PHARM LAW EXAM 1 QUESTIONS AND ANSWERS ALREADY PASSED

PHARM LAW EXAM 1 QUESTIONS AND ANSWERS ALREADY PASSED under what administrative agency does the FDA fall under? - Answers -department of health and human services, center for medicare and medicaid what act created the FDA? - Answers -pure food and drug act of 1906 ` define the food, drug and cosmetic act of 1938 - Answers -no drug could be marketed until proven safe for use under the conditions of the label and approved by the FDA -exempted drugs before 1938 -(does not have to work) define the durham humphrey amendment - Answers -created two classes of drugs, prescription (legend) and otc define the kefauver-harris amendment - Answers -drug efficacy amendment -stated drugs must be both safe and effective -established good manufacturing practices -FDA regulates prescription drug advertising define the comprehensive drug abuse prevention and control act of 1970 - Answers -classification of controlled substances what does title I of the drug quality and security act of 2013 outline? - Answers -compounding -sterile drug compounders do not have to a licensed pharmacy -patient specific rx not necessary what does title II of the drug quality and security act of 2013 outline? - Answers -steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs -steps in place to quarantine, investigate, notify FDA and others -needs to be implemented by 11/27/24 what does HIPAA stand for? - Answers -Health -Insurance -Portability -Accountability -Act define adulteration - Answers -a drug or device that consists of any filthy, putrid or decomposed substance -held under unsanitary conditions or filth -does not conform with current good manufacturing practice -poisonous, deleterious, or unsafe -ex: dirty tray, repackaging, temperature controlled define misbranding - Answers -representation made by manufacturer on the label or labeling -false or misleading labeling -ex: must include habit forming, established names of drugs, adequate information for use, adequate directions for use if the expiration date is listed as 1/23, what is the expiration date? - Answers -1/31/2023 -the last day of the month describe how NDC (national drug code) numbers work - Answers -10 digits separated into three segments (4/4/2, 5/3/2, or 5/4/1) -segment 1: manufacturer -segment 2: product -segment 3: package size what book is useful for therapeutic equivalent drugs? - Answers -orange book what book is useful for biological equivalents? - Answers -purple book what are the rules for drug advertisements? - Answers -not misleading or related to an unlawful activity -give the drugs name -cannot suggest use, who benefits, who should take it -must give brand name and generic -true statement of the drugs: name, formula, brief summary of ADRs, CIs, and effectiveness, fair balanced between side effects and effectiveness -should include material facts define the inflation reduction act - Answers -signed into law by biden in 2022 -requires federal govt to negotiate prices for some drugs covered under medicare part b and d -require drug companies to pay rebates to medicare if prices rise faster than inflation -cap out of pocket spending for medicare part d -limit monthly cost sharing for insulin to $35 -eliminate cost sharing for adult vaccines -expand eligibility define patient protection and affordable care act - Answers -obamacare (2010) -26 yr olds stay on parents insurance -bc coverage -pre-existing conditions -expanded medicaid eligibility