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119-hr-8269119th CongressWALLET

CLEAR LABELS Act

Sponsored By: Representative McCormick, Richard [R-GA-7]

Introduced

Summary

This bill would require drug labels and related certificates to disclose the product's original manufacturer and key supply‑chain details for finished drugs and active pharmaceutical ingredients. It would let that information appear directly on packaging or through a link, barcode, QR code, or other access to a searchable electronic portal.

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  • Patients and caregivers could access who made a medicine and where it came from via label text or a linked portal. This includes packer or distributor info and quantity statements for packaged drugs.
  • Drug manufacturers, packers, and distributors would have to list the original manufacturer of the finished product and each active pharmaceutical ingredient. They must make the data available electronically and provide paper copies or package inserts on request.
  • Suppliers of active pharmaceutical ingredients must include the original manufacturer's name, place of business, and a unique facility identifier on labels and certificates of analysis.
  • The Health Secretary would write implementing regulations, may allow reasonable variations or electronic placements, and set an effective date at least one year after final rules take effect. The bill also exempts certain finished drug markings from specified Tariff Act marking rules when labeled under the Federal Food, Drug, and Cosmetic Act.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 2 benefits, 0 costs, 0 mixed.

New drug labels list manufacturers

This bill would require finished drug product labels to identify the original maker of each active ingredient and the finished drug maker. Labels must show name, place of business, and a facility identifier, or provide a link, barcode, QR code, or other access to a searchable portal with that information. Any API label or certificate of analysis would also need the original API maker's name, place of business, and facility identifier. If there are multiple possible API makers, all must be listed on the label or in the portal. Manufacturers, packers, or distributors would have to make this information available electronically and give a paper copy or package insert if someone asks. The Secretary would write rules to implement these changes and could allow reasonable variations; the rules could not take effect earlier than one year after final regulations and would apply to drugs made on or after the effective date.

Tariff marking exemption for drugs

The bill would add an exemption so finished drug products that are marked under the new drug-labeling rules would not have to follow the general country-of-origin marking requirements in the Tariff Act. The exemption would only apply to finished drug products that meet the bill's labeling standard.

Sponsors & CoSponsors

Sponsor

McCormick, Richard [R-GA-7]

GA • R

Cosponsors

  • Rep. DeLauro, Rosa L. [D-CT-3]

    CT • D

    Sponsored 4/14/2026

  • Rep. Fuller, Clay [R-GA-14]

    GA • R

    Sponsored 6/3/2026

Roll Call Votes

No roll call votes available for this bill.

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