Summary

Requires drug labels for medicines intended for humans to list any ingredient that is (or is derived from) a major food allergen or a gluten-containing grain and to identify each such ingredient (and the specific grain when applicable). The requirement becomes effective on the earlier of a date set by the Secretary of Health and Human Services or two years after enactment.

• Drug labels for human-use medicines must disclose any ingredient that is a major food allergen or derived from one.
• Drug labels must identify gluten-containing grains (wheat, barley, rye, and crossbred hybrids) when present or derived.
• Requirement becomes effective on the earlier of an HHS-set date or two years after enactment.
• The change is implemented by adding a misbranding provision to the Federal Food, Drug, and Cosmetic Act.
• Manufacturers will need to review ingredient sourcing and may need to update labels and product information.
• FDA enforcement tools for misbranded drugs would apply to noncompliance.
• No new funding is provided; implementation would use existing agency authorities and resources.
• The law targets human drugs only and does not change food labeling rules for foods or non-drug articles.