APC: On amoxicillin compounding, APC urges—and FDA acts

December 2, 2022

On amoxicillin compounding, APC urges—and FDA acts

At APC’s urging, FDA has released a final guidance document stipulating minimum steps pharmacies that compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products.

The steps include only compounding from FDA-approved beta-lactam tablets and capsules instead of bulk drug substances; use of dedicated or disposable equipment, utensils, and personal protective equipment; trituration of the FDA-approved product after wetting it with a quantity of the suspension vehicle sufficient to eliminate formation of product dust; and six other essential steps.

APC supported its plea to FDA with results of a survey showing the difficulty its members are facing in sourcing amoxicillin suspension.

Read more about the new guidance here.