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Mandatory Gluten Labeling for Medicines: Enhanced Transparency for Patients.

New regulations mandate that labels on human-use drugs clearly disclose the presence of ingredients derived from gluten-containing grains. This will allow individuals with gluten intolerance or celiac disease to choose medications more safely, avoiding adverse reactions. The act aims to enhance patient safety and awareness.
Key points
Drugs containing gluten must clearly state this on their labels.
The label must identify the specific gluten-containing grain (e.g., wheat, barley, rye) from which the ingredient is derived.
The rules will take effect no later than two years after enactment, or sooner if determined by the Secretary of Health and Human Services.
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Additional Information
Print number: 117_HR_2435
Sponsor: Rep. Ryan, Tim [D-OH-13]
Process start date: 2021-04-08