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Fda Regulations

Registre officiel Administration et juridique

FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

Code source Site web Documentation

Installation

Ajoutez ceci à la configuration MCP de votre client (Claude Desktop : claude_desktop_config.json ; Cursor : .cursor/mcp.json ; VS Code et les autres utilisent la même forme « mcpServers »).

Remote (streamable-http)
Claude Code 
claude mcp add --transport http fda-regulations 'https://gateway.pipeworx.io/fda-regulations/mcp'
Configuration JSON (Claude Desktop, Cursor, VS Code) 
{
    "mcpServers": {
        "fda-regulations": {
            "type": "http",
            "url": "https://gateway.pipeworx.io/fda-regulations/mcp"
        }
    }
}

Documentation

Tirée du README du projet sur GitHub, actualisée chaque semaine. Les liens ouvrent GitHub.

Sommaire
  1. mcp-fda-regulations
  2. Tools
  3. Quick Start
  4. No MCP client? Call it over HTTP
  5. Standalone (no gateway account)
  6. Using with ask_pipeworx
  7. More
  8. License

mcp-fda-regulations

FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

Part of Pipeworx — an MCP gateway connecting AI agents to 1679+ live data sources.

Tools

ToolDescription
fda_regulationGet the full text of one FDA regulation — a US Food & Drug Administration rule codified in 21 CFR — by its citation. Returns the exact regulatory wording currently in force. Answers "what does 21 CFR 211 require", "what is the FDA regulation for X", "does the FDA require X", "read 21 CFR 211.100", "the FDA good manufacturing practice rule". Forgiving citation input: "211.100", "21 CFR 211.100", "§211.100", even "211.100(a)" (paragraph stripped to the section). Covers 21 CFR part 211 current good manufacturing practice (cGMP / GMP) for finished drugs, part 210 cGMP general, part 820 quality system regulation / QMSR for medical devices, part 801 medical device labeling, part 101 food labeling / nutrition facts, part 314 new drug applications (NDA/ANDA), part 807 device establishment registration, part 111 dietary supplement cGMP, part 1308 controlled substance schedules — the whole of Title 21 (food, drugs, devices, cosmetics, biologics). This is FDA REGULATIONS (the rules/regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Pass a whole part (e.g. "211" or "820") to get that part's section list. Example: fda_regulation({ citation: "211.100" }) -> written procedures / process control; fda_regulation({ citation: "21 CFR 101.9" }) -> nutrition labeling. Keyless.
fda_searchKeyword search across FDA regulations — US Food & Drug Administration rules in 21 CFR. Answers "what FDA regulations cover X", "the FDA regulation / rule about X", "find the FDA requirement for X". Great for topics: good manufacturing practice (GMP / cGMP), quality system regulation, medical device labeling, drug labeling, nutrition facts / food labeling, new drug applications, dietary supplements, cosmetics, biologics, controlled substances, current good manufacturing practice for drugs and devices. Returns matching FDA regulations with citation (21 CFR), heading, excerpt, and source URL. This searches FDA REGULATIONS (regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Example: fda_search({ query: "medical device labeling" }); fda_search({ query: "good manufacturing practice", limit: 15 }). Keyless.

Quick Start

Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):

{
  "mcpServers": {
    "fda-regulations": {
      "url": "https://gateway.pipeworx.io/fda-regulations/mcp"
    }
  }
}
What this endpoint actually serves

tools/list at https://gateway.pipeworx.io/fda-regulations/mcp returns the tools in the table above plus the shared Pipeworx meta-tools — ask_pipeworx, discover_tools, search_within, remember/recall and the rest of the gateway-wide set. So the tool count you see is larger than this table: a single-pack endpoint currently lists roughly 30 shared tools alongside the pack's own. The connection's initialize response states its exact scope, and is the authoritative answer for a given day.

This is deliberate, not multiplexing by accident. The meta-tools are what let a scoped connection answer a question this pack does not cover — via ask_pipeworx, which routes across the whole catalog — without you adding a second MCP server. There is currently no way to mount a pack endpoint without them; if the extra schemas cost you more context than the routing is worth, connect to the full gateway once rather than to several pack endpoints.

Or connect to the full Pipeworx gateway to get every pack's tools listed directly, instead of just this one's:

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://gateway.pipeworx.io/mcp"
    }
  }
}

Both URLs reach the same gateway and the same 1679+ data sources. The only difference is which pack's tools are listed directly; ask_pipeworx reaches all of them from either one.

No MCP client? Call it over HTTP

curl -X POST https://gateway.pipeworx.io/v1/tools/fda_regulation \
  -H 'Content-Type: application/json' \
  -d '{"citation":"211.100"}'

No account needed for the first calls. Inspect any tool: GET https://gateway.pipeworx.io/v1/tools/fda_regulation. Find one: POST https://gateway.pipeworx.io/v1/tools/search_packs with {"query":"..."}.

Standalone (no gateway account)

This package also runs as a local stdio MCP server — no Pipeworx account, no gateway round-trip:

{
  "mcpServers": {
    "fda-regulations": {
      "command": "npx",
      "args": ["-y", "@pipeworx/mcp-fda-regulations"]
    }
  }
}

Or run it directly to confirm it starts:

npx -y @pipeworx/mcp-fda-regulations

It speaks MCP over stdin/stdout and answers initialize/tools/list/tools/call for only this pack's tools — none of the shared meta-tools the gateway connection above adds. Same source, same tools, no ask_pipeworx routing.

Using with ask_pipeworx

Instead of calling tools directly, you can ask questions in plain English — this works on the pack endpoint above as well as on the full gateway:

ask_pipeworx({ question: "your question about Fda Regulations data" })

The gateway picks the right tool and fills the arguments automatically.

More

License

MIT

Questions fréquentes

Qu'est-ce que Fda Regulations ?

FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

Comment installer Fda Regulations ?

Il fonctionne comme serveur distant. Dans Claude Code : claude mcp add --transport http fda-regulations 'https://gateway.pipeworx.io/fda-regulations/mcp'. Pour les autres clients, collez la configuration JSON de cette page dans leurs réglages MCP.

Faut-il une clé API pour Fda Regulations ?

Son entrée au registre n'indique aucune clé ni secret obligatoire. Certaines fonctions peuvent tout de même demander un compte auprès du service auquel il se connecte.

Fda Regulations est-il open source ?

Oui. Son code est sur GitHub sous licence MIT.

Qui maintient Fda Regulations ?

Il est publié par pipeworx-io. AI.tn le référence sans le maintenir ni le recommander.

Issu du registre MCP officiel. Être listé n'est pas une recommandation : vérifiez le code et les permissions d'un serveur avant de lui donner accès à vos données.