The Federal Food, Drug, and Cosmetic Act defines blood as a drug. Thus, multiple sections of the general drug manufacturing regulations apply to blood products and specific regulations for blood and blood components.
Many of the regulations are simply good practices. Several practices are taught, coached, and mentored, from initial training in laboratory science to job training and competency assessments. These practices are part of department policies and procedures. For example, using the oldest supplies first to prevent outdating is a good practice. Without knowing that a federal regulation supports the practice, some individuals might be tempted to take a shortcut to save time. Knowing the regulations provides a sound basis for setting policies and decision making when writing new procedures and considering revisions to existing procedures.
