FDA's Regulation of Controlled Substances Term Paper by scribbler

FDA's Regulation of Controlled Substances
A review of the U.S. Food and Drug Administration (FDA)'s regulation of controlled substances.
# 153154 | 2,971 words | 8 sources | APA | 2013 | US

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The paper looks at the history of the U.S. Food and Drug Administration (FDA) and discusses the groups of controlled substances known as narcotics, stimulants, depressants, hallucinogens and cannabis, and the five recognized schedules of controlled substances. The paper discusses the assessments of pharmaceutical producers and the FDA regarding the potential benefits of a drug versus its potential risks and examines the role of the Drug Enforcement Administration (DEA). The paper discusses the Risk Evaluation and Mitigation Strategy (REMS) that goes beyond product labeling to supervise risks, and points out major problems in the present recommended REMS such as the fact that there are no commonly satisfactory definitions for the terms misuse, abuse, overdose and deaths.

From the Paper:

"The U.S. Food and Drug Administration (FDA) is an organization of the U.S. Department of Health and Human Services. It progresses the country's wellbeing by shielding customers against health hazards that typically are beyond a person's power. The agency's beginning goes back to the 1906 publication of Upton Sinclair's novel The Jungle, which portrayed in striking detail the rubbish and unhygienic practices then existing at the Chicago stock-yards. The public's irritated reaction encouraged Congress to pass the Food and Drugs Act of 1906, which was the first federal law designed at stopping interstate commerce in misbranded and adulterated foods, beverages, and drugs. Enforcement of this somewhat limited act was given to the U.S. Department of Agriculture's (USDA) Bureau of Chemistry, which in 1930 developed into the FDA (Food and Drug Administration, 2011).
"The flaw of the law was completely exposed in 1937, when an extensively marketed toxic elixir of sulfanilamide caused the death of 107 people including several children. Subsequent to another outburst of public annoyance, Congress approved the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), which totally renovated and significantly widened the FDA's powers and responsibilities. The law's key necessities required new drugs to be revealed to be secure previous to being marketed; defined contaminated and misbranded food; certified standards of individuality, excellence, and fill-of-container for foods; and sanctioned the FDA to inspect facilities producing regulated products (Food and Drug Administration, 2011)."

Sample of Sources Used:

  • Controlled Substances. (2011). Retrieved February 2, 2011, from Answers Web site: http://www.answers.com/topic/controlled-substances
  • DEA Active Controlled Substances Act (CSA) Registrants Database. (n.d.). Retrieved February 3, 2011, from NTIS Web site: http://www.ntis.gov/products/dea-csa.aspx
  • Food and Drug Administration. (2011). Retrieved February 2, 2011, from Answers Web site: http://www.answers.com/topic/food-and-drug-administration
  • Pain & Policy Studies Group. (2009). Retrieved February 3, 2011, from Web site: http://www.painpolicy.wisc.edu/domestic/REMS.pdf
  • Risk Evaluation and Mitigation Strategies (REMS) - A Brief History. (2009). Retrieved February 2, 2011, from Web site: http://www.paragonrx.com/rems-hub/rems-history/

Cite this Term Paper:

APA Format

FDA's Regulation of Controlled Substances (2013, May 05) Retrieved March 25, 2023, from https://www.academon.com/term-paper/fda-regulation-of-controlled-substances-153154/

MLA Format

"FDA's Regulation of Controlled Substances" 05 May 2013. Web. 25 March. 2023. <https://www.academon.com/term-paper/fda-regulation-of-controlled-substances-153154/>