“To amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting, and for other purposes.”
No CRS summary available for this bill.
This section expands FDA drug manufacturing reports under the Federal Food, Drug, and Cosmetic Act to include supply chain information specified by regulation or guidance—such as identities of suppliers of each active pharmaceutical ingredient (API), API intermediate, and in-process material used, and amounts of the drug manufactured using materials from each supplier—and requires submission up to four times per year (from annually), with the new requirements effective no earlier than six months after final FDA regulations or guidance are issued. (Thus, these reports, which registered facilities currently submit annually to identify manufactured drugs and production volumes for supply monitoring, will provide greater transparency into drug inputs and origins.)
This section amends the misbranding provisions of the Federal Food, Drug, and Cosmetic Act by revising labeling requirements in section 502(b) and adding new requirements in section 502(d). Specifically, it (1) requires labels on drugs, including active pharmaceutical ingredients (APIs), to include the name, place of business, and unique facility identifier of the original manufacturer (with regulatory flexibility for variations) and requires any accompanying certificate of analysis for an API drug to include such information for the original manufacturer; and (2) requires drug labeling, including for APIs, to identify the original manufacturer of each API, each subsequent manufacturer (if different), and any packer or distributor (with regulatory flexibility for variations or alternative placement, including electronic means).