Regulatory Resource Manual

This reference work provides a compilation of US Federal rules, regulations and guidelines on the operation of a blood bank. It also gives background material that is used as the basis for the inspection process, including excerpts from various sections of the Code of Federal Regulations.

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This is a compilation of the US Federal rules, regulations and guidelines that have an impact on the operations of the blood bank. This new manual provides background information that is the basis for the inspection process, including: excerpts of various sections of the Code of Federal Regulations, the FDA Compliance Program Guidance Manual, FDA Compliance Policy Guides, FDA guidelines, joint statements, CDC recommendations, OSHA, HCFA and DOT requirements and numerous references.