# Fda Regulations (npm · @pipeworx/mcp-fda-regulations)

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

- Trust score: 81/100 (high trust)
- Change this week: +3
- Registry status: active
- Liveness: live
- Owner verified: no
- Last scored: 2026-11-05

## Components

- remote · `gateway.pipeworx.io`: 70/100, [markdown](https://verifymcp.io/servers/pipeworx-io-fda-regulations/fda-regulations-mcp.md), [page](https://verifymcp.io/servers/pipeworx-io-fda-regulations/fda-regulations-mcp)
- npm · `@pipeworx/mcp-fda-regulations`: 81/100 (this document), [markdown](https://verifymcp.io/servers/pipeworx-io-fda-regulations/pipeworx-mcp-fda-regulations.md), [page](https://verifymcp.io/servers/pipeworx-io-fda-regulations/pipeworx-mcp-fda-regulations)

## Channel facts

- Registry: `npm`
- Package: `@pipeworx/mcp-fda-regulations`
- Version: `0.2.1`
- Transport: `stdio`

## Trust breakdown

How this component scores in each security and reliability category. Every signal is checked automatically from public evidence about the published package, including repeated runs of it in an isolated sandbox, and we only credit what we can confirm. Scores are 0–100 per category. Scoring method: https://verifymcp.io/docs/scoring (what has changed: https://verifymcp.io/docs/scoring/changelog)

Scored 2026-11-05.

- **Supply Chain Security**: 100/100
  - No malware found by supply-chain analysis.
  - No known CVEs affecting this package version or its production dependencies.
  - No install/post-install scripts declared.
  - No production dependencies, so there is no dependency health to assess.
- **Provenance & Transparency**: 97/100
  - Source repository is publicly reachable at the declared URL.
  - Cryptographically verified build provenance (signed, bound to pipeworx-io/mcp-fda-regulations).
  - Clear OSI-approved license (MIT).
  - Actively maintained (last published 3 days ago).
  - Disclosure check failed: no security disclosure policy was found in the source repository.
- **Schema Quality & AI Usability**: 58/100
  - AI-judged instruction clarity (good).
  - Context-footprint check failed: tool/resource definitions use about 706 tokens (~353/item across 2 items; 2 tools + 0 resources), over budget; trim descriptions and params.
  - Usage-examples check failed: none of the tools include examples.
- **Stability & Change Management**: 23/100
  - Stability observed for 7 of 30 days with no destabilising changes; credit accrues until the full window elapses.
- **Tool Coverage**: 100/100
  - 100% of tools have a non-trivial description (not blank, and not just the tool's name).
  - 100% of tool parameters carry a description.
- **Tool Safety**: 100/100
  - No prompt-injection markers were found in the server instructions, tool names or descriptions we captured.
  - We read all 2 captured tool definition(s), and no name or description among them implies an irreversible operation.
  - An AI judge read all 3 captured unit(s) of tool text and found none that tries to manipulate the model reading it.
- **Capabilities**: 100/100
  - Implements a supported MCP spec version (2025-11-25); the latest is 2026-07-28.

## Install

### How do I install the Fda Regulations MCP server?

Fda Regulations runs locally as an npm package, launched with npx -y @pipeworx/mcp-fda-regulations. Ready-made configuration for Claude, Cursor, VS Code, Codex and 5 more is on this page, copied from each client's own documentation.

### Claude

```bash
claude mcp add pipeworx-io-fda-regulations -- npx -y @pipeworx/mcp-fda-regulations
```

### Cursor

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

### VS Code

```json
{
  "servers": {
    "pipeworx-io-fda-regulations": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-regulations"
      ]
    }
  }
}
```

### Codex

```bash
codex mcp add pipeworx-io-fda-regulations -- npx -y @pipeworx/mcp-fda-regulations
```

### opencode

```json
{
  "$schema": "https://opencode.ai/config.json",
  "mcp": {
    "pipeworx-io-fda-regulations": {
      "type": "local",
      "command": [
        "npx",
        "-y",
        "@pipeworx/mcp-fda-regulations"
      ],
      "enabled": true
    }
  }
}
```

### OpenClaw

```bash
openclaw mcp add pipeworx-io-fda-regulations --command npx --arg -y --arg @pipeworx/mcp-fda-regulations
```

### Hermes

```yaml
mcp_servers:
  pipeworx-io-fda-regulations:
    command: "npx"
    args: ["-y", "@pipeworx/mcp-fda-regulations"]
```

### Netclaw

```json
{
  "McpServers": {
    "pipeworx-io-fda-regulations": {
      "Transport": "stdio",
      "Command": "npx",
      "Arguments": [
        "-y",
        "@pipeworx/mcp-fda-regulations"
      ]
    }
  }
}
```

### Vellum

```bash
assistant mcp add pipeworx-io-fda-regulations -t stdio -c npx -a -y @pipeworx/mcp-fda-regulations
```

### Other

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

## Changelog

Every change recorded for this component, newest first. Days that predate change tracking, or that we cannot explain, say so: "we were watching and nothing happened" and "we were not watching" are different claims.

### 2026-11-04 (score 81, +1)

No change was recorded against any check on this day. Stability & Change Management went from 17 to 20. That category is still filling its 30-day observation window: 5 days of observed history at the previous scan, 6 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-11-02 (score 80, +1)

No change was recorded against any check on this day. Stability & Change Management went from 10 to 13. That category is still filling its 30-day observation window: 3 days of observed history at the previous scan, 4 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-11-01 (score 79, +1)

- [security regression] Tool safety: pass → unverified
- [security] Stability: Stability not yet verified: we do not have a sandbox capture of the MCP schema this version of the package serves yet.
- [functional regression] Security disclosure: unverified → fail
- [functional regression] Tool coverage: 100 → unverified
- [functional regression] Capabilities: pass → unverified
- [functional improvement] Stability: unverified → 0.10
- [functional] First check of Schema quality: unverified
- [functional] Package version: 0.2.0 → 0.2.1

### 2026-10-29 (score 78)

First indexed and scored.

## MCP tools (2)

### `fda_regulation` (~403 tokens)

Get 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.

Input parameters:

- `citation` (string, required): FDA regulation citation. A section: "211.100", "21 CFR 211.100", "§820.35", "211.100(a)". Or a whole part: "211", "part 820" -> returns the part's section list.

### `fda_search` (~247 tokens)

Keyword 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.

Input parameters:

- `limit` (number): Max results to return, 1-20 (default 10).
- `query` (string, required): FDA-regulation topic or phrase, e.g. "medical device labeling", "good manufacturing practice", "nutrition labeling", "quality system", "new drug application".

## Diagnostics

Captured diagnostic sections: Provenance, Dependencies. The full working is on the page: https://verifymcp.io/servers/pipeworx-io-fda-regulations/pipeworx-mcp-fda-regulations#diagnostics

## Score history

- 2026-11-05: 81
- 2026-11-04: 81
- 2026-11-03: 80
- 2026-11-02: 80
- 2026-11-01: 79
- 2026-10-31: 78
- 2026-10-30: 78
- 2026-10-29: 78

## Common questions

### What is the Fda Regulations MCP server?

Fda Regulations is an MCP server listed in the public MCP registry as io.github.pipeworx-io/fda-regulations. FDA Regulations MCP, US Food & Drug Administration regulations (21 CFR). This page covers its npm package (@pipeworx/mcp-fda-regulations).

### Is the Fda Regulations MCP server safe to use?

Fda Regulations scores 81 out of 100 on VerifyMCP. We found no known CVEs affecting it as of 5 November 2026. It declares no install or post-install scripts. Its build provenance is signed and verified. That is a record of what we were able to check automatically, not an endorsement. The category breakdown on this page shows every signal behind the number, including the ones we could not confirm.

### What tools does the Fda Regulations MCP server expose?

Fda Regulations exposes 2 tools: fda_regulation, fda_search. Their descriptions and schemas cost roughly 650 tokens of context every time the server is loaded.

### Is the Fda Regulations MCP server still maintained?

Fda Regulations is still listed as active in the MCP registry. We last reached this channel on 5 November 2026. Those dates come from our own scans of the registry and the channel itself, not from anything the publisher announced.

### What licence is the Fda Regulations MCP server under?

Fda Regulations declares the MIT licence, which is OSI-approved. That covers the source only, and says nothing about the cost of any service it calls.

## Links

- npm package: https://www.npmjs.com/package/@pipeworx/mcp-fda-regulations
- Socket report: https://socket.dev/npm/package/@pipeworx/mcp-fda-regulations
- Repository: https://github.com/pipeworx-io/mcp-fda-regulations
- Website: https://pipeworx.io/packs/fda-regulations
- Changelog RSS feed: https://verifymcp.io/servers/pipeworx-io-fda-regulations/pipeworx-mcp-fda-regulations.xml
- Changelog JSON feed: https://verifymcp.io/servers/pipeworx-io-fda-regulations/pipeworx-mcp-fda-regulations.json
- HTML version of this page: https://verifymcp.io/servers/pipeworx-io-fda-regulations/pipeworx-mcp-fda-regulations