Monday, 9 January 2012

FDA Regulations on Cord Blood Banking

The Food and Drug Administration has outlined regulations governing the collection and storage of cord blood, as well as the use of stem cells from within cord blood under Title 21 Part 1271 of the Code of Federal Regulations.  Otherwise known as the Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) section, the legislation governs the use of biologics intended for therapeutic purposes in humans.

These regulations define HCT/Ps as "articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient."  Amongst other items, the regulations also include some provisions governing registration and listing requirements for establishments that manufacture and process HCT/Ps.  These provisions discuss donor eligibility and recommend current good tissue practises.  These stages include harvesting, processing, manufacture, storage, labeling, packaging, and distribution and are intended as methods to prevent the introduction, transmission and spread of communicable diseases in humans.

If you are seriously considering processing and storing your child's cord blood, then please take the time to make sure you have read the regulations and understand them.

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