USA – FDA issues pharmacy compounding guidance due to amoxicillin shortage

Due to the current shortage of amoxicillin oral antibiotic powder for suspension, the Food and Drug Administration (FDA) has issued guidance on the preparation of compounded versions of certain beta-lactam oral suspension products.

Compounded products are not approved by the FDA as they have not undergone review for safety, effectiveness, or quality. Increased demand for amoxicillin oral antibiotic suspension products, coupled with requests for clarification on the preparation of compounded versions, have prompted the Agency to issue recommendations for pharmacists in state-licensed pharmacies and federal facilities not registered as outsourcing sites…