Beginning May 25, 2005 establishments engaged in the collection, processing, storage and distribution of human gametes or embryos will be required to comply with FDA rules. These regulations are specified in 21 CFR (Code of Federal Regulations) Part 1271. The regulations consist of three major parts:
- Registrations Final Rule
- Donor Eligibility Final Rule
- Current Good Tissue Practices Final Rule (CGTP)
Assisted reproductive technology establishments are required to comply only with Registration and Donor Eligibility rules.
These rules are designed to ensure that all cell/tissue donors are properly screened and tested to prevent communicable disease transmission. In addition the CGTP Rule govern methods used in HCT/Ps (Human cells, tissues, or cellular or tissue-based products) as well as facilities and controls used for the manufacture of HCT/Ps. This rule requires compliance with current good manufacturing practices (CGMP) and quality systems regulations.
The final rule affects several types of entities involved in HCT/P activities including conventional tissue banks such as bone, skin, heart valve, semen and other reproductive tissue, etc. and those processing hematopoietic stem and progenitor cells, and eye banks.
Assisted reproductive technology establishments and semen/embryo banks are subject only to the inspection and enforcement procedures as they apply to donor eligibility requirements. The FDA estimates that there are over 500 reproductive tissue establishments in the US subject to regulation.
All four of the California Cryobank establishments have been registered with the FDA since 2001 and are in full compliance with all its regulations. As required in Sec. 1271.55 (a)(3) of the FDA donor eligibility final rule we will include with each shipment of donor semen a Summary of Records that documents the tests performed on the donor and an interpretation of the results.
Download, print, and submit the Contract Establishment Agreement by email to email@example.com. Once this form has been received it will be signed and returned to the facility. If you have any questions please contact the Compliance Manager at firstname.lastname@example.org.
Donor specimens processed prior to May 25, 2005 are not subject to the new rules. Therefore, no retro-active qualifications or special labeling requirements are necessary for these specimens.