Guidance on Compounding Amoxicillin Due to Shortages

Due to increased demand for amoxicillin oral powder and subsequent shortages, FDA 11/18 issued an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by pharmacists. The agency says it has received requests for clarification about preparation of compounded versions of the products from FDA-approved tablets and capsules.

“The guidance describes steps to reduce the risk of cross-contamination between these and other products,” the agency says. “Amoxicillin is a beta-lactam drug, and compounding this drug in an environment without appropriate safety measures could lead to cross-contamination of other drug products. Beta-lactam drugs can cause life-threatening allergic reactions in some patients.”

Amoxicillin is commonly used for treating bacterial infections in children, among other uses.