University of Phoenix
Regulatory Agency: Food and Drug Administration
The regulation of all areas of health care in The United States falls to The United States Department of Health and Human. One such area is the regulation on medications dispensed within the United States. The section of The United States Department of Health and Human Services responsible for regulation on medications is the Food and Drug Administration (FDA). Whereas the FDA has many functions, such as regulation of food, cosmetics, tobacco, and animal medicine, one of the well-known functions of the FDA is pharmacy regulation. The FDA has a long history of ensuring public safety in relation to pharmaceutical medications. History of the Food and Drug Administration
The regulation of the distribution of drugs in the United States dates back to colonial days. The beginnings of drug regulation began with imported drug inspections in 1848. Fourteen years later, in 1862 President Abraham Lincoln started the first regulatory agency, the Bureau of Chemistry, which was a branch of the Department of Agriculture. The Bureau of Chemistry was the predecessor of the modern day FDA (FDA Milestones, 2006). In 1902, Congress passed the Biologics Control Act. The enactment of this piece of legislature was to ensure the safety of products used to prevent and treat disease in humans. The year 1912 saw even more drug regulations with the enactment of the Sherley Amendment, which required truth in labeling on medications to prevent the fraudulent claims of therapeutic benefits of medications (FDA Milestones, 2006). In 1927, the separation of the Bureau of Chemistry into two entities occurred. The government gave the Food, Drug, and Insecticide Administration all regulatory functions, and the government gave Bureau of Chemistry and Soils non-regulatory functions. In 1930, the government changed the name of the regulatory agency removing the word Insecticide from the title and shortened the name to the Food and Drug Administration, known commonly as the FDA (FDA Milestones, 2006). It was in 1937 that the FDA started taking shape into what is the familiar agency of modern times. The deaths of 107 individuals from taking a medication contaminated with a poisonous solvent spurred the 1938 passing of the Food, Drug, and Cosmetic Act (FD&C Act). Congress passed the FD&C Act to mandate the safety of medications before pharmaceutical companies can market them in The United States (FDA Milestones, 2006). In 1940, the Federal Safety Agency took over the functions of the FDA from the Department of Agriculture. This move marks even more regulations on pharmaceuticals by the Federal Government in the interest of public safety. One of these historical legislative moves are the Durham-Humphries Amendment that dictated drugs that a physician had to prescribe and a licensed pharmacy had to distribute, which the FDA enacted in 1951. The year 1962 marked another landmark in FDA history with the restriction of sale of Thalidomide in the United States. The publication of this move sparked public support for stricter regulations on drugs (FDA Milestones, 2006). The 1970s and 1980s brought about even more regulations in ensuring the safety of drug distribution in the United States. The FDA made over-the-counter (OTC) medications safer through stricter requirements on labeling and through the addition of tamper evident packaging. During this time, the FDA also enacted the use of warning labels of potential risks for substances found to cause cancer. In 1988, the government reformed the FDA as an agency under the Department of Health and Human Services and the President of the United States assigned a Commissioner over the FDA (FDA Milestones, 2006). The 1990s also brought about more regulations from the FDA. The FDA classified cigarettes as a “drug delivery device” and...