Florida MPJE All Answers Correct

Florida MPJE All Answers Correct 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 OTC drugs is by ️FTC ADRs must be reported on which form ️Med Watch Form If a Manufacturer is not registered the drugs are considered ️Misbranded If a facility produces substandards of strength, quality, or purity drugs are considered _________? ️Adulterated Pharmacies that compound large amounts of drug not based on an individual's Rx must register with the FDA as a _____________? ️Manufacturer and meet cGMP Poison Prevention Packaging Act ️This act states: - Pharmacy must dispense drugs using Child-resistant containers (exceptions: sl nitro, chloestyramine, erthyromycin, prednisone) - may use reversible caps - cannot reuse containers - Patient may make a blanket request for non child resistant containers (verbal request is