Regulatory Oversight of Human Tissue

When the tissue bank industry emerged, federal regulations were nonexistent. Even though tissue transplantations are similar to organ transplantations, the two entities are treated completely differently. Traditionally, organs have been thoroughly regulated by the federal government and individual state governments. The same cannot be said for human tissue (Williams et al., 2014). Until 1993, the idea of regulating the tissue industry was foreign. The government did not have regulations for tissue banks until the 1990s, when it was discovered there was a need to protect the public from the possibility of transmitting disease through tissue transplants. Even with this pressing need, it still took years to enact regulations.

Today, human tissue is regulated by the Center for Biologics Evaluation and Research (See 21 C.F.R. ยงยง 1270-1271). The federal regulations act as a base for the state regulations to stand on. The regulations created by the states require that tissue banks comply with federal regulations, but often the state regulations appear more specific and better enforced. The states appear to give additional protection and instructions to tissue banks than the federal regulations do. Florida, New York, Maryland, and California have enacted their own state regulations and standards for tissue banks that operate in their states. In addition, the American Association of Tissue Banks has its own voluntary regulations and accreditation guidelines for all tissue banks. In order to legally comply with federal regulations, tissue banks must register with the U.S. Food and Drug Administration. Many do not register, and thus exist under the radar of government supervision (Williams et al., 2014).

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