Florida MPJE 2023/2024 Latest Update Graded A+

Florida MPJE 2023/2024 Latest Update Graded A+ Food, Drug, and Cosmetic Act (FDCA) 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 Mandates the storage, handling, and record-keeping requirements for prescription drug samples - *A community pharmacy that is NOT affiliated w/ a healthcare entity may NOT be in possession of prescription drug samples* Prohibits re-sale of prescription drugs purchased from hospitals or healthcare facilities - done to prevent diversion of drugs due to price diversion since hospitals receive lower prices for drugs than community pharmacies Drug Quality and Security Act of 2013 (DQSA) Amendments (DCQA & DSCSA) to the FDCA that addressed two primary topics: 1. Large-scale compounding by pharmacies 2. Establishment of a framework for a uniform track-and-trace system for Rx drugs throughout the supply chain to prevent counterfeit drugs Drug Compounding Quality Act (DCQA) 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 - passed in response to fungal meningitis outbreak in 2012 due to contaminated injectable steroids What is a 503A pharmacy? traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required) ****Follow USP 797*** Interstate distribution of compounded drugs is limited to 5% of the total prescription orders dispensed or distributed by such pharmacy (effective 10/22/22 in FL) 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 bulk drugs that have a clinical need and/or on shortage - NOT EXEMPT FROM cGMP Drug Supply Chain Security Act (DSCSA) "Track