Due to increased demand, the U.S. Food and Drug Administration (FDA) has added amoxicillin oral powder for suspension to the drug shortage list and has issued guidance — in effect immediately — on its compounding.
Because of the shortage, the FDA has received requests for clarification about preparation of compounded versions of those products from FDA-approved tablets and capsules. The guidance describes the preparation of beta-lactam oral antibiotic suspension products by a licensed pharmacist in a state-licensed pharmacy or federal facility. In addition, it describes steps to reduce the risk of cross-contamination between these and other products.
Amoxicillin, which is widely used for the treatment of bacterial upper and lower respiratory infections in the pediatric population, 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.
The FDA is working with drug manufacturers to address this shortage.