The DEA has revoked the certificate of registration held by a Rayford, Texas, pharmacy following allegations that the business repeatedly filled prescriptions for 17 patients in the face of unresolved red flags of abuse and diversion (Rayford ACP; Decision and Order, 87 Fed. Reg. 56705 (Sept. 15, 2022)).

The agency found through an administrative proceeding that each of the controlled substance prescriptions at issue was outside of the usual course of professional practice of pharmacy in Texas and in violation of the pharmacy’s corresponding responsibility under 21 C.F.R. §1306.04(a).

According to the DEA’s findings, the pharmacy dispensed controlled substances on numerous occasions without documenting the resolution of various red flags, including cocktail prescribing for 11 patients, therapeutic duplication for 12 patients, early refills for two patients, and long distances for two patients.

For example, the agency determined, the pharmacy dispensed at least 39 prescriptions to one patient without documenting the resolution of multiple red flags, including combination prescribing, therapeutic duplication and/or early refills.

Regarding two patients, the pharmacy conceded that it “did not appropriately exercise its corresponding responsibility” because it dispensed controlled substances without documenting the resolution of red flags for combination prescribing.

The DEA also established that the pharmacy dispensed at least 19 prescriptions for controlled substances to another retail patient who lived approximately 60 miles from the pharmacy without documenting the resolution of the red flag of traveling a long distance.

The pharmacy dispensed two short-acting opioids along with a benzodiazepine, which raised red flags for both therapeutic duplication and cocktail prescribing, the agency found. In addition, the pharmacy dispensed hydrocodone six days early along with alprazolam, which raised red flags for both early refills and cocktail prescribing.

Federal, State Requirements

“Both federal and Texas law impose an independent, corresponding responsibility on pharmacists to ensure that a prescription is issued for a legitimate medical purpose and within the usual course of professional practice,” the agency said.

“In this matter,” the DEA determined, “the government did not allege that [the pharmacy] dispensed the subject prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, the government alleged that [the pharmacy] violated the corresponding responsibility regulation for each of the patients at issue in this matter by repeatedly dispensing controlled substances without addressing or resolving clear red flags.”

“Agency decisions have consistently found that prescriptions with the same red flags at issue here were so suspicious as to support a finding that the pharmacists who filled them violated the agency’s corresponding responsibility due to actual knowledge of, or willful blindness to, the prescriptions’ illegitimacy,” the DEA said.

The DEA also noted that Texas law “explicitly states that the geographical distance between the practitioner and the patient or between the pharmacy and the patient is a reason to suspect that a prescription may have been authorized in violation of the practitioner’s standard of practice” (22 Tex. Admin. Code §291.29(c)(4)).

The state’s administrative code also requires early refills to be identified and resolved and the resolution to be documented before the drug is dispensed (22 Tex. Admin. Code §291.33(c)(2)(A)(i)(X)).

Consequently, the DEA found, Rayford ACP’s failure to document the resolution of a red flag violated Texas law.

Violations Denied

Although the pharmacy admitted that it violated its corresponding responsibility with respect to two patients, it denied that one patient’s prescription presented a red flag based on distance “in spite of clear Texas law to the contrary,” the agency said. The pharmacy also “consistently” denied that the controlled substance prescriptions for its hospice patients presented any red flags, according to the DEA, despite one pharmacy official’s expert testifying to the contrary.

“A registrant’s acceptance of responsibility for misconduct is not adequate when the registrant does not understand what the law requires,” the agency noted.

The DEA also noted that the pharmacy’s misconduct “was far from a one-time occurrence.” Consequently, the agency determined, the sanction of registration revocation was appropriate.

The DEA order is effective Oct. 17, 2022.