The FDA regulates drugs.
Generally considered to have been officially established in 1927, the Food and Drug Administration is the U.S government agency responsible for controlling and supervising the safety of food, drugs, cosmetics, tobacco products, biopharmaceuticals, medical devices, veterinary products and eletromagnetic radiation-emitting devices (ERED). It is even responsible for some regulations that are not categorically related to food and drugs, such as disease control on products regarding certain household pets to sperm donation. As it applies to drugs, the FDA has various regulations depending on whether the drug is over-the-counter (OTC) or controlled (requiring a prescription).
Controlled Drugs
Any drug that is designated as a controlled drug must be dispensed by prescription only. There are, of course, exemptions in emergency situations, but these are are closely regulated by other sublaws. Furthermore, these controlled drugs must carry a warning on the label when given out to the patient. It must read "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed." However, the label is not required for controlled drugs used in blind clinical investigations.
Over-the-Counter Drugs
An over-the-counter drug must be manufactured in compliance with approved good manufacturing practices, and the establishment where the drug is manufactured must be registered. In addition, it must have a "uses" section that describes the established uses of the drug under appropriate testing so the patient is aware of the definite application of the drug. Furthermore, all drugs must have a general warning reading "Keep out of reach of children," highlighted in bold font.
Drug Advertisements
The FDA even regulates the advertisement of drugs. Under its laws, the advertisement of a prescription drug must present a true statement that briefly summarizes its side effects, cautions, special considerations and important notes. This includes advertisements done through media such as television, radio, and telephone communications. Furthermore, it is prohibited to misrepresent any information regarding the ingredients of the drug or the dosage required. All ingredients must be listed in the same order as they are on the drug packaging, and the inactive ingredients cannot be portrayed to be a significant constituent.
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