Bill > S3788

This bill, known as the CLEAR LABELS Act, aims to enhance transparency in the pharmaceutical supply chain by amending the Federal Food, Drug, and Cosmetic Act. It mandates that drug labeling must include the name, place of business, and a unique facility identifier of the original manufacturer for both active pharmaceutical ingredients (APIs) and finished drug products, or provide a link, barcode, QR code, or other means to access this information electronically. The "original manufacturer" is defined as the last establishment to conduct substantial manufacturing activities before the product enters interstate commerce. Additionally, the bill requires that this information be made available in paper copy upon request and exempts finished drug products that comply with these new labeling requirements from certain customs country of origin marking rules. The Secretary of Health and Human Services will issue regulations to implement these changes, with a delayed effective date to allow for compliance.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3788/all-info