This spiral-bound, 5" x 7.5" book is a compilation of FDA regulations and guidance documents on biologics, blood products and Good Tissue Practice. It includes such topics as:
• Good Manufacturing Practice for human blood and blood products
• Biological product standards
• Donor eligibility standards for human cells and tissues
What's the Price?
• 1-249 copies: $18.95 • 250-499 copies: $17.95
• 500-749 copies: $16.95 • 750+ copies: $15.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• CFR Title 21: Food and Drugs (Revised as of April 1, 2023)
600 Biological Products: General
601 Licensing
606 Current Good Manufacturing Practice for Blood and Blood Components
607 Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products
610 General Biological Products Standards
630 General Requirements for Blood, Blood Components, and Blood Derivatives
640 Additional Standards for Human Blood and Blood Products
680 Additional Standards Miscellaneous Products
1270 Human Tissue Intended for Transplantation
1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
• FDA Draft Guidance for Industry
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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