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Federally licensed plasma collection and manufacturing organizations

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Organizations and facilities need FDA licenses for either plasma collection or the manufacture of derivatives from plasma, or both, depending on the activities they conduct. In the past decade, this system has undergone considerable consolidation.

Countries other than the United States have nonremunerated plasma donor programs; however, few, if any, of these provide all of the plasma needs. The US system of paid plasma donors produces about 80% of the US and 60% of the world’s plasma supply [35]. Thus, the United States is a major exporter of plasma or finished product derivatives.

Transfusion Medicine

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