November 18, 2022

Amoxicillin shortage: Can compounders help?

The start of cold and flu season has led to an immense spike in respiratory illness and also a shortage of amoxicillin oral suspension.

In the wake of the infant formula shortage, we must make sure we do everything we can to keep our pediatric patients healthy. We’d like to think compounders can help mitigate the problem, but we need your help.

Hospitals and some pharmacies would like to be able to compound amoxicillin suspension from the commercially available amoxicillin tablets or capsules. Trouble is, FDA’s Insanitary Conditions Guidance requires compounders to completely and comprehensively separate beta-lactams from non beta-lactam products, which many pharmacies, including those in hospitals, cannot accommodate.

APC has reached out to FDA about this concern and to ask the agency to consider temporary enforcement discretion that might allow 503A pharmacies to meet this current shortage need.

But we need some data to help quantify the scope of the problem, so we’ve launched a short survey of compounders. Please complete it ASAP so that we can share the result with FDA—and perhaps provide a solution that can save lives. The survey will only be open through Wednesday, November 23 at 8PM ET.