CLEAR LABELS Act
Sponsored By: Senator Rick Scott
Introduced
Summary
This bill would force clearer drug labeling by making companies disclose the original manufacturer and supply‑chain details for active ingredients and finished drugs. It would let that information appear directly on the label or be reached through a link, barcode, QR code, or searchable electronic portal and require paper inserts on request.
Show full summary
- Patients and pharmacists would get clearer origin info. Labels or an electronic portal must identify the original maker of each active pharmaceutical ingredient and the finished product so people can see who made what.
- Manufacturers, packers, and distributors would need to add the name, place of business, and a unique facility identifier or provide an access mechanism. The bill defines “original manufacturer” as the single last establishment to do substantial manufacturing before a product entered interstate commerce, and it lets the FDA allow reasonable variations or alternate placements including electronic options.
- Customs and regulators would be aligned so finished drugs labeled under the new rule may be exempt from usual country‑of‑origin marking. The FDA would set implementation rules that take effect no earlier than one year after final regulations and apply to drugs made on or after that date.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Drug origin labels and transparency
This bill would require drug labels to show the original manufacturer’s name, place of business, and a unique facility ID. For finished drugs it would require listing the original manufacturer for each active ingredient, the original finished-product maker, and the packer or distributor — or provide a link, barcode, QR code, or searchable portal with that information. API labels would also need the original manufacturer info unless it already appears on an accompanying label and certificate of analysis. Makers, packers, or distributors would have to provide the information online and give a paper package insert on request. The FDA would write rules to implement this and could give at least one year after final rules before they take effect, applying to drugs made on or after that date.
Customs marking exemption for drugs
If enacted, finished drug products that are labeled the way the food and drug law requires would be exempt from two specific country-of-origin marking rules in the Tariff Act. The exemption would take effect when the bill becomes law. This would mainly reduce customs paperwork and compliance steps for importers and drug manufacturers.
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Sponsors & CoSponsors
Sponsor
Rick Scott
FL • R
Cosponsors
Kirsten Gillibrand
NY • D
Sponsored 2/5/2026
Tommy Tuberville
AL • R
Sponsored 2/5/2026
Katie Britt
AL • R
Sponsored 2/5/2026
Ron Johnson
WI • R
Sponsored 2/5/2026
Ashley Moody
FL • R
Sponsored 2/12/2026
Mike Lee
UT • R
Sponsored 3/9/2026
Kevin Cramer
ND • R
Sponsored 3/11/2026
James Risch
ID • R
Sponsored 3/23/2026
Chuck Grassley
IA • R
Sponsored 3/25/2026
Pete Ricketts
NE • R
Sponsored 3/25/2026
Joni Ernst
IA • R
Sponsored 4/13/2026
Roll Call Votes
No roll call votes available for this bill.
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