fipp law review Exam Questions and Answers With Verified Solutions 2025
what did the Pure Food and Drug act of 1906 do? - ✔✔prohibited interstate sale of adulterated and
misbranded food and drugs and addresses some product labeling issues
what were the product labeling issues addressed in the pure food and drug act? - ✔✔-labels cannot be
false or misleading about ingredients
-no requirement to disclose ingredients
-11 dangerous ingredients were identified but could be used as long as listed (cocaine, heroine, ect)
what did the pure food and drug act of 1906 lead to? - ✔✔the creation of the modern day food and
drug administration (FDA)
what is the Sulfanilamide tragedy of 1937? - ✔✔-Tennessee drug company marketed "Elixir
Sulfanilamide" as a wonder drug for ailments from gonorrhea to sore throats
-dug contained chemical analog of antifreeze "diethyl glycol"
-killed over 105 people (adults and children) which created a public outcry
-failure to list ingredients or test the safety of those ingredients was not a violation of the 1906 pure
food and drug act
What did the sulfanilamide tragedy lead to? - ✔✔giving enforcement authority to the federal food,
drug, and cosmetic act of 1938
what was the Federal food, drug, and cosmetic act of 1938? - ✔✔set of laws passed by congress in 1938
which gave authority to the US food and drug administration to oversee the safety of food, drugs, and
cosmetics
what were the FD&C requirements that came from the federal food, drug, and cosmetic act of 1938? -
✔✔-drug labels must include directions for safe use
-required pre-market approval for new drugs to ensure safety
-prohibited false therapeutic claims for drugs
-authorized factory inspections
, -FDA given regulatory authority over medical devices and cosmetics for the first time
adulteration definition? - ✔✔-contains any poisonous or deleterious substance which may render it
injuries to uses when used as directed
-contains any filthy, putrid, or decomposed substance (ie expired drugs)
-prepared, packaged, or held under unsanitary conditions and became contaminated or rendered
injuries
-has a poisonous or deleterious container
-contains an unapproved food or color additive
misbranded definition? - ✔✔-incorrect drug, patient name, prescriber name, or directions
-is missing poison prevention ot tamper-resistant packaging
-OTC products without "adequate directions for use"
-prescription package/products without "adequate directions for use"
-does not meet FDA regulations regarding standard od identity, quantity, or fill
1951 Durham-Humphrey Amendment - ✔✔defined 2 categories of medications:
1. legend = prescription
2. over the counter
defined which drugs are:
-habit forming
-not safe except under a practitioner care
-drugs limited to prescription sale as part of a new drug application
-required that "Caution: Federal law prohibits dispensing without a prescription" on label = Rx Only
-prescription exemption for manufactures
-require pharmacists must label prescription products prior to dispensing
what did the 1951 Durham-Humphrey Amendment also establish? - ✔✔-process for receiving,
recording, and dispensing oral telephone prescription
what did the Pure Food and Drug act of 1906 do? - ✔✔prohibited interstate sale of adulterated and
misbranded food and drugs and addresses some product labeling issues
what were the product labeling issues addressed in the pure food and drug act? - ✔✔-labels cannot be
false or misleading about ingredients
-no requirement to disclose ingredients
-11 dangerous ingredients were identified but could be used as long as listed (cocaine, heroine, ect)
what did the pure food and drug act of 1906 lead to? - ✔✔the creation of the modern day food and
drug administration (FDA)
what is the Sulfanilamide tragedy of 1937? - ✔✔-Tennessee drug company marketed "Elixir
Sulfanilamide" as a wonder drug for ailments from gonorrhea to sore throats
-dug contained chemical analog of antifreeze "diethyl glycol"
-killed over 105 people (adults and children) which created a public outcry
-failure to list ingredients or test the safety of those ingredients was not a violation of the 1906 pure
food and drug act
What did the sulfanilamide tragedy lead to? - ✔✔giving enforcement authority to the federal food,
drug, and cosmetic act of 1938
what was the Federal food, drug, and cosmetic act of 1938? - ✔✔set of laws passed by congress in 1938
which gave authority to the US food and drug administration to oversee the safety of food, drugs, and
cosmetics
what were the FD&C requirements that came from the federal food, drug, and cosmetic act of 1938? -
✔✔-drug labels must include directions for safe use
-required pre-market approval for new drugs to ensure safety
-prohibited false therapeutic claims for drugs
-authorized factory inspections
, -FDA given regulatory authority over medical devices and cosmetics for the first time
adulteration definition? - ✔✔-contains any poisonous or deleterious substance which may render it
injuries to uses when used as directed
-contains any filthy, putrid, or decomposed substance (ie expired drugs)
-prepared, packaged, or held under unsanitary conditions and became contaminated or rendered
injuries
-has a poisonous or deleterious container
-contains an unapproved food or color additive
misbranded definition? - ✔✔-incorrect drug, patient name, prescriber name, or directions
-is missing poison prevention ot tamper-resistant packaging
-OTC products without "adequate directions for use"
-prescription package/products without "adequate directions for use"
-does not meet FDA regulations regarding standard od identity, quantity, or fill
1951 Durham-Humphrey Amendment - ✔✔defined 2 categories of medications:
1. legend = prescription
2. over the counter
defined which drugs are:
-habit forming
-not safe except under a practitioner care
-drugs limited to prescription sale as part of a new drug application
-required that "Caution: Federal law prohibits dispensing without a prescription" on label = Rx Only
-prescription exemption for manufactures
-require pharmacists must label prescription products prior to dispensing
what did the 1951 Durham-Humphrey Amendment also establish? - ✔✔-process for receiving,
recording, and dispensing oral telephone prescription
