The sulfanilamide elixer tragedy of 1937 resulted in the government passing the Food, Drug and
Cosmetic Act (FDCA) of 1938 that specified which one of the following: - ✔✔That new drugs must have
FDA approval prior to marketing
Which of the following accurately describe(s) the FDA today? - ✔✔The agency regularly relies on advice
from outside experts
The agency is housed under DHHS
A manufacturer of an industrial solvent promoted that its product when applied to the skin would cure
eczema, but specifically proclaimed that its product is a solvent, not a drug. The FDA is investigating
whether the product should be considered as a drug. Which of the following would be the best answer
regarding the claim to cure eczema. - ✔✔The claim to cure eczema would likely make the product a
drug and the proclamation is irrelevant
Assume in the above example that the manufacturer made no claim or representation about its product
for the use in eczema, but rather a consumer accidently found it effective for treating eczema and
advertised this result on the Internet. Which would be correct? - ✔✔The FDA would not likely regard the
product as a drug
Part C of the drug definition excludes food from articles intended to affect the function or structure of
the body. Congress likely intended which of the following by this exclusion: - ✔✔That foods are only
excluded when used for their ordinary purpose as foods
Infant formulas best fit under the definition of: - ✔✔Special dietary food
A manufacturer made a powder from corn stalks and compressed it into tablets for oral use. The
manufacturer made no claims or representations about the product. This product could best be
described as: - ✔✔Dietary supplement
, 8: In the above example, assume that the manufacturer promoted the product for the purpose of
improving gastric motility. This claim would likely mean that the product would be considered: - ✔✔A
dietary supplement
A manufacturer made a health claim for its dietary supplement product that has never been approved
by the FDA by regulation or through the significant scientific agreement test. Evidence does exist,
however, to support the claim. Which of the following would be correct as a result of the Pearson
decision? - ✔✔The FDA would not allow the claim
Which of the following would be correct regarding ephedra products? - ✔✔They are no longer on the
market
A pharmacist counsels patients that certain dietary supplements might be effective for particular
diseases even though there is little to no proof of their efficacy in those diseases. Which of the following
would be correct? - ✔✔The pharmacist is not violating the FDCA, provided he is counseling and not
promoting
A drug manufacturer sent brochures about the drug to prescribers. Which of the following would be the
most important determination as to whether the brochures are labeling? - ✔✔Whether the brochures
can be considered as accompanying the drug
A pharmacist received vials of an injectable drug. The solution containing the drug has always been
clear, but the vials the pharmacist received contained a pink tinted solution. Even though the pharmacist
has dispensed hundreds of vials in the past he did not notice the color difference and dispensed the vial
for injection. The drug was contaminated and the patient was harmed. The FDA investigated. Which of
the following would be the best answer pursuant to the FDCA? - ✔✔The pharmacist violated the Act
and probably did not act in good faith.
A manufacturer initiated a Class I recall of its product. This means: - ✔✔The product has a reasonable
probability of causing serious adverse health consequences or death
A product may be adulterated under which of the following condition(s). - ✔✔Its strength differs from
that on the label
It contains a decomposed substance
The manufacturing facility where it is made is contaminated
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