Governmental regulations existat both the federal and state level. At the federal level, the US Food andDrug Administration (FDA) is responsible for enforcing the regulations forhuman cells, tissues, and cellular- and tissue-based products. Cellularproducts are regulated under either cGTP 21CFR 1271, cGMP 21 CFR 210, or inpart under the device regulations. Cell therapy products that are more thanminimally manipulated (including all gene therapy products) most often needan FDA IND exemption and at least Institutional Review Board (IRB) approvalbefore use. Some states have developed licensure processes, certificateprograms, and so on, but other states have few specific regulations.

There are three voluntaryprofessional organizations that set standards and accredit variouscomponents of hematopoietic stem cell transplantation (HSCT). The threefoundations are the Foundation for the Accreditation of Cellular Therapy(FACT), the American Association of Blood Banks (AABB), and the NationalMarrow Donor Program (NMDP).

The Foundation for theAccreditation of Cellular Therapy is a partnership between twoorganizations, one based on clinical outcome while the other is laboratorybased. In concert, they provide minimal guidelines and standards to allsources and phases for facilities and individuals who perform HSCT. It isimportant to know your program’s specific regulations under FDA, state, andother voluntary accredited programs.