Definition of Legend Drug

legend drug

Legend Drug – in the United States, any drug that requires a physician or other appropriately licensed health-care provider (such as a dentist, optometrist, or podiatrist) to write a prescription and a pharmacist to dispense the medication.

The federal approval and regulatory process determines which drugs are legend drugs, the labels of which must carry the admonition, “Caution: Federal law prohibits dispensing without a prescription.” Each state further regulates the prescribing and dispensing of legend drugs, though practices are fairly consistent across states.

Such regulation includes the kind of information that must appear on the dispensing label and the manner in which the pharmacist must discuss the drug’s intended benefits and potential risks with the person reciving the medication. It is common to refer to legend drugs simply as prescription drugs.


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