The FDA decides whether a drug product may be sold without a prescription or over the counter. The legal basis is the misbranding provision of the FDCA. A prescription-only drug must bear the prescription legend, limiting sale to prescription only. The substantive basis for this decision is, briefly, whether the product can be labeled adequately for a layman to recognize indications for the drug, to understand its directions for use, and to use it safely.
Appropriate indications for use of a nonprescription medicine are self-limiting problems, such as coughs and colds. The FDA decides whether a layperson should be able to discriminate these from serious diseases that may have similar symptoms in their early stages. So, for example, labeling of nonprescription cough preparations includes warnings to consult a doctor if the cough is accompanied by certain other symptoms or if it persists.
The FDA has authority to regulate advertising of prescription medications to professionals and laymen, but only limited authority over the advertising of nonprescription drug products. Advertising of OTC drugs is actually under the authority of the Federal Trade Commission. Claims made for nonprescription drugs should have a scientific basis, and corrective advertising can be required by the FTC. For example, Warner-Lambert once claimed that Listerine mouthwash prevents colds and sore throats. The FTC found this claim to be unsubstantiated and required Warner-Lambert to include a corrective message in subsequent advertising.
Nonprescription medicines are important aspects of medications use for a number of reasons. First, OTC status is not limited to the safest drugs available. An international comparison of which medicines are available without a prescription in various nations of the industrialized world shows that legal, ethical, and political considerations may be as important as safety data. For example, asthma is a dangerous, non-self-limiting disease that requires medical attention. Epinephrine, a potent drug, was approved by the FDA in 1939. Most epinephrine products are prescription-only. However, epinephrine administered by a metered-dose inhaler is available without a prescription for treatment of asthma. (The FDA has expressed concern regarding OTC status for this dosage form.)
Penicillin is very safe (apart from occasional, possibly severe, allergies). It is almost without pharmacological effects in humans. But it is a prescription-only medicine almost worldwide. The conditions that are to be treated with penicillin almost always need medical attention. There would be no reliable means to limit the OTC sale of penicillin in the United States to those few indications that patients can manage for themselves.
A relatively safe drug like famotidine or ranitidine may be classified as prescription-only in one country because experts in that country consider its indications (gastric ulcers or esophageal reflux) to be dangerous for people to treat without medical attention. In another country this issue may not be considered as important, and the drug may be classified as nonprescription.
Second, nonprescription drugs can cause toxicity, side effects, and drug interactions. Aspirin is sold OTC in practically every country, and other more potent drugs in its class are available OTC in most countries. These drugs can cause severe, even fatal, gastrointestinal bleeding. Aspirin affects blood coagulation and interacts with the anticoagulant effect of the prescription drug warfarin. Cimetidine is a safe enough drug to be sold OTC in the United States, but it can interact with a number of other OTC and prescription-only drugs. Perhaps they are OTC because their labeled indications are self-limiting.
In general, in the United States an OTC medicine can be sold in any retail outlet. There are, however, a few exceptions in the United States — schedule V controlled substances and insulin. Controlled substances in schedule V are those with the least potential for abuse. Most are cough suppressants containing codeine or antidiarrheal preparations. They must be sold by pharmacies because of DEA record-keeping requirements.
Federal law provides that insulin can be sold without a prescription. However, many state laws require that it be sold only in pharmacies. A possible third group of pharmacy-only medications in the United States are products that a manufacturer wishes to restrict to sale through a pharmacy or that a pharmacy keeps "behind the counter." Some eyedrops are sold only in this manner. Some other countries maintain a category of pharmacy-only non-prescription drugs that can be sold only in pharmacies or only by pharmacists or trained pharmacy assistants. Some countries do not enforce legal requirements, and prescription-only medications are freely available in pharmacies or even other shops.
Dietary supplements can be legally marketed in the United States without an NDA, if the manufacturer and distributor do not make therapeutic claims for the product that would cause it to fall under the definition of a drug. So-called nutriceuticals are marketed under the Dietary Supplement and Health Education Act of 1994 (DSHEA). Because nutraceuticals are not regulated as drugs and do not require the research needed to support an NDA, scientific data supporting claimed benefit(s) are not always as available for nutraceu-ticals as for traditional pharmaceuticals. Also, rigid quality control standards are not required for nutraceuticals, and substantial variability can occur in both potency and purity.
There is considerable vagueness about the difference between an article intended for use as a drug and one that is promoted for use as a drug. The phrasing of the law in passive voice leaves wide open who would be doing the intending or promoting.
For example, St. John's wort is used by many people in the United States and Europe as an antidepressant. There is clinical literature available to support its use as an antidepressant, with specific dosage recommendations, precautions, etc. Companies that manufacture and distribute it in the United States make claims that it can improve mood. Certainly some people who buy it in the United States intend to use it as a drug under the legal definition. Until the FDA decides that these claims have become therapeutic claims, it can remain a dietary supplement.
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