This bill would change the Federal Food, Drug, and Cosmetic Act to require more detailed labeling for many drugs and active pharmaceutical ingredients (APIs). For finished drug products in package form, labels must include the name, place of business, and a unique facility identifier for the manufacturer, packer, or distributor, or provide a link, barcode, QR code, or other way to access a searchable electronic portal with that information. For APIs, any accompanying label and certificate of analysis must show the name, place of business, and unique facility identifier of the original manufacturer. For finished drug products, labeling must identify the original manufacturer of each API, the original manufacturer of the finished drug product, and the packer or distributor, or provide a link or code to a portal with that information. If there are multiple potential manufacturers of an API, the bill allows listing all such manufacturers in the label or portal. The bill requires manufacturers to make the information available electronically and to provide a package insert or a paper copy on request. It defines "original manufacturer" as the single last establishment to do substantial manufacturing before the product enters interstate commerce. The Secretary of Health and Human Services must issue regulations to implement the API and finished-product labeling rules; those regulations take effect no earlier than one year after final publication and apply to drugs manufactured on or after the effective date. The bill also amends the Tariff Act of 1930 to exempt finished drug products labeled under these rules from certain country-of-origin marking requirements.
No publicly available information on federal cost estimates, budget effects, or compliance costs is included in the bill text. The bill does require the Secretary to write regulations but does not provide cost estimates.
No publicly available information.
No publicly available information.