Law & Ethics CH 3 Questions with
100% Correct Answers
The Food, Drug, and Cosmetic Act was passed in? Correct Answer: 1938
The Pure Food and Drug Act was of what year and prohibited what? Correct
Answer: 1906; Prohibited the interstate distribution or sale of adulterated and
misbranded food and drugs
The Harrison Narcotics Tax Act was part of? Correct Answer: The Internal
Revenue Code
The labeling of a medication in a way that is false or misleading is referred to
as? Correct Answer: Misbranding
The first U.S. act prohibiting the interstate distribution or sale of adulterated or
misbranded food and drugs was passed in? Correct Answer: 1906
The FDA is a branch of which department, that controls all drugs for legal use?
Correct Answer: U.S. Department of Health and Human Services
Which act was designed to protect the public health by requiring that only safe
and proper labeled drugs may be introduced into interstate commmerce?
Correct Answer: The Durham-Humphrey Amendment
In 1937, the Massengill Company introduced Elixir Sulfanilamide into the market,
which contained a solution containing what substance? Correct Answer:
Diethylene glycol
Which act required that pharmaceutical manufactuers file a New Drug
Application with the FDA? Correct Answer: Food, Drug, and Cosmetic Act
, Which act offers federal financial incentives to commercial and nonprofit
organizations for the development of drugs? Correct Answer: Orphan Drug Act
Which law was passed to establish clear criteria for classifications of legend and
OTC drugs? Correct Answer: Durham-Humphrey Amendment
When patients agree to be part of a study that tests a new drug, they must be
thoroughly educated about its possible medical risks. This is referred to as?
Correct Answer: Informed consent
Orphan drugs are used for the following disorders or conditions EXCEPT? Correct
Answer: Cystic fibrosis, blepharospasm & snake bit
NOT hepatitis A
Before the FDA prevented thalidomide from reaching the U.S. market, it had to
be tested around the world as? Correct Answer: A tranquilizer, sedative, & an
anti-nauseant during pregnancy
Answer: all of the above
The five controlled substance "schedules" were established by the? Correct
Answer: Comprehensive Drug Abuse Prevention and Control Act
Which act requires that most legend drugs be packed in child-resistant
containers? Correct Answer: Poison Prevention Packaging Act
The act that restricted the sale of drugs by requiring a prescription was the?
Correct Answer: Durham-Humprey Amendment
The Kefauver-Harris Amendment required that drug products must be _______
and ________, as well as _________. Correct Answer: Pure, effective as well as
safe
100% Correct Answers
The Food, Drug, and Cosmetic Act was passed in? Correct Answer: 1938
The Pure Food and Drug Act was of what year and prohibited what? Correct
Answer: 1906; Prohibited the interstate distribution or sale of adulterated and
misbranded food and drugs
The Harrison Narcotics Tax Act was part of? Correct Answer: The Internal
Revenue Code
The labeling of a medication in a way that is false or misleading is referred to
as? Correct Answer: Misbranding
The first U.S. act prohibiting the interstate distribution or sale of adulterated or
misbranded food and drugs was passed in? Correct Answer: 1906
The FDA is a branch of which department, that controls all drugs for legal use?
Correct Answer: U.S. Department of Health and Human Services
Which act was designed to protect the public health by requiring that only safe
and proper labeled drugs may be introduced into interstate commmerce?
Correct Answer: The Durham-Humphrey Amendment
In 1937, the Massengill Company introduced Elixir Sulfanilamide into the market,
which contained a solution containing what substance? Correct Answer:
Diethylene glycol
Which act required that pharmaceutical manufactuers file a New Drug
Application with the FDA? Correct Answer: Food, Drug, and Cosmetic Act
, Which act offers federal financial incentives to commercial and nonprofit
organizations for the development of drugs? Correct Answer: Orphan Drug Act
Which law was passed to establish clear criteria for classifications of legend and
OTC drugs? Correct Answer: Durham-Humphrey Amendment
When patients agree to be part of a study that tests a new drug, they must be
thoroughly educated about its possible medical risks. This is referred to as?
Correct Answer: Informed consent
Orphan drugs are used for the following disorders or conditions EXCEPT? Correct
Answer: Cystic fibrosis, blepharospasm & snake bit
NOT hepatitis A
Before the FDA prevented thalidomide from reaching the U.S. market, it had to
be tested around the world as? Correct Answer: A tranquilizer, sedative, & an
anti-nauseant during pregnancy
Answer: all of the above
The five controlled substance "schedules" were established by the? Correct
Answer: Comprehensive Drug Abuse Prevention and Control Act
Which act requires that most legend drugs be packed in child-resistant
containers? Correct Answer: Poison Prevention Packaging Act
The act that restricted the sale of drugs by requiring a prescription was the?
Correct Answer: Durham-Humprey Amendment
The Kefauver-Harris Amendment required that drug products must be _______
and ________, as well as _________. Correct Answer: Pure, effective as well as
safe
