What is required for a drug to be switched from prescription to over-the-counter status?

For a drug to be switched from prescription to over-the-counter (OTC) status, it must have a proven record of safety. This requirement ensures that the medication can be used safely without the supervision of a healthcare professional. The safety profile of the drug is crucial because OTC medications need to be safe for self-medication by the general public in a variety of situations, including without the guidance of a health care provider.

The evaluation process for a switch from prescription to OTC involves an assessment by regulatory authorities, which includes reviewing evidence that the product is safe for consumer use under the conditions specified on the label. The record of safety must demonstrate that the benefits of making the drug available without a prescription outweigh the risks, thereby allowing consumers to use it effectively without professional oversight.

Other factors, such as consumer demand or marketing studies, may influence the decision-making process but are not formal requirements. Votes from healthcare professionals may provide insight or advocacy for a change, but ultimately, the switch hinges primarily on the safety and efficacy of the drug.