# Understanding the Donor Milk Safety Act

This bill makes it easier for hospitals and milk banks to use donated human breast milk by reducing the paperwork and regulatory requirements they currently face. Right now, donated breast milk is treated like a pharmaceutical drug and requires extensive FDA approval and testing before it can be used. This bill would change that by allowing donated milk that has been treated to reduce bacteria and germs to be handled more like infant formula—with simpler safety rules instead of the full drug approval process.

The practical effect is that donated breast milk would become more accessible to newborns who need it, particularly premature babies and infants whose mothers cannot produce milk. Hospitals and milk banks would spend less time on bureaucratic compliance and more time distributing milk to babies who need it. The bill gives the FDA one year to update its regulations to make this change official. For parents and healthcare providers, this means donated milk could reach vulnerable newborns faster and with fewer delays, while still maintaining basic safety standards through the bioburden reduction process (which kills harmful bacteria in the milk).

The bill essentially recognizes that donated human breast milk, when properly treated to remove contaminants, is fundamentally different from a drug and shouldn't be regulated as heavily as one. It's a targeted change aimed at removing unnecessary red tape while keeping safety protections in place through the milk treatment process itself.

Donor Milk Safety Act

DeLauro, Rosa L.

Donor Milk Safety Act This bill treats human milk that has gone through a bioburden reduction process (e.g., pasteurized donor milk) as an exempt infant formula (i.e., specialized infant formula) for purposes of certain regulatory standards.