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*
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*
