The U.S. Congress passed the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) because of “the increasing use of prescription controlled substances by adolescents and others for non-medical purposes, which [had] been exacerbated by drug trafficking on the internet.”[1] The Ryan Haight Act was passed in order to prevent the internet from being exploited to facilitate illegal drug activity. The statute imposes several limitations on prescribing and dispensing controlled substances, including:
- Except in specific circumstances, it is prohibited for a practitioner to issue a prescription for controlled substances regulated by the Drug Enforcement Administration (DEA) by means of the internet without having conducted at least one in-person medical evaluation.
- A website that fits within the definition of an “online pharmacy”[2] must obtain from DEA a modification of its DEA pharmacy registration that expressly authorizes such online activity.[3]
On April 6, 2009, the DEA published an interim final rule that served to (1) clarify certain provisions of the Ryan Haight Act, (2) amend certain DEA regulations that implemented the Ryan Haight Act, and (3) request comments on these amendments.[4] The interim final rule directed the DEA to create a special registration for telemedicine with the goal of increasing patients’ access to practitioners who can prescribe controlled substances via telehealth in limited circumstances. In 2018, the Support for Patients and Communities Act was signed into law, establishing a one-year deadline for the DEA to promulgate regulations for the special registration of practitioners who may prescribe controlled substances based on telemedicine encounters.
On September 30, 2020, the DEA published the final rule titled “Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008” adopting the interim final rule as final, and including the minor technical changes made by subsequent DEA rules (the “Final Rule”). The Final Rule went into effect on October 30, 2020. To date, there is no regulation implementing the special registration for telemedicine providers.
As discussed in Goodwin’s March 25, 2020 Client Alert, the declaration of a Public Health Emergency (PHE) on January 21, 2020 in response to COVID-19 triggered a federal law that temporarily allows for the expanded use of telemedicine in prescribing controlled substances for the duration of the PHE. However, this allowance will expire at the end of the PHE. On March 31, 2020, the DEA published “How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency” that provides guidance for providers prescribing controlled substances via telemedicine until the end of the PHE.
For questions regarding prescription drugs and telemedicine, reach out to your contact at Goodwin or a lawyer in Goodwin’s healthcare practice.
[1] S. Rep. No. 110-521, at 1 (2008).
[2] The definition of “online pharmacy” includes, among others, those persons who operate the types of rogue websites that the Ryan Haight Act was designed to eliminate.
[3] 21 U.S.C. 841(h).
[4] See 74 FR 15596.
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