DEA Considering Regulation of Telepharmacy PracticeNovember 18, 2021 – Articles
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations. Specifically, the Notice seeks input from state regulatory authorities, professional associations, industry participants, and the general public, which DEA will use to better inform itself about the practice, industry, and state-level regulation of telepharmacy, as well as to guide DEA in the development of stronger controlled substance-related regulations applicable to telepharmacy practice.
While the scope of practice of telepharmacy currently varies from state to state, telepharmacy is generally understood to be the remote provision of pharmacist care through the use of telecommunication and other technologies to patients located at a separate dispensing site. For example, telepharmacy care may include a remote pharmacist’s provision of drug utilization review, patient counseling services, and drug therapy monitoring. Similarly, telepharmacy may include a remote pharmacist’s supervision of satellite dispensing sites or automated remote dispensing machines.
Despite tremendous growth in the telepharmacy industry over the past decade, the practice of telepharmacy remains undefined by the Controlled Substances Act (CSA) and DEA regulations. As such, telepharmacy providers currently operate in a legal gray area that inconsistently falls into the purview of current DEA regulations if controlled substances are involved in the provision of telepharmacy services.
For example, under current DEA regulations, telepharmacies are prohibited from using the internet to facilitate the dispensing of controlled substances unless DEA has issued them a modified “Online Pharmacy” registration under 21 CFR 1301.19 or the telepharmacy falls within one of 10 exceptions to the Ryan Haight Online Pharmacy Consumer Protection Act (the Ryan Haight Act). To date, however, there are no online pharmacies registered with DEA. Further, DEA does not interpret any of the 10 Ryan Haight Act exceptions as providing safe harbor protection to telepharmacies where possible regulatory non-compliance may occur in the provision of telecommunication-based services. Under current DEA regulation, telepharmacy providers who meet the Ryan Haight Act’s “electronic prescriptions of controlled substances” exception may fill electronically prescribed controlled substance prescriptions, but they are prohibited from filling written prescriptions.
Given the lack of detailed regulation governing the practice of telepharmacy as well as the varying methods in which telepharmacy services are provided, DEA is using the Notice to more clearly identify how the telepharmacy practice operates and what industry-standard practices have developed over recent years. DEA has invited all industry stakeholders to comment on its development to telepharmacy regulations, which represents a unique opportunity for telepharmacy practice stakeholders to positively affect DEA rulemaking in this space.
Should you or your organization wish to learn more about the practice of telepharmacy or wish to provide comments on the DEA Notice, please contact one of Dinsmore’s health law or life sciences practice group attorneys.