Over the past several years, the blood banking community has been moving along a never-before-seen path, and along the way there has been a lot of fear and uncertainty. The community is responding to the advent of supply chain contracts and health-care reform legislation. Industry-wide, there have been adjustments in manufacturing, increases in automation, decreases in the demand for blood, decreases in revenues, and increases in the level of competition that have not been seen historically. Lean and efficient are two words that continue to stay at the forefront of the focus. Various manufacturers are partnering with other manufacturers to develop a framework for the future successes of their organizations through center mergers, acquisitions, joint ventures, center openings and/or closings. Under 21 CFR 601.12, licensed biological product manufacturers must report these changes to the FDA. In this session, speakers from various organizations will discuss the regulatory requirements needed to move forward with establishment changes, the underlying drivers behind some of the joint agreements, the process used to develop the plans, and some specific challenges and benefits that have resulted from the endeavors.