Over-the-counter drug

OTC Bayer medication with child-resistant packaging (cap) and tamper-resistant carton and innerseal
Photo of the packaging of four medicines dispensed in the United Kingdom showing their Product Licence Numbers and symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P), or lacking either, denoting General Sales List (GSL). From top to bottom: mebendazole (P), amlodipine (POM), diazepam (POM), paracetamol (GSL).

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional,[1] as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.[2]

The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription.[3] In contrast, prescription drugs require a prescription from a doctor or other health care professional and should only be used by the prescribed individual.[4] Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient's needs or the provision of patient education. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.

  1. ^ Cite error: The named reference :0 was invoked but never defined (see the help page).
  2. ^ "Over-the-Counter Medicines: What's Right for You?" U.S. Food and Drug Administration (30 April 2009). Retrieved 4 July 2012.
  3. ^ "Understanding Over-the-Counter Medicines". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 14 August 2019. Retrieved 26 August 2019.
  4. ^ "Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. 25 April 2019.