AHA Supports Interim Final Rule Modifying FDA Notification of Discontinuance Requirements
February 15, 2012 | Risk Management News
The American Hospital Association (AHA) has expressed its support for an interim final rule that amends the U.S. Food and Drug Administration’s (FDA) postmarketing reporting obligations with respect to notification of discontinuance requirements for medications in a February 10, 2012, letter to FDA. Specifically, the interim final rule formalizes and expands upon the definitions of two terms related to the agency’s existing manufacturer reporting requirement. First, it defines “discontinuance” to include both permanent and temporary discontinuances in the manufacture of a drug that could lead to a disruption in supply of the product.