I. Introduction

On November 17, 2021, the United States Department of Justice, Drug Enforcement Administration (Agency) issued an Order to Show Cause and Immediate Suspension of Registration (collectively, OSC/ISO) to Pharmacy Place, LLC, of Houston, Texas (Respondent).^[1] OSC/ISO, at 1, 10-11. The OSC/ISO immediately suspended, and proposed the revocation of, Respondent's Drug Enforcement Administration (DEA or Government) certificate of registration, No. FP8885785 (registration), pursuant to 21 U.S.C. 824(d) and (a)(4), respectively, “because . . . [Respondent's] continued registration constitutes `an imminent danger to the public health or safety'” and “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. at 1.

The OSC/ISO more specifically alleges that, according to an “independent pharmacy expert retained by the DEA” who “reviewed patient profile data, Texas Prescription Monitoring Program data, and prescriptions reported as filled by Respondent,” Respondent “filled many controlled substance prescriptions outside the usual course of pharmacy practice” and “in contravention of . . . [its] `corresponding responsibility' under 21 CFR 1306.04(a)” from March 16, 2020, through August 19, 2021. Id. at 2. The OSC/ISO also alleges that Respondent violated recordkeeping requirements.^[3]

A DEA Administrative Law Judge (ALJ) determined that Respondent filed a written statement, dated January 20, 2022 (Written Statement), in lieu of requesting a hearing and, accordingly, issued an Order Terminating the Proceedings on January 25, 2022.^[4] 21 CFR 1316.49 (2022) (replaced by current rule in effect Nov. 2022).^[5] The Government filed its RFAA on September 20, 2023.^[6]

Having thoroughly analyzed the record and applicable law, the Agency summarizes its findings and conclusions. First, the OSC/ISO includes specific and detailed factual allegations that Respondent violated Texas law and the CSA. Infra section III. Second, Respondent timely filed its Written Statement, and its Written Statement explicitly and implicitly acknowledges its receipt of the OSC/ISO. Supra. Third, Respondent's Written Statement, other than explicitly and unambiguously admitting the statement, not the allegation, portion of OSC/ISO paragraph 28 about “shared addresses” red flags, is ambiguous about whether Respondent admits unlawfully filling controlled substance prescriptions for individuals sharing the same address, does not respond directly or specifically to any of the OSC/ISO's factual allegations, does not include documentary evidence disproving, or even disputing, any of the OSC/ISO's factual allegations, and does not take responsibility, let alone unequivocal responsibility, for any violation alleged in the OSC/ISO. Infra sections III and V; supra n.5. Fourth, the RFAA presents a prima facie case of the OSC/ISO's general allegations, except for the third through fifth recordkeeping allegations. Infra section III. Fifth, the record includes substantial evidence, indeed unequivocal and uncontroverted evidence, that Respondent's controlled substance fills during the period covered by the OSC/ISO violated Texas law and, thus, its CSA corresponding responsibility, and that Respondent violated two recordkeeping rules. 21 CFR 1304.21(a), 1304.22(c); infra section III; infra n.11. Finally, the Agency concludes that Respondent's continued registration would be inconsistent with the public interest and that it did not unequivocally accept responsibility for its legal violations. 21 U.S.C. 824(a)(4); infra sections IV and V. Accordingly, the Agency will revoke Respondent's registration.

II. The CSA and Texas Pharmacists' Professional Responsibility

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 in the context of the Act's requirement that Schedule II controlled substances may be dispensed only by written prescription, “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.” 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).

An order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§ ] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Id. Accordingly, a pharmacy's registration authorizes it to “dispense,” or “deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of, . . . a practitioner.” 21 U.S.C. 802(10).

The OSC/ISO 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/ISO, 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) (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 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 ( printed page 48894) circumstances rather than any single factor.” Id. Several of those red flag factors are relevant to the adjudication of the OSC/ISO.

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).

Texas law 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.” ⁸ Id. § 291.33(c)(2)(A)(iv) (2019-2020). 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).

III. Findings of Fact

A. The Government's Case

The RFAA includes three sworn, under penalty of perjury, Declarations, one each by two Houston DIs and one by the Government's proposed expert, Registered Pharmacist Katherine Salinas. GX 3, GX 4, and GX 5, respectively.

The content of the DIs' sworn Declarations is internally consistent and consistent with each other. Accordingly, the Agency affords both DIs' Declarations full credibility.

The sworn Declaration of the Government's proposed expert states that she is a former Compliance Officer with the Texas State Board of Pharmacy.^[9] The content of the Government's proposed expert's Declaration, setting out the standard of practice of Texas pharmacies and of Texas pharmacists' professional responsibilities, is accurate. Supra section II. The Agency, therefore, finds that the Government's proposed expert qualifies as an expert in pharmacy compliance with Texas laws and rules, and accepts her as such in this adjudication. Accordingly, the Agency affords the Government's expert's Declaration full credibility. As such, the Agency affords full credibility to the Government's expert's analyses of the record evidence, including her Declaration statements that (1) “between at least March 5, 2020[,] to September 23, 2021, the . . . Respondent repeatedly filled prescriptions for controlled substances without addressing or resolving red flags of abuse or diversion, in violation of the minimum standard of care that governs the practice of pharmacy in the State of Texas,” (2) these, Respondent's repeated fills in violation of the minimum standard of care in Texas, are a violation of Respondent's “corresponding responsibility to only dispense legitimate prescriptions,” and (3) Respondent “filled prescriptions for L.N.W., R.B., J.P., M.F., T.J.P., J.F., M.R., L.H., L.D.W., A.H.G., P.A.T., M.L.P., N.J., J.W.W., J.J.W., J.W., [and] C.R.M. . . . outside the usual course of professional practice.” ^[10] GX 5, at 6, 25; infra.

Regarding service of the OSC/ISO, the second Houston DI's Declaration states that “[o]n or about November 22, 2021, . . . [she] personally served the . . . [Respondent] with a copy of the signed OTSC/ISO.” GX 4, at 3; see also Written Statement, at 1, 6, 8, 9, 12, 13, 14 (explicit and implicit references to the OSC/ISO and its content in the Written Statement). Accordingly, the Agency finds unequivocal and uncontroverted record evidence that Respondent received the OSC/ISO before it submitted its Written Statement dated January 20, 2022.^[11]

Moreover, the documentary evidence submitted with the RFAA concerning the alleged illegal controlled substance fills corresponds precisely with the unlawful dispensing allegations in the OSC/ISO. Among other things, this means, and the Agency finds unequivocal and uncontroverted record evidence, that Respondent had notice of every dispensing allegation, and data points supporting each allegation, before it submitted its Written Statement. Regardless, Respondent did not include evidence in its Written Statement countering the Government's evidence of specific dispensing violations.

The Agency finds substantial record evidence that the documentation submitted with the RFAA does not fully support OSC/ISO paragraph allegations 31.c, 31.d, and 31.e., but that it does support the rest of the OSC/ISO's recordkeeping allegations. OSC/ISO, at 10.

In sum, the Agency finds substantial record evidence that the RFAA presents a prima facie case for the OSC/ISO's dispensing allegations as to Drs. A.N., G.K., and M.K., and for the first two ( printed page 48895) OSC/ISO recordkeeping allegations (paragraphs 31.a and 31.b.). RFAA, at 44-229.

B. Respondent's Case

As already discussed, the only input from Respondent in the Agency record is the Written Statement signed by Respondent's Counsel. Supra, section I. Nothing, whether documentary evidence or a sworn-to declaration, is attached to the Written Statement. Id., infra section III.C. While the Written Statement does not include evidence, it provides the Agency with insight into Respondent's position concerning the OSC/ISO. Supra n.5. In this case, the Written Statement disputes most, and possibly all, of the OSC/ISO's allegations.^[12] Written Statement, at 4-13. Yet, had Respondent complied fully with applicable federal and Texas law, it would possess documentary evidence disputing the OSC/ISO's dispensing allegations and the first two recordkeeping allegations. Infra, sections III.C and III.D. For example, this documentary evidence would include the legally required, under Texas law, documentation that it identified and resolved red flags before filling the associated controlled substance and, under the CSA, the required records that it avers it provided to the DIs and that the DIs returned to it “two weeks later.” Written Statement, at 10 (“The DEA found everything to be in order, and two weeks later, returned all the records and information they requested.”); see also, e.g., id. at 4-5; supra section II. Accordingly, the Agency concludes that no weight may be attached to the matters asserted in the Written Statement because the matters asserted in it are argument, not admissible evidence. Supra n.5.

C. The Unlawful Dispensing Allegations: Dispensing Controlled Substances Without Identifying and Resolving the Red Flag Factors of Pattern Prescribing, Prescribing Controlled Substances Commonly Known To Be Abused, Prescribing the Highest Strength and/or Large Quantities of Controlled Substances, a Practitioner's Prescribing the Same or Similar Controlled Substances to Individuals Who Share the Same Address, and Payment by Cash or Cash Equivalents

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 Respondent filled controlled substance prescriptions issued by Drs. A.N., G.K., and M.K. without identifying, resolving, and documenting the resolution of red flag factors, as alleged in the OSC/ISO, and in violation of the CSA and Texas law. GX 5, at 1-25, GX 3E-3U. The red flag factors that, according to the unequivocal and uncontroverted record evidence, Respondent failed to identify, resolve, and create and maintain written red flag resolution documentation for are pattern prescribing, prescribing of controlled substances commonly known to be abused, prescribing the highest strengths and/or large quantities of controlled substances indicating a lack of individual drug therapy, multiple persons with the same address presenting substantially similar controlled substance prescriptions from the same practitioner, and consistently paying for the controlled substances with cash more often than through insurance. GX 5, at 1-4. The unequivocal and uncontroverted record evidence also includes that “All State of Texas pharmacists have access to these [Texas dispensing legal] requirements, and are required to pass a jurisprudence examination in order to become a licensed pharmacist,” and that “All State of Texas licensed pharmacists know he/she is required to exercise reasonable caution in practice to prevent diversion by following common sense and proper dispensing practices.” Id. at 3. Accordingly, there is unequivocal and uncontroverted record evidence that Respondent “knowingly” filled controlled substance prescriptions that were not issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.^[13] 21 CFR 1306.04(a), Tex. Health & Safety Code § 481.074(a) (2019), 22 Tex. Admin. Code § 291.29 (2018), 22 Tex. Admin. Code § 291.33 (2019-2020); GX 3E-3U, GX 5, at 1-25; supra sections II, III.A., and III.B.^[14]

For example, the Agency finds unequivocal and uncontroverted record evidence that, during the approximate thirteen-month period between June 12, 2020, and July 13, 2021, Respondent unlawfully released into the community about 5,463 tablets of hydrocodone-acetaminophen 10-325 mg and carisoprodol 350 mg for nine individuals based on controlled substance prescriptions issued by the same practitioner. GX 5, at 9-17 and GX 3H, 3I, 3K, 3L, 3M, 3N, 3O, 3P, and 3Q. Each of the nine individuals paid cash for all of these Schedule II and Schedule IV controlled substance tablets. GX 5, at 9-10, 12-16 and GX 3H, at 1, GX 3I, at 1, GX 3J, at 1, GX 3K, at 1, GX 3L, at 1, GX 3M, at 1, GX 3N, at 1, GX 3O, at 1, GX 3P, at 1, and GX 3Q, at 1. All of these prescriptions were written for large quantities and the highest available dosages of hydrocodone-acetaminophen 10-325 mg and carisoprodol 350, controlled substances commonly known to be abused. GX 5, at 9-10, 12-16.

By way of further example, the Agency finds unequivocal and uncontroverted record evidence that, during the approximate eleven-month period between March 16, 2020, and February 19, 2021, Respondent unlawfully released into the community a total of about 4,642 tablets of hydrocodone-acetaminophen 10-325 mg and carisoprodol 350 mg for three individuals who share the same address and based on prescriptions issued by the same practitioner. GX 5, at 17-19 and GX 3R, 3S, and 3T.

In sum, the Agency finds unequivocal and uncontroverted record evidence that the Government presented a prima ( printed page 48896) facie case that Respondent filled controlled substance prescriptions outside the usual course of pharmacy practice and in violation of its corresponding responsibility. 21 CFR 1306.04(a), Tex. Health & Safety Code § 481.074(a) (2019), 22 Tex. Admin. Code § 291.29 (2018), 22 Tex. Admin. Code § 291.33 (2019-2020).^[15]

D. The Recordkeeping Allegations

The Agency finds that the evidence the Government submitted is unequivocal and uncontroverted record evidence that Respondent violated recordkeeping requirements.^[16] OSC/ISO, at 10 (paragraphs 31.a. and 31.b.), supra sections III.A. and III.B. Specifically, the two DIs' credible, sworn Declarations state that Respondent did not have the dispensing records, biennial inventory, and most recent inventory records that the DIs requested, constituting substantial record evidence of Respondent's recordkeeping violations. GX 3, at 2, GX 4, at 2.

According to the Written Statement, Respondent “denies” the recordkeeping allegations, and claims that it “willingly provided the DEA with all the documentation they requested.” Written Statement, at 2, 10. Respondent further states that “DEA found everything to be in order, and two weeks later, returned all the records and information they requested.” Id. at 2, 10. If, as the Written Statement states, Respondent received back the records and information that DEA found to be in order, then Respondent could have attached those records and information to the Written Statement to prove its unsworn claims that it complied with the DIs' records request. In fact, Respondent did not submit any evidence, let alone this specific evidence, to support its claims of its compliance with recordkeeping requirements.

Under such circumstances, this Agency has applied, and it also applies here, the “adverse inference rule.” As the D.C. Circuit explained, “[s]imply stated, the rule provides that when a party has relevant evidence within his control which he fails to produce, that failure gives rise to an inference that the evidence is unfavorable to him.” Int'l Union, United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v. Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (D.C. Cir. 1972). The Court reiterated this rule in Huthnance v. District of Columbia, 722 F.3d 371, 378 (D.C. Cir. 2013). According to this legal principle, Respondent's decision not to provide records gives rise to an inference that any such evidence is unfavorable to Respondent.

In sum, Respondent's unsworn and unsupported claims that it provided the requested records to the DIs are insufficient to rebut the prima facie recordkeeping violation case that the Government presented as to OSC/ISO subparagraphs 31.a. and 31.b. Supra. Accordingly, the Agency finds substantial record evidence that Respondent violated federal recordkeeping requirements.^[17] 21 CFR 1304.21(a) and 1304.22(c).^[18]

IV. Discussion

A. The CSA and the Public Interest Factors

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).^[19]

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 (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. ( printed page 48897)

B. Factors B and/or D—Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Relating to Controlled Substances

Allegation That Respondent's Continued Registration Would Be Inconsistent With the Public Interest

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), 1304.21(a), 1304.22(c); Tex. Health & Safety Code § 481.074(a) (2019); 22 Tex. Admin. Code § 291.29 (2018), § 291.33 (2019-2020); supra sections III.C. and III.D.

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 III.C. and III.D. 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.

V. Sanction

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 submit a written statement in lieu of requesting a hearing. As already discussed, the Written Statement is signed by Respondent's counsels and, as such, is not evidence. Supra section I, n.5. Nor does it attach evidence. Id. Instead, it denies, without offering proof, the existence of any legal violation. As such, the Written Statement does not offer evidence to refute the Government's prima facie case. Respondent has not convinced the Agency that it understands that its filling of controlled substance prescriptions fell short of the applicable legal standards and that this substandard controlled substance prescription filling 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 controlled substance prescription filling or recordkeeping will comply with legal requirements.

The unequivocal and uncontroverted record evidence is that Respondent's founded violations resulted in the unlawful release of over 10,000 controlled substance tablets over a sixteen-month period. Supra section III.C. The tablets unlawfully released into the community were hydrocodone-acetaminophen and carisoprodol, controlled substances known to be abused and diverted. Id.

The Written Statement does not 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.

Order

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. FP8885785 issued to Pharmacy Place, LLC. 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 Pharmacy Place, LLC, to renew or modify this registration, as well as any other pending application of Pharmacy Place, LLC, for registration in Texas. This Order is effective December 1, 2025.

Signing Authority

This document of the Drug Enforcement Administration was signed on October 9, 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 .