Drug Information Update- New industry guidance “Requirements for Transactions with First Responders under Section 582 of the Federal FD&C Act-Compliance Policy

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Today, the FDA published a new guidance for industry, “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy.” This guidance describes FDA’s compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act for trading partners engaged in transactions with first responders, and is in effect until further notice by the Agency.