Are outdated drugs adulterated or misbranded?

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

Answer: (B)

Outdated drugs are considered adulterated because they no longer meet the standard for strength, quality, or purity after the labeled shelf life. When a drug has expired, its potency can decline and its chemical stability may be compromised, making the product potentially unsafe or ineffective. That failure to meet the required specifications is the essence of adulteration. Misbranding would involve labeling problems—false or misleading labeling—not simply an expired product with accurate labeling. If the label correctly states the expiration date and other information, it isn’t misbranded; the issue lies with the product’s degraded quality, not the labeling.