Tag: FDA drug registration
-
FDA OTC Drug Registration: Regulatory Entry Point for Non-Prescription Products
Over-the-counter (OTC) drugs are medicines that consumers can purchase without a prescription, but they are still regulated as drugs under US law. Any company that manufactures, processes, packs, or labels OTC drug products for the US market must comply with FDA OTC drug registration and listing requirements enforced by the U.S. Food and Drug Administration…
-
US FDA Drug Establishment Registration: A Practical Guide for Compliance-Ready Facilities
Any facility that manufactures, processes, packs, or labels drugs for the United States market must comply with US FDA Drug Establishment Registration regulations. This requirement is administered by the U.S. Food and Drug Administration (FDA) and applies equally to domestic and foreign drug manufacturing facilities. FDA establishment registration is a legal obligation. Facilities that are…