TX MPJE

Food Drug and Cosmetic Act of 1938 - answer-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 - answer-Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - answer-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) - answer-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) - answer-Drug Compouding Quality Act; Drug Supply Chain Security Act Drug Compounding Quality Act - answer-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 - answer-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) - answer-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... - answer-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 - answer-adulteration and misbranding Adulteration: a drug is adulterated if.... - answer-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... - answer-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 packaging act OTC product is c