The procurement, processing, distribution, or use of human milk for the purpose of human consumption shall be construed to be, and is declared to be for all purposes, the rendition of a service by each and every nonprofit organization and its employees participating therein, and shall not be construed to be, and is declared not to be, a sale of the human milk for any purpose or purposes.
Chapter 4.75Human Milk
Section § 1647
This law clarifies that when nonprofit organizations and their employees are involved in collecting, processing, distributing, or using human milk for consumption, it is considered a service, not a sale. This distinction means that the activities related to human milk are not treated as commercial transactions.
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Section § 1648
This law section explains that hospitals which collect, process, store, or distribute human milk specifically for a mother to use for her own child do not need a tissue bank license. However, they must follow the standards set by the Human Milk Banking Association of North America or other department-approved standards for handling human milk.
Hospitals that handle human milk in other ways must obtain a tissue bank license. Additionally, no screening tests are required for milk a mother donates for her child's exclusive use. The department will review hospital procedures related to human milk as part of its regular oversight.
(a)CA Health and Safety Code § 1648(a) A hospital
collecting, processing, storing, or distributing human milk collected from a mother exclusively for the mother’s own child, or a hospital storing or distributing human milk obtained from a tissue bank that is licensed pursuant to Chapter 4.1 (commencing with Section 1635), is exempt from the requirements of Chapter 4.1 (commencing with Section 1635). Hospitals that collect, process, store, or distribute human milk in any other circumstance shall obtain a tissue bank license pursuant to Chapter 4.1 (commencing with Section 1635).
(b)CA Health and Safety Code § 1648(b) A hospital that is exempt from tissue bank licensure pursuant to subdivision (a) shall 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 the department.
(c)CA Health and Safety Code § 1648(c) Notwithstanding any other provision of law, no screening tests shall be required to be performed on human milk collected from a mother exclusively for the mother’s own child.
(d)CA Health and Safety Code § 1648(d) The department shall assess hospital processes for collecting, processing, storing, or distributing human milk pursuant to its current practice, as required by Chapter 2 (commencing with Section 1250).
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