USLegal:Over-the-counter

Over-the-counter, or OTC, is the United States legal status of a medicine that the law permits to be sold directly to the public, without a prescription, for use according to its labeling.

Like the prescription category, the over-the-counter category was given its modern statutory shape by the Durham-Humphrey Amendment of 1951, which amended the Federal Food, Drug, and Cosmetic Act of 1938 to divide medicines into those that require a prescriber and those that do not. A medicine is over-the-counter precisely when it falls outside the prescription test: when it can be used safely and effectively by the public with no professional supervision, given adequate labeling.

For most of the twentieth century the safety and effectiveness of the thousands of over-the-counter products already on the market had never been systematically reviewed. Beginning in 1972 the Food and Drug Administration undertook the OTC Drug Review, a decades-long evaluation of over-the-counter ingredients by therapeutic class. It produced the system of over-the-counter monographs: rule-like standards that set, for each class, the active ingredients, doses, labeling, and indications under which a product is recognized as safe and effective and may be marketed without separate approval. The monograph system was overhauled by the CARES Act of 2020.

Statutory and regulatory basis

Over-the-counter status rests on the Federal Food, Drug, and Cosmetic Act. A medicine that does not meet the prescription test of 21 U.S.C. § 353(b) is, by default, an over-the-counter medicine. Most over-the-counter medicines reach the market under a monograph rather than through individual premarket approval; the monograph process is now governed by section 505G of the Act, 21 U.S.C. § 355h, enacted by the over-the-counter monograph reform provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020. Over-the-counter medicines must bear the standardized "Drug Facts" panel required by Food and Drug Administration regulation.

Criteria

A medicine is suitable for over-the-counter status when a person can, from the labeling alone, select it correctly, use it safely, and recognize when to stop or to seek a prescriber. This generally requires that the condition treated be one a person can identify without a diagnosis, that the medicine have a wide margin of safety at the labeled dose, that it carry a low potential for harm through misuse, and that it not require laboratory or clinical monitoring. A medicine first approved as prescription only may be moved to over-the-counter status through the Rx-to-OTC switch process when evidence shows these conditions are met.

In practice

An over-the-counter medicine may be bought without a prescription and without the involvement of a pharmacist. A subset of over-the-counter medicines are kept "behind the counter": sold without a prescription but stored where a pharmacy staff member must retrieve them, sometimes with a quantity limit or an identification check. The most prominent example is pseudoephedrine, placed behind the counter nationwide by the Combat Methamphetamine Epidemic Act of 2005 because it can be diverted to the illicit manufacture of methamphetamine. Over-the-counter status is independent of insurance coverage; many over-the-counter medicines are paid for out of pocket.

Medicines in this status

The medicine pages that carry the over-the-counter legal status are indexed here.