Summary

Clarifies that artificial intelligence and machine learning systems can be recognized as valid prescribers of drugs, but only if two conditions are met: the technology is allowed to prescribe under the relevant State’s law, and it is approved, cleared, or authorized by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. This does not give AI automatic prescribing power. It sets guardrails so pharmacies and health systems know when an AI/ML tool may issue a lawful prescription. States keep control over scope-of-practice, and FDA must have authorized the technology as a regulated medical device or similar product.

Key Points

• Recognizes AI/ML tools as potential prescribers only when permitted by State law and authorized by FDA.
• Sets a clear federal standard for when AI‑issued prescriptions are valid under the FD&C Act.
• Leaves scope‑of‑practice decisions to States; no federal preemption is created.
• Requires FDA approval, clearance, or authorization of the AI/ML technology as a regulated product.
• Pharmacies must verify both State and FDA status before dispensing on an AI‑generated prescription.
• Does not change drug approval requirements or who can dispense medications.
• No new programs, spending, or taxes are created.
• Encourages alignment among State regulators, FDA oversight, and pharmacy workflows.

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