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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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