Governmental regulations exist at both the federal and the state level. At the federal level, the U. S. Food and Drug Administration (FDA) is responsible for enforcing the regulations for human cells, tissues, and cellular-and tissue-based products. Cellular products are regulated either under cGTP 21CFR 1271, cGMP 21 CFR 210, or in part under the device regulations. Cell therapy products that are more than minimally manipulated (including all gene therapy products) most often need an FDA IND exemption and at least Institutional Review Board (IRB) approval before use. Some states have developed licensure processes, certificate programs, and so on, but other states have few specific regulations.

There are three voluntary professional organizations that set standards and accredit various components of hematopoietic stem cell transplantation (HSCT). The three foundations are Foundation for the Accreditation of Cellular Therapy (FACT), The American Association of Blood Banks (AABB), and the National Marrow Donor Program (NMDP).

Foundation for the Accreditation of Cellular Therapy is a partnership between two organizations, one that is based on clinical outcome and the other that is laboratory based. Combined, they provide minimal guidelines and standards to all sources and phases for facilities and individuals who perform HSCT. It is important to know your program's specific regulations under FDA, state, and other voluntary accredited programs.