NURS 3100 Exam 1 Practice

A pharmaceutical rep. comes to the physician's office and says his company's pharmaceutical laboratory is marketing a drug that does not need approval by the FDA. What is the best response by the nurse?

1. Any pharmaceutical lab in America must have approval from the FDA

2. Is this an OTC drug? They do not need approval by the FDA

3. Is your pharmaceutical lab private? Only public pharmaceutical labs need approval from FDA

4. Your pharmaceutical lab must be involved in academic research because they are exempt from approval by the FDA

The correct answer is: Any pharmaceutical lab in America must have approval from the FDA

The correct response is **A. Any pharmaceutical lab in America must have approval from the FDA**. This is the best response because all pharmaceutical laboratories in the United States are required to have approval from the Food and Drug Administration (FDA) for the drugs they produce, regardless of whether the drug is over-the-counter (OTC), private, or involved in academic research. Options B, C, and D are incorrect because they provide information that is not true regarding the FDA approval process for pharmaceutical labs.