Skip to main content
Glama

Fda Regulations

by io.github.pipeworx-io
OverviewDiscussionsAdmin

Fda Regulation

fda_regulation
Read-onlyIdempotent

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 Schema

TableJSON Schema
NameRequiredDescriptionDefault
citationYesFDA 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.

Schema Changelog

Changes observed during successful MCP inspections.

  1. Changed1 schema field changed
    • addedInput schema / examples
      Added value: +[
+  {
+    "citation": "211.100"
+  },
+  {
+    "citation": "21 CFR 820.35"
+  }
+]
  2. First observed

TDQS

A4.7/5.0
Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already declare readOnlyHint, idempotentHint, destructiveHint. The description adds behavioral context: returns exact wording, forgiving input, covers specific parts. No contradiction.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The description is relatively long but every sentence adds value: examples, scope, sibling differentiation. It's front-loaded with purpose and examples, though slightly verbose.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness5/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

With one parameter and no output schema, the description covers input flexibility, legal scope, and use cases completely. Combined with annotations, it leaves no ambiguity.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters5/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema covers 100% with description. The tool description adds extensive examples, input formats (citations, whole parts), and usage patterns, going well beyond the schema's brief description.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description explicitly states it retrieves the full text of FDA regulations by citation, using specific verbs ('Get'). It distinguishes from sibling tools by mentioning openfda tools for data, making the purpose clear.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines5/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

It provides explicit when-to-use ('to get regulatory text') and when-not-to-use ('for FDA DATA use openfda tools'), with concrete examples of queries and citations.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

All Fda Regulations toolsInspect
Try in Browser
RayrunBuild, deploy, and operate MCP servers without becoming an infrastructure team.ray.runAd

Glama MCP Gateway

Add one secure layer between your agents and this server.

Resources