1. Guideline for Quality Assurance in Blood EstablishmentsDocket Number 91N-0450. Center for Biologies Evaluation and Research (HFM-635). Food and Drug Administration. 1995
2. 21 CFR Part 606 Current Good Manufacturing Practice Regulations for Blood and Blood Components. Code of Federal Regulations, Title 21, Volume 7, Parts 600 to 799, 1999.
3. Proposed Approach to Regulation of Cellular and Tissue-based Products. Food and Drug Administration. Docket Number 97N-0068. 1997.
4. Request for Proposed Standards for Unrelated Allogeneic Peripheral and Placental/Umbilical Cord Blood Hematopoietic Stem/Progenitor Cell Products; Request for Comments. 63 FR 2985. 1998.
5. Code of Federal Regulations (Title 21). Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General, 21 CFR 210-211, 1978.