Florida MPJE Questions and Answers 100% Pass

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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-Humph... rey 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 [Show More]

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