Skip to main content icon/video/no-internet

In the United States, therapeutic drugs are classified into two categories: prescription drugs and over-the-counter (OTC) drugs. OTC drugs, or nonprescription drugs, refer to those drugs that can be obtained without a prescription. Often OTC drugs began as prescription drugs and were later switched to OTC status. These drugs are used to treat a wide range of health ailments such as bodily aches, coughs, colds, allergies, and heartburn.

There are currently more than 300,000 OTC products that include about 800 active ingredients that constitute one of the more than 80 therapeutic classes of OTC drugs. Six out of every 10 medications bought by consumers are OTC drugs. Often, OTC drugs have the same ingredients as a prescription drug, but have a much lower dose of the active ingredient. Examples of OTC classifications include antacids, analgesics, cold remedies, stimulants, sedatives, laxatives, allergy drugs, and weight control products. OTC drugs also include more than just medications. For example, toothpaste, antiperspirants, eye drops, and sunscreens are all examples of products that are considered OTC drugs.

Characteristics of OTC drugs generally include that their benefits outweigh their risks, the potential for misuse and abuse is low, and the consumer can use them for self-diagnosed conditions without the need of a health practitioner to evaluate the safe and effective use of the product.

In the United States, regulation of OTC drugs is under the auspices of the Food and Drug Administration. Access to nonprescription drugs has many potential benefits, such as improved accessibility, reduced drug costs, fewer visits to healthcare providers, and improved autonomy in self-care. Conversely, potential disadvantages include risks related to misdiagnosis, misperceptions of safety, poorer compliance, and the risk of abuse. OTC drugs should not be confused with dietary supplements, which do not fall under the same regulations.

Regulation

While OTC regulation may vary by country, the common function of regulatory agencies is to protect the health and safety of the general population. OTC regulation is aimed at ensuring the safety, efficacy, and quality of the therapeutic goods that are marketed to the public. OTCs are regulated at the national level in some jurisdictions and at the state and/or national level in others. In most jurisdictions therapeutic goods must be registered before they are allowed to be marketed, and there is usually some differentiation between prescription and over-the-counter classification. In many countries, a third class, behind-the-counter (BTC) drugs, refer to those drugs that do not require a prescription, but do require a pharmacist's approval for dispensing. While this practice exists in the United States, BTC is not an official category. In the United States, OTC drugs are regulated at the national level by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) Office of Nonprescription Drug Products. Other agencies are involved in specific aspects of OTC monitoring, including the U.S. Federal Trade Commission, which has authority in OTC advertising, and the U.S. Consumer Product Safety Commission (CPSC), which provides leadership and guidance on regulatory and scientific issues to Congress; state legislatures; and federal, state, and international government agencies.

...

  • Loading...
locked icon

Sign in to access this content

Get a 30 day FREE TRIAL

  • Watch videos from a variety of sources bringing classroom topics to life
  • Read modern, diverse business cases
  • Explore hundreds of books and reference titles

Sage Recommends

We found other relevant content for you on other Sage platforms.

Loading