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A chemically synthesized polypeptide was not a biological product and was not going to be regulated as a drug under the FD&C Act unless the polypeptide otherwise met the statutory definition of a biological product . This definition was scientifically appropriate, but at the last minute, the latest appropriations bill (enacted in December of 2019) further amended the definition of biological product to remove (except any chemically synthesized polypeptide) . Now, in the definition documented below, there is no differentiation between protein and polypeptide

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