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:

The overall talking points — a brief synopsis of the issues

Compounders can meet shortage drug needs ongoing.

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 GFI #256 on Animal Compounding: By what authority?

FDA is misreading an obscure section of AMDUCA. It doesn’t make sense … and it puts animals in jeopardy.

Compounding MOU: FDA has underestimated the administrative burden on states.

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’s threat to cBHT puts millions of patients at risk.

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.

DHA’s Recoupment Action Against Compounding Pharmacies

We need members of Congress to contact DHA about this egregious accusation of fraud by compounding pharmacies and improper recoupment action.