Florida MPJE Study Guide 2024 Seamon Already Graded A

Florida MPJE Study Guide 2024 Seamon Already Graded A 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 that OTC drugs must be labeled with adequate directions for use (drug facts label) - Pregnancy and breast-feeding warning - Calcium, Sodium, Magnesium, Potassium content - 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 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 the manufacturer is sooner) - Lot number - business name of packager (E.g., Mercy Hospital or Palmetto General Hospital) - Quantity -Rx only + Habit-forming warning if applicable While 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 --> 505(b)(2) Paper NDA may be used where there is extensive data to support use (No clinical data is required) - 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 the FDA on Med Watch Form Manufacturers are required to report ADRs Healthcare professionals and patients are voluntary - All drug labels must-have a brand and generic name