“A bill to amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information.”
No CRS summary available for this bill.
This section revises drug misbranding requirements under the Federal Food, Drug, and Cosmetic Act to enhance supply chain transparency by requiring labels on packaged finished drug products to include the name, place of business, and unique facility identifier of the manufacturer, packer, or distributor—or a link, barcode, QR code, or other means to access a searchable electronic portal with such information (previously, only name and place of business). It further establishes the following labeling obligations: (1) for active pharmaceutical ingredients, accompanying labels and certificates of analysis must identify the original manufacturer by name, place of business, and unique facility identifier; (2) for finished drug products, labeling must identify by name, place of business, and unique facility identifier the original manufacturer of each active pharmaceutical ingredient, the original manufacturer of the finished drug product, and any packer or distributor (or portal access means), with all potential active pharmaceutical ingredient manufacturers listed if multiple exist; (3) such information must also be available via package insert or paper copy upon request; and (4) "original manufacturer" means the last establishment conducting substantial manufacturing activities prior to interstate commerce introduction. The Secretary of Health and Human Services must issue implementing regulations for active pharmaceutical ingredient and finished drug product requirements, allowing reasonable variations or alternatives (including electronic means), with an effective date no earlier than one year after final regulations' publication and applicability to drugs manufactured thereafter. (Thus, these changes promote traceability to combat counterfeit drugs and ensure accountability across the supply chain.)
This section establishes a new exception to country-of-origin marking requirements for imported finished drug products that are marked in accordance with FDA labeling rules (i.e., section 502(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act, requiring the name and place of business of the manufacturer, packer, or distributor). (Thus, such drug products are exempt from the general requirement under 19 U.S.C. 1304(a)-(b) that imported articles bear a conspicuous, legible, and permanent English indication of their country of origin for the ultimate purchaser.)