APC Issue Briefs (updated September 2020)
Coming to Compounders on Capitol Hill VIRTUAL? Excellent! Read up on the major issues facing compounders — the ones we’ll be covering at CCHv. Each is a one- or two-page PDF you can read, download, or print:
Americans needed help in the pandemic. Compounders have stepped up, with FDA’s permission. Now the agency should acknowledge how much more compounders can do … and let them do it.
FDA is misreading an obscure section of AMDUCA. It doesn’t make sense … and it puts animals in jeopardy.
FDA has had 23 years to create that MOU and get buy-in from the states. Unfortunately, the “final” MOU, released by FDA in May, fails to address earlier concerns raised by states and pharmacy groups.
FDA stacked the deck to get study results it can use to restrict cBHT. But that “study” is little more than a selective review, and it’s deeply flawed.
We need members of Congress to contact DHA about this egregious accusation of fraud by compounding pharmacies and improper recoupment action.