On November 17, 2021, the United States Drug Enforcement Administration (DEA) issued an advance notice of regulatory proposal (the Notice) regarding its potential development of telepharmacy regulations. Specifically, the notice seeks input from state regulators, professional associations, industry participants and the general public, which the DEA will use to better inform itself about practice, industry and state level regulation of telepharmacy, as well as to guide the DEA in developing more stringent controlled substance regulations applicable to the practice of telepharmacy.
Although the scope of practice of telepharmacy currently varies from state to state, telepharmacy is generally understood as the remote delivery of pharmacist care through the use of telecommunications and other technologies to patients located on a separate distribution site. For example, telepharmacy care may include the provision by a remote pharmacist of a review of drug use, patient counseling services, and monitoring of drug therapy. Likewise, telepharmacy can include remote pharmacist supervision of satellite distribution sites or remote vending machines.
Despite the phenomenal growth of the telepharmacy industry over the past decade, the practice of telepharmacy is still not defined by the Controlled Substances Act (CSA) and DEA regulations. As such, telepharmacy providers currently operate in a legal gray area that inconsistently falls within the scope of current DEA regulations if controlled substances are involved in the provision of telepharmacy services.
For example, under current DEA regulations, telepharmacy is prohibited from using the Internet to facilitate the distribution of controlled substances, unless the DEA has issued them an amended “online pharmacy” registration under of 21 CFR 1301.19 or that telepharmacy falls under one of the 10 exceptions to Ryan. Haight Online Pharmacy Consumer Protection Act (the Ryan Haight Act). To date, however, no online pharmacy is registered with the DEA. Further, the DEA does not interpret any of the 10 exceptions in the Ryan Haight Act as providing safe haven protection for telepharmacy when regulatory non-compliance may arise in the provision of telecommunications-based services. Under current DEA regulations, telepharmacy providers who meet the Ryan Haight Act’s “electronic controlled substance prescription” exception can fill electronically prescribed controlled substances prescriptions, but are prohibited from filling out prescriptions. written prescriptions.
Given the absence of detailed regulations governing the practice of telepharmacy as well as the different methods in which telepharmacy services are provided, the DEA uses the notice to more clearly identify the functioning of telepharmacy practice and standard practices. industry that have developed over the past few years. The DEA has invited all industry stakeholders to comment on its evolution towards the regulation of telepharmacy, which represents a unique opportunity for stakeholders in the practice of telepharmacy to positively influence the regulation of the DEA in this regard. space.
© 2021 Dinsmore & Shohl LLP. All rights reserved.Revue nationale de droit, volume XI, number 323