The CFR Mini-Handbook contains the most important portions of the Code of Federal Regulations that relate to blood banking, transfusion medicine, and cellular therapy, including regulatory updates posted since the 2017 edition of the Mini-Handbook was published. This handy resource eliminates the need to carry several unwieldy volumes, presenting the regulations as they appear in the original sources, while making them portable and easily accessible.
Included are the regulations found in the following CFR parts:
- Part 210-Current good manufacturing practice in manufacturing, processing, packaging, or holding of drugs; general.
- Part 211-Current good manufacturing practice for finished pharmaceuticals.
- Part 600-Biological products; general.
- Part 601-Licensing.
- Part 606-Current good manufacturing practice for blood and blood components.
- Part 607-Establishment registration and product listing for manufacturers of human blood and blood products.
- Part 610-General biological products standards.
- Part 630-General requirements for blood, blood components and blood derivatives.
- Part 640-Additional standards for human blood and blood products.
- Part 660-Additional standards for diagnostic substances for laboratory tests.
- Part 820-Quality system regulation.
- Part 1270-Human tissue intended for transplantation.
- Part 1271-Human cells, tissues, and cellular and tissue-based products.
- Part 493-laboratory requirements.
(AABB, 2018, soft cover, 552 pages, ISBN 978-1-56395-985-1>)
View Table of Contents (pdf)
View Sample Pages (pdf)