Blood Banks and Biologics

The LFS Biologics Section is responsible for surveys & investigations of:

• Blood banks and collection centers
• Hematopoietic progenitor cell banks and collection centers
• Cord blood banks and collection centers
• Transfusion-related Investigations
• Plasma collection facilities

Contact information

To contact the Blood Banks and Biologics section please email LFSBiologics@cdph.ca.gov

Guidelines for Initial License Application

• Blood Bank and Donor Centers (PDF)
• Cord Blood (PDF)
• Plasma Centers (PDF)
  

Guidelines for Renewal Application

• Biologics License Renewal Instructions

Information for Reportable Disease

• CDPH Center for Infectious Diseases
• California Reportable Disease Information Exchange (CalREDIE)

Applicable California Laws and Regulations

• California Health and Safety Code:
  Sections 1279, 1600-1630, 1645
• California Code of Regulations - Title 17:
  Sections 950-1028 Production and Distribution of Biologics, Licensure
• California Business and Professions Code:
  Sections 1200-1327 (Also see Sections 650-657 for billing issues and Sections 119 & 125 for license offenses)
• Applicable Standards adopted into California’s Biologics Law:
• AABB Standards for Blood Banks and Transfusion Services - Current Edition 
• AABB Standards for Cellular Therapy Services - Current Edition 
• Other References:
• AABB Standards Portal, current and past editions
• Clinical Laboratory Improvement Amendments (CLIA) Regulations
• CMS.gov website