FDA Drug Shortage Supply Change Report

Pharma supply-chain, procurement, and regulatory-operations teams provide bounded drug shortage watches. The Actor reads official openFDA shortage records and returns source-linked change alerts, descriptive supply reports, and JSON exports.

It uses the official openFDA Drug Shortages API. No API key or login is required for normal use; an optional user-supplied openFDA key can be provided for regular high-volume use. The Actor never returns the source contact field and does not make medical, treatment, safety, causal, legal, or procurement recommendations.

Store Quickstart

1. Start with initialRunMode: "baseline_only" to save the current public records without rows or charges.
2. Run the same monitorKey later with generateReport: true and emitUnchanged: false to receive only new or changed records.
3. Use initialRunMode: "emit_backfill" once when an explicit first report is wanted. Set emitExport: true for a compact source-linked export.

Run the next report

• Review source-linked device clearance changes with FDA 510(k) Device Clearance Landscape Report.
• Compare public drug patent, exclusivity, and product-lifecycle changes with FDA Orange Book Patent & Exclusivity Change Report.

Example 1: current injectable watch

{
  "watches": [{
    "id": "current-injectables",
    "statuses": ["Current"],
    "dosageForms": ["Injection"],
    "updateDateFrom": "2026-01-01",
    "updateDateTo": "2026-12-31"
  }],
  "monitorKey": "hospital-injectables",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitUnchanged": false
}

Example 2: named product and manufacturer watch

{
  "watches": [{
    "id": "hydromorphone-hospira",
    "genericNames": ["Hydromorphone Hydrochloride Injection"],
    "companyNames": ["Hospira"],
    "packageNdcs": ["0409-1805-01"]
  }],
  "monitorKey": "named-product-watch",
  "initialRunMode": "emit_backfill",
  "generateReport": true,
  "emitExport": true,
  "maxChargeUsd": 25
}

Example 3: availability and update watch

{
  "watches": [{
    "id": "limited-or-unavailable",
    "availabilities": ["Limited Availability", "Unavailable"],
    "updateTypes": ["New", "Revised"],
    "therapeuticCategories": ["Cardiovascular"]
  }],
  "monitorKey": "availability-review",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitExport": true
}

Outputs and pricing

The primary output is a descriptive change report. Raw records are optional and lower priced.

Event	Price	What it contains
fda-shortage-row	$0.005	One normalized public shortage record
fda-shortage-change-alert	$0.25	One source-linked new or changed-record alert
fda-shortage-supply-report	$10	Aggregate report by status, availability, company, and generic name
fda-shortage-export	$6	Compact source-linked JSON export

The first baseline run and a later unchanged run emit zero rows and zero charge. A run fails closed if planned charges exceed maxChargeUsd, a configured event is unknown, delivery does not return charge proof, or state cannot be saved.

What the change types mean

• shortage_record_added: a matching public record was not in the previous snapshot.
• availability_changed: the public availability field changed.
• status_changed: the public status field changed.
• supply_update_changed: another tracked public update, date, presentation, or information field changed.

These are source changes, not conclusions about clinical care or future supply.

Compliance guardrails

• Official https://api.fda.gov/drug/shortages.json only.
• No login, browser automation, private FDA system, or bypass behavior.
• The API key is optional and is never written to output, state, audit data, or source URLs.
• Source contact fields are excluded from normalized output.
• No replacement-drug suggestions, treatment directions, safety conclusions, causal conclusions, procurement recommendations, or patient-specific interpretations.
• Verify the linked FDA record and consult qualified professionals before acting.

Integration

See docs/integration-guide.md for recurring state-safe runs, and docs/sample-output.json for the report/alert/export contract.

See also

• FDA 510(k) Device Clearance Landscape Report
• FDA Orange Book Patent & Exclusivity Change Report

The neighboring actor covers public device-clearance records. This Actor is limited to openFDA drug-shortage record changes.