Biologics License Renewal Application Instructions

It is the responsibility of the Biologics facility to annually renew. Letters or email reminders are an adjunct to this process, but not required. Original license applications, renewals, or fax copies, without the accompanying fees do not constitute licensing or renewal. If you have any questions, do not hesitate to call or email regarding this information.

Required Forms & Documents:

The biologics license renewal forms require an original signature of the Medical Director, and must be returned via postal mail. Make any corrections in the appropriate location on the personnel or renewal forms. In addition, please do not staple or fold the submitted renewal application forms.

If you have had difficulty with mail delivery of your license, please include a self-addressed envelope with the renewal packet. If you have any questions, please do not hesitate to call or email regarding this process:  LFSBiologics@cdph.ca.gov 

Forms can be accessed on the Laboratory Field Services (LFS) forms page.

• LAB 175 (PDF) — Application for Renewal of License for the Production of Biologics (include hours of operation and two contact names with email. As necessary add, delete, or modify off-site collection centers).

• LAB 118 (PDF) — Blood Bank Personnel Report (include two current and valid email addresses).

• Resume or CV for physician Medical Director(s) or co-directors added since last renewal.

• Cover letter from the Medical Director for physicians deleted since last renewal.

Required Fee:

Submit the non-refundable renewal application fee in the form of a check or money order. Credit card payments are not accepted. Please write your biologics license ID number (e.g. XXX 123456) on your check or money order. Make the check or money order payable to: State of California, Department of Public Health. There are no additional fees for more than three collection sites.

The fee schedule for both initial application and renewal of biologics licenses is determined by section 1616.5 of the California Health and Safety Code (CHSC), and adjusted by the annual fee increase provisions of CHSC 100450, subdivision (a).

For a full list of renewal application fees please refer to the Laboratory Field Services fee schedule (PDF).
 

Please return the completed renewal packet and the fee to the address below:

California Department of Public Health 
Laboratory Field Services (Biologics)
850 Marina Bay Parkway, Bldg. P-1st floor 
Richmond, CA 94804

 ​​For additional information or assistance, you may email LFSBiologics@cdph.ca.gov.