The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam oral antibiotic suspension products.
The agency said it has been asked to clarify how compounded versions of products from FDA-approved tablets and capsules currently in shortage can be prepared, as FDA’s insanitary conditions guidance states beta-lactam drugs are required to be processed with “complete and comprehensive separation from non-beta-lactam products.”
FDA said that amoxicillin oral antibiotic suspension products have reportedly seen increased demand and amoxicillin oral antibiotic powder for these suspension products is currently listed in FDA’s drug shortage list…
