Florida MPJE Exam Questions and Answers 100% Pass Sherman Antitrust Act - Correct Answer ✔️✔️-This act: Outlaws agreements t hat 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 b efore 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 feed ing 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 m ay outweigh risks X - unsafe in humans - risks always outweighs benefits Unit Dose Drugs - Labeling requirements - Correct Answer ✔️✔️-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 - Correct Answer ✔️✔️-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 reg istered - drugs are Misbranded - If a facility produces substandards of strength, quality or purity drugs are adulterated Advertising of Rx drugs is by - Correct Answer ✔️✔️-FDA Advertising of OTC drugs is by - Correct Answer ✔️✔️-FTC ADRs must be reported on which form - Correct Answer ✔️✔️-Med Watch Form If a Manufacturer is not registered the drugs are considered - Correct Answer ✔️✔️-
Misbranded If a facility produces substandards of strength, quality, or purity drugs are considered _________? - Correct Answer ✔️✔️-Adulterated Pharmacies that compound large amounts of drug not based on an individual's Rx must register with the FDA as a _____________? - Correct Answer ✔️✔️-Manufacturer and meet cGMP Poison Prevention Packaging Act - Correct Answer ✔️✔️-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 ok) - Physician may request an individual Rx be non child resistant but cannot make a blanket request - Hospitals are exempt - Manufacturers may market one size as non c hild resistant Identify some drugs that are exempt from PPPA - Correct Answer ✔️✔️-- sl nitro - chloestyramine - erythromycin - prednisone
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