PHYSICIAN ASSISTANT LICENSE BEING SUSPENDED.”  5 Id. In response to the application's direction to provide the result of the incident, Applicant stated: “I SURRENDERED MY MN DEA REGISTRATION.” Id.

These descriptions most closely resemble circumstances relating to DEA registration number MP4140478, which Applicant surrendered for cause on November 16, 2021. Id.

Though Applicant made some disclosures, he failed to disclose that he surrendered two additional DEA registrations. Specifically, he failed to disclose that on June 4, 2013, he surrendered for cause DEA registration number MP2562432, and on January 30, 2015, he surrendered for cause DEA registration number MP3221417. Id. at 13.

Liability Question 3 asked: “Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?” Id. Applicant answered “yes” to Liability Question 3. Id. In response to the application's direction to provide the date and location, Applicant stated: “May 1, 2021,” and “MINNESOTA.” Id.

In response to the application's direction to provide the nature of the incident, Applicant stated: “I DIVERTED PROPOFOL FOR SELF-USE IN AUGUST OF 2020 IN THE COUNTRY OF CURACAO WHILE ON A COVID-19 RAPID RESPONSE TEAM. I SELF-REPORTED THIS DIVERSION TO THE MINNESOTA HEALTH PROFESSIONALS SERVICES PROGRAM.” Id.

In response to the application's direction to provide the result of the incident, Applicant stated: “MY MINNESOTA PHYSICIAN ASSISTANT LICENSE WAS SUSPENDED.” Id. These descriptions most closely resemble circumstances relating to the indefinite suspension of Applicant's Minnesota physician assistant license, number 10593, on September 11, 2021. Id.

Again, Applicant failed to disclose the incidents in West Virginia, Florida, North Dakota, and Minnesota that made his application, number W16005281M, and his renewal application of registration number MP4140478, false. Id. at 13-14. Additionally, Applicant failed to disclose that on March 11, 2023, Applicant's Minnesota physician assistant license, number 10593, was suspended and the suspension was stayed. Id. at 14.

Applicant is deemed to have admitted that in 2007, he was addicted to zolpidem  6 and underwent treatment at a chemical addiction recovery program for sedative-hypnotic addiction. RFAAX 1, at 4.

In 2013, Applicant was abusing carisoprodol  7 and was being monitored by the Florida Professionals Resource Network. Id. at 6. In April 2013, Applicant wrote a prescription for a volleyball teammate for 90 tablets of carisoprodol that authorized refills, and in exchange, Applicant's volleyball teammate promised to fill the prescription and provide Applicant with 30 carisoprodol tablets. Id. Applicant's volleyball teammate supplied Applicant with 30 of the carisoprodol tablets, which Applicant consumed. Id.

Approximately one month later, Applicant wrote another prescription for a different volleyball teammate for 90 tablets of carisoprodol that authorized refills, and in exchange, Applicant's second volleyball teammate promised to fill the prescription and provide Applicant with 30 carisoprodol tablets. Id. Applicant's second volleyball teammate supplied Applicant with 30 of the carisoprodol tablets, which Applicant consumed. Id.

In the summer of 2013, Applicant ordered carisoprodol tablets through the internet not for a legitimate medical purpose and not within the usual course of Applicant's professional practice. Id. The carisoprodol tablets were delivered to Applicant while he was a patient at a chemical addiction recovery program, which he attended from June 2013 to August 2013. Id.

On October 8, 2014, and October 20, 2014, Applicant tested positive for carisoprodol on two separate toxicology screens, when he did not have a prescription for carisoprodol. Id. at 7.

In November 2015, Applicant consented to a stipulation and order issued by the Minnesota Board of Medical Practice after Applicant demonstrated completion of in-patient chemical dependency treatment, regular attendance at self-help program meetings, and random drug testing administered by the Florida Professionals Resource Network. Id. The stipulation and order required Applicant to demonstrate three years of uninterrupted recovery from substance abuse. Id.

In November 2020, Applicant stole propofol from an operating room for his own personal use. Id. at 8.

In September 2021, Applicant was subject to a stipulation and order issued by the Minnesota Board of Medical Practice that required Applicant to demonstrate six months of uninterrupted recovery from substance abuse, negative results on twelve random toxicology screens per quarter, regular attendance at self-help meetings in support of recovery, completion of a neuropsychological evaluation, and certification from medical professionals that Applicant was competent to safely resume practice. Id.

A DEA registration may be denied, suspended, or revoked upon a finding that the applicant or registrant materially falsified any application filed pursuant to or required by the Controlled Substances Act (CSA). 21 U.S.C. 824(a)(1). 8 To present a prima facie case for material falsification, the Government's record evidence must show (1) the submission of an application, (2) containing a false statement and/or omitting information that the application requires, (3) when the submitter knew or should have known that the statement is false and/or that the omitted information existed and the application required its disclosure, and (4) the false statement and/or required but omitted information is material, that is, it “connect[s] to at least one of [the section 823] factors that, according to the CSA, [the Administrator] `shall' consider” when analyzing “whether issuing a registration `would be inconsistent with the public interest.' ” Frank Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21 U.S.C. 823 and Kungys, 485 U.S. at 771). The Government must establish material falsification with record evidence that is clear, unequivocal, and convincing. Kungys, 485 U.S. at 772; Stirlacci, 85 FR at 45230-39.

First, the Government must prove that the applicant or registrant submitted an application for registration pursuant to the CSA. 21 U.S.C. 824(a)(1); see also 21 U.S.C. 822 (persons required to register); 21 U.S.C. 823(g)(1) (registration requirements).

Second, the Government must prove that the application contained a false statement or omitted information that the application required, either of which may constitute a material falsity. See, e.g., Emed Medical Company LLC and Med Assist Pharmacy, 88 FR 21719, 21720 (2023) (applicant falsely answered “no” to Liability Question 3 on seventeen applications when the true answer was “yes”); Richard J. Settles, D.O., 81 FR 64940, 64945-46 (2016) (applicant failed to disclose an interim consent agreement restricting his license based on findings that he issued controlled substance prescriptions without federal or state legal authority to do so). In making this assessment, the Agency will examine the entire application, including registrant's “yes/no” answers to the liability questions and any follow-up response(s). Daniel A. Glick, D.D.S., 80 FR 74800, 74802, 74808-09 (2015). To establish an omission, the Government must show both that omitted information existed and that the application required inclusion of that information. See, e.g., Richard A. Herbert, M.D., 76 FR 53942, 53956 (2011) (omission of a probation which the application required to be identified); Michel P. Toret, M.D., 82 FR 60041, 60042 (2017) (Voluntary Surrender Form alone is insufficient evidence to find material falsification based on registrant's “no” answer to the question regarding “surrender[s] (for cause)”).

Third, the Government must prove that the applicant or registrant knew or should have known that the statement is false and/or that the omitted information existed and the application required its disclosure. See John J. Cienki, M.D., 63 FR 52293, 52295 (1998) (“[I]n finding that there has been a material falsification of an application, it must be determined that the applicant knew or should have known that the response given to the liability question was false.”); Samuel Arnold, D.D.S., 63 FR 8687, 8688 (1998) (“It is also undisputed that Respondent knew that his Ohio dental license had previously been suspended.”); Bobby Watts, M.D., 58 FR 46995, 46995 (1993) (“Respondent knew that the Tennessee Board of Medical Examiners had suspended his medical license on May 7, 1987, and had placed his state medical license on probation on May 2, 1988.”); see also Stirlacci, 85 FR at 45236-37 & nn.22-23 (collecting cases).

Fourth, the Government must prove that the false statement and/or required but omitted information is “material.” Kungys holds that a statement is material if it is “predictably capable of affecting, i.e., had a natural tendency to affect, the [Agency's] official decision,” or stated differently, “had a natural tendency to influence the decision.” Kungys, 485 U.S. at 771-72. As already discussed, materiality, for the purposes of the CSA, is tied to the factors that the Administrator “shall” consider when determining whether issuance of a registration “would be inconsistent with the public interest.” 21 U.S.C. 823; Kungys, 485 U.S. at 771-72; Stirlacci, 85 FR at 45234, 45238.

The Government has the burden of proof in this proceeding, and the Agency must make its findings based on clear, unequivocal, and convincing record evidence. 21 CFR 1301.44(d); Kungys, 485 U.S. at 772; Stirlacci, 85 FR at 45230-39. Here, the Agency finds that the Government's record evidence presents a prima facie case that Applicant submitted five materially false applications. 21 U.S.C. 824(a)(1).

The Agency finds the following facts based on clear, unequivocal, and convincing record evidence. On January 6, 2012, Applicant submitted an application for DEA registration, which was assigned control number W12001098M. RFAAX 1, at 9. Liability Question 3 asked whether Applicant had ever had any adverse action against a state professional license, to include revocation, suspension, probation, or denial. Id. Applicant falsely answered “no.” Id. Applicant's “no” answer to Liability Question 3 was false because he knew or should have known that information existed that the application required to be disclosed in response to Liability Question 3. Id. Specifically, Applicant knew or should have known that in July 2007 his West Virginia nursing license was suspended and that in October 2008 his Florida nursing license was suspended. Id.

Additionally, Applicant's false answer was material. The CSA provides that suspension of a state license is one basis by which the Attorney General may suspend or revoke a DEA registration, and therefore, it is a relevant statutory factor for determining whether issuance or maintenance of a registration is inconsistent with the CSA. 9 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an applicant has had a state license suspended is a relevant factor DEA must consider when reviewing an application, and failure to disclose such information has “a natural tendency to influence the [Agency's] decision.” Kungys, 485 U.S. at 771-72.

Accordingly, the falsity in Applicant's January 2012 application directly affected the statutory analysis that DEA was required to make when it reviewed his application. 21 U.S.C. 823(g)(1), 824(a)(3). Thus, the falsity was material because it was “predictably capable of affecting . . . [DEA's] official decision” regarding whether Applicant met “the requirements for” registration. Kungys, 485 U.S. at 771.

In sum, the Agency finds clear, unequivocal, and convincing record evidence that Applicant's January 6, 2012 application for DEA registration, control number W12001098M, was materially false. 21 U.S.C. 824(a)(1); RFAAX 1, at 9.

The Agency finds the following based on clear, unequivocal, and convincing record evidence. On October 12, 2013, Applicant submitted an application for DEA registration, which was assigned control number W13085169M. RFAAX 1, at 9. Liability Question 3 asked whether Applicant had ever had any adverse action against a state professional license, to include revocation, suspension, probation, or denial. Id. Applicant falsely answered “no.” Id. Applicant's “no” answer to Liability Question 3 was false because he knew or should have known that information existed that the application required to be disclosed in response to Liability Question 3. Id.

Specifically, Applicant knew or should have known that in July 2007 his West Virginia nursing license was suspended, in October 2008 his Florida nursing license was suspended, and in 2012 his application for a physician assistant license was denied in North Dakota. Id. at 9-10.

Additionally, Applicant's false answer was material. The CSA provides that suspension or lack of a state license is one basis by which the Attorney General may suspend, revoke, or deny a DEA registration, and therefore, it is a relevant statutory factor for determining whether issuance or maintenance of a registration is inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an applicant has had a state license suspended or denied is a relevant factor DEA must consider when reviewing an application, and failure to disclose such information has “a natural tendency to influence the [Agency's] decision.” Kungys, 485 U.S. at 771-72.

Accordingly, the falsity in Applicant's October 2013 application directly affected the statutory analysis that DEA was required to make when it reviewed his application. 21 U.S.C. 823(g)(1), 824(a)(3). Thus, the falsity was material because it was “predictably capable of affecting . . . [DEA's] official decision” regarding whether Applicant met “the requirements for” registration. Kungys, 485 U.S. at 771.

In sum, the Agency finds clear, unequivocal, and convincing record evidence that Applicant's October 12, 2013 application for DEA registration, control number W13085169M, was materially false. 21 U.S.C. 824(a)(1); RFAAX 1, at 9-10.

The Agency finds the following based on clear, unequivocal, and convincing record evidence. On January 21, 2016, Applicant submitted an application for DEA registration, which was assigned control number W16005281M. RFAAX 1, at 10. Liability Question 2 asked, in part, whether Applicant has ever surrendered for cause a federal controlled substances registration. Id. Liability Question 3 asked whether Applicant had ever had any adverse action against a state professional license, to include revocation, suspension, probation, or denial. Id. at 11. Applicant answered “yes” to Liability Questions 2 and 3 and provided additional information to the follow-up prompts regarding date, location, nature, and result. Id. at 10-11.

Despite truthfully answering “yes,” Applicant failed to disclose all the required information in response to Liability Question 3. Specifically, Applicant's follow-up responses failed to disclose that in July 2007 his West Virginia nursing license was suspended; in October 2008 his Florida nursing license was suspended; in 2012 his application for a physician assistant license was denied in North Dakota; and in January 2014, November 2014, January 2015, and November 2015, his Minnesota physician assistant license was suspended. Id. Accordingly, Applicant's response to Liability Question 3 was false because he knew or should have known information existed that the application clearly required be disclosed in response to Liability Question 3. 10 Id.

Additionally, Applicant's false answer was material. The CSA provides that suspension or lack of a state license is one basis by which the Attorney General may suspend, revoke, or deny a DEA registration, and therefore, it is a relevant statutory factor for determining whether issuance or maintenance of a registration is inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an applicant has had a state license suspended or denied is a relevant factor DEA must consider when reviewing an application, and failure to disclose such information has “a natural tendency to influence the [Agency's] decision.” Kungys, 485 U.S. at 771-72.

Accordingly, the falsity in Applicant's January 2016 application directly affected the statutory analysis that DEA was required to make when it reviewed his application. 21 U.S.C. 823(g)(1), 824(a)(3). Thus, the falsity was material because it was “predictably capable of affecting . . . [DEA's] official decision” regarding whether Applicant met “the requirements for” registration. Kungys, 485 U.S. at 771.

In sum, the Agency finds clear, unequivocal, and convincing record evidence that Applicant's January 21, 2016 application for DEA registration, control number W16005281M, was materially false. 21 U.S.C. 824(a)(1); RFAAX 1, at 10-11.

The Agency finds the following based on clear, unequivocal, and convincing record evidence. On February 11, 2020, Applicant submitted an application to renew DEA registration number MP4140478. RFAAX 1, at 12. Liability Question 3 asked whether Applicant had ever had any adverse action against a state professional license, to include revocation, suspension, probation, or denial. Id. Applicant answered “yes.” Id.

Despite truthfully answering “yes,” Applicant failed to disclose all the required information in response to Liability Question 3. In response to the application's request for the date of the incident that prompted the “yes” answer, Applicant stated, “February 11, 2020,” the date he submitted the application. Id. In response to the application's request for the location, nature, and result of the incident, Applicant stated: “NOTHING NEW TO REPORT.” Id. Applicant's response to Liability Question 3 was false because he continued to fail to disclose the incidents that made his January 21, 2016 application, control number W16005281M, false. Id. Specifically, Applicant failed to disclose that in July 2007 his West Virginia nursing license was suspended; in October 2008 his Florida nursing license was suspended; in 2012 his application for a physician assistant license was denied in North Dakota; and in January 2014, November 2014, January 2015, and November 2015, his Minnesota physician assistant license was suspended. Id. at 11-12. Accordingly, Applicant's response to Liability Question 3 was false because he knew or should have known information existed that the application required be disclosed in response to Liability Question 3. Id.

Additionally, Applicant's false answer was material. The CSA provides that suspension or lack of a state license is one basis by which the Attorney General may suspend, revoke, or deny a DEA registration, and therefore, it is a relevant statutory factor for determining whether issuance or maintenance of a registration is inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an applicant has had a state license suspended or denied is a relevant factor DEA must consider when reviewing an application, and failure to disclose such information has “a natural tendency to influence the [Agency's] decision.” Kungys, 485 U.S. at 771-72.

Accordingly, the falsity directly affected the statutory analysis that DEA was required to make when it reviewed Applicant's application. 21 U.S.C. 823(g)(1), 824(a)(3). Further, the falsity was material because it was “predictably capable of affecting . . . [DEA's] official decision” regarding whether Applicant met “the requirements for” registration. Kungys, 485 U.S. at 771.

In sum, the Agency finds clear, unequivocal, and convincing record evidence that Applicant's February 11, 2020 application to renew DEA registration number MP4140478 was materially false. 21 U.S.C. 824(a)(1); RFAAX 1, at 12.

On May 2, 2023, Applicant submitted an application for DEA registration, which was assigned control number W23054133M. RFAAX 1, at 12. Liability Question 2 asked, in part, whether Applicant has ever surrendered for cause a federal controlled substances registration. Id. Applicant answered “yes.” Id. In response to the application's follow-up prompts, Applicant provided a date, location, and description of events that most closely resembled circumstances relating to the surrender of DEA registration number MP4140478 in November 2021 in Minnesota. Id. at 4, 12.

Applicant, however, failed to disclose that he had previously surrendered two other DEA registrations in Minnesota. Specifically, he failed to disclose that on June 4, 2013, he surrendered for cause DEA registration number MP2562432, and on January 30, 2015, he surrendered for cause DEA registration number MP3221417. Id. at 3, 12-13. Although Applicant indicated that he “SURRENDERED [HIS] MN DEA REGISTRATION,” the information he provided on the application related to the surrender of only one Minnesota DEA registration, when, in fact, he previously held two additional DEA registrations that he also surrendered. Id. at 12-13. Accordingly, Applicant's response to Liability Question 2 was false because he knew or should have known information existed that the application required be disclosed in response to Liability Question 2. Id.

Liability Question 3 asked whether Applicant had ever had any adverse action against a state professional license, to include revocation, suspension, probation, or denial. Id. at 13. Applicant answered “yes.” Id. In response to the application's follow-up prompts, Applicant disclosed information that most closely resembled circumstances relating to the suspension of his Minnesota physician assistant license in September 2021. Id.

Applicant, however, failed to disclose additional adverse actions against state licenses that he knew or should have known were required to be disclosed in response to Liability Question 3. Specifically, he failed to disclose that in 2007 his nursing license was suspended in West Virginia; in 2008 his nursing license was suspended in Florida; in 2012 his application for a physician assistant license was denied in North Dakota; and in January 2014, November 2014, January 2015, November 2015, and March 2023, his physician assistant license was suspended in Minnesota. Id. at 13-14. Although Applicant disclosed one suspension of his physician assistant license in Minnesota in 2021, he failed to disclose suspensions of his Minnesota physician assistant license in 2014, 2015, and 2023. Id. Accordingly, Applicant's response to Liability Question 3 was false because he knew or should have known information existed that the application required be disclosed in response to Liability Question 3. Id.

Additionally, Applicant's false answers to Liability Questions 2 and 3 were material. The CSA provides that suspension or lack of a state license is one basis by which the Attorney General may suspend, revoke, or deny a DEA registration, and therefore, it is a relevant statutory factor for determining whether issuance or maintenance of a registration is inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical Company LLC and Med Assist Pharmacy, 88 FR at 21720. Furthermore, a surrender for cause of a DEA registration implicates an applicant's or registrant's experience handling controlled substances and non-compliance with controlled substances laws, which are relevant considerations under Public Interest Factors B and D. 21 U.S.C. 823(g)(1). Thus, whether an applicant has had a state license suspended, an application for licensure denied, and/or has surrendered a previous DEA registration are all relevant factors DEA must consider when reviewing an application, and failure to disclose such information has “a natural tendency to influence the [Agency's] decision.” Kungys, 485 U.S. at 771-72.

Accordingly, the falsities directly affected the statutory analysis that DEA was required to make when it reviewed Applicant's application. 21 U.S.C. 823(g)(1), 824(a)(3). Further, the falsities were material because they were “predictably capable of affecting . . . [DEA's] official decision” regarding whether Applicant met “the requirements for” registration. Kungys, 485 U.S. at 771.

In sum, the Agency finds clear, unequivocal, and convincing record evidence that Applicant's May 2, 2023 application for DEA registration, control number W23054133M, was materially false. 21 U.S.C. 824(a)(1); RFAAX 1, at 12-13.

Further, although the instant OSC concerns whether Applicant's May 2023 application should be granted, the Agency's decision to deny this application may also be based on the material falsification of Applicant's January 2012, October 2013, January 2016, and February 2020 applications, because 21 U.S.C. 824(a)(1) provides that a registration may be revoked or denied based on the material falsification of “any application filed pursuant to or required by” the CSA. RFAAX 1, at 9-12.

Congress enacted the CSA “to conquer drug abuse and control the legitimate and illegitimate traffic in controlled substances.” Gonzales v. Raich, 545 U.S. 1, 12 (2005). A particular concern of Congress was “the need to prevent the diversion of drugs from legitimate to illicit channels,” and it “devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.” Id. at 12-13. To protect the American people and ensure compliance with the CSA, Congress empowered the Agency  11 to deny, suspend, or revoke a registration if it would be inconsistent with the public interest. 21 U.S.C. 823(g)(1); 21 U.S.C. 824(a)(4); Gonzales v. Oregon, 546 U.S. 243, 251 (2006).

In determining whether Applicant's proposed registration is inconsistent with the public interest, the Agency analyzes five statutorily established “public interest factors.” Gonzales v. Oregon, 546 U.S. at 251; 21 U.S.C. 823(g)(1)(A)-(E). The five factors are:

(A) The recommendation of the appropriate State licensing board or professional disciplinary authority.

(B) The applicant's experience in dispensing, or conducting research with respect to controlled substances.

(C) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.

(E) Such other conduct which may threaten the public health and safety.

21 U.S.C. 823(g)(1)(A)-(E).

These five public interest factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93; Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. David H. Gillis, M.D., 58 FR 37507, 37508 (1993). Any one factor, or combination of factors, may be decisive, Gillis, 58 FR at 37508, and the Agency “may give each factor the weight . . . deem[ed] appropriate in determining whether a registration should be revoked or an application for registration denied.” Morall v. Drug Enf't Admin., 412 F.3d 165, 185 n.2 (D.C. Cir. 2005) (Henderson, J., concurring) (quoting Robert A. Smith, M.D., 70 FR 33207, 33208 (2007)); see also Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007).

While the Agency is required to consider each of the factors, it “need not make explicit findings as to each one.” MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. U. S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009)); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). “In short, . . . 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; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Eleventh Circuit has recognized, Agency decisions have explained that findings under a single factor can support the denial of an application for registration. Jones Total Health Care Pharmacy, 881 F.3d at 830; Pharmacy Doctor Enterprises, Inc. v. Drug Enf't Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019).

In this matter, the Government's evidence is confined to Factors B, D, and E. RFAA, at 4; RFAAX 1, at 4. Evidence is considered under Factors B and D when it reflects experience dispensing controlled substances and compliance or non-compliance with laws related to controlled substances. Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). Evidence is considered under Factor E when it constitutes “[s]uch other conduct which may threaten the public health and safety.” 21 U.S.C. 823(g)(1)(E). To determine whether Applicant's registration is in the public interest, the Agency will evaluate the Government's allegations that Applicant has diverted controlled substances by issuing illegitimate prescriptions for the purpose of obtaining pills for personal use and that Applicant has a lengthy history of abusing controlled substances. 12

The Government has the burden of proof in this proceeding and the Agency must make its public interest findings based on substantial record evidence. 5 U.S.C. 556(d); 5 U.S.C. 706(2)(E); 21 U.S.C. 877; 21 CFR 1301.44(d). If the Government meets its burden of establishing a prima facie case that granting Applicant's registration application is not in the public interest, then the burden shifts to Applicant to rebut the Government's case. Pharmacy Doctor Enterprises, 789 Fed. Appx. at 729 (citing Jones Total Health Care Pharmacy, 881 F.3d at 830). Here, the Agency finds that the Government's record evidence presents a prima facie case that Applicant's registration would be inconsistent with the public interest. 21 U.S.C. 824(a)(4).

A lawful controlled substance order or prescription is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a); RFAAX 1, at 2. Therefore, “a physician who engages in the unauthorized practice of medicine is not a practitioner acting in the usual course of professional practice.” United Prescription Servs., Inc., 72 FR 50397, 50407 (2007).

Further, a registrant acts outside the usual course of professional practice and in a manner inconsistent with the public interest when he or she issues controlled substance prescriptions to individuals for the purpose of receiving some of the pills in return. See Michael E. Smith, D.V.M., 87 FR 4944, 4950-51 (2022) (finding registrant violated 21 CFR 1306.04(a) and his registration was inconsistent with the public interest where he issued fraudulent prescriptions for controlled substances in order to obtain the drugs for personal use); Roger A. Pellmann, M.D., 76 FR 17704, 17709 (2011) (registrant violated federal law by obtaining controlled substances for “office use,” when he, in fact, was diverting the drugs to another individual and himself); Steven B. Brown, M.D., 75 FR 65660, 65662 (2010) (finding registrant violated 21 CFR 1306.04(a) by issuing controlled substance prescriptions in exchange for the individual to provide the registrant with half of the pills); Randall Relyea, D.O., 73 FR 40378, 40380 (2008) (finding registrant's registration to be inconsistent with the public interest where he issued controlled substance prescriptions to individuals with no medical need and instructed them to give the drugs to him).

Here, Applicant admits that around April and May 2013, he issued two prescriptions for carisoprodol in order to obtain some of the pills for personal use. RFAAX 1, at 6. Accordingly, the undisputed record evidence establishes, and the Agency finds, that Applicant has issued controlled substance prescriptions outside the usual course of professional practice and not for legitimate medical purposes in violation of 21 CFR 1306.04(a). See also Smith, 87 FR at 4950-51; Pellmann, 76 FR at 17709; Brown, 75 FR at 65662; Relyea, 73 FR at 40380.

Further, the Agency finds that this misconduct reflects poorly on Applicant's experience handling controlled substances and demonstrates non-compliance with Federal law governing controlled substances. 21 U.S.C. 823(g)(1)(B), (D). Accordingly, the Agency finds substantial record evidence that Applicant's registration would be inconsistent with the public interest. 21 U.S.C. 824(a)(4).

Past DEA decisions have consistently held that “registrants who self-abuse controlled substances may endanger public health and safety,” and that such misconduct may be considered under Factor E. See Brewster Drug, Inc., 85 FR 19020, 19026 (2020) (collecting cases).

Here, Applicant's admissions establish that Applicant has a long history of abusing controlled substances. Specifically, in 2007 Applicant was addicted to zolpidem and underwent treatment at a chemical addiction recovery program. RFAAX 1, at 4. In addition, in 2013 Applicant was abusing carisoprodol and was in a chemical addiction recovery program. Id. at 6. Further, despite being in treatment for addiction to carisoprodol, Applicant ordered carisoprodol tablets through the internet not for a legitimate medical purpose and not within the usual course of his professional practice. Id. On two occasions in 2014, Applicant tested positive for carisoprodol when he did not have a prescription for carisoprodol. Id. at 7. In November 2020, Applicant stole propofol from an operating room for personal use. Id. at 8. In 2015 and 2021, Applicant was subject to orders issued by the Minnesota Board of Medical Practice that, among other things, required Applicant to undergo treatment for chemical dependency, attend self-help program meetings, undergo random drug testing, and demonstrate sobriety. Id. at 7-8.

In sum, the Agency finds substantial record evidence that Applicant has abused a variety of controlled substances over a period of many years and continued to do so even after he had been monitored and required to undergo treatment for substance abuse. Id. at 4, 6-8. The Agency finds that this lengthy history of substance abuse constitutes “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(g)(1)(E); Brewster Drug, Inc., 85 FR at 19026. Accordingly, the Agency finds substantial record evidence that Applicant's registration would be inconsistent with the public interest. 21 U.S.C. 824(a)(4).

The Agency has found by clear, unequivocal, and convincing record evidence that Applicant submitted five materially false applications for DEA registration and substantial record evidence that his registration would be inconsistent with the public interest due to having committed acts of diversion and demonstrating a lengthy history of substance abuse. 21 U.S.C. 823(g)(1)(B), (D), (E); 21 U.S.C. 824(a)(1), (4). When the Government establishes a prima facie case for sanction, as it did here, the Agency then determines the appropriate sanction, which may include denial of an application for registration. 21 U.S.C. 823(g)(1); see also Pharmacy Doctors Enterprises, 789 Fed. Appx. at 734 (the Agency is entitled to choose a sanction); Jeffrey Stein, M.D., 84 FR 46968, 46972-73 (2019); Scott Hansen, A.R.N.P., 90 FR 27338, 27341 (2025).

At this stage, the burden is on Applicant to show why he can be entrusted with a registration. Morall, 412 F.3d at 174; Jones Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D., 83 FR 18882, 18904 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual. Stein, 84 FR at 46972; see also Jones Total Health Care Pharmacy, 881 F.3d at 833.

As past performance is the best predictor of future performance, the Agency requires that an applicant who has committed acts inconsistent with the public interest accept responsibility for those acts and demonstrate that they will not engage in future misconduct. See Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). Moreover, the Agency requires an applicant's unequivocal acceptance of responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024); Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31. The Agency also considers the need to deter similar acts by the applicant and by the community of registrants. Stein, 84 FR at 46972-73.

Here, Applicant failed to request a hearing and answer the allegations contained in the OSC, and did not otherwise avail himself of the opportunity to prove to the Agency that he can be entrusted with a registration. See supra Section I. Thus, there is no record evidence that Applicant takes responsibility, let alone unequivocal responsibility, for the misconduct proven by record evidence. Accordingly, he has not convinced the Agency that he can be entrusted with the responsibilities of a registration.

Further, the interests of specific and general deterrence weigh in favor of denial. Applicant's misconduct in this matter concerns the submission of registration applications that contained material falsities, improper prescribing for the purpose of obtaining controlled substances for personal abuse, and a lengthy history of abusing controlled substances. Thus, the proven misconduct goes to the heart of the CSA's “strict requirements regarding registration” and its “closed regulatory system” specifically designed “to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.” Gonzales v. Raich, 545 U.S. at 12-14. If the Agency were to issue a registration to Applicant under these circumstances, it would send a dangerous message that compliance with the law is not essential to obtaining a registration.

In sum, Applicant has not offered any credible evidence on the record that rebuts the Government's case for denial of his application, and Applicant has not demonstrated that he can be entrusted with the responsibility of a DEA registration. Accordingly, the Agency will order the denial of Applicant's application for registration.

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny the application for a DEA Certificate of Registration, Control No. W23054133M, submitted by David S. Pecora, P.A., as well as any other pending application of David S. Pecora, P.A., for registration in Minnesota. This Order is effective November 17, 2025.

This document of the Drug Enforcement Administration was signed on October 1, 2025, by Administrator Terrance Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .