The new donor eligibility and current good tissue practices for human cell, tissue, cellular and tissue-based products are effective May 25, 2005.
New FDA donor eligibility and current good tissue practice requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps) are effective May 25, 2005. These requirements represent a culmination of the FDA's efforts to establish a comprehensive new system for regulating HCT/Ps.
The donor eligibility requirements are designed to prevent the transmission of communicable diseases when these products are transplanted. In most cases, a donor who tests positive for a particular disease or who possesses clinical signs or risk factors for such a disease will be considered ineligible, and cells and tissues from that donor would not be used. New requirements related to the record-keeping, quarantine, storage, and labeling of the HCT/Ps have also been established by the FDA.
The donor eligibility requirements apply to traditional tissues such as musculoskeletal, skin, and eye tissues that have been required to be screened and tested for HIV, Hepatitis B virus (HBV), and Hepatitis C virus (HCV). Under the new requirements, reproductive tissue (semen, ova, and embryos), hematopoietic stem cells derived from cord blood and peripheral blood sources (circulating blood sources as opposed to bone marrow), cellular therapies, and other innovative products are also regulated.
Exceptions from the requirements for donor eligibility testing and screening include autologous HCT/Ps (cells or tissue removed from and transplanted back into the same person) and reproductive cells or tissues from a sexually intimate partner. Certain cells and tissues are subject to donor testing and screening, but may be used with appropriate communication, labeling, and documentation of the relevant results even if the donor is determined to be ineligible. These include: (1) reproductive cells or tissues from a directed donor, (2) those for use in first or second-degree blood relatives, and (3) those that meet a documented urgent medical need.
The new framework does not include whole organs or minimally manipulated bone marrow, which are regulated by the Health Resources and Services Administration. It also does not cover blood products for transfusion or cellular or tissue-based products derived from animals, which the FDA regulates under the biologics license requirements and other applicable regulations.
Human cell, tissue, and cellular and tissue-based product (HCT/P) establishments will also be required to manufacture their products in compliance with current good tissue practices (CGTPs). CGTPs govern the methods used in, and the facilities and controls used for: the manufacture of HCT/Ps, recordkeeping, and the establishment of a quality program. The FDA has also issued new regulations regarding labeling, reporting, inspections, and enforcement that will apply to those HCT/Ps manufacturers regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products.
The regulations will be effective for HCT/Ps collected on or after May 25, 2005.
For more information regarding this topic, see the Food, Drug and Cosmetics Law Reporter. The Reporter provides the full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act. Learn more.
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