In this blog post, Bruce Lehr asks why we need two classes of compounding. Lehr argues:
His entire post can be read here
I say if compounders want to act like small drug manufacturers they shouldn't be called compounders and should be required to adhere to the existing drug manufacturing regulations and be overseen as such. Then the FDA would have clear oversight without any more legislative needs for "clarity".
His entire post can be read here
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