The US Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) recently published a Q&A document concerning 21 CFR Part 1271 final rule Human Cells, Tissues, and Cellular and Tissue-Based Products on its website.

This document pays tribute to the comments CBER received to the interim final rule, published on May 25, 2005. After reviewing those comments FDA published the final rule without changes. It became effective immediately (June 19, 2007). But CBER decided to release its position to certain questions with the aim to provide a quick reference to the provisions.

The questions which are discussed in the Q&A document focus on donor screening and testing and related labelling.

The points discussed are:

• Why did FDA publish the final rule on donor screening and testing and related labelling for HCT/Ps?
• What are the changes in the final rule and how is the final rule different from the donor eligibility final rule?
• Does FDA require screening and testing of embryo donors?
• What is the timing of sample collection for donors of peripheral blood stem/progenitor cells; bone marrow when considered an HCT/P; and oocytes?
• For a cadaveric donor, why did FDA delete the requirement in 1271.80(b) regarding specimen collection at the time of recovery?

Find CBER's answers to these questions at
http://www.fda.gov/cber/rules/gtpq&a.htm

You may download the pdf version of the final final rule from http://www.fda.gov/cber/rules/hctdnr.pdf
This document contains all the comments received on the interim final rule.

Human Cells, Tissues, and Cellular and Tissue-Based Products are becoming more and more important for industry. Please let us know if you are interested in this new topic in order to consider this development for the future planning. Please send an E-Mail to info@gmp-compliance.org if you are interested in this topic.

Author:
Dr Ulrich Herber
On behalf of the European Compliance Academy (ECA)