Florida MPJE questions with correct answers

Sherman Antitrust Act - Answer This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act - Answer This act states: No adulterated or misbranded drugs in interstate commerce Adulteration - Answer Gross - Think inside the capsule Misbranded - Answer Improperly labeled - think outside the bottle FDCA - Answer This act requires: ingredients are disclosed on bottle drug must be proven safe before marketing authorizes FDA inspection of manufactures and distributors Public Health Service Act - Answer This act: - biologic drugs approved under BLA not NDA - reviewed for purity, potency, and safety Durham- Humphrey Labeling Amendments to FDCA - Answer This act: - allows for refills - establishes Rx and OTC OTC requirements of Durham-Humphrey - Answer This act states: - must be labeled with adequate directions for use (drug facts label)