The CLEAR LABELS Act is a proposed U.S. federal bill that would require prescription drug labels to clearly disclose the original manufacturer and country/region of origin, for both the finished drug product and its active pharmaceutical ingredients (APIs), so that patients and healthcare providers better understand where medicines and their APIs actually come from and regulators gain more transparency.
Core elements of the bill (brief)
- Scope: All prescription drugs dispensed in the United States, including both brand‑name and generic products and each API used in them.
- Label requirements: Patient‑facing prescription labels must clearly show the “original manufacturer” name and location for each API and for the finished dosage form, as well as information on packaging and repackaging entities.
- Country‑of‑origin disclosure: Labels must indicate the country of origin for the finished drug and for every API; this may appear directly on the label or be provided via a QR code/link pointing to a public website or database.
- Public database: The bill directs FDA to create and maintain a public electronic database listing all prescription drugs and their APIs, including the country of origin and manufacturer information, available for public and regulatory use.
Legislative intent and goals
- Background issue: Many prescription drugs and APIs are manufactured overseas (notably in China and India), while current U.S. rules often only require listing the distributor or repackager, making it difficult for the public to know the true manufacturing site and supply chain.
- Objectives:
- Increase supply‑chain transparency so patients, pharmacists, and prescribers can factor origin and potential quality risks into product selection and substitution decisions.
- Strengthen oversight of risks associated with dependence on foreign manufacturing by giving FDA and policymakers better visibility into where drugs and APIs are produced, aiding inspections, recalls, and risk management.
Potential impact on packaging and labeling
- On‑pack presentation: Drug packaging will need additional fields for origin country/region and original manufacturer details, or at least a QR code that links patients to an online page showing detailed supply‑chain information.
- Industry impact: Manufacturers would have to map and maintain more granular supply‑chain data, update U.S. packaging artwork and printing plates, and support continuous data submission and updates to FDA’s database.
