Sponsors (13)
The bill significantly improves traceability and enforcement to boost drug safety and supply‑chain transparency while imposing meaningful compliance costs, potential large civil penalties, delayed full protections, and limits on public disclosure—benefiting patient safety at the expense of added burdens and some reduced near‑term transparency for industry and consumers.
Patients and hospitals: The bill requires labeling/records that identify original API and finished-drug manufacturers, enabling faster, targeted recalls and safety investigations and reducing exposure to unsafe lots.
Consumers (patients): Greater supply‑chain transparency about where drugs and active ingredients are made, helping people make informed choices and increasing public trust.
Hospitals, pharmacies, importers and small drugmakers: FDA–CBP coordination and joint rulemaking reduce duplicative requirements and streamline import clearance, cutting delays for drug shipments and compliance burden.
Small manufacturers, distributors and pharmacies: New labeling, certificates of analysis, and IT/packaging requirements create significant compliance and administrative costs that may increase drug prices or delay market entry.
Small businesses and dispensers: The bill authorizes substantial civil financial penalties (including up to 25% of a lot's value) that could disproportionately burden small firms and raise operational risk even for inadvertent errors.
Patients, hospitals and researchers: Allowing trade‑secret/confidentiality protections for commercial information limits public access to details about regulated products and public‑health decisions, reducing transparency and oversight.
Based on analysis of 6 sections of legislative text.
Requires API labels, COAs, and finished drug labels (or electronic access) to identify original manufacturers and key supply‑chain entities and adds civil penalties for noncompliance.
Requires labels and certificates of analysis (COAs) for active pharmaceutical ingredients (APIs) and finished drug products to identify original manufacturers and key supply‑chain entities, and allows FDA to enforce the requirement with civil penalties. The rule applies only to products manufactured or packaged on or after five years from enactment and preserves trade‑secret and confidential‑business information protections. Also directs FDA to coordinate with U.S. Customs and Border Protection to avoid duplicative burdens and creates a new civil‑penalty authority (up to 25% of the lot value) with factors for assessing penalties and protections against criminal prosecution for disclosure failures.
Official title: Amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information.
Introduced February 5, 2026 by Richard Lynn Scott · Last progress February 5, 2026