NJ MPJE ACTUAL TEST PAPER 2026 QUESTIONS
WITH SOLUTIONS GRADED A+
◉ Prescription drug advertising is regulated by the _____, while OTC
drug advertising is regulated by the _____. Answer: -FDA
-FTC (Federal Trade Commission)
◉ Any false or misleading statements in a drug advertisement could
be considered _____. Answer: -misbranding
◉ Pure Food and Drug Act (1906) description Answer: -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 Answer: -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 Answer: -*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 Answer: -*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 Answer: -
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 another term used to describe prescription drugs. Answer:
-legend drugs
WITH SOLUTIONS GRADED A+
◉ Prescription drug advertising is regulated by the _____, while OTC
drug advertising is regulated by the _____. Answer: -FDA
-FTC (Federal Trade Commission)
◉ Any false or misleading statements in a drug advertisement could
be considered _____. Answer: -misbranding
◉ Pure Food and Drug Act (1906) description Answer: -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 Answer: -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 Answer: -*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 Answer: -*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 Answer: -
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 another term used to describe prescription drugs. Answer:
-legend drugs
