OTC Drugs & the Rx-to-OTC Switch

Definitions & terminology

• OTC / non-prescription drug — a medicine legally purchased and used by the consumer without a prescription from a registered medical practitioner, for self-recognised, self-limiting or chronic-stable conditions, by reading the label alone; the defining legal feature is the absence of a prescription-only restriction, not a positively-listed property.
• Prescription drug / legend drug (POM) — a drug whose label bears the legend Rx — to be sold on the prescription of a registered medical practitioner only; safe use requires a practitioner's diagnosis, supervision and monitoring.
• Rx-to-OTC switch (reclassification) — the regulatory process by which a drug — or a particular dose, indication, pack size or route — previously available only on prescription is reclassified for non-prescription sale.
• Self-medication — use of medicines by individuals to treat self-recognised disorders or symptoms; OTC drugs are the lawful tool of responsible self-medication.
• Behind-the-counter (BTC) / pharmacist-only — an intermediate tier (UK P class) sold without a prescription but only under a pharmacist's supervision (e.g. emergency contraception) — a middle ground between POM and free OTC sale.
• Terminology caution: non-prescription is the regulator's preferred term; OTC is the commercial/colloquial term. In India both are used loosely because no statutory definition of OTC exists.