Bill > HR3810

This bill, the Drug Origin Transparency Act of 2023, aims to enhance drug manufacturing amount information reporting and labeling requirements. The key provisions are: 1. It amends the Federal Food, Drug, and Cosmetic Act to require drug manufacturers to report more detailed information on their supply chain, including the identity and amounts of active pharmaceutical ingredients, intermediates, and in-process materials sourced from each supplier. These reports must be submitted more frequently than annually, up to 4 times per year. 2. It requires drug labels, including for active pharmaceutical ingredients, to include the name, place of business, and unique facility identifier of the original manufacturer. The Secretary may provide reasonable variations in implementing these new labeling requirements. 3. It also requires drug labeling to include the name and place of business of the original manufacturer of each active pharmaceutical ingredient, any different manufacturer, and the packer or distributor, if any. The Secretary may provide reasonable variations or alternative placements for this labeling information, including by electronic means. The overall goal of the bill is to enhance transparency and traceability in the drug supply chain, particularly for the origins of active pharmaceutical ingredients.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/118th-congress/house-bill/3810/all-info