FDA Purple Book MCP Server

A Model Context Protocol (MCP) server exposing the FDA Purple Book — the database of licensed biological products (reference biologics, biosimilars, and interchangeables), with BLA numbers, applicants, approval dates, and exclusivity expiry. Complements fda-orange-book-mcp-server (small-molecule patents/exclusivity). One of 100+ servers in the Bio MCP monorepo.

Connect

https://fda-purple-book-mcp-server.quentincody.workers.dev/mcp

Local dev runs at http://localhost:8903/mcp (./scripts/dev-servers.sh fda-purple-book).

Tools

• purple_book_search — discover endpoints (Code Mode catalog search)
• purple_book_execute — Code Mode: api.get("/products", { ... }) in a V8 isolate
• purple_book_query_data — SQL over large responses auto-staged into per-session SQLite
• purple_book_get_schema — inspect a staged dataset's schema

Single endpoint /products; filter by proprietary_name, proper_name, applicant, bla_number, license_type (351(a) / 351(k) Biosimilar / 351(k) Interchangeable), ref_product_proper_name, center, or any column (case-insensitive substring). Date columns also expose <col>_iso (YYYY-MM-DD) — stage results then run SQL on e.g. ref_product_exclusivity_exp_date_iso for exclusivity-cliff queries. Every _execute result carries a _meta.citation (FDA Purple Book, U.S. Public Domain). Not affiliated with or endorsed by FDA.

Architecture / maintenance

• Archetype: bulk — no live upstream API. src/lib/http.ts downloads the monthly Purple Book CSV (stable fda.gov/media/182175/download, with a dated-accessdata fallback) and caches it in-memory (24h TTL); src/lib/api-adapter.ts serves a synthetic /products surface over the cache. Large query results stage via the normal Code Mode >30KB path.
• Drift risk: low (column schema stable). Refresh cadence: monthly upstream; the 24h in-memory cache picks up new files automatically. Known gaps: generic exclusivity_expiration_date column is blank upstream (legacy); exclusivity attaches to the reference/interchangeable row, not the biosimilar row; D-Mon-YY 2-digit years parsed best-effort into _iso (raw retained).

Development

./scripts/dev-servers.sh fda-purple-book
pnpm --filter fda-purple-book-mcp-server run deploy

See docs/adding-mcp-servers.md and the build plan docs/plans/2026-06-26-evidence-genomics-mcp-servers.md.