Bill · S. 3788· Senate(119-S-3788)
CLEAR LABELS Act
- Introduced
- 2/5/2026
- Last activity
- 7/27/2026 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
- Sponsored by
- Rick Scott
- Cosponsors
- - 11 - 1
- Introduced
- On Calendar
What this bill would do
This bill, known as the "CLEAR LABELS Act," seeks to amend the Federal Food, Drug, and Cosmetic Act. It requires drug labeling to include specific information about the original manufacturer and the supply chain. For active pharmaceutical ingredients, the label or certificate must include the name and place of business of the original manufacturer. Finished drug products must include the name and place of business of the original manufacturer of the ingredient, the manufacturer of the finished product, and any packer or distributor. Information can be provided via direct printing or through electronic means like barcodes or QR codes. The law also establishes civil penalties for noncompliance and outlines how these requirements apply to manufactured goods.
Yes
Does this give people more protection from unfair business practices?+5
The bill increases consumer protection by requiring transparency regarding the original manufacturer and full supply chain of drugs.
Does this make what the government does easier for the public to see?+4
The bill increases transparency in the drug supply chain by mandating specific manufacturer disclosure requirements.
Does this make health care easier to get in general?+2
The bill improves healthcare transparency through electronic access to drug manufacturing and supply chain information.
The opposite
Would business owners be better off under this?-3
The bill imposes new labeling requirements and potential civil penalties of up to 25 percent of a lot's value for noncompliance.
Who it would affect, and how
Potential Positive Impacts for People
-
Enhanced Supply Chain Transparency: The bill requires drug labeling to include the name, place of business, and unique facility identifier for original manufacturers, finished drug manufacturers, and packers or distributors (Section 2). This provides more detailed information regarding the origin of medications.
-
Increased Accessibility of Information: Manufacturers can provide required information through searchable electronic portals, barcodes, or QR codes, or provide paper copies to any individual who requests one (Section 2).
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Clarified Manufacturer Definitions: The act defines an "original manufacturer" as the establishment conducting the majority of significant manufacturing phases, which provides a specific standard for what must be reported (Section s 2).
Potential Negative Impacts for People
-
Financial Penalties for Noncompliance: If a person fails to comply with the new labeling requirements, the Secretary has the discretion to determine the drug is misbranded and can assess a civil monetary penalty up to 25 percent of the total value of the drug product lot (Section 2 and Section 3).
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Potential Administrative Burdens: There is an acknowledgment of a potential administrative burden on manufacturers of active pharmaceutical ingredients and finished drug products regarding the overlap or conflict with existing customs requirements (Section 4).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Economy And Finance
- Improves Consumer Protection+5
- Governance And Ideology
- Improves Government Transparency+4
- Demographic And Interest Groups
- Good For Business Owners-3
- Healthcare
- Improves Healthcare Access+2
- 7/27/2026
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
- 7/22/2026
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 7/13/2026
- 1 Cosponsor added.
- 4/13/2026
- 1 Cosponsor added.
- 3/25/2026
- 2 Cosponsors added.
- 3/23/2026
- 1 Cosponsor added.
- 3/19/2026
- Committee on Health, Education, Labor, and Pensions. Hearings held.
- 3/11/2026
- 1 Cosponsor added.
- 3/9/2026
- 1 Cosponsor added.
- 2/12/2026
- 1 Cosponsor added.
- 2/5/2026
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 4 Cosponsors added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
- Alan Armstrong
Republican · Oklahoma
Katie BrittRepublican · Alabama
Kevin CramerRepublican · North Dakota
Joni ErnstRepublican · Iowa
Chuck GrassleyRepublican · Iowa
Kirsten GillibrandDemocrat · New York
Ron JohnsonRepublican · Wisconsin
Mike LeeRepublican · Utah
Ashley MoodyRepublican · Florida
James RischRepublican · Idaho
Pete RickettsRepublican · Nebraska
Tommy TubervilleRepublican · Alabama