FDA - Food and Drug Administration

The FDA stands for Food and Drug Administration, the department that governs every food and medicinal product. FDA also regulates the Cord Blood under the category of ‘Human Cells, Tissues, and Cellular and Tissue Based-Products’ known as HCT/P’s. Center for Biologics Evaluation and Research (CBER) is the division of the FDA that regulates HCT/P’s. The section that involves FDA regulations for Human Tissue Intended for Transplantation is known as 21 CFR Part 1270. Recently, the FDA announced a Tissue Action Plan that involves three newer rules and their effectuation. These three new rules make up 21 CFR Part 1271:

• On 21 January 2004, it was made mandatory for all the Cord Blood banks to get registered with FDA. This meant that any of the Cord Blood banks that have a laboratory must present themselves on the webpage of the FDA Registered Establishments.
• The second rule was announced on 20 May 2004 that came into action on 25 May 2005 that referred to the donor eligibility. When it is cord blood, the donor is baby but the rule then required more screening of donors for some contagious diseases. The alteration was that that according to previous standards the blood was screened for HIV I & II and Hepatitis B & C but now they must also be screened for syphilis, CMV, HTLV, CJD and vCJD that made the donation more reliable.
• The final rule that FDA established was the standards of current Good Tissue Practice (GTP) for the laboratories that process HCT/P’s. The final rule was issued on 19 November 2004 but came into action on 25 May 2005. The rule was meant to keep contamination or cross-contamination while handling HCT/P’s.

All these FDA rules are applied to only those cord blood processes that were done on or after 25 May 2005. The final rule empowers FDA inspecting any cord blood laboratories to determine compliance with an important provision of 21 CFR Part 1271. A review of FDA inspections of HCT/P facilities were confronted in AABB meeting on 23 October 2006 that stated that a total of 1960 HCT/P establishments have been registered with the FDA and out of them, 30% or 603 were devoted to PBSC – Peripheral Blood Stem Cells or cord blood (page 5). Furthermore, during October 2005 to July 2006, thirty of those establishments were inspected (page 25) and out of them, ten were issued FDA – 483 citations. This citation can be considered as a typical average rate for the tissue industry (page 24). However, the commonest causes of citations (page 29) lack of sufficient documentations that describes procedures.
This comprises the summary of the FDA regulations for umbilical cord blood that is banked for family use. When a patient gets umbilical cord blood from the Public Cord Blood Bank, it is generally from a donor who is unrelated and there the hospital where the patient has been treated should be having a clinical trial registered with Investigational New Drug status (refer IND section).
Overall, when the Stem Cells from the umbilical cord blood are manipulated in a way that it can be considered something related to administration of the drug, they should processed under GMP regulations that are summarized as below