NJ MPJE
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
-FTC (Federal Trade Commission)
Any false or misleading statements in a drug advertisement could be considered _____. - ANS -
misbranding
Pure Food and Drug Act (1906) description - ANS -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 - 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*
,-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 - 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
,-*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
-authorized *refills and telephone prescriptions*
-required adequate *directions for use*
_____ is another term used to describe prescription drugs. - ANS -legend drugs
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
, -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
-reducing drug diversion
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
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*
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
-FTC (Federal Trade Commission)
Any false or misleading statements in a drug advertisement could be considered _____. - ANS -
misbranding
Pure Food and Drug Act (1906) description - ANS -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 - 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*
,-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 - 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
,-*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
-authorized *refills and telephone prescriptions*
-required adequate *directions for use*
_____ is another term used to describe prescription drugs. - ANS -legend drugs
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
, -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
-reducing drug diversion
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
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*
