Regulatory Information

As required by law, a company operating as a food manufacturer within U.S. Food and Drug Administration (FDA) and the Department of Homeland Security guidelines must be registered as such. International Milk Bank will operate as just a processing milk bank.  The company will not produce infant formulas, nor add any mineral products to the donor human milk it receives and processes.  However, due the integrity and high standards including the FDA’s Pasteurized Milk Ordnance (PMO) and the Human Milk Bank Association of North America (HMBANA) quality and safety standards.  IMB has chosen to set, our methods, equipment, facility, operation and controls are structured to meet and exceed any such  requirements.  Our industrial facility is designed for pharmaceutical certification for Current Good Manufacturing Process (CGMP), a globally recognized standard.
Additionally, in states or countries that define and regulate human milk as a tissue and may require specific tissue bank licenses, International Milk Bank will meet or exceed all requirements. These regulations are specific to the proper collection, handling and distribution of human tissues, particularly human breast milk. International Milk Bank intends to maintain all required tissue banking licenses.