“No Compounding Allowed” Drugs Would Be Established Under Senate Draft Bill
This article was originally published in The Pink Sheet Daily
A $15,000 annual establishment fee for “compounding manufacturers” could net FDA $45 million for inspecting those compounding sites.
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After House Republicans indicate legislation expanding agency’s oversight of compounding is unlikely, FDA could consider other regulatory options, like changing internal policies or hoping a court clarifies its regulatory authority.
Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.