What is required for hospital blood banks that collect blood but do not ship across state lines?

For hospital blood banks that collect blood but do not ship across state lines, registration with the FDA is a fundamental requirement. The FDA regulates blood banks to ensure the safety and efficacy of the blood supply. Registration serves as a means for the FDA to maintain oversight of the facilities that are involved in blood collection, processing, testing, and storage, even if the blood is not transported across state lines.

This registration is a necessary step for compliance with federal standards, ensuring that the facility meets the essential operational and safety protocols established by the FDA. While other aspects like accreditation by organizations such as AABB or inspection by CAP and JCAHO are beneficial and can serve to enhance the quality and safety of the blood bank's operations, they are not mandatory for facilities that do not engage in interstate commerce. Therefore, registration with the FDA is the correct requirement in this specific context.