Summary: H.R. 8269 – CLEAR LABELS Act (119th Congress)

Purpose

The CLEAR LABELS Act aims to enhance transparency in pharmaceutical labeling by requiring drug labels to include information about the original manufacturer and the supply chain. The bill targets both finished drug products and active pharmaceutical ingredients (APIs), with the goal of improving traceability and accountability for drug manufacturing and distribution.

Key Provisions

1) Expanded labeling requirements for finished drug products (Section 502(b))

• A finished drug product in package form must bear labeling that includes:
  • (A) The name, place of business, and a unique facility identifier of the original manufacturer, packer, or distributor, or a link/barcode/QR code (or other means) to access a searchable electronic portal containing such information.
  • (B) An accurate statement of the quantity of contents (weight, measure, or numerical count), with reasonable variations permitted and exemptions for small packages via regulations.
• The labeling must also provide, for finished drug products,:
  • (i) The original manufacturer of each active pharmaceutical ingredient (API).
  • (ii) The original manufacturer of the finished drug product.
  • (iii) The packer or distributor, or a link/barcode/QR code to access a portal containing such information.
• If multiple potential manufacturers exist for the API, labeling or the portal must identify all such manufacturers.
• If an API has multiple potential manufacturers, the requirement can be satisfied by identifying all manufacturers or by making them accessible through the portal.

2) Requirements for APIs on labeling (Section 502(b)(2))

• For APIs, the accompanying label and certificate of analysis must include the name, place of business, and a unique facility identifier of the original manufacturer.

3) Accessibility and disclosure (Section 502(b)(4))

• In addition to electronic access, manufacturers, packers, or distributors must provide the information in paper form (package insert or copy) to any individual who requests it.

4) Definitions and scope of “original manufacturer” (Section 502(b)(5))

• “Original manufacturer” means the single last establishment to conduct substantial manufacturing activities prior to introduction of the API or finished drug product into interstate commerce.

5) Implementation and regulatory timeline (Section 502(b)(6))

• The Secretary shall issue regulations to implement subparagraphs (2) and (3) and may allow reasonable variations in implementation or alternative labeling placement (including electronic means).
• Regulations must take effect no earlier than 1 year after final regulations are published and apply to drugs manufactured on or after the effective date.

6) Customs/portability provision (Section 304 of the Tariff Act) – Exemption

• Finished drug products marked in accordance with the FDC Act labeling requirements are exempt from certain customs country-of-origin marking requirements.

Affected Parties

• Drug manufacturers, packers, and distributors of finished drug products.
• Manufacturers of active pharmaceutical ingredients (APIs).
• Import/export processes at customs, due to the cross-reference with tariff marking exemptions.
• Consumers and healthcare providers seeking more traceable drug-source information (through electronic portals or paper copies on request).

Procedural and Timeline Aspects

• The bill was introduced in the House on April 14, 2026, by Rep. Rich McCormick (and Rep. Rosa DeLauro as co-sponsor).
• Referred to the House Ways and Means and Energy and Commerce Committees (subject to later determination of consideration by the Speaker).
• Regulations to implement the labeling requirements must be issued by the Secretary, with an effective date not earlier than one year after publication of final regulations, applying to drugs manufactured on or after that date.

Implications and Potential Impacts

• Enhanced transparency in the pharmaceutical supply chain, enabling tracing of the original manufacturers for APIs and active drug products.
• Possible increased costs and administrative burden for manufacturers due to new labeling, data collection, and portal requirements.
• Creation of a centralized or accessible electronic portal to host original manufacturer and supply chain data (alongside optional barcode/QR code access).
• Potential improvements in supply chain accountability, counterfeit deterrence, and rapid response capabilities in case of quality or safety events.

Note: The bill also establishes an exemption from certain customs country-of-origin markings for finished drug products that comply with the new labeling requirements.