Florida MPJE Questions and Answers with Verified Solutions

Florida MPJE Questions and Answers with Verified Solutions Sherman Antitrust Act This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act This act states: No adulterated or misbranded drugs in interstate commerce Adulteration Gross - Think inside the capsule Misbranded Improperly labeled - think outside the bottle FDCA 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 This act: - biologic drugs approved under BLA not NDA - reviewed for purity, potency, and safety Durham- Humphrey Labeling Amendments to FDCA This act: - allows for refills - establishes Rx and OTC OTC requirements of Durham-Humphrey 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 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? 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 Unit Dose Drugs - Labeling requirements These items are required on which labels? - generic name or brand - not both - strength - dosage form - exp date (1 yr or earlier if manufacturer is sooner) - Lot number - business name of packager - qty -Rx only + Cautionary statement (if applies) ** directions for use are not required on dose but should be stored where can be accessed easily Kefauver-Harris Drug Efficacy Amendments to FDCA This act states: - drugs must be proven effective before marketing - creates NDA and SNDA Phase I, II, and III research - studies require informed consent and IRB approval - IND required to test new drugs in humans (FDA has 30 days to issues "clinical hold" or else study can proceed - mandates informed consent in clinical research - ADRs must be reported to FDA on Med Watch Form Manufacturers are required to report ADRs Healthcare professionals and patients are voluntary - All drug labels must have brand and generic name - Advertising FDA for Rx FTC for OTC - Establishes cGMP - current good manufacturing practices - Manufacturers must register facility and be inspected every 2 years - If not registered - drugs are Misbranded - If a facility produces substandards of strength, quality or purity drugs are adulterated Advertising of Rx drugs is by FDA Advertising of