ROCKVILLE, Md.-In hopes of assuring safe, contamination-free use of human cells and tissue in medical procedures, the Food and Drug Administration (FDA; ww.fda.gov) has put into effect a series of new rules for “Good Tissue Practice” (GTP)-including the methods, facilities and controls used to manufacture such products as corneas, heart valves, musculoskeletal tissue, and cellular therapies.

As of May 25, biotech manufacturers are required to recover, process, store, label, package, and distribute human cells, tissue, and cellular and tissue-based products in a way that prevents introduction or spread of communicable diseases. The rule also requires manufacturers to report adverse reactions and product deviations, to have labeling that contains accurate and complete information, and to allow FDA inspections to ensure compliance with regulations.

Another related rule, finalized more than a year ago but not going into effect until this May, focuses on donor screening and testing measures to help prevent use of contaminated tissue having the potential to transmit infectious diseases. An earlier rule concerning registration and listing for manufacturers of human cellular and tissue-based products went into effect in January 2004.

“Together, these three rules will improve public health and, equally important, increase confidence in these new technologies,” says FDA Commissioner Dr. Lester Crawford. Comment from industry as well as health professionals and consumers went into the FDA’s final ruling.

The new GTP regulations expand upon initial human-tissue rules established by the FDA in 1993, which included the requirement that tissue donors be tested for communicable diseases such as HIV and hepatitis. The FDA says the latest GTP rules provide more comprehensive protection to prevent the transmission of communicable diseases, including the flexibility to deal with new and emerging infectious disease threats. III