Tag: Durham humphrey amendment

Before a single pill can be dispensed to a patient, new drugs must undergo a rigorous approval process that can take over a decade to complete. What is the FDA dispensing process is not a single counter procedure, but a comprehensive, multi-layered regulatory framework involving manufacturers, distributors, and licensed pharmacists to ensure public safety.

The pivotal Durham-Humphrey Amendment of 1951 legally separated drugs into two classes: prescription and nonprescription, providing the foundation for modern drug classification. This crucial distinction is the root of the naming convention, addressing the question: **Why are they called OTC drugs?**