Читать книгу Transfusion Medicine - Jeffrey McCullough - Страница 51

Blood is considered a drug and is regulated by the FDA. The legal basis for this regulation of blood, blood components, and plasma derivatives is provided by two separate but overlapping statutes, one governing “biologics” and one governing “drugs.” The biologics law requires that any “virus, therapeutic serum, toxin, anti‐toxin, or analogous product” be prepared in a facility holding an FDA license [36]. A separate law, the Pure Food and Drugs Act, covers drugs intended for the “cure, mitigation, or prevention of disease,” and thus includes biologics such as blood and blood components or plasma derivatives. Thus, blood banks are subject to the biologics and the drug regulatory process. The federal requirements for blood banks are specified in the Code of Federal Regulations. In addition, the FDA publishes “guidelines” that specify the agency’s recommendations of specific policies, procedures, or actions regarding any aspect of the acquisition of blood.

FDA law requires that all organizations involved in “collection, preparation, processing, or compatibility testing … of any blood product” [36] register with the FDA. This registration allows the organization to collect blood and prepare blood components for its own use. If the organization wishes to ship the components across state lines or engage in commerce by selling the products to other organizations, the organization must obtain an FDA license for this purpose. Thus, for practical purposes, most hospitals that collect blood or prepare blood components for their own use are registered, but not licensed, because they do not ship blood in interstate commerce. Most blood centers are licensed, because they supply multiple hospitals, some of which may be in other states. In addition, blood centers may wish to participate in blood resource sharing with blood centers in other states, and thus need to be licensed for interstate shipment of blood.

Federal licensure is intended to ensure that the facility in which the biologic is produced will provide products with high purity and quality. In addition to licensing the facility or establishment, this law requires that each biologic product itself be licensed by the FDA. Thus, to produce a licensed biologic, an organization must have an establishment license describing the facility in which the product is produced and a product license describing the specific product being produced. Over the years, this law has been specifically amended to include the terms blood and blood component or derivative to make it clear that blood is subject to the biologics’ regulation. Blood banks and plasma derivative manufacturers are inspected every other year by the FDA, and they must submit a report annually to the FDA indicating which products are collected, tested, prepared, and distributed.

When an organization applies for an FDA license to produce blood components or plasma derivatives, it must provide the credentials of the person in charge (responsible head) and of those responsible for determining donor suitability, blood collection, and laboratory processing and testing. In addition, it must provide blueprints and floor plans of the facility; descriptions of all equipment; indications of any other activities occurring in the facility; provisions for housekeeping, pest control, ventilation, lighting, and water systems; other occupants of the building; activity in adjacent buildings; record maintenance systems; validation of all systems; quality‐control/assurance programs; procedures for receipt and handling of raw materials; source of starting materials; methods and facilities for any chemical purification; inactivation or transfer steps; formulation and final product preparation; computer systems; and other miscellaneous information.

Along with the establishment license, the organization must file a product license application for each product it plans to produce in the facility. For whole blood and components, the product application involves basic information about the manufacturer (organization), facility, product, standard operating procedures, blood donor screening tests, frequency of donation, donor medical history, presence of a physician, phlebotomy supplies, venipuncture technique, collection technique, allowable storage period, storage conditions, disposal of contaminated units, supplies and reagents, label control processes, procedures for reissue of blood, and a brief summary of experience testing 500 samples. For the manufacture of plasma derivatives, the product license application involves the manufacturer’s (organization’s) name; the establishment name; procedures for determining donor suitability, including medical history, examination by physician, laboratory testing, and methods of preparing the venipuncture site and collecting the plasma; methods to prevent circulatory embolism and to ensure return of red cells to the proper donor; minimum intervals between donation and maximum frequency of donation; techniques for immunizing donors; laboratory tests of collected plasma; techniques of preparing source plasma and storing it; methods to ensure proper storage conditions and identification of units; and label control systems and shipping conditions and procedures.