Procedures for Domestic Blood Product Establishments

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
  7. Procedures for Domestic Blood Product Establishments

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Section
607.20

Who must register and submit a blood product list.

Section
607.21

Times for establishment registration and blood product listing.

Section
607.22

How to register establishments and list blood products.

Section
607.25

Information required for establishment registration and blood product listing.

Section
607.26

Amendments to establishment registration.

Section
607.30

Updating blood product listing information.

Section
607.31

Additional blood product listing information.

Section
607.35

Blood product establishment registration number.

Section
607.37

Public disclosure of establishment registration and blood product listing information.

Section
607.39

Misbranding by reference to establishment registration, validation of registration, or to registration number.