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What about Rules and Regulations?

  • The rules and regulations that processors of bovine serum must respect are complex and change often. For detailed information click here
  • Some regulations directly affecting finished bovine serum, apply to other materials of animal origin as well. They are in place to ensure that the movement of products from one country to another, and their subsequent manipulation, does not pose a risk to animal or human health.
  • When bovine serum, or other materials of animal origin, are used in the manufacture of products such as pharmaceuticals, additional rules are in place to ensure that the material can safely be used in its intended application.



  • Export and import of animal by-products such as bovine serum necessarily involves collaboration between different national and international regulatory bodies.
  • Information on the animal health status of countries/regions provided by the WOAH is the basis upon which decisions relating to the movement of animal by-products are made.
  • Veterinary controls worldwide are often based upon the rules and regulations established by the United States Department of Agriculture (the USDA) and by the European Commission – the two largest global markets for animal-derived products being the USA and Europe.


Use in the Manufacture of Human and Animal Medicinal Products

  • Bovine serum has a long and extensive history of safe use in the manufacture of human and veterinary pharmaceutical products and in other applications as well.
  • Serum (together with other animal-derived materials) destined for use as a raw material in the manufacture of medicinal products is subject to particularly stringent additional requirements relating to quality and safety.
  • Numerous regulatory bodies worldwide are involved in setting standards and defining requirements that impact bovine serum either directly or indirectly.
    • In the USA these are the USDA, the Food and Drug Administration (FDA) and the United States Pharmacopoeia.
    • Both USDA and FDA have in place regulations that address in detail the control of bovine serum that is to be used in the manufacture of medicinal products.
    • In Europe the bodies are the European Commission, the European Directorate for the Quality of Medicines and Healthcare (EDQM which is responsible, for the European Pharmacopoeia) and the European Medicines Agency (EMA).
  • Scientific advice is also issued by supra-national organizations such as the World Health Organization (WHO) and the World Organization for Animal Health (WOAH).


Click here to see the previous section, FBS Availability and Uses

Click here to see the next section, How to Mitigate Risk using FBS

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