PTCB Pharmacy Law Practice Test |Question With 100% Correct Answers | Verified

FDA - label requirements for use of OTC products prohibits adulterated or misbranded drugs, enforces safety and effectiveness of food, medication, biological products, cosmetics, and radioactive substances NDA - application for new drug must be filed with FDA before being commercially available Durham-Humphrey Amendment - aka Prescription Drug Amendment, separates drugs into legend or non-legend Kefauver-Harris Amendment - label requirements for manufacturers and dispenser to patients requires manufacturer to register, be inspected, report drug rxns PPIs - patient package inserts (for oral contraceptives, inhalers, etc) must include: indications for use, contraindications, warnings, precaution, dose Occupational and Safety Act 1970 - reduced hazards in workplace, rise to OSHA (occupational safety and health administration) all pharmacies need to: -post poison control number -reference guide for toxicities -MSDS Poison Prevention Packaging Act - pharmacies must use child resistant resistant containers Drug Listing Act - assigns unique and permanent drug code to each medication Federal Hazardous Substance Act - involves use and disposal of hazardous material in pharmacy setting