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Skip Navigation LinksHome > Advocacy > Regulatory Affairs > Cellular Therapies > HCT/Ps > Current Good Tissue Practice

Current Good Tissue Practice

In November 2004, the FDA issued a final rule requiring HCT/P establishments to operate in accordance with Current Good Tissue Practice (CGTP) for the collection, donor screening, donor testing, processing, storage, labeling, packaging and distribution of HCT/Ps to prevent the introduction, transmission and spread of communicable diseases. The core CGTP requirements cover facilities, environmental controls, equipment, supplies and reagents, recovery, processing and processing controls, labeling controls, storage, and distribution (including receipt and predistribution shipment). The regulations for CGTPs are found in 21 CFR 1271 Subpart D; FDA recommendations for compliance with the regulations also are available.