Regulations and Regulatory Mechanisms Related to Transfusion Medicine in the United States of America

  • J. S. Epstein
Chapter
Part of the Developments in Hematology and Immunology book series (DIHI, volume 27)

Abstract

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.

Keywords

Human Immunodeficiency Virus Type Blood Product Source Plasma Product Claim Interstate Commerce 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Leitman SF, Klein HG, Melpolder JJ, et al. Clinical implications of positive tests for antibodies to human immunodeficiency virus type 1 in asymptomatic blood donors. N Engl J Med 1989;321:917–24.PubMedCrossRefGoogle Scholar
  2. 2.
    Wells MA, Wittek AE, Epstein JS, et al. Inactivation and partitioning of human T-cell lymphotropic virus, type III, during ethanol fractionation of plasma. Transfusion 1986;26:210–3.PubMedCrossRefGoogle Scholar
  3. 3.
    Alter H, Epstein JS, Swenson S, et al. Determination of the prevalence of HIV-1 p24 antigen in US blood donors: Assessment of efficacy for blood donor screening. N Engl J Med 1990;323:1312–7.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 1992

Authors and Affiliations

  • J. S. Epstein

There are no affiliations available

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