No Independent Status for Excipients

There is no process or mechanism currently in place within the FDA to independently evaluate the safety of pharmaceutical excipients. Instead, for drugs subject to FDA premarket approval, excipients are only approved as components of new drugs. 

Formulation of finished pharmaceuticals has always been somewhat of an art, rather than totally a science. Attempts to completely objectify regulation of with excipients have been largely ignored by the regulators. The pharmaceutical industry, 

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