FDA Issues Third Set of Regulations for Tissue Banks

FDA on Thursday issued new regulations for tissue banks that process donated skin, ligaments and bones for transplant to help prevent infection and disease, the AP/Seattle Post-Intelligencer reports. The regulations, which will take effect in May, require tissue banks to follow specific steps when they recover, process, label, package and distribute donated human cells, tissues and similar products for transplant. In addition, the rules require tissue banks to report certain adverse reactions, to accurately and completely label products and allow FDA inspections.

Some states regulate tissue banks, but few federal rules exist. The new regulations mark the last of three sets issued by FDA. In January, FDA issued rules that require tissue banks to register with the agency and allow regular inspections. FDA in May issued regulations that require tissue banks to screen donors for certain infectious diseases. "Most tissue transplants are safe and successful, but serious adverse events have occurred," Jesse Goodman, director of the FDA Center for Biologics Evaluation and Research, said, adding, "We believe these rules represent a significant public health advance."

Sen. Susan Collins (R-Maine), who led two hearings of the Senate Government Affairs Committee on federal regulations for tissue banks, said that the rules "are long overdue," adding, "This rule is a major step toward ensuring that tissue contaminated with life-threatening diseases is not transplanted into unsuspecting patients" (Meckler, AP/Seattle Post-Intelligencer, 11/18).