ABSTRACT

Regulations are the site of the real action. A glance at the Code of Federal Regulations (CFR), wherein all Federal Regulations are compiled in excruciating detail, will demonstrate how busy the Regulators have been; a possible portent for the future. There are many Federal Agencies which promulgate Regulations. For purposes of this text, the most important, by far, is the Food and Drug Administration (FDA). The FDA was originally a part of the Department of Agriculture but was moved in 1940 to the Department of Health Education and Welfare, now the Department of Health and Human Services. Regulation of Drug Promotion had been the responsibility of the Federal Trade Commission until 1967, when it was moved to the FDA. The Federal Communications Commission works closely with the FDA on direct-to-consumer Rx Drug Advertising. The Drug Enforcement Administration was established in 1973 under the Nixon Administration. Its basic charge is to prevent the distribution of illegal narcotics.