In regulatory terms, which option describes a 'legend' drug?

• A. Drugs that are controlled substances
• B. Drugs available without prescription
• C. Drugs that require a prescription
• D. Drugs that are investigational

Answer: (C)

Legend drugs are prescription-only medicines. The term comes from labeling that warns a drug cannot be dispensed without a physician’s authorization, often with a legend like “Federal law prohibits dispensing without a prescription.” This distinguishes them from drugs that can be bought over the counter (no prescription needed) and from investigational drugs (not approved for general use). While some prescription drugs are controlled substances, the label legend concept specifically concerns the requirement for a prescription, not the drug’s status as a controlled substance. So the description that matches a legend drug is drugs that require a prescription.