The vast majority of centers in the United States are also Systems and efficiency In addition to the FDA, many of the plasma collection centers are also licensed and regulated by other authorities, including those of the European Union and Asia. The FDA, under a statutory license-and-inspection program, monitors the plasma collection industry, which as of late 2019 boasts more than 800 plasma collection centers. The United States supplies the largest amount, by nation, of plasma for fractionation in the world. This complexity carries through with several different legal frameworks in which collection entities might operate. It has a mixture of both public and private payers for various therapies, and many states within the Union also have requirements and individualized health care policies. The US represents a complex health care infrastructure. While the system has evolved to a twin-model system of coexistence, it has evolved that way through a variety of forces including those of the market, regulatory systems, and health-care delivery rather than through any centralized mandate. Other distinctions also exist, many of which are predicated on the addition of pathogen reduction technologies which are universal in the manufacture of PDMPs but have not yet been introduced to all transfusable components. By contrast, blood donors donate cellular components and the time for a return to donation suitability is longer: 56 days for a single unit of whole blood. As an example, plasma donors in the United States are allowed to donate twice in a seven-day period, as cellular elements are returned. The bifurcation of systems in the regulatory sphere has also helped shape both industries, with a recognition of different risk assessments and different donation parameters. In the US, the Food and Drug Administration restricts Source Plasma use to non-transfusable purposes. The definitions of Source Plasma have been long enshrined in regulatory systems. While the distinction has not always been present, and delineation sometimes gets blurred (see below), the blood sector has primarily relied on non-compensated donation for transfusion purposes since the 1970’s, while the plasma collection sector has primarily relied on compensated donation for Source Plasma, the raw material in manufacturing plasma-derived medicinal products (PDMPs). The United States, historically a nation with significant focus on commercial growth and a tendency toward market solutions, has what can be called a “dual” system of blood and plasma collection. Systems of blood and plasma collection frequently differ in both broad and specific terms, country-by-country.
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