GTPs
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Regulatory Status
As of May 25, 2005, tissue transplantation is regulated by FDA under Title 21 CFR Part 1270, Human
Tissue Intended for Transplantation and Part 1271, Current Good Tissue Practices. These regulations
mandate that blood from each donor be tested for the presence of antibodies to HIV-1, HIV-2, HBV
surface antigen and HCV. Screening for behavioral and high risk information is also required. The
regulations also stipulate that tissue processors must develop and validate procedures for
prevention of contamination and cross-contamination.
RTI has fully validated the appropriate methodologies.