NJ MPJE Questions and Answers Already Passed

NJ MPJE Questions and Answers Already Passed Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. -misbranding Pure Food and Drug Act (1906) description -mandated accurate product labeling and required that the ingredients used in drugs met the *standards of strength, quality, and purity in USP* -required that the food or drug label *could not be false or misleading*, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine had to be listed -required that *no adulterated or misbranded drugs could be sent through interstate commerce* Food Drug and Cosmetic Act (1938) description -resulted from the *sulfanilamide deaths due to diethylene glycol poisoning* -required that the manufacturer (not the FDA) prove the *safety* of a drug before it could be marketed -*defined* foods, drugs, dietary supplements, cosmetics, and devices drug adulteration description -*filthy, putrid, or decomposed* -prepared, packaged, or *stored under unsanitary conditions* where it may become contaminated, including lack of tests that confirm quality and purity -*does not comply with CGMPs* -contains an *unsafe color additive* -contains a drug recognized in the official compendia, but *it's strength is different from official standards, or the purity or quality is lower than the official standards* -contains a drug that is not recognized in official compendia, but its *strength is different from that listed on the label, or the purity or quality is lower than that listed on the label* *drugs can be both adulterated AND misbranded (i.e. strength or purity is compromised AND this is not presented on the label) drug misbranding description -*lack of required information* on the package and in the labeling -*any false or misleading information*, such as imitating the properties of another drug or promising false cures -lack of special precautions needed to prevent decomposition that must be *specified on the package* (e.g. "protect from light" or "keep in original container) -illegible information -lack of the proprietary or established generic name -the *ingredients differ from the standard strength, quality, or purity as determined by USP* -lack of the manufacturer, packer, and distributor location -*improper packaging* (e.g. no package insert or medication guide) or improper or incomplete labeling of additives -deficiency in packaging requirements determined by the *Poison Prevention Packaging Act* Durham-Humphrey Amendment (1951) description -first time clear distinction was made between *OTC and prescription drugs* -drugs that were habit forming, those considered unsafe except under expert supervision due to toxicity, and those limited to Rx only by the manufacturer's NDA were made available only by prescription -authorized *refills and telephone prescriptions* -required adequate *directions for use* _____ is