What Is OTC Drug Establishment RegistrationOver-the-counter (OTC) drugs are widely used for treating common ailments without the need for a prescription. For manufacturers, distributors, and packagers of these products, OTC drug establishment registration is a mandatory requirement. This registration, regulated by the FDA, ensures that all companies involved in the production or distribution of OTC drugs comply with the necessary safety, manufacturing, and labeling standards.

Who Needs OTC Drug Establishment RegistrationAll parties involved in the production and distribution of OTC drugs must complete OTC drug…