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  1. Safety & Availability (Biologics)

Security Resources For Manufacturers of Biological Products

The physical security of biological products and the facilities in which they are manufactured and otherwise held is an important public health issue. Effective security can help prevent terrorism, counterfeiting, or tampering activities that could harm United States citizens by, among other things, disrupting medical supplies. Therefore, the physical security of regulated products is an important focus for CBER. The following list of resources may be helpful in protecting facilities and products. Of course, manufacturers are free to research other resources or consult with physical security experts, as necessary.

Food and Drug Administration

Department of Homeland Security

  • Protected Critical Infrastructure Information Program (PCII)

Federal Emergency Management Agency

  • Security Risk Management Publications

Centers for Disease Control

  • Emergency Preparedness for Business

Journal Article

  • "Implementation of Biosurety Systems in a Department of Defense Medical Research Laboratory", Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, Vol. 2, No. 1, 2004.


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