RAC Exam - Devices US UPDATED Exam Questions and CORRECT Answers
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Course
RAC
Institution
RAC
RAC Exam - Devices US UPDATED Exam
Questions and CORRECT Answers
Regulations - Correct Answer- interpret laws and describe how they will be enforced
guidance document - Correct Answer- used to convey FDA's current thinking or enforcement
priorities - not legally binding
Sherley Amendment - C...
RAC Exam - Devices US UPDATED Exam
Questions and CORRECT Answers
Regulations - Correct Answer- interpret laws and describe how they will be enforced
guidance document - Correct Answer- used to convey FDA's current thinking or enforcement
priorities - not legally binding
Sherley Amendment - Correct Answer- prohibited labeling medicines with false therapeutic
claims intended to defraud the purchaser
Pure Food and Drug Act of 1906 - Correct Answer- prohibited misbranded and adulterated
foods, drinks and drugs from entering interstate commerce
FD&C Act - Correct Answer- 1938 - repealed 1906 law and sherley amendment -
manufacturers were required to provide scientific proof new drugs were safe for their
intended use before being placed on the market; cosmetics and medical devices regulated;
prohibited adding poisonous substances to food unless unavoidable or required in production;
FDA given authority to bring federal court injunctions, product seizures, and criminal
prosecutions
Public Health Service Act of 1944 - Correct Answer- gave FDA authority over biological
products (vaccines and serums)
Durham-Humphrey Amendment of 1951 - Correct Answer- clarified what constituted a
prescription vs over the counter drug - required "Caution" statement
Food Additives Amendment of 1958 - Correct Answer- established criteria for food to be
considered adulterated, mislabeled or harmful
Kefauver-Harris Amendment of 1962 - Correct Answer- requires proof of safety and efficacy
before a drug can be marketed in the US
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