|Title:||The Early years of federal food and drug control (A Fischelis publication on recent history and trends of pharmacy)|
|Format:||txt lrf lrf mobi|
|ePUB size:||1489 kb|
|FB2 size:||1925 kb|
|DJVU size:||1248 kb|
|Category:||Cooking Education and Reference|
|Publisher:||American Institute of the History of Pharmacy with the cooperation of the American Pharmaceutical Association (1982)|
In The Early Years of Federal Food and Drug Control, 8-27. Madison, Wi. American Institute of the History of Pharmacy, 1982 (on the coming of the federal statute that brought vaccines, sera, and antitoxins under regulation). Korwek, Edward L. "Human Biological Drug Regulation: Past, Present, and Beyond the Year 2000. Food and Drug Law Journal 50, Special Issue (1995): 123-150. American Institute of the History of Pharmacy, 1982 (how the United States Pharmacopoeia and the National Formulary became official drug compendia under the 1906 act).
This article is about the history of the United States Food and Drug Administration. Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances.
Published online: 16 August 2012. Mary E. Fissell, Patients, power and the poor in eighteenth-century Bristol, Cambridge History of Medicine, Cambridge University Press, 1991, pp. xi, 266, illus.
For almost 70 years, federal legislation has been impacting the practice of pharmacy. In almost every case, the purpose of this legislation has been to protect the health, safety, and welfare of the patient from the potential risks of drug use or misuse. Most of this federal legislation has been initiated in response to issues and concerns at a certain point in time. For example, the Federal Food, Drug, and Cosmetic (FDC) Act passed by Congress was done as a safety concern because of the deaths of over 100 individuals who consumed a drug product containing antifreeze.
Federal controls over the drug supply, namely banning the importation of adulterated drugs, started in 1848. Thirty years later a drug tragedy in which over 100 people were killed by a poisonous solvent used to dissolve the wonder drug sulfanilamide, greatly dramatized the need to broaden existing legislation and ensure product safety before marketing. One of the Bureau's early laboratories is shown here. After the passage of the Food and Drugs Act in 1906, which forbade adulteration and misbranding of foods, drinks, and drugs in interstate commerce, the Bureau of Chemistry was given the task of investigating violations and preparing cases for the courts. In 1927 a separate law enforcement agency, the Food and Drug Administration, was formed.
Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848. The following chronology describes some of the milestones in the history of food and drug regulation in the United States. Eleven physicians meet in Washington, . to establish the . Pharmacopeia, the first compendium of standard drugs for the United States.
1938 Federal Food, Drug and Cosmetic (FD&C) Act Tragedy:Sulfanilamide made with poisonous solvent causes 107 deaths. Result:Requires manufacturers to prove the safety of products before marketing. 1941 Two unrelated events Insulin Amendment requires FDA to test and certify purity and potency of insulin. Tragedy:nearly 300 deaths and injuries from distribution of sulfathiazole tablets tainted with phenobarbital. Result:FDA revises manufacturing and quality controls drastically,the beginning of what will later be called GMPs
Pharmacy refers to the health care related profession that deals with both the fields of health science as well as chemistry . The word pharmacy was coined from the Greek word pharmakon meaning medicine or drug. Therefore, a pharmacist is a medicine or drug man. While the classes of professionals legally permitted to prescribe medications are physicians, dentists, veterinary doctors and senior registered nurses, pharmacists are required by law to be experts in the preparation, preservation, distribution, and handling of drugs. Some notable nations contributed to the development of the medical profession in the early times. Important amongst them are.
Pure food" became the rallying cry among a divergent group of campaigners who lobbied Congress for a law regulating foods and drugs. James Harvey Young reveals the complex and pluralistic nature not only of that crusade but also of the broader Progressive movement of which it was a significant strand.
Throughout history, governments have regulated food and drug products. Federal regulation of the industry began on a large scale in the early twentieth century when Congress enacted the Pure Food and Drugs Act of 1906. The regulatory agency spawned by this law – the . Food and Drug Administration (FDA) – now directly regulates between one-fifth and one-quarter of . gross domestic product (GDP) and possesses significant power over product entry, the ways in which food and drugs are marketed to consumers, and the manufacturing practices of food and drug firms. Finally, in 1902 Congress enacted the Biologics Control Act to regulate the safety of vaccinations and serums used to prevent diseases in humans. The 1906 Pure Food and Drugs Act and the 1906 Meat Inspection Act.