Drug labels would have to disclose true manufacturing origin under new bill
Placed on the calendarS. 3788Latest action
Sponsor: Rick Scott · Senator · FL
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Official title: CLEAR LABELS Act
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
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The CLEAR LABELS Act would require drug labels to name the actual manufacturing facility, not just the distributor.
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What does this do?
This bill would require labels on active pharmaceutical ingredients and finished drugs to identify the "original manufacturer" — the last facility that did substantial manufacturing — along with a unique facility identifier. This information could appear on the label itself or be accessible via barcode, QR code, or online portal, with paper disclosure available on request. It also exempts compliant drugs from separate customs country-of-origin marking rules.
Who does it affect?
Drug manufacturers, packagers, and distributors would face new labeling and disclosure requirements, particularly those using overseas ingredients or manufacturing; pharmacists, doctors, and consumers would gain more visibility into drug origins.
Why does it matter?
Companies relying on foreign manufacturing or ingredients would need to change labeling practices and disclosure systems, and the FDA must first write implementing regulations before requirements take effect.
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Where does it stand?
- IntroducedFeb 5, 2026
- Senate committee
- Senate voteYou are here · Jul 27, 2026
- House
- The president's desk
Right now: it was placed on the , and the official record shows no floor action on it since. If the House changes it, it goes back to the Senate before reaching the president.
Latest action: — Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
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