# run-fda-otc-ae-reporting

`station__microgram__run-fda-otc-ae-reporting` · external (needs EXECUTION_BACKEND_URL configured) · domain `microgram` · pv-relevance `pv-core`

FDA OTC postmarketing adverse event reporting obligations: routes by product status and seriousness per FDA Guidance 'Postmarketing AE Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application' (2009) and Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006)

> **Note:** This tool routes through an external execution backend. If `EXECUTION_BACKEND_URL` is unset on the server, calls return JSON-RPC error `-32603 "Tool execution backend not configured"`. Tools with `backend: native` execute in-process and are always callable.

## Agent metadata

- `idempotent`: unknown
- `read_only`: unknown
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `serious` *boolean* (required) — Input parameter: serious
- `reporter_type` *string* (required) — Input parameter: reporter_type
- `product_status` *string* (required) — Input parameter: product_status

## Example call

```json
POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__microgram__run-fda-otc-ae-reporting",
    "arguments": {
      "serious": false,
      "reporter_type": "",
      "product_status": ""
    }
  }
}
```

## Related

- [/tools](/tools) — all 3062 tools
- [/tools/microgram__run-fda-otc-ae-reporting](/tools/microgram__run-fda-otc-ae-reporting) — HTML page
- [/tools/microgram__run-fda-otc-ae-reporting/json](/tools/microgram__run-fda-otc-ae-reporting/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide