Pharmacy Law History Overview

PHARMACY LAW
History Overview: 1906-Present

Federal Regulation of Medications: Development, Production, and Marketing

The Federal Food, do do drugss and Cosmetic come (FDCA) provides for the comprehensive regulation of all drugs introduced into intestate commerce. The intent of the justice is to protect consumers from adulterated or mislabeled foods, drugs, cosmetics, or devices.

Historical Overview of the FDCA

Pure Food and Drug Act of 1906

The law set asideed the adulteration and misbranding of foods and drugs in interstate commerce. This law fell short of providing the protection the Congress intended.
Examples of this can be United States Vs Johnson, 221 U.S. 488, when the U.S. Supreme Court decision held that the misbranding provision in the law did not prevent false or misdirect efficacy claims. In Johnson, the manufacturer claimed on the label that the drug was effective against cancer, knowing that this representation was false.
The Johnson decision prompted Congress to mend the Pure Food and Drug Act in 1912 to prohibit false and fraudulent efficacy claims. Still, the act failed to achieve its purpose.
condescension public awareness that the 1906 law was inadequate, there was no hot legislation until 1938.



Even though there was a apportion of pressure in building a new law, the atom smasher for this to happen was the sulfanilamide elixir tragedy of 1937. On those times sulfanilamide was single of the first “miracle” anti-infective sulfa drugs marketed. A manufacturer thought of fashioning this drug in its elixir form using Diethylene glycol as the best solvent (now-a-days used only for industrial purposes). The solvent proved to be a deadly toxicant and 107 deaths were ultimately attributed to this elixir. Because the 1906 law had not granted the FDA the authority to ostracize unsafe drugs, the FDA had to remove the product on the basis of a technical misbranding violation- that an elixir must contain alcohol, and the product did not.

FDCA of 1938

With...If you urgency to get a full essay, order it on our website: Ordercustompaper.com



If you want to get a full essay, wisit our page: write my paper