Patient Access to Unapproved Drugs (Pharmacist)

Patient Access to Unapproved Drugs (Pharmacist) is organized by Connect Educate Impact (CEI).

Initial Release Date: April 1, 2021
Planned Expiration Date: April 1, 2024

Description:
The Food and Drug Administration (FDA) has recently indicated that the agency plans to terminate its “Unapproved Drugs Initiative” (UDI). This initiative has been a component of the “Prescription Drug Wrap-Up” undertaken by the agency to review all marketed unapproved drugs and to require agency approval of all unapproved drugs as a condition of their continued marketing. This course will examine the implications for patients, pharmacists, and prescribers of the FDA plan to terminate the UDI.

Objectives:
Upon successful completion of this knowledge-based CPE course, pharmacists should be able to:
• Identify the legal principles applicable to new drug approval and the availability of unapproved new drugs in patient care.
• Evaluate the criteria used by the Food and Drug Administration (FDA) to approve a drug as safe and effective.
• Compare the federal “Right to Try” law with the FDA’s “Project Facilitate.”
• Recognize the heightened responsibilities for pharmacies following the FDA's termination of its Unapproved Drugs Initiative.