Regulatory Agency: Food and Drug Administration
Regulatory Agency: Food and Drug Administration
Victoria Steele
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
Victoria Steele
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
References: Axcan Pharma. (2010). Product update: Questions and answers. Retrieved August 21, 2010 from http://www.axcan.com/patient_product_qa.php?lang=1. FDA. (2010). About the FDA organization charts. Retrieved August 20, 2010 from http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/default.htm. FDA. (2010). FDA fundamentals. Retrieved August 20, 2010 from http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm. FDA Milestones. (2006). FDA Consumer, 40(1), 36. Retrieved from MasterFILE Premier database.