Legal implications of preparing and dispensing approved drugs for unlabeled indications

The legal issues surrounding the potential liability of a pharmacist for dispensing or preparing drugs under conditions not contained in the FDA-approved labeling of a product are examined. Although the specific issue of liability of a pharmacist for preparing a drug in a nonapproved manner or dispensing a drug for a nonapproved use has not been adjudicated, based on evolving legal principles it appears that the pharmacist under certain circumstances may be held responsible for the drugs so prepared or dispensed. Preparation of a drug which is adulterated under the federal Food, Drug and Cosmetic Act appears to be negligent, although its precise effect will be dependent upon state law. Liability for dispensing for nonapproved uses will be minimized if the pharmacist, in the exercise of sound professional judgment, concludes that the use is rational, safe, and reasonable.