Ryan Haight Online Pharmacy Consumer Protection Act of 2008

md.jpgOne significant development in the area of medical and pharmacy practice was the passage last year of The Ryan Haight Online Pharmacy Consumer Protection Act of 2008. This Act modifies the Controlled Substances Act to address the facilitation of the purchase or dispensing or controlled substances via the internet.
Under current DEA regulations, dispensing includes the not just the sale or provision of a prescription drug, but also the issuance of a prescription. The Act also seeks to define components of telemedicine involving controlled substances. The Act takes effect today. On April 6, 2009, the DEA issued interim rules on the implementation of the Act while regulations are formalized. The interim rules require any on-line pharmacy or physician practicing telemedicine to register with the DEA. However, some definitions and the commentary pertaining to the scope of the Act include some interesting positions as to the potential scope of the Act.
keyboard.jpgAmong the changes to the current Controlled Substances Act is a requirement of a face to face physician encounter prior to the issuance of a prescription for a controlled substances and a definition of a “covering physician” and “in person medical evaluation.” The regulatory definition of a “valid prescription” now is part of the statute and includes, in addition to the previous requirement that a prescription be “for a legitimate medical purpose in the usual course of a physician’s practice” to include that the practitioner must have conducted a least one in-person medical evaluation of the patient or be a covering physician.
The in-person evaluation requirement requires that the evaluation be in the physical presence of the physician regardless of what healthcare worker conducts the evaluation. Although there is an argument that since the first part of the Act’s provisions only applies to prescriptions facilitated by the internet, and the valid prescription language does as well, any practitioner in an abundance of caution should govern their conduct accordingly.
A copy of the Act was too large to upload, but can be found by searching online for 21 CFR Par t 1 300, 1 301 , 1 304, et al. Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008; Final Rule.