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Regulatory Information

As required by law, Prolacta Bioscience is registered as a food manufacturer with the U.S. Food and Drug Administration (FDA). The United States FDA Center for Food Safety and Applied Nutrition has determined that Prolacta’s added-mineral products are to be regulated as exempt infant formulas. As such, Prolacta Bioscience is required to be in compliance with Federal regulations governing the production and labeling of such items as covered by statute in 21 CFR 100-169, and, in particular, parts 105-107 dealing with infant foods.

Additionally, the states of California, New York and Maryland define and regulate human milk as a tissue which requires State specific tissue bank licenses. These regulations are specific to the proper collection, handling and distribution of human tissues, particularly human breastmilk. Prolacta Bioscience maintains a current tissue banking license from these states.

Healthcare Providers in the states of California, New York and Maryland can contact us for assistance in obtaining a tissue bank license.