Blood Banks and Biologics

The LFS Biologics Program is responsible for license application review, approval, renewal, survey and investigation of:

• Community Blood Banks and Collection Centers
• Hospital Blood Banks
• Blood and Blood Components Collection Centers
• Cord Blood Banks and Collection Entities
• Plasma Collection Centers
• Biologics Processing and/or Storage Facilities

Contents:

                                        Announcement

California Biologics Licensure requirement for
Platelet-Rich Plasma (PRP) producers in California

It has come to the attention of the California Department of Public Health, Laboratory Field Services (LFS), that many facilities prepare PRP for the prevention or treatment of disease. If your facility produces PRP products that fall under the statutory mandate for licensure defined in California Health and Safety Code (HSC) 1602.5(a), 1600.1, and 1600.5, please contact LFSbiologics@cdph.ca.gov​ immediately for guidance on the application process and requirement for a California Biologics License.

New License Application

Mail requirements with original signatures to the mailing address found below.

Requirements:

 LAB 114 - Biologics License Application (PDF)
 LAB 118 - Personnel Report (PDF)
 Application fee (See Fee Schedule​). Make check payable to CDPH/LFS.
 Supporting Documents: List of document varies depending on operation type. You may contact LFSBiologics@cdph.ca.gov​ for further instructions.

Mail requirements with original signatures to the mailing address found below.

Requirements:

 LAB 175 - Application for Renewal (PDF)
 LAB 118 - Personnel Report (PDF)
 Application fee (See Fee Schedule). Make check payable to CDPH/LFS.

Change Application​

• Change of Medical Directors
• Change of Ownership
• Change of Address

Mail requirements with original signatures to the mailing address found below.

Requirements:

 LAB 114 - Biologics License Application (PDF)
 LAB 118 - Personnel Report (PDF)
 Application fee (See Fee Schedule ​). Make check payable to CDPH/LFS.
 Supporting Documents: Required document varies depending on type of change, please contact LFSBiologics@cdph.ca.gov​ for further ​instructions.

A Patient’s Guide to Blood Transfusion

Click the desired button to download the PDF brochure:

Donor Adverse Events (DAE)

Amendment of California Health and Safety Code (HSC)§ 1607​ took effect on January 1, 2023. A blood bank shall annually report to the department any adverse donor event requiring emergency medical intervention.

• Notice of Reporting Donor Adverse Events (DAE)(PDF)
• Download DAE Excel​ file reporting tool​ (XLSX)​​​

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:
• Clinical Laboratory Improvement Amendments (CLIA) Regulations
• CMS.gov website​​​​​