Pharmacists' “Corresponding Responsibility” Part II: The Legal Consequences

By Hunter DeKoninck & Scott Brinks

This post is Part II of a two-part series on the corresponding responsibility. Part I titled “Pharmacists' “Corresponding Responsibility” Part I: The Legal Requirements” covered the legal requirements related to pharmacists’ corresponding responsibility. This post discusses the legal consequences for pharmacies and pharmacists when controlled substance prescriptions are dispensed without fulfilling the corresponding responsibility. Identifying and resolving red flags may feel burdensome for pharmacy personnel who are already over-worked pharmacy personnel and for pharmacies who already wrestle with impossible thin margins for individual prescriptions, but it must be prioritized. My hope is that these two blog posts help ease that burden and bring clarity to DEA's requirements,

Disclaimer: The information provided in DeKo Law blog posts is for general informational and educational purposes only and does not constitute legal or regulatory advice. Do not rely solely on this content for compliance. Instead, consult with qualified legal counsel or regulatory professionals for advice regarding your obligations under the CSA and DEA’s regulations.

Pharmacies and pharmacists should appreciate who can be held liable for non-compliance because, in many cases, they both have skin in the game. For that reason, it is in the interests of both pharmacies and pharmacists to work in tandem toward full compliance regarding their controlled substance dispensing decisions. This post discusses the various types of liability pharmacies and pharmacists face for violations of the corresponding responsibility.

Administrative Liability

DEA’s regulations make clear the corresponding responsibility “rests with the pharmacist” (21 CFR § 1306.04(a)); however, the pharmacy is the DEA registrant responsible for all conduct carried out under its registration. Therefore, pharmacies alone remain administratively liable for violations of the corresponding responsibility. As discussed in prior posts, DEA can pursue various types of enforcement action in response to violations, including LOAs, MOAs, ISOs and OTSCs. At the end of the day, should DEA decide to pursue administrative action in response to pharmacists’ dispensing of controlled substances in the face of red flags (i.e. failure to perform their corresponding responsibility), it can only be directed at the DEA-registered pharmacy.

Considering the administrative liability they face for non-compliance, pharmacies must partner with their staff pharmacists, invest in tools that support their corresponding responsibility efforts and monitor how effective pharmacists’ efforts are in practice. Every pharmacy that dispenses controlled substances should develop and maintain robust policies and procedures (and regular internal training on their implementation) to ensure their staff pharmacists understand what red flags they are responsible for identifying and what they must do to adequately dispel such flags when identified.

Consider engaging DeKo Law and Brinks DEA Consulting to advise on your potential administrative risk with your current dispensing practices and to support you in bringing your practices into compliance.

Civil Liability Under 21 U.S.C. § 842

For cases that DEA refers to DOJ for prosecution, pharmacies could face crippling civil liability under 21 U.S.C. § 842(a)(1) for violations of DEA’s corresponding responsibility requirement. See e.g. Cherokee Nation v. McKesson Corp., No. CIV-18-056-RAW, 2021 WL 1200093, at 6 (E.D. Okla. Mar. 29, 2021) (“pharmacies, not merely pharmacists, have obligations to ‘resolve red flags’ before dispensing controlled substances concerning suspicious prescriptions”); Heartland Pharmacy, Inc. v. Rosen, No. 21-14037-CV-MIDDLEBROOKS, 2021 WL 650350, at 4 (S.D. Fla. Feb. 18, 2021); United States v. Howen, No. 121CV00106DADSAB, 2022 WL 18420744, (E.D. Cal. Aug. 9, 2022). Moreover, in assessing the pharmacy’s role in ensuring its pharmacists fulfill corresponding responsibility obligations, federal courts have held they must implement policies and systems that provide pharmacists with adequate tools and training necessary to fulfill their corresponding responsibility. See In re Nat'l Prescription Opiate Litig., 589 F. Supp. 3d 790; Cty. of Lake v. Purdue Pharma, L.P., 477 F. Supp. 3d 613; Cnty. of Lake v. Purdue Pharma, L.P., 589 F. Supp. 3d 739.

It is worth taking a minute to consider just how significant this liability can be. Civil penalties for violations of 21 U.S.C. § 842(a) generally take the form of monetary penalties that are paid by the defendant to the government. The CSA provides a maximum civil penalty of $25,000 for dispensing violations under 21 U.S.C. § 842(a). 21 U.S.C. § 842(c)(1)(A). However, this penalty amount is adjusted every year for inflation so, in reality, the inflation-adjusted amount is now $82,950. To make matters worse, DOJ almost exclusively pursues this maximum penalty amount and it does so on a per violation basis. As an illustration, if DOJ alleges a pharmacy dispensed 100 prescriptions in violation of the corresponding responsibility requirement, the pharmacy’s potential civil liability is $8.3M.

While there is much less convincing federal case law on the issue, some within DOJ have taken the position that pharmacists are also civilly liable for their failure to perform their corresponding responsibility—even  though the requirement only exists in DEA’s regulations and pharmacists are not DEA registrants.  In short, the argument for pharmacist liability is with how Congress drafted the CSA’s penalty section. Unlike other provisions of 21 U.S.C. § 842(a) that limit their application to “any person who is a registrant,” the provision specific to dispensing violations applies to “any person who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of section 829 of this title.” 21 U.S.C. § 842(a)(1). Some have taken the position that, since 21 U.S.C. § 842(a)(1) was not limited only to persons who are “a registrant,” civil liability can be extended to pharmacists as well as pharmacies.

In reality, it is extremely rare that pharmacists (particularly those who do not own the pharmacy itself) are held civilly liable for violations of the corresponding responsibility requirement—penalties are almost always limited to the pharmacy. Nevertheless, we have defended individual staff pharmacists in cases where DOJ decided to only pursue civil penalties against the dispensing pharmacist and not the pharmacy. So, it is critical that pharmacists appreciate this risk and understand the penalties they could face for violations.

If you’re a pharmacy or pharmacist, don’t wait until you’re facing penalties or lawsuits. Contact DeKo Law for expert guidance on reducing risk in your dispensing practices and for representation if you’re under investigation or facing civil action. Protect your business before problems arise.

Criminal Liability Under 21 U.S.C. § 841

Whereas civil liability is often concentrated on pharmacies rather than pharmacists, courts have more commonly imposed criminal liability under 21 U.S.C. § 841(a)(1) against both pharmacies and pharmacists. See United States v. Moore, 423 U.S. 122, 122, 96 S. Ct. 335, 336, 46 L. Ed. 2d 333 (1975) (“by its terms § 841 reaches ‘any person’; [i]t does not exempt (as it could have) ‘all registrants’ or ‘all persons registered under this Act.’”); United States v. Hayes, 595 F.2d 258, 259 (5th Cir. 1979) (“when a pharmacist fills a prescription that he knows is not a prescription within the meaning of the regulations he is subject to the penalties of § 841”).

While § 842’s civil penalties are generally geared toward DEA registrants, § 841’s criminal penalties are not. The scope of § 841 extends to any person knowingly engaging in unlawful activities with controlled substances, which could include DEA registrants, pharmacists, illicit drug dealers, transnational gangs, etc. The question of whether a person faces criminal liability turns on whether that person intentionally and knowingly violated the CSA. In the context of corresponding responsibility violations, a pharmacist could only be held criminally liable if he knew the underlying prescription was unlawful and he knew it was unlawful to dispense the controlled substances and he still decided to dispense them. In other words, criminals know they are breaking the law. Pharmacies and pharmacists should only concern themselves with potential criminal liability if they know they have been illegally dispensing controlled substances.

Conclusion

Pharmacists are the final checkpoint in the controlled substance distribution chain. By exercising sound judgment when handling controlled substance prescriptions, taking affirmative action to fully resolve red flags and documenting their investigative efforts, pharmacists are able to protect themselves and their pharmacies against administrative liability, civil liability and, in certain instances, criminal liability.

Please contact DeKo Law if you need a legal assessment of your existing corresponding responsibility practices, which will identify areas of risk and potential non-compliance. That assessment would include legal advice and recommendations on how to further strengthen those practices, particularly in this post-COVID telemedicine environment. Likewise, contact Brinks DEA Consulting if you have needs regarding the implementation of your corresponding responsibility policies or if you need assistance with mock inspections or audits of your red flag dispelling activities.