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.

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

David B. Brushwood, R.Ph, J.D.
Senior Lecturer, The University of Wyoming School of Pharmacy
Pharmacy Law Content Developer, CEimpact

David Brushwood does not report any actual or potential conflicts of interest in relation to this continuing pharmacy education course.

Course fee includes course, course materials, and CPE credit submission to CPE Monitor.
Course is non-refundable
Initial Release Date: April 1, 2021
Planned Expiration Date: April 1, 2024

This program is provided for educational purposes. CEimpact is not a law firm and does not provide legal advice of any kind. For legal advice, please contact a licensed attorney.

Copyright 2021, CEimpact. All Rights Reserved. Any reproduction of this course without express permission is strictly forbidden.