Rxonly

Rx-only is a designation used on pharmaceutical products to indicate that the medicine requires a prescription from a qualified health professional for purchase and use. The term originates from the Latin "recipe" meaning "take." In many regulatory systems, medicines are classified as either prescription-only (Rx or POM) or over-the-counter (OTC). The Rx-only status is typically indicated on the product’s labeling and packaging.

Regulatory context varies by jurisdiction. In the European Union, prescription-only medicines are known as prescription-only medicines (POM) and require a prescription to be dispensed. The EU framework, including the European Medicines Agency and member-state competent authorities, governs classification and marketing authorization. In the United States, prescription status is determined by the Food and Drug Administration and enforced under the Federal Food, Drug, and Cosmetic Act. Packaging may display "Rx Only" to denote prescription use. Other countries maintain similar frameworks, often requiring professional oversight for administration or dispensing of certain medicines.

Rationale for the designation centers on safety and appropriate use. Requiring medical evaluation, diagnosis, appropriate dosing, and monitoring for adverse effects and drug interactions helps manage risks, ensures suitable indications, and supports pharmacovigilance. The Rx-only category is typically applied to medicines that carry higher risks if misused or misinterpreted, or require monitoring in special populations such as pregnant individuals, the elderly, or patients with comorbidities.

Examples of medicines commonly subject to Rx-only status include antibiotics, many systemic therapies, several antidepressants, sedatives, certain analgesics, biologics, and other high-risk or closely monitored products, though exact classifications vary by country and product.