Federal Drug Laws in the United States

Which act was the first federal drug law passed in the United States?

• The Food and Drugs Act of 1906

• The Durham-Humphrey Amendment

• The Kefauver-Harris Amendment

• The Food, Drug, and Cosmetic Act of 1938

What was the main purpose of the 1912 amendment to the Food and Drugs Act?

• To require accurate labeling of drugs to prevent substitution or mislabeling of ingredients

• To ban all drugs not approved by the FDA

• To allow over-the-counter sales of all drugs

• To require all drugs to be flavored

Which tragedy led to the passage of The Food, Drug, and Cosmetic Act of 1938?

• The use of thalidomide in pregnant women

• The marketing of Elixir of Sulfonamide

• The passage of the Durham-Humphrey Amendment

• The Kefauver-Harris Amendment

What is the main responsibility of the Food and Drug Administration (FDA) as described in the text?

• To review data and evaluate the safety of drugs

• To manufacture drugs

• To advertise drugs to physicians

• To sell drugs to the public

According to the Durham-Humphrey Amendment, what defines prescription drugs?

• Drugs that can only be given to patients under the care of a physician

• Drugs that are flavored for children

• Drugs that are sold over the counter

• Drugs that are only available in hospitals

Why did the FDA refuse to approve thalidomide for use in the United States?

• There was not enough evidence about its safety

• It was too expensive

• It was not effective for morning sickness

• It was not manufactured in the United States

What was a major outcome of the 1962 Kefauver-Harris Amendment?

• Drugs had to be shown to be both safe and effective before being marketed

• All drugs were banned from the market

• Only over-the-counter drugs were allowed

• Manufacturers could sell drugs without reporting side effects

How did the burden of proof for drug safety change after the Food, Drug, and Cosmetic Act of 1938?

• It shifted to the drug manufacturers to prove their product was safe

• It remained with the government to prove fraud

• It was eliminated entirely

• It was given to the patients

The Elixir of Sulfonamide tragedy influenced drug legislation in the United States in which of the following ways?

• It led to the passage of the Food, Drug, and Cosmetic Act of 1938, which required proof of drug safety before marketing.

• It resulted in the banning of all elixirs.

• It caused the FDA to stop reviewing drugs.

• It led to the creation of the United States Pharmacopeia.

The impact of the Kefauver-Harris Amendment on drug safety and effectiveness was that:

• It required drugs to be both safe and effective before marketing and mandated reporting of adverse side effects.

• It allowed drugs to be sold without testing.

• It removed the FDA’s authority to regulate drugs.

• It only applied to over-the-counter drugs.