Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
Blood for transfusion is a drug or, more specifically, a biological medicine.1 The US Food and Drug Administration regulates blood for purity, potency, and safety under the Food, Drug, and Cosmetic Act of 1938. Regulatory authorities in most developed countries prescribe blood collection, storage, testing, labeling, and intended use. Facilities for blood component “manufacture” are licensed and inspected for compliance with current good manufacturing practices. Where blood differs from small-molecule pharmaceuticals and recombinant biologics is in its unit-to-unit heterogeneity (batch variability). Although blood donors are qualified as suppliers of “raw material” by rigorous selection and testing standards, each donor is biologically distinct. Therefore, every unit of blood is considered its own batch. Despite the acknowledged batch variability, unit-to-unit differences are not expected to be so significant as to affect transfusion outcomes. However, the association of donor characteristics with transfusion outcomes has not been carefully investigated.
Klein HG. Blood Donor Demographics and Transfusion Recipient Survival—No Country for Old Men?. JAMA Intern Med. 2016;176(9):1315-1316. doi:10.1001/jamainternmed.2016.3355