Hospitals, Blood Centers, and Licensing — Keeping Blood Safe and Available
Blood donation and transfusion are highly regulated to ensure the safety, quality, and reliability of the blood supply for patients in hospitals. In the United States and many other countries, organizations that collect, test, process, and distribute blood products — including blood centers and hospital transfusion services — must follow strict federal standards and register or obtain licenses with regulatory agencies such as the U.S. Food and Drug Administration (FDA). These requirements help ensure that every unit of donated blood is safe, properly handled, and suitable for use in medical care.
Hospitals rely on licensed blood establishments and accredited blood banks to supply blood and blood components for surgeries, trauma care, cancer treatments, and other medical needs. Licensing and oversight include facility inspections, adherence to manufacturing and testing rules, and ongoing reporting to maintain high safety standards. This regulatory framework protects both donors and recipients while supporting a consistent, dependable blood supply for healthcare systems.
