Regulatory Compliance Search API: Federal Register & openFDA

The Regulatory Compliance Search API is a high-performance, browser-free Apify Actor that queries official government REST endpoints—specifically the Federal Register API v1 and the openFDA Drug Enforcement API v1—and unifies their results into a single, normalized JSON dataset.

It eliminates the fragmentation of monitoring federal rulemaking and pharmaceutical enforcement actions across separate tools, delivering clean, structured data for compliance officers, legal tech developers, and AI/RAG pipelines.

[!IMPORTANT] Scope Notice & Legal Disclaimer: This Actor provides targeted access strictly to official Federal Register publications and openFDA Drug Enforcement recall records. It does NOT provide complete legal or global regulatory coverage (e.g., state-level statutes, international dockets, SEC EDGAR financial filings, or European ESEF reporting are unsupported). Outputs do not constitute legal, medical, or regulatory compliance advice. Always verify original documents via official agency URLs.

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Key Features

• Cross-Source Normalization: Seamlessly combines Federal Register documents (Rules, Proposed Rules, Notices, Executive Orders) and openFDA Drug Recalls (Class I, II, III) into one standardized schema (RegulatoryComplianceRecord).
• 100% API-Driven: Queries official, SLA-backed public REST APIs (federalregister.gov and api.fda.gov). No fragile HTML web scraping, headless browsers, or DOM selectors.
• Advanced Upstream Filtering:
  • Federal Register: Filter by search terms, document types, issuing agency slugs/IDs, date ranges (YYYY-MM-DD), and sort order (newest, oldest, relevance).
  • openFDA: Filter using full Lucene search syntax (e.g., reason_for_recall:"contamination", classification:"Class I").
• Built-in Resilience & Deduplication: Automatic handling of HTTP 429 rate limits with exponential backoff. Global in-memory deduplication ensures you never pay for duplicate records within a run.
• AI & RAG Ready: Clean JSON output structure optimized for direct ingestion into LLM vector databases (Pinecone, Qdrant, Chroma) and agent frameworks (LangChain, LlamaIndex, MCP).

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Input Parameters

Field	Type	Default	Description
sources	Array	["FEDERAL_REGISTER", "OPEN_FDA"]	Active sources to query. Controls execution order and global record allocation.
federalRegisterTerm	String	Optional	Keyword or phrase query for Federal Register (e.g., "cybersecurity", "sanctions").
federalRegisterDocumentTypes	Array	Optional	Filter by document type: "Rule", "Proposed Rule", "Notice", "Executive Order".
federalRegisterAgencies	Array	Optional	Array of agency slugs or IDs (e.g., ["federal-communications-commission"] or ["161"]).
federalRegisterPublicationDateFrom	String	Optional	Earliest publication date in YYYY-MM-DD format.
federalRegisterPublicationDateTo	String	Optional	Latest publication date in YYYY-MM-DD format.
federalRegisterOrder	String	"newest"	Result ordering: "newest", "oldest", or "relevance".
openFdaSearch	String	Optional	openFDA Lucene query expression (e.g., reason_for_recall:"contamination").
openFdaApiKey	String	Optional	Optional private openFDA API key for elevated rate limits. Passed securely to api.fda.gov.
pageSize	Integer	100	Upstream records requested per page (1–100).
maxItems	Integer	100	Maximum total unique dataset records to save globally (1–10,000).
maxPagesPerSource	Integer	100	Maximum upstream pages to fetch per source (1–1,000).

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Input Examples

Example 1: Cross-Source Multi-Agency Search

{
  "sources": ["FEDERAL_REGISTER", "OPEN_FDA"],
  "federalRegisterTerm": "cybersecurity",
  "federalRegisterDocumentTypes": ["Rule", "Proposed Rule"],
  "openFdaSearch": "reason_for_recall:\"contamination\"",
  "pageSize": 50,
  "maxItems": 100
}

Example 2: Targeted Federal Register Agency Monitoring

{
  "sources": ["FEDERAL_REGISTER"],
  "federalRegisterTerm": "spectrum",
  "federalRegisterAgencies": ["federal-communications-commission"],
  "federalRegisterPublicationDateFrom": "2026-01-01",
  "federalRegisterOrder": "newest",
  "maxItems": 25
}

Example 3: openFDA Class I Drug Recall Search

{
  "sources": ["OPEN_FDA"],
  "openFdaSearch": "classification:\"Class I\" AND status:\"Ongoing\"",
  "pageSize": 20,
  "maxItems": 50
}

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Output Schema & Dataset Views

Every saved record adheres strictly to the RegulatoryComplianceRecord dataset schema:

Field	Type	Description
id	String	Unique deterministic record ID (FR-<document_number> or `FDA-<recall_number
source	String	Source authority ("FEDERAL_REGISTER" or "OPEN_FDA").
title	String	Document title or normalized product description snippet.
documentType	String	Normalized category: "RULE", "PROPOSED_RULE", "NOTICE", "EXECUTIVE_ORDER", or "ENFORCEMENT_RECALL".
authorityAgency	String	Issuing agency or FDA recalling firm.
publicationDate	String	Publication or report date in YYYY-MM-DD format.
severityClassification	String	Risk level: "CLASS_I", "CLASS_II", "CLASS_III", "RULEMAKING", or "INFORMATIONAL".
status	String	Status: "ACTIVE", "PROPOSED", "ONGOING", "TERMINATED", or "COMPLETED".
summary	String	Plaintext abstract, recall reason, or document excerpt.
url	String	Canonical URL to official government publication or safety alert.
pdfUrl	String | Null	Direct link to official PDF document (Federal Register only; null for openFDA).
geography	Object	Jurisdiction object containing country, state, city, and distributionPattern.
sourceDataRaw	Object	Complete, un-mutated JSON payload received from upstream API.
retrievedAt	String	ISO 8601 UTC timestamp of retrieval.

Output Sample JSON

{
  "id": "FR-2026-15123",
  "source": "FEDERAL_REGISTER",
  "title": "Review of Submarine Cable Landing License Rules and Procedures...",
  "documentType": "RULE",
  "authorityAgency": "Federal Communications Commission",
  "publicationDate": "2026-07-27",
  "severityClassification": "RULEMAKING",
  "status": "ACTIVE",
  "summary": "In this document, the Federal Communications Commission adopted a Second Report and Order...",
  "url": "https://www.federalregister.gov/documents/2026/07/27/2026-15123/review-of-submarine-cable...",
  "pdfUrl": "https://www.govinfo.gov/content/pkg/FR-2026-07-27/pdf/2026-15123.pdf",
  "geography": {
    "country": "United States",
    "state": null,
    "city": null,
    "distributionPattern": null
  },
  "sourceDataRaw": { ... },
  "retrievedAt": "2026-07-27T09:21:13.107Z"
}

Dataset Views

• overview: Tabular view displaying id, source, title, documentType, authorityAgency, publicationDate, severityClassification, status, and url.
• federal-register: Filtered view for Federal Register items with pdfUrl.
• openfda-enforcement: Filtered view for openFDA recalls highlighting geography.

Key-Value Store OUTPUT Summary

At run completion, a summary object is written to the Key-Value store under key OUTPUT:

{
  "status": "SUCCEEDED",
  "selectedSources": ["FEDERAL_REGISTER", "OPEN_FDA"],
  "recordsWritten": 100,
  "duplicatesSkipped": 0,
  "invalidRecords": 0,
  "sourceResults": [
    {
      "source": "FEDERAL_REGISTER",
      "pagesFetched": 1,
      "recordsReceived": 50,
      "recordsWritten": 50,
      "stopReason": "SOURCE_EXHAUSTED",
      "errorCode": null
    }
  ],
  "startedAt": "2026-07-27T09:21:10.000Z",
  "finishedAt": "2026-07-27T09:21:13.251Z"
}

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AI & RAG Use Cases

1. RAG Knowledge Base Ingestion: Feed clean, structured regulatory updates directly into vector databases (Pinecone, Qdrant, Chroma) to power enterprise compliance AI assistants.
2. Automated Regulatory Horizon Scanning: Monitor agency rulemakings (PROPOSED_RULE) and critical drug recalls (CLASS_I) to trigger real-time compliance workflow alerts.
3. AI Agent Tooling / Function Calling: Integrate structured regulatory search into AI agent frameworks (LangChain, LlamaIndex, AutoGen, MCP).
4. Pharma & Supply Chain Risk Intelligence: Cross-reference pharmaceutical suppliers against openFDA enforcement actions and safety alerts.

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Limitations & Scope Boundaries

• Supported Sources: Federal Register API v1 and openFDA Drug Enforcement API v1 ONLY.
• Unsupported Coverage: Does NOT search SEC EDGAR filings, European ESEF financial reporting, state court dockets, or international regulatory bodies.
• Upstream Rate Limits: Federal Register public limit (~1,000 req/hr). openFDA public limit (240 req/min, 1,000 req/day/IP; supply openFdaApiKey for up to 120,000 req/day).
• Compliance Disclaimer: Data is retrieved directly from official government REST APIs without alteration. Always verify original document links before taking regulatory or legal action.

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Pricing

• Pay-Per-Event (PPE): USD 0.002 per record ($2.00 per 1,000 records). Charged only for successfully saved unique dataset items.
• Platform Usage Costs: Compute, memory, and proxy costs are passed through directly without actor startup fees or markup.

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Local Development & Verification

# Install dependencies
pnpm install --frozen-lockfile

# Run test suite
pnpm test

# Check TypeScript types & build
pnpm typecheck
pnpm build

# Validate JSON Schemas
pnpm validate:schemas