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What is the legal authority for regulating biological products?
Biological products are approved for marketing under provisions of the Public Health Service Act (PHS Act). However, because most biological products also meet the definition of 'drugs' under the Federal Food, Drug, and Cosmetic Act (FD&C Act), they are also subject to regulation under FD&C Act provisions. CBER has also been delegated authority to regulate certain drugs closely related to biologics, such as anticoagulants packaged in plastic blood collection containers. CBER regulates these as drugs under the FD&C Act. Similarly, some medical devices used in blood banks to produce biologics are regulated by CBER under the FD&C Act's Medical Device Amendments of 1976. Examples of such devices are automated cell separators, empty plastic containers and transfer sets, and blood storage refrigerators and freezers.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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