Regulations and Regulatory Mechanisms Related to Transfusion Medicine in the United States of America
In the United States of America (US), federal regulation of blood-related products began with “therapeutic serum” defined under the Virus, Serum and Toxins Act of 1902, which was passed in response to an occurrence of tetanus contaminated diphtheria anti-toxin. Subsequently, in reaction to shocking public disclosures of worthless and dangerous patient medications, the US Congress passed the Food and Drug Act of 1906. This law provided the first legal definition of a drug subject to regulation, and declared that drugs distributed in interstate commerce may not be misbranded, adulterated, poisonous or deleterious. Additional authority to regulate blood and blood products was derived by consideration of blood as a drug under this act, although this indirect authority was later successfully contested in court.
KeywordsHuman Immunodeficiency Virus Type Blood Product Source Plasma Product Claim Interstate Commerce
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