New Bill Requires Labels to Reveal Where Your Medicine Is Manufactured
Washington, Friday, 6 February 2026.
This bipartisan legislation mandates country-of-origin labeling for prescription drugs, addressing the critical oversight where consumers know the source of their clothing but not the life-saving medicine they ingest.
Legislative Action to End Obscurity
On Thursday, February 5, 2026, Senators Rick Scott (R-Fla.) and Kirsten Gillibrand (D-N.Y.) formally introduced the Clear Labels Act, a bipartisan effort to illuminate the opaque origins of prescription medications [1]. Supported by Senators Ron Johnson (R-Wis.), Tommy Tuberville (R-Ala.), and Katie Britt (R-Ala.), the legislation aims to empower patients, doctors, and pharmacists with critical data regarding where drugs are manufactured [1]. This legislative move follows a hearing by the Senate Special Committee on Aging on January 29, 2026, where manufacturers faced criticism for concealing the locations of drug production facilities [1]. The bill serves as a direct response to growing concerns regarding the United States’ reliance on foreign pharmaceutical products and components [2].
Closing the Transparency Gap
Senator Scott, serving as the committee chair, characterized the current lack of information as “wholly irresponsible,” noting the disparity between the detailed labeling required for food and clothing versus the ambiguity surrounding ingested medicines [1]. Under current regulations, the Food and Drug Administration (FDA) permits manufacturers to list the name and address of a single company involved in the supply chain, effectively hiding the physical location of the factory where the drug was made [3]. The proposed Clear Labels Act would amend Section 502 of the Federal Food, Drug, and Cosmetic Act to mandate that labels include the name, address, and unique facility identifier of the original manufacturer for both the finished drug product and its active pharmaceutical ingredients (APIs) [2].
The “Made in America” Misconception
A primary driver for this legislation is the complexity of global supply chains, which often obscures the true origin of pharmaceutical components. Stephen Schondelmeyer, a professor at the University of Minnesota, highlighted a significant loophole: a pharmaceutical product can currently be labeled “Made in the USA” simply because the finished tablet was pressed in a facility in New Jersey, even if the active ingredients were sourced from a factory in China [3]. To rectify this, the act proposes the creation of an FDA-maintained electronic database available to the public, detailing country-of-origin information for all APIs used in prescription drugs approved for use in the U.S. [2].
Regulatory Failures and Safety Risks
The push for statutory transparency is underscored by significant lapses in regulatory oversight and safety concerns regarding foreign manufacturing. Since 2013, the FDA has permitted over 20 overseas factories, primarily located in India, to continue exporting medications to the U.S. despite identified safety concerns [1]. Furthermore, an investigation by the Associated Press revealed that the FDA had failed to inspect more than 2,000 manufacturing labs in over five years [3]. The legislation acts on findings from a bipartisan investigation that utilized ProPublica’s “Rx Inspector” tool, launched in late 2025, which exposed data gaps by aggregating factory location and inspection histories for nearly 40,000 generic drugs [1].
Industry Response and Implementation
While the initiative has garnered bipartisan support as a measure to protect American patients and reinforce domestic security, industry experts emphasize that labeling is only one component of supply chain resilience [2]. Michael Ganio, senior director of pharmaceutical practice and quality at the American Society of Health-System Pharmacists (ASHP), noted that while public disclosure is supported, knowing a drug’s country of origin does not automatically determine its quality or prevent shortages [3]. The ASHP suggests that without additional incentives for purchasers to select reliable domestic manufacturers, the positive impacts of labeling reforms may be limited [3].