If a drug leaves an outpatient pharmacy and is then re-dispensed, is it adulterated or misbranded?

• A. Adulterated
• B. Misbranded
• C. Both adulterated and misbranded
• D. Neither adulterated nor misbranded

Answer: (A)

Adulteration is the right concept here because it deals with the product’s quality and safety, not the labeling. If a drug leaves the outpatient pharmacy and is later re-dispensed, its integrity may have been compromised by storage, handling, or repackaging, which can make the product adulterated. Misbranding, on the other hand, concerns the labeling or packaging being false or misleading or missing required information; simply re-dispensing a drug does not, by itself, make the labeling incorrect. So the scenario points to adulteration rather than misbranding.