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US SB3788
Bill
AI Summary
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Requires finished drug products to include labeling identifying the original manufacturer of each active pharmaceutical ingredient (API), the finished drug manufacturer, and any packer or distributor, along with their place of business and unique facility identifier
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Allows supply chain information to be provided via package label, link, barcode, QR code, or searchable electronic portal, with paper copies available upon request
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Mandates that active pharmaceutical ingredients include manufacturer identification on accompanying labels and certificates of analysis
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Defines "original manufacturer" as the last establishment to conduct substantial manufacturing activities before the drug enters interstate commerce
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Exempts finished drug products from customs country-of-origin marking requirements if they comply with the new FDA labeling standards; regulations take effect no earlier than 1 year after publication
Legislative Description
CLEAR LABELS Act Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act
Health
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2/5/2026