āEffective January 1, 2025, AB 3059 exempts a GACH that solely stores or distributes pasteurized donor human milk from the requirement to obtain a tissue bank license, if it obtained the donor human milk from a CDPH licensed tissue bank. A GACH that is exempt from tissue bank licensure pursuant to this bill must comply with the most current standards established for the collection, processing, storage, or distribution of human milk by the Human Milk Banking Association of North America, or other standards approved by CDPH.
The information in this AFL is a brief summary of the provisions of AB 3059. Facilities are responsible for following all applicable laws. CDPH's failure to expressly notify facilities of statutory or regulatory requirements does not relieve facilities of their responsibility for following all laws and regulations. Facilities should refer to the full text of all applicable sections of HSC and the California Code of Regulations to ensure compliance.
For questions concerning tissue bank licensure, please contact CDPH's Laboratory Field Services program.
Sincerely,
Original signed by Chelsea Driscoll
Chelsea Driscoll
Acting Deputy Director
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