Addresses and Definitions

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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Current Good Manufacturing Practices for Transfusion Services (online CE course)
Addresses and Definitions

Title 21 Part 600 of the Code of Federal Regulations (CFR) addresses general biological good manufacturing practices. This is where a transfusion services laboratory can locate the addresses for notifications if and when needed, including the addresses for:
  • Center for Biologics Evaluation and Research (CBER)
    • Adverse experience reports
    • Biological product deviation reports
    • Fatality reports
  • Center for Drug Evaluation and Research (CDER)
    • Licensed products regulated by CDER (drugs)
    • Post-marketing adverse experience reporting
Definitions for the terms that are used in Part 600 are also included at the beginning of the section.