TX MPJE LATEST UPDATE GRADED A+

TX MPJE LATEST UPDATE GRADED A+ Food Drug and Cosmetic Act of 1938 Followed deaths by sulfanalimide elixier; required new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, costmetic, and medical device safety Durham-Humphrey Act of 1951 Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and established GMPs; gave FDA jurisdiction over Rx drug advertising Prescription Drug Marketing Act of 1987 (4 things) PDMA; bans reimportation of Rx drugs and insulin produced in US (except by manufacturer); bans sale, trade, or purchase of Rx drug samples in the pharmacy; exception is pharmacies owned by charitable organizations or by city/state/county govt providing care to indigent population; may only be provided at no charge to patient; mandates storage, handling, and recordkeeping requirements for prescription drug samples; prohibits, with some exceptions, resale of prescription drugs purchased by hospitals Drug Quality and Security Act of 2013 (2 topics) Drug Compouding Quality Act; Drug Supply Chain Security Act 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; These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions Drug Supply Chain Security Act Provides uniform national framework for electronic track/trace system for Rx drugs through supply chain (exempt are blood products, radioactive drugs, imaging drugs, certain IV fluids, dialysis solutions, medical gases, compounded drugs); must provide "transaction data"; pharmacies that are distributing (instead of dispensing to patient), must have wholesale distribution license The only exemptions to having "distribution license" under DSCSA are: (4) When two entities are same ownership; dispenser in providing product to another dispenser on a patient specific basis; distributing under emergency medical reasons; when distributing "minimal quantities" to a license practitioner for office use "Transaction data" under DSCSA includes... Transaction information (drug name, strength, dosage form, NDC, size/number of containers, date, name and address of owners; Transaction history (paper/electronic statement of prior transaction info all the way back to manufacturer; Transaction statement (done by seller saying they are legit) 2 prohibited acts under the FDCA adulteration and misbranding Adulteration: a drug is adulterated if.... Contains filthy/decomposed substance; prepared in unsanitary conditions; methods do not conform to CGMPs; container is composed of poisonour substances; unsafe color additive; falls below USP quality/purity standard; strength differs than what it represents Misbranding: a drugs is misbranded if... Labeling is false or misleading in any way; Prescription drug label and manufacturer label fails to contain: name/address of manufacturer, packer, or distributor, name of drug, quantity, weight of active ingredient, "Rx only", route of admin, special storage instructions, lot number, expiration date, package insert; OTC fails to contain certain things (separate card); drug is liable to deterioation; container is misleading; drug is exact imitation of anotehr drugs; dangerous to health if used as suggested in labeling; packaged/labeled in violation of poison prevention