Regulatory Agency: Food and Drug Administration Essay

1617 Words Jan 25th, 2011 7 Pages
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
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The 1990s also brought about changes in requirements for pediatric drug safety in the form of the Pediatric Rule in 1998. The 1990s also brought about change in drug testing in women of childbearing age, which the FDA banned in 1977. This change opened drug studies to participants of both genders, regardless of age (FDA Milestones, 2006). The year 2000 brought about the reversal of the FDA’s ruling and regulation of tobacco as a drug. Further protection for children came in 2002 through the Best Pharmaceuticals for Children Act, which further improved the efficiency and safety of drugs for children. In 2003, drugs marketed for use in animals came under the FDA protection umbrella. The Animal Drug User Fee Act helped to ensure the safety of drugs used in veterinary settings. In 2004, in response to potential terrorist attacks, the BioShield Act allowed the FDA to expedite the approval process of drugs to treat potential chemical, nuclear, and biological contaminations (FDA Milestones, 2006).
Source and Scope of Authority The Federal Government regulates the FDA’s actions and is the source of its authority. Since its inception, the FDA has been under federal regulation. The first regulation was through the department of agriculture, then Public Health Service, and finally through the Department of Health and Human Services. These various federal departments of regulation have each contributed to the
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