Over-the-counter (OTC) drugs are medicines that may be sold without a prescription, in contrast to prescription drugs. In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" are required to obtain a New Drug Application ("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective ("GRAS/E") from this requirement. The Federal Trade Commission regulates advertising of OTC products. This is in contrast to prescription drug advertising, which is regulated by the FDA.
The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The programs for FDA safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency.
For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety. It regulates other products with a set of published standards enforced with a modest number of facilities inspections. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drugs are available only by prescription by default. A change to Over the Counter (OTC) status is a separate process and the drug must be approved through an NDA first.
A drug that is approved is said to be "safe and effective when used as directed."
The Drug Enforcement Administration (DEA) is a United States Department of Justice law enforcement agency tasked with combating drug smuggling and use within the U.S. Not only is the DEA the lead agency for domestic enforcement of the drug policy of the United States (sharing concurrent jurisdiction with the Federal Bureau of Investigation), it also has sole responsibility for coordinating and pursuing U.S. drug investigations abroad. The DEA has a registration system in place which authorizes medical professionals, researchers and manufacturers access to "Schedule I" drugs. Authorized registrants receive a "DEA number" that is to be solely used for tracking controlled substances. The DEA number, however, is often used by the industry as a general "prescriber" number as a unique identifier for anyone who can prescribe medication.
The U.S. Environmental Protection Agency (EPA or sometimes USEPA) is an agency of the federal government of the United States charged with protecting human health and with safeguarding the natural environment: air, water, and land.
The United States Department of Defense (DOD or DoD) is the federal department charged with coordinating and supervising all agencies and functions of the government relating directly to national security and the military. The organization and functions of the DOD are set forth in Title 10 of the United States Code
