BCPS Regulatory Practice Test

Under the FD&C Act, which statement best defines drugs?

Articles that are foods Articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease Devices used for diagnosis Medications used for pest control

Correct Answer:

Articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease

Explanation:

Under the FD&C Act, what makes a product a drug is its intended use to diagnose, cure, mitigate, treat, or prevent disease in humans or animals (and, more broadly, to affect the structure or function of the body). The statement describing articles intended for diagnosing, curing, mitigating, treating, or preventing disease matches that core criterion, so it best defines a drug. Foods are regulated separately as foods, not drugs. Devices are a distinct category with their own definitions, and pest-control products fall under EPA pesticide regulation, not FDA drug regulation.

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