title: Blood safety. The Food and Drug Administration's role.
abstract: The federal government has a role in protecting consumers from threats to the blood supply. These threats range from the residual risks of known infection, to emerging infections that may contaminate the blood supply, to complacency in the area of adherence to product standards and Current Good Manufacturing Practices. The Food and Drug Administration is tasked with oversight of the safety of the nation's blood supply. The Food and Drug Administration's regulation of blood and blood components includes preapproval for products entering interstate commerce and adherence to Current Good Manufacturing Practices for all blood components. Oversight for Current Good Manufacturing Practices compliance includes inspection and reporting requirements. These regulatory programs are coupled with the Public Health Service's ongoing research and epidemiological surveillance. The goals of these programs are to prevent another infectious disease epidemic from infecting the blood supply as did the acquired immunodeficiency syndrome in the early 1980s and to further improve blood safety.
authors.affiliation: Division of Blood Applications, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD 20852-1448, USA.
authors.forename: M
authors.initials: M
authors.lastname: Gustafson
mesh_terms: D001803:Blood Transfusion / Q000331:legislation & jurisprudence / Q000592:standards; D003140:Communicable Disease Control / Q000331:legislation & jurisprudence* / Q000592:standards; D003141:Communicable Diseases / Q000635:transmission; D006801:Humans; D065227:Transfusion Reaction; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D014492:United States Public Health Service