A recent Fifth Circuit decision rejected the Drug Enforcement Agency’s (DEA) long-standing interpretation of its own regulations on pharmacist duties and significantly limits the DEA’s ability to establish a pharmacist’s violation of corresponding responsibility on red flags. The ruling marks an important development and may spur continued discussion about how federal and state standards intersect and shape pharmacists’ responsibilities.
Pharmacists’ Corresponding Responsibility Under Federal Law
Pharmacists have traditionally been seen as professionals who simply fill prescriptions according to doctors’ orders. However, over the years pharmacists have come under greater legal scrutiny, and even more so since the onset of the opioid epidemic in 2017. Indeed, DEA regulations impose “a corresponding responsibility” on pharmacists alongside the prescribers (21 C.F.R. 1306.04). The DEA’s position has been that a pharmacist must refuse to fill a prescription if there is reason to know that the prescription was not written for a legitimate medical purpose.
Courts have emphasized the significant discretion and legal responsibility held by pharmacists. In the 2019 case United States v. Oakley, the U.S. Department of Justice asserted that pharmacists are the last line of defense against the diversion of controlled substances. The District Court agreed, and stated that by dispensing controlled substances without a legitimate medical purpose and outside the usual course of professional practice, pharmacies contribute to the ongoing public health crisis.
Red Flags to Assess Pharmacists’ Liability
To assess pharmacists’ liability in cases involving drug overdoses or death, courts have considered various “red flags” which they deem create “reasonable suspicion” that a prescription is not legitimate. See United States v. City Pharmacy, 2017 WL 1405164, at *4; United States v. Lawson, 682 F.2d 480, 483 n.6 (4th Cir. 1982) (referring to “flags of illegitimacy”). Many of these “red flags” are also referenced in the Pharmacist’s Manual, Appendix D, which lists “criteria which may indicate no legitimate medical purpose.”
- Unusual Prescription Volume Indicators
One prominent red flag is the presence of significantly more prescriptions than what is typical. High-prescribing doctors and nurse practitioners are sometimes referred to as “whales.” A practitioner who writes a greater number of prescriptions compared to others in the same area, especially when prescriptions intended to last a month are refilled more frequently or groups of patients present similar prescriptions from the same physician in a short period, is cause for concern. Other warning signs include patients from out of the area, payments made out-of-pocket, high quantities of controlled substances and unusually high daily prescription counts. - Suspicious Handwriting in Controlled Substance Prescriptions
Signs of forgery are another red flag highlighted by the DEA and state Boards of Pharmacy. For example, prescriptions with handwriting that is excessively neat, those that appear photocopied, are written in different colored inks, use non-standard abbreviations, or have directions written without abbreviations, should be scrutinized closely. - High-Risk Drug Combinations
Certain drug combinations, often referred to as “cocktails,” are a further indication of potential drug abuse. Synergistic-acting medications can also be concerning, such as methadone and clonazepam for a patient with respiratory issues. While not required by federal law, pharmacists are expected to take advantage of their state’s Prescription Monitoring Program (PMP) to review their patients’ complete controlled substance prescription history to identify prescriptions filled elsewhere.
Fifth Circuit’s Interpretation of Corresponding Responsibility
In a Feb. 13, 2026, decision, the Fifth Circuit rejected the DEA’s long-standing interpretation of its own regulations on pharmacist duties. In Neumann’s Pharm., L.L.C. v DEA, No. 25‑60068, 2026 WL 411942 (5th Cir., Feb. 13, 2026), the DEA argued, as it has for many years, that a pharmacist should be judged under a “knows or has reason to know” standard when deciding whether there was a violation. In other words, the DEA’s position was that a pharmacist could be held federally liable for dispensing a prescription if they had reason to suspect it was forged or otherwise invalid.
The court disagreed, holding that federal liability arises only based on actual knowledge that a prescription was invalid at the time it was dispensed. The ruling therefore heightens the government’s burden of proof for liability under the Controlled Substances Act, approximating the mens rea requirement in criminal cases. The court held:
Although § 1306.04(a) is not itself a criminal statute, a violation is a criminal offense, and often a felony, under 21 U.S.C. § 841. And background principles of criminal law strongly support applying the knowledge requirement to each element of the violation. The deeply rooted presumption is that the Government must prove the defendant’s mens rea with respect to each element of a federal offense. (Internal quotation marks omitted.)
The court distinguished willful blindness from the DEA’s impermissible negligence standard. Willful blindness remains a valid basis for liability because it involves a “subjective state of mind.”
Notably, the decision does not modify pharmacists’ duties under state law; rather, it clarifies how federal standards should be applied. This important ruling, however, is likely to spur discussion about the intersection of federal and state standards and shape pharmacists’ responsibilities.
Our Experience in Pharmacist Liability and DEA Compliance Matters
Staying ahead of pharmacy developments, Harris Beach Murtha provides comprehensive legal services tailored to the medical and life sciences industry. Our firm defends pharmacist professional malpractice cases, serves as general counsel for pharmacies, assists with Pharmacy Benefit Manager audits, and provides services for regulatory compliance. The Medical and Life Sciences Industry Team is nationally renowned for its success in representing clients across the spectrum, from major pharmaceutical companies to independent pharmacies.
If you need assistance with these or related matters, please reach out to attorney Marina Plotkin at (212) 313-5409 and mplotkin@harrisbeachmurtha.com; attorney Jesse C. Wang at (212) 912-3570 and jcwang@harrisbeachmurtha.com; or the Harris Beach Murtha attorney with whom you most frequently work.
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