Hematopoietic stem cell (HSC) transplantation is a promising therapy for cancer, leukemia, and a variety of non-malignant diseases. Standard-setting for this field has been spurred by increased availability of novel HSC sources (e.g., umbilical cord blood from unrelated donors), increasing complexity of laboratory processes used to manipulate the graft, heightened awareness of infectious disease transmission by biologic products, increased recognition by third-party payers of HSC transplantation as a covered health benefit, and growing emphasis on quality improvement programs in health care. Many aspects of HSC transplantation are now subject to regulatory oversight by the US Food and Drug Administration (FDA). In 1997, the FDA published “A proposed approach to the regulation of cellular and tissue-based products” (Fed Regist 1997;62:9721), which outlined a graded approach to regulation based on risk to the recipient of a particular tissue source and its intended use. For HPC products from autologous or related donor sources that are “minimally manipulated”, regulatory requirements would consist of facility registration and listing of products with the FDA, and certification that the facility meets professional standards. More extensively manipulated products and those from unrelated donors would be subject to more stringent requirements, including use of the investigational new drug (IND) or biologics license application (BLA) mechanism for product licensure. The two professional organizations in the US most engaged in development of standards and accreditation for HSC transplantation are the American Association of Blood Banks (AABB) and the Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT). AABB's HSC standards were first published in 1991 as part of the 14th edition of the Standards for Blood Banks and Transfusion Services but were later developed in 1996 as a freestanding volume. In 2000, the 2nd edition of those standards were published as Standards for Hematopoietic Progenitor Cell Services, which presents a matrix of quality management and technical requirements based on the ISO 9000 approach. FAHCT's Standards for Hematopoietic Progenitor Cell Collection, Processing, and Transplantation were also published in 1996, the product of combining the laboratory standards of the International Society of Hematotherapy and Graft Engineering (ISHAGE) with the clinical standards of the American Society of Bone Marrow Transplantation (ASBMT). Other than the inclusion of clinical transplantation requirements in FAHCT's standards and the ISO 9000 format of AABB's standards, the two sets of standards are fully compatible with regard to donor screening, collection, processing, storage, and distribution of HSC products. The National Marrow Donor Program (NMDP) began in 1987 to facilitate HSC transplantation between unrelated donor and recipient pairs, and immediately established a standards-setting and accreditation process applicable to all donor recruitment, collection, and transplant centers associated with the registry. While less elaborate than those of AABB and FAHCT with regard to laboratory processing, NMDP standards emphasize requirements for donor screening and certification of expertise in the transplant center.