FDA GUIDANCE GIVES RECOMMENDATIONS ON RECONSTITUTING BLOOD PRODUCTS

The FDA has issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood for treatments for hematological malignancies.

The guidance specifies the procedures and appropriate regulations that govern preparing a biologics license application for placental and umbilical cord products, focusing on current good manufacturing practice (cGMP) requirements.

The covered products must be minimally manipulated and intended for hematopoietic reconstruction in patients with hematological malignancies who are unrelated to the donors. These products are known as hematopoietic progenitor cells, cord (HPC-C).

Because the FDA considers umbilical or placental blood collected to process into HPC-C an intermediate product, the agency lacks specific manufacturing regulations. The guidance specifies the sections of the Federal Food, Drug and Cosmetic Act that must be followed to conform to cGMPs.

Most applicable cGMP regulations are found in 11 subparts of 21 CFR Part 211, the guidance says. The subparts cover information on personnel, buildings, equipment, labeling and returned drug products.

The draft guidance can be viewed at www.fda.gov/cber/gdlns/cordbld.pdf (http://www.fda.gov/cber/gdlns/cordbld.pdf).