119th (2025–2027)
H.R. 8269
The CLEAR LABELS Act would require drug manufacturers to display detailed supply chain information on all prescription and over-the-counter drug labels and packaging. Specifically, drugs would need to show the name, location, and unique facility identifier of the original manufacturer of active pharmaceutical ingredients, the finished drug product manufacturer, and any distributors involved, either directly on the label or through accessible electronic portals like QR codes and barcodes. The bill applies to both finished drug products and active pharmaceutical ingredients used in drugs, and manufacturers must also provide paper copies of this information to anyone who requests them. Drug manufacturers would have at least one year from when the FDA issues final regulations to comply with the new labeling requirements, and the bill includes an exemption from existing customs country-of-origin marking rules for drugs that follow these new labeling standards.