Hot Topics in Pharmacy: Deregulation, Safety, and the FDA: Why Prescription Standards Matter

Efforts to deregulate certain prescription drugs outside the Food and Drug Administration’s (FDA) established review framework are gaining momentum in several states, raising concerns about patient safety and regulatory consistency. This episode explores ASHP’s new policy opposing such legislative actions and highlights the risks of bypassing evidence‑based FDA pathways for Rx‑to‑over-the-counter (OTC) switches. We’ll also examine past attempts to move medications, such as statins and other drug classes, to OTC status and why these proposals did not meet FDA standards. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.