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Pharmacology for Nurses, 6e (Adams)
Chapter 2 Drug Approval and Regulation
1) A 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).”
Answer: 1
Explanation:
1. Any pharmaceutical laboratory must obtain approval from the Food and Drug
Administration (FDA) before marketing a drug.
2. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must
obtain approval from the Food and Drug Administration (FDA) before marketing these
drugs.
3. Private pharmaceutical laboratories must obtain approval from the Food and Drug
Administration (FDA) before marketing a drug.
4. Pharmaceutical laboratories involved in academic research must obtain approval from
the Food and Drug Administration (FDA) before marketing a drug.
Page Ref: 12-13
Cognitive Level: Applying
Client Need/Sub: Physiological Integrity: Pharmacological and Parenteral Therapies
Standards: QSEN Competencies: V.B.1 Demonstrate effective use of technology and
standardized practices that support safety and quality. | AACN Essential Competencies: V.1
Demonstrate basic knowledge of healthcare policy, finance and regulatory environments;
including local, state, national, and global healthcare trends. | NLN Competencies: Quality and
Safety: Policies and procedures. | Nursing/Integrated Concepts: Nursing Process: Analysis
Learning Outcome: 2-2 Discuss the role of the U.S. Food and Drug Administration (FDA) in the
drug approval process.
MNL Learning Outcome: 2.2 Examine the role of the U.S. Food and Drug Administration in the
process of drug approval and drug safety.