Florida MPJE Exam Questions with 100% Correct Answers

Sherman Antitrust Act Correct Answer This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act Correct Answer This act states: No adulterated or misbranded drugs in interstate commerce Adulteration Correct Answer Gross - Think inside the capsule Misbranded Correct Answer Improperly labeled - think outside the bottle FDCA Correct 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 Correct Answer This act: - biologic drugs approved under BLA not NDA - reviewed for purity, potency, and safety Durham- Humphrey Labeling Amendments to FDCA Correct Answer This act: - allows for refills - establishes Rx and OTC OTC requirements of Durham-Humphrey Correct Answer This act states: - must be labeled with adequate directions for use (drug facts label) - pregnancy/ breast feeding warning - domestic contact information to receive ADR report - OTC drugs approved under OTC monograph or NDA Rx requirements of Durham-Humphrey Correct Answer This act states: - Rx must be labeled with adequate info for use (package insert) - Rx approved under NDA - grandfathered pre 1938 Durham-Humphrey Act established Pregnancy Categories What are they? Correct Answer A - safe in humans B - safe in animals - no data in humans C - Unknown safety in humans D - unsafe in humans - benefits may outweigh risks X - unsafe in humans - risks always outweighs benefits