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.
Of note, the guidance provides steps to address the potential for cross-contamination thereby minimizing the possibility for hypersensitivity or allergic reactions. For facilities that intend to compound beta-lactam oral antibiotic suspensions, monitoring and reporting allergic reactions from unintentional beta-lactam exposure from the use of non-beta-lactam products is also recommended.
According to the guidance, pharmacies that receive reports of anaphylactic shock or allergic reactions from unintentional exposure should stop compounding beta-lactam products. Adverse events or quality problems from compounded products should be reported to the FDA’s MedWatch Adverse Event Reporting Program.
Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food Drug and Cosmetic Act. November 2022. Accessed November 28, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounding-certain-beta-lactam-products-shortage-under-section-503a-federal-food-drug-and-cosmetic