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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, physicians and nurse practitioners, though physician assistants do an increasing amount of drug prescribing under a physician's supervision. It is generally required that an MD, DO, DPM, NP, DVM, DDS, DMD, OD, or PA write the prescription; basic-level registered nurses (as opposed to advanced practice nurses such as a nurse practitioner, clinical nurse specialist, nurse anesthetist, and nurse midwife), emergency medical technicians, psychologists (but not psychiatrists, who are physicians), and social workers as examples, do not have the authority to prescribe drugs.

Unlike most other countries, the United States does not have governmental control of prescription drug prices, and US drug prices are usually viewed as very expensive in comparison to those countries who do. For those with health insurance, many health insurance programs (generally paid partially or in full by the patient's employer) have prescription payment plans where the patient pays only a small copayment and the pharmacy is reimbursed for the remaining cost by the insurance company using the premiums collected from all of the insured individuals and their employers. The uninsured typically must pay whatever higher drug price their local pharmacy charges. Some indigent people can get assistance through publicly funded drug assistance programs such as Medicaid or private support through drug company prescription assistance programs.

The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration is charged with implementing this law.

As a general rule, over the counter drugs are used to treat conditions not necessarily requiring care from a health care provider and will have been proven to meet higher safety standards for self-medication by patients. Often a lower dosage of a drug will be approved for OTC use, while higher dosages will remain the province of a prescription; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s but is still available in doses up to four times the OTC dose for use in cases of severe orthopedic pain.

Herbal preparations, vitamins, minerals, and food supplements are not regulated by the FDA, so the individual consumer must be aware of the potentially-negative effects of using these preparations and also the potential interactions with prescription drugs they may be taking.

In the United States, the term "prescription drug" is most commonly used, but they are also called legend drugs or Rx-only drugs, after the requirements of Federal and state laws that all such drugs bear a "legend" prohibiting sale without a prescription; though more complex legends have been used, on most original drug packaging today the legend simply says "Rx only". In the United King