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A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug.

Dispensation of prescription drugs often includes a package insert (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.

In the United States, the Federal Food, Drug, and Cosmetic Act defines what requires a prescription. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, and medical practitioners. It is generally required that an MD, DO, PA, OD, DPM, DVM, DDS, or DMD write the prescription; basic-level registered nurses, medical assistants, clinical nurse specialists, nurse anesthetists, and nurse midwives, emergency medical technicians, psychologists, and social workers as examples, do not have the authority to prescribe drugs.

The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies.

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