The pharmaceutical representative comes to the physician's office and says his company's pharmaceutical laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is the best response by the nurse?
1. "Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration (FDA) before marketing a drug."
2. "Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration (FDA)."
3. "Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from the Food and Drug Administration (FDA)."
4. "Your pharmaceutical laboratory must be involved in academic research because they are exempt from approval by the Food and Drug Administration (FDA)."
Correct Answer: 1
Rationale: Any pharmaceutical laboratory, whether private, public, or academic, must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs.
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