1 for specific request mail
NJ MPJE Questions and Correct Answers | Latest
Update
Neither _____ nor _____ are required by an ANDA. Ans: -pre-clinical
animal studies
-clinical studies
*bioequivalence only
Prescription drug advertising is regulated by the _____, while OTC drug
advertising is regulated by the _____. Ans: -FDA
Assignment Expert
-FTC (Federal Trade Commission)
Guru01 - Stuvia
Any false or misleading statements in a drug advertisement could be
considered _____. Ans: -misbranding
Pure Food and Drug Act (1906) description Ans: -mandated accurate
2026
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 Ans: -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 Ans: -filthy, putrid, or decomposed
, 2 for specific request mail
-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
Assignment Expert
-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
Guru01 - Stuvia
*drugs can be both adulterated AND misbranded (i.e. strength or purity is
compromised AND this is not presented on the label)
2026
drug misbranding description Ans: -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
, 3 for specific request mail
-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 Ans: -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
Assignment Expert
-authorized refills and telephone prescriptions
Guru01 - Stuvia
-required adequate directions for use
_____ is another term used to describe prescription drugs. Ans: -legend
drugs
2026
Durham-Humphrey required that OTC drugs contain _____ in the Drug
Facts Label. Ans: -adequate directions for use
©
*e.g. safety in pregnancy and breast feeding, calcium, sodium,
magnesium, potassium content, etc.
Kefauver-Harris Amendment (1962) description Ans: -resulted from the
thalidomide tragedy
-required that manufacturers prove that their drug is both safe AND
effective in clinical studies before it can be approved (previously, drugs
just needed to be safe)
-required that manufacturers continue to report serious side effects to
the FDA after their drug is marketed (e.g. Post-Market Surveillance)
-individuals must give their informed consent when they are study
subjects of a clinical trial
, 4 for specific request mail
-FDA must perform retrospective evaluation of drug effectiveness for
drugs approved between 1938 and 1962
-FDA established Current Good Manufacturing Practices (CGMPS) for drug
manufacturing and must perform inspections
-FDA was given oversight to regulate the advertising of prescription
drugs
The Controlled Substances Act of 1970 was designed to establish a _____
of the manufacturing, distribution, and dispensing of drugs with the
purpose of _____. Ans: -closed system
Assignment Expert
-reducing drug diversion
Guru01 - Stuvia
The Poison Prevention and Packaging Act of 1970 requires a number of
household substances and drugs to be packaged in _____. Ans: -child-
resistant (C-R) packaging
2026
The Drug Listing Act of 1970 required that all drug establishments
register with the FDA and all drugs have a unique _____. Ans: -NDC
©
number
The NDC number contains _____ digits with _____ segments. Ans: -10-11
-3
three segments of an NDC Ans: 1. labeler code: first 4 or 5 digits
assigned by the FDA that correspond to the manufacturer
2. product code: middle 3 or 4 digits determined by the labeler that
correspond to the drug's strength, dosage, and formulation
3. package code: last 1 or 2 digits determined by the labeler that
correspond to the drug's package size and type
NJ MPJE Questions and Correct Answers | Latest
Update
Neither _____ nor _____ are required by an ANDA. Ans: -pre-clinical
animal studies
-clinical studies
*bioequivalence only
Prescription drug advertising is regulated by the _____, while OTC drug
advertising is regulated by the _____. Ans: -FDA
Assignment Expert
-FTC (Federal Trade Commission)
Guru01 - Stuvia
Any false or misleading statements in a drug advertisement could be
considered _____. Ans: -misbranding
Pure Food and Drug Act (1906) description Ans: -mandated accurate
2026
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 Ans: -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 Ans: -filthy, putrid, or decomposed
, 2 for specific request mail
-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
Assignment Expert
-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
Guru01 - Stuvia
*drugs can be both adulterated AND misbranded (i.e. strength or purity is
compromised AND this is not presented on the label)
2026
drug misbranding description Ans: -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
, 3 for specific request mail
-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 Ans: -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
Assignment Expert
-authorized refills and telephone prescriptions
Guru01 - Stuvia
-required adequate directions for use
_____ is another term used to describe prescription drugs. Ans: -legend
drugs
2026
Durham-Humphrey required that OTC drugs contain _____ in the Drug
Facts Label. Ans: -adequate directions for use
©
*e.g. safety in pregnancy and breast feeding, calcium, sodium,
magnesium, potassium content, etc.
Kefauver-Harris Amendment (1962) description Ans: -resulted from the
thalidomide tragedy
-required that manufacturers prove that their drug is both safe AND
effective in clinical studies before it can be approved (previously, drugs
just needed to be safe)
-required that manufacturers continue to report serious side effects to
the FDA after their drug is marketed (e.g. Post-Market Surveillance)
-individuals must give their informed consent when they are study
subjects of a clinical trial
, 4 for specific request mail
-FDA must perform retrospective evaluation of drug effectiveness for
drugs approved between 1938 and 1962
-FDA established Current Good Manufacturing Practices (CGMPS) for drug
manufacturing and must perform inspections
-FDA was given oversight to regulate the advertising of prescription
drugs
The Controlled Substances Act of 1970 was designed to establish a _____
of the manufacturing, distribution, and dispensing of drugs with the
purpose of _____. Ans: -closed system
Assignment Expert
-reducing drug diversion
Guru01 - Stuvia
The Poison Prevention and Packaging Act of 1970 requires a number of
household substances and drugs to be packaged in _____. Ans: -child-
resistant (C-R) packaging
2026
The Drug Listing Act of 1970 required that all drug establishments
register with the FDA and all drugs have a unique _____. Ans: -NDC
©
number
The NDC number contains _____ digits with _____ segments. Ans: -10-11
-3
three segments of an NDC Ans: 1. labeler code: first 4 or 5 digits
assigned by the FDA that correspond to the manufacturer
2. product code: middle 3 or 4 digits determined by the labeler that
correspond to the drug's strength, dosage, and formulation
3. package code: last 1 or 2 digits determined by the labeler that
correspond to the drug's package size and type
