Which statement best defines off-label use?

Which statement best defines off-label use?

• A. Using a medication for purposes other than labeling
• B. Using a medication for its labeled purpose
• C. Using only generic drugs
• D. Using the drug outside the country

Answer: (B)

Off-label use means using a medication for indications, doses, routes, or patient populations that are not listed in the approved labeling. The description that matches this idea is using a medication for purposes other than labeling. Using the drug exactly for its labeled purpose is on-label use, not off-label. The other options—using generic drugs or using the drug outside the country—do not define off-label use.

Off-label use means using a medication for indications, doses, routes, or patient populations that are not listed in the approved labeling. The description that matches this idea is using a medication for purposes other than labeling. Using the drug exactly for its labeled purpose is on-label use, not off-label. The other options—using generic drugs or using the drug outside the country—do not define off-label use.