The CLEAR LABELS Act, also known as Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings, would amend the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(b)) to require prescription drug labeling to include original manufacturer and supply chain information.[1]
This bill (S.3788) was introduced in the Senate by Senator Rick Scott (R-FL) on February 5, 2026 and referred to the Committee on Health, Education, Labor, and Pensions. A Senate committee hearing was held on March 19, 2026. As of this writing, there are a total of 11 Senate cosponsors, 10 Republicans and 1 Democrat (NY). A related bill (H.R.8269) was also introduced in the House by Rep. Richard McCormick (R-GA) on April 14, 2026 and was referred to both the Committee on Ways and Means and the Committee on Energy and Commerce. The House bill currently has a total of 2 cosponsors, with the addition of a Democrat from Connecticut.
The Act proposes that pharmaceutical labels must identify the country (or countries) of not only the finished drug product but also of the individual active pharmaceutical ingredients (APIs) contained within. The Act would require the creation of an electronic database containing country of origin information for all APIs used in drug products approved in the US. Finished drug products would include information about the packer, or distributor (if any), or a link, barcode, QR code, or other means to access the searchable electronic portal containing such information. Manufacturers, packers, or distributors must make this information available both electronically and through a package insert or in paper copy upon request.
What is the impetus for this legislation? … The proponent has stated that many prescription drugs and/or their APIs are manufactured overseas.[2] Some industry pundits speculate that the goal of these bills is to move to a more protectionist domestic manufacturer environment. Some argue that domestic manufacturing of API can lead to more enforceable regulatory manufacturing practices that could positively impact drug quality or safety that may ultimately benefit consumers.
Who will bear the cost of the creation and maintenance of the publicly accessible “searchable electronic portal” is not detailed in the bill. The expense for manufacturers to comply with the requirements of this bill, or potentially transition manufacturing to domestic sites (if consumer demand moves in that direction), has not been calculated at this early stage; ideally the prescription drug manufacturing community would be involved in the expected implementation timelines of this bill if enacted into law. Online sources, such as GovTrack.US, predict that the bill has a low probability of being enacted, but PHSL will continue to monitor the expected impact of this legislation.
[1] H.R.8269 – 119th Congress (2025-2026): CLEAR LABELS Act. https://www.congress.gov/bill/119th-congress/house-bill/8269/titles
S.3788 – 119th Congress (2025-2026): CLEAR LABELS Act. https://www.congress.gov/bill/119th-congress/senate-bill/3788/text
[2] “Sen. Rick Scott Announces CLEAR LABELS Act to Hold Drug Manufacturers Accountable and Strengthen Supply Chain Oversight,” Senator Rick Scott, January 29, 2026.
https://www.rickscott.senate.gov/2026/1/sen-rick-scott-introduces-clear-labels-act-to-hold-drug-manufacturers-accountable-and-strengthen-supply-chain-oversight