Florida MPJE Questions and Answers 100% Pass

Florida MPJE Questions and Answers 100% Pass Food, Drug, and Cosmetic Act of 1938 Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 "Drug Efficacy Amendment" New drugs must be SAFE and EFFICACIOUS Established GMPs FDA oversees prescription drug advertising Prescription Drug Marketing Act of 1987 Prevents re-importation of a drug into US Prohibited hospital and healthcare entities from reselling their pharmaceuticals Bans sale, trade, or purchase of prescription drug samples Storage, handling, and record-keeping requirements for prescription drug samples Prohibits re-sale of prescription drugs purchased from hospitals or healthcare facilities Drug Compounding Quality Act Maintains traditional compounding regulations but establishes new section to FDCA that allows facilities that are compounding sterile pharmaceuticals to register with FDA as outsourcing facility (503B) These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions What is a 503A pharmacy? traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required) ****Follow USP 797*** What are requirements for outsourcing facilities? Have a licensed pharmacist Register as an outsourcing facility Report to the Secretary of HHS on registering and every 6 months Be inspected by the FDA Report serious adverse events within 15 days Label products with identifying statement as compounded products Only compound drugs that have a clinical need a and/or on shortage Drug Supply Chain Security Act (DSCSA) "Track and Trace Amendment" FDA Form 3911 Track and trace form to report illegitimate products to the FDA ***Must also notify trading partners within 24 hours*** What license must pharmacies that are "distributing" have? Wholesale distribution license What is adulteration? - filthy, putrid, decomposed substance - prepped or stored in unsanitary conditions - does not meet gmp's - includes unapproved color additive -contains drug recognized in or not official compendia, but its strength, purity, or quality is lower than the official standards - container can leach into product - substituted active ingredient What is misbranding? Label is defaced or misleading Labeling is missing any of the required information What information must be on a prescription drug's manufacturer's labeling? Name and address of manufacturer Brand and/or generic of drug Net quantity (units, weight, etc.) Weight of active ingredients per dose Federal "Rx Only" for legend drugs Route of administration (unless taken orally) Any special storage requirements Expiration date Adequate info/