Federal and State Requirements for HCT/Ps: An Overview

The Food and Drug Administration (FDA) is close to finalizing its program for the regulation of human cells, tissues, and cellular or tissue-based products (HCT/Ps). On May 25, 2005, the donor eligibility and current good tissue practice (CGTP) final rules take effect, putting into place the last major components of the new regulatory program for HCT/Ps. The CGTP regulation is somewhat more restricted in scope than originally proposed, but it still represents a substantial regulatory burden.