Regulation of plasma for fractionation in the United States

Plasma for fractionation (PF) to make plasma derived medicinal products is in high demand, particularly in middle- and low-income countries. The World Health Organization (WHO), the Council of Europe (CoE), and most regulatory authorities globally, seek to develop national blood systems based on voluntary unpaid donations and to work towards the goal of self-sufficiency. Currently, however, commercial blood establishments in the United States and elsewhere supply at least 80% of the source plasma used in the world, which they obtain from paid donors. Here we review the regulations and standards of the United States Food and Drug Administration (FDA) and the voluntary standards of the Plasma Protein Therapeutic Association (PPTA) which ensure the safety and quality of PF, and the safety and health of the donor relative to the donation process. Countries that are developing their own national blood systems might consider adopting some of these measures to expand their blood collection to paid as well as voluntary unpaid donors.