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H.R. 3821119th CongressIn committeeLatest action Jun 6, 2025Decoded by AI · checked against the record
The plain-language version leads. The official text is always the reference.
HR 3821 would require drug labels to disclose allergen-derived ingredients, giving manufacturers up to two years to comply.
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HR 3821 would require prescription and over-the-counter drug labels to clearly identify any ingredients derived from major food allergens or gluten-containing grains, including wheat, barley, and rye. A drug would be considered mislabeled under federal law if it contains those ingredients without disclosing them. Manufacturers would have up to two years after enactment to update their labels, or sooner if the Department of Health and Human Services sets an earlier deadline.
People with food allergies, celiac disease, or gluten sensitivities who take medications regularly are the primary population affected. Pharmaceutical companies would also be affected, as they would need to review and update product labeling across their drug lines.
Current federal allergen disclosure rules apply to food products but not to medicines, meaning drug fillers, coatings, and binders derived from allergens can appear on labels without clear identification. Patients who need this information currently must conduct their own research or contact manufacturers directly rather than finding it on the packaging.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: a House committee is reviewing it. If the Senate changes it, it goes back to the House before reaching the President.
Latest action: — Referred to the House Committee on Energy and Commerce.