2023-24150. Blue Mint Pharmacy; Decision and Order

On July 26, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Blue Mint Pharmacy (Registrant) of Houston, Texas. Request for Final Agency Action (RFAA), Government Exhibit (RFAAX) 2, at 1. The OSC/ISO informed Registrant of the immediate suspension of its DEA Certificate of Registration (registration), Control No. FB4121327, pursuant to 21 U.S.C. 824(d), alleging that Registrant's continued registration constitutes “`an imminent danger to the public health or safety.'” Id. The OSC/ISO also proposed the revocation of Registrant's registration, alleging that Registrant's continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4), 823(g)(1)) ^[1] .

The Agency makes the following findings of fact based on the uncontroverted evidence submitted by the Government in its RFAA dated April 17, 2023.^[2]

I. Findings of Fact

Texas Standard of Care

DEA consulted Ms. Katherine Salinas, RPh, as an expert regarding the standard of care in the state of Texas for pharmacy practice.^[3] RFAAX 4, at 1. According to Ms. Salinas, the Texas standard of care requires that when dispensing a controlled substance, Texas pharmacists must ensure that the prescription for the controlled substance is valid, pursuant to a valid patient-practitioner relationship, and issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. Id. at 1–2. Further, prior to dispensing a controlled substance, a pharmacist must resolve any questions regarding the prescription with the prescriber and maintain written documentation of any such discussions. Id. at 2. A pharmacist must also review the patient's medication record and “at a minimum identify clinically significant: . . . (III) reasonable dose and route of administration; . . . (IV) drug-drug interactions; . . . and (X) proper utilization, including overutilization or underutilization.” Id.; see also 22 Tex. Admin. Code section 291.33(c)(2)(A)(i). According to Ms. Salinas, “[a]ll [s]tate of Texas pharmacists have access to these requirements[ ] and are required to pass a jurisprudence examination in order to become a licensed pharmacist.” RFAAX 4, at 2. Further, “[a]ll [s]tate of Texas pharmacists know [that they are] required to exercise reasonable caution in practice to prevent diversion by following common sense and proper dispensing practices.” Id. at 3.

In particular, Ms. Salinas noted the Texas State Board of Pharmacy “Red Flag Checklist,” which is available to all Texas pharmacists on the Texas State Board of Pharmacy's website and also provided during pharmacy compliance inspections. Id. The red flags listed on the checklist include pattern prescribing; ^[4] prescriptions for controlled substances commonly known to be abused such as opioids or muscle relaxants; prescriptions for controlled substances at the highest strength and/or in large quantities; ^[5] patients obtaining similar controlled substance prescriptions from multiple practitioners; multiple patients sharing the same address and obtaining similar controlled substance prescriptions from the same practitioner; and patients consistently paying for controlled substance prescriptions with cash rather than through insurance. Id. at 3–4. Ms. Salinas stated that Texas pharmacists must document how they address and resolve any red flags and must have prevention techniques in place to deter the dispensing of fraudulent controlled substance prescriptions, such as contacting doctors to verify prescriptions, searching the Texas Medical Board website, talking with patients, and checking patient identification cards. Id. at 4.

Ms. Salinas concluded her explanation of the Texas standard of care by stating that “a pharmacist must engage in a verification process of a prescription.” Id. at 5. Further, Ms. Salinas stated: “If a pharmacist does not believe a prescription is for a legitimate medical purpose, the pharmacist should not fill it.” Id. Ms. Salinas also noted that “[a]s a Compliance Officer, when [she identifies] a recurring pattern of certain combinations of controlled substances, with the same dosage and in large quantities to various patients, being paid for in cash instead of using insurance, [her] opinion is that the pharmacy is inappropriately dispensing controlled substance prescriptions and/or engaging in diversion activity.” Id.

Expert Review of Registrant's Dispensing

Applying the Texas standard of care, Ms. Salinas reviewed Registrant's PMP data from approximately February 1, 2021, through March 31, 2022, Registrant's patient profiles for the fourteen patients at issue, and copies of certain controlled substance prescriptions issued to the fourteen patients. Id. Ultimately, Ms. Salinas concluded, and the Agency agrees, that between February 1, 2021, and March 31, 2022, Registrant repeatedly filled prescriptions for controlled substances for the fourteen patients at issue without addressing or resolving red flags of abuse or diversion in violation of the Texas standard of care and thus outside the usual course of professional practice. Id. at 5–6, 18.

Patients A.W., M.F., and D.H.

Registrant filled nearly identical prescriptions for patients A.W., M.F., and D.H., who all shared an address. Specifically, between January 31, 2022, and March 2, 2022, Registrant filled prescriptions for Patient A.W. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 85 tablets of 350 mg carisoprodol. RFAAX 4, at 6; see also RFAAX 3, Attachment B. Further, between December 31, 2021, and March 15, 2022, Registrant filled prescriptions for Patient M.F. for 120 tablets of 10/325 mg hydrocodone/acetaminophen and 85 tablets of 350 mg carisoprodol. RFAAX 4, at 11; see also RFAAX 3, Attachment H. Finally, between June 17, 2021, and August 26, 2021, Registrant filled prescriptions for Patient D.H. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 90 tablets of 350 mg carisoprodol. RFAAX 4, at 14; see also RFAAX 3, Attachment K.

In reviewing the prescriptions for these three individuals, Ms. Salinas found that all of the prescriptions were issued by the same practitioner, Dr. G.K., who prescribed the same controlled substances in identical or substantially similar quantities to multiple patients; both the hydrocodone/acetaminophen and the carisoprodol, controlled substances known to be abused, were prescribed in large quantities and at the highest dosage; the three patients shared the same address; and all three patients paid cash for all of the prescriptions. RFAAX 4, at 6, 11–12, 14–15; see also RFAAX 3, Attachments B, H, K. Ms. Salinas did not find any evidence that Registrant addressed these red flags of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. RFAAX 4, at 6–7, 12, 15; see also RFAAX 3, Attachments B, H, K.

Patient J.A., D.W., C.E, and S.F.

Registrant filled nearly identical prescriptions for patients J.A., D.W., C.E., and S.F, who all shared an address. Specifically, between January 26, 2022, and March 25, 2022, Registrant filled prescriptions for Patient J.A. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 85 tablets of 350 mg carisoprodol. RFAAX 4, at 7; see also RFAAX 3, Attachment C. Further, between January 18, 2022, and March 17, 2022, Registrant filled prescriptions for Patient D.W. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 85 tablets of 350 mg carisoprodol. RFAAX 4, at 8; see also RFAAX 3, Attachment D. Between January 4, 2022, and March 3, 2022, Registrant filled prescriptions for Patient C.E. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 85 tablets of 350 mg carisoprodol. RFAAX 4, at 10; see also RFAAX 3, Attachment G. Finally, between December 30, 2021, and March 24, 2022, Registrant filled prescriptions for Patient S.F. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 90 tablets of 350 mg carisoprodol. RFAAX 4, at 12; see also RFAAX 3, Attachment I.

In reviewing the above prescriptions issued to the four patients, Ms. Salinas found that all of the prescriptions were issued by the same practitioner, Dr. G.K., who prescribed the same controlled substances in identical or substantially similar quantities to multiple patients; both the hydrocodone/acetaminophen and the carisoprodol, controlled substances known to be abused, were prescribed in large quantities and at the highest dosage; the four patients shared the same address and three of the patients (J.A., D.W., and S.F.) shared the same phone number; and all four patients paid cash for all of the prescriptions. RFAAX 4, at 7–8, 10–11, 13; RFAAX 3, Attachments C, D, G, I. Ms. Salinas did not find any evidence that Registrant addressed these red flags of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. RFAAX 4, at 7–13; see also RFAAX 3, Attachments C, D, G, I.

Patients A.B. and C.B.

Between January 17, 2022, and March 18, 2022, Registrant filled prescriptions for both Patient A.B. and Patient C.B. for 120 tablets of 10/325 mg hydrocodone/acetaminophen and 90 tablets of 350 mg carisoprodol. RFAAX 4, at 9–10; see also RFAAX 3, Attachment E, F. In reviewing the prescriptions, Ms. Salinas found that all of the prescriptions were issued by the same practitioner, Dr. G.K., who prescribed the same controlled substances in identical or substantially similar quantities to multiple patients; both the hydrocodone/acetaminophen and the carisoprodol, controlled substances known to be abused, were prescribed in large quantities and at the highest dosage; and Patients A.B. and C.B. paid cash for all of the prescriptions. Id. Ms. Salinas did not find any evidence that Registrant addressed these red flags of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. Id.

Patient T.P.

Between July 8, 2021, and September 10, 2021, Registrant filled prescriptions for Patient T.P. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 85 tablets of 350 mg carisoprodol. RFAAX 4, at 13–14; see also RFAAX 3, Attachment J. In reviewing the prescriptions, Ms. Salinas found that all of the prescriptions were issued by the same practitioner, Dr. G.K., who prescribed the same controlled substances in identical or substantially similar quantities to multiple patients; both the hydrocodone/acetaminophen and the carisoprodol, controlled substances known to be abused, were prescribed in large quantities and at the highest dosage; Patient T.P. shared the same phone number as Patient M.F.; and Patient T.P. paid cash for all of the prescriptions. RFAAX 4, at 14; see also RFAAX 3, Attachment J. Ms. Salinas did not find any evidence that Registrant addressed these red flags of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. RFAAX 4, at 14; see also RFAAX 3, Attachment J.

Patient G.A.

Between February 24, 2021, and February 9, 2022, Registrant filled prescriptions for Patient G.A. for 120 tablets of 10/325 mg hydrocodone/acetaminophen and 90 tablets of 350 mg carisoprodol. RFAAX 4, at 15; see also RFAAX 3, Attachment L. In reviewing the prescriptions, Ms. Salinas found that the prescriptions were issued by multiple, different practitioners. RFAAX 4, at 14–15; see also RFAAX 3, Attachment L. Ms. Salinas did not find any evidence that Registrant addressed this red flag of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. RFAAX 4, at 16; see also RFAAX 3, Attachment L.

Patient K.G.

Between February 1, 2021, and March 15, 2022, Registrant filled prescriptions for Patient K.G. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 80 tablets of 350 mg carisoprodol. RFAAX 4, at 16; see also RFAAX 3, Attachment M. In reviewing the prescriptions, Ms. Salinas found that the prescriptions were issued by multiple, different practitioners. Id. Ms. Salinas did not find any evidence that Registrant addressed this red flag of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. Id.

Patient L.J.

Between March 12, 2021, and March 23, 2022, Registrant filled prescriptions for Patient L.J. for 112 tablets of 10/325 mg hydrocodone/acetaminophen and 80 tablets of 350 mg carisoprodol. RFAAX 4, at 17; see also RFAAX 3, Attachment N. In reviewing the prescriptions, Ms. Salinas found that the prescriptions were issued by multiple, different practitioners. Id. Ms. Salinas did not find any evidence that Registrant addressed this red flag of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. Id.

Patient T.T.

Between February 4, 2021, and March 8, 2022, Registrant filled prescriptions for Patient T.T. for 110 tablets of 10/325 mg hydrocodone/acetaminophen and 80 tablets of 350 mg carisoprodol. RFAAX 4, at 17; see also RFAAX 3, Attachment O. In reviewing the prescriptions, Ms. Salinas found that the prescriptions were issued by multiple, different practitioners. Id. Ms. Salinas did not find any evidence that Registrant addressed this red flag of abuse or diversion and, as a result, opined that Registrant violated the minimum standard of care for a Texas pharmacy and operated outside of the usual course of professional practice. RFAAX 4, at 17–18; see also RFAAX 3, Attachment O.

II. Discussion

A. The Five Public Interest Factors

Under the CSA, “[a] registration . . . to . . . 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 [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a). In making the public interest determination, the CSA requires consideration of the following factors:

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

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

(C) The [registrant]'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)

The Agency considers these public interest factors in the disjunctive. Robert A. Leslie, M.D.,68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173–74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D.,58 FR 37507, 37508 (1993).

While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1),^[6] the Government's evidence in support of its prima facie case for revocation of Registrant's registration is confined to Factors B and D. See RFAA, at 23–29. Moreover, the Government has the burden of proof in this proceeding. 21 CFR 1301.44.

Here, the Agency finds that the Government's evidence satisfies 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).

B. Factors B and D

Evidence is considered under Public Interest Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances. See Sualeh Ashraf, M.D.,88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,87 FR 21156, 21162 (2022). In the current matter, the Government has alleged that Registrant violated numerous federal and state laws regulating controlled substances. RFAAX 2, at 2.^[7] Specifically, federal law requires that “[a] prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice,” and that “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a), 1306.06; see also21 U.S.C. 829. Federal law also emphasizes that although “[t]he 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).

As for state law, Texas regulations require that “[a] pharmacist may not . . . dispense or deliver a controlled substance . . . except under a valid prescription and in the course of professional practice.” Tex. Health & Safety Code section 481.074(a)(1).^[8] The Texas Board of Pharmacy sets forth numerous “operational standards” for pharmacists filling prescriptions, requiring, firstly, that pharmacists “review the patient's medication record. Such review shall at a minimum identify clinically significant . . . (III) reasonable dose and route of administration; . . . (VI) drug-drug interactions; . . . and (X) proper utilization, including overutilization or underutilization.” 22 Tex. Admin. Code section 291.33(c)(2)(A)(i). Further, “[u]pon identifying any clinically significant conditions [or] situations[,] . . . the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner.” Id. section 291.33(c)(2)(A)(ii). A pharmacist must also ensure that “[p]rior to dispensing, any questions regarding a prescription drug order [ ] be resolved with the prescriber and written documentation of these discussions [be] made and maintained.” Id. section 291.33(c)(2)(A)(iv). Finally, a pharmacist must consider the various “red flag factors” in preventing the non-therapeutic dispensing of controlled substances, including, among others: pattern prescribing; prescriptions for controlled substances commonly known to be abused; prescriptions for controlled substances at the highest strength and/or in large quantities; patients obtaining similar controlled substance prescriptions from multiple practitioners; multiple patients sharing the same address and obtaining similar controlled substance prescriptions from the same practitioner; and patients consistently paying for controlled substance prescriptions with cash rather than through insurance. Id. section 291.29(f).

Here, the record demonstrates that Registrant repeatedly filled prescriptions for controlled substances for multiple patients without adhering to Texas' “operational standards” for pharmacists filling prescriptions and without addressing or resolving numerous and blatant red flags of abuse and/or diversion. Because Registrant's conduct clearly violates the Texas standard of care—thus rendering its dispensing outside the usual course of professional practice—and clearly violates the various federal and state regulations described above, the Agency hereby sustains the Government's allegations that Registrant repeatedly violated federal and state law relating to controlled substances.

Accordingly, the Agency finds that Factors B and D weigh in favor of revocation of Registrant's registration and thus finds Registrant's continued registration to be inconsistent with the public interest in balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds that Registrant failed to provide sufficient evidence to rebut the Government's prima facie case.

III. Sanction

Where, as here, the Government has established grounds to revoke Registrant's registration, the burden shifts to the registrant to show why it can be entrusted with the responsibility carried by a registration. Garret Howard Smith, M.D.,83 FR 18882, 18910 (2018). When a registrant has committed acts inconsistent with the public interest, it must both accept responsibility and demonstrate that it has undertaken corrective measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195,77 FR 62316, 62339 (2012) (internal quotations omitted). Trust is necessarily a fact-dependent determination based on individual circumstances; therefore, the Agency looks at factors such as the acceptance of responsibility, the credibility of that acceptance as it relates to the probability of repeat violations or behavior, the nature of the misconduct that forms the basis for sanction, and the Agency's interest in deterring similar acts. See, e.g.,Robert Wayne Locklear, M.D.,86 FR 33738, 33746 (2021).

Here, Registrant did not request a hearing, submit a corrective action plan, respond to the OSC/ISO, or otherwise avail itself of the opportunity to refute the Government's case. As such, Registrant has made no representations as to its future compliance with the CSA nor made any demonstration that it can be entrusted with registration. Moreover, the evidence presented by the Government clearly shows that Registrant violated the CSA, further indicating that Registrant cannot be entrusted. Accordingly, the Agency will order the revocation of Registrant's registration.

Order

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. FB4121327 issued to Blue Mint Pharmacy. 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 Blue Mint Pharmacy, to renew or modify this registration, as well as any other pending application of Blue Mint Pharmacy, for additional registration in Texas. This Order is effective December 4, 2023.

Signing Authority

This document of the Drug Enforcement Administration was signed on October 25, 2023, by Administrator Anne Milgram. 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 .

Heather Achbach,

Federal Register Liaison Officer, Drug Enforcement Administration.

Footnotes

1.  Effective December 2, 2022, the Medical Marijuana and Cannabidiol Research Expansion Act, Public Law 117–215, 136 Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended the Controlled Substances Act (CSA) and other statutes. Relevant to this matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC/ISO, as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA throughout.

2.  Based on the Declaration from a DEA Diversion Investigator, the Agency finds that the Government's service of the OSC/ISO on Registrant was adequate. RFAAX 3, at 5. Further, based on the Government's assertions in its RFAA, the Agency finds that more than thirty days have passed since Registrant was served with the OSC/ISO and Registrant has neither requested a hearing nor submitted a corrective action plan and, therefore, has waived any such rights. RFAA, at 2; see also21 CFR 1301.43 and 21 U.S.C. 824(c)(2).

3.  For Ms. Salinas' qualifications, see RFAAX 4, Attachment P. Ms. Salinas is currently employed by the Texas State Board of Pharmacy as a Compliance Officer, and one of her duties is to inspect all classes of pharmacies for compliance with Texas pharmacy rules and regulations. RFAAX 4, at 1.

4.  Pattern prescribing is when “ `a pharmacy dispenses a reasonably discernible pattern of substantially identical prescriptions for the same controlled substances, potentially paired with other controlled substances, for numerous persons, indicating a lack of individual drug therapy in prescriptions issued by the practitioner.' ” Id.

5.  Such prescriptions can indicate a lack of individual drug therapy in prescriptions issued by the practitioner. Id.

6.  As to Factor A, the record contains no evidence of a recommendation from any state licensing board or professional disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an absence of such evidence “does not weigh for or against a determination as to whether continuation of the [Registrant's] DEA certification is consistent with the public interest.” Roni Dreszer, M.D.,76 FR 19434, 19444 (2011). As to Factor C, there is no evidence in the record that Registrant has been convicted of an offense under either federal or state law “relating to the manufacture, distribution, or dispensing of controlled substances.” 21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, there are a number of reasons why one who has engaged in criminal misconduct may never have been convicted of an offense under this factor. Dewey C. MacKay, M.D.,75 FR 49956, 49973 (2010). Agency cases have therefore found that “the absence of such a conviction is of considerably less consequence in the public interest inquiry” and is therefore not dispositive. Id. Finally, as to Factor E, the Government's evidence fits squarely within the parameters of Factors B and D and does not raise “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(g)(1)(E). Accordingly, Factor E does not weigh for or against Registrant.

7.  The Agency need not adjudicate the criminal violations alleged in the instant OSC/ISO. Ruan v. United States, 142 S. Ct. 2,370 (2022) (decided in the context of criminal proceedings).

8.  Texas law notes that “[a] pharmacist may not . . . dispense a controlled substance if the pharmacist knows or should have known that the prescription was issued without a valid patient-practitioner relationship.” Id. section 481.074(a)(2). Further, it is unlawful in Texas for any “registrant or dispenser” to knowingly deliver a controlled substance in violation of sections 481.070–481.075 of the Texas Health and Safety Code. Id. section 481.128.