FDA Issues Guidance on Preparing Beta-Lactam Antibiotics, Which are Linked to Severe Allergic Reactions

A shortage of the antibiotic medication amoxicillin has prompted federal regulators to issue immediate guidance for best practices preparing beta-lactam oral antibiotics, which can cause severe allergic reactions in some patients if contaminated with other antibiotic products.

The FDA issued the guidance for compounding pharmacies on November 18, which was published in the Federal Register and will be effective immediately.

There is an acute shortage of amoxicillin oral antibiotics, which are widely used to treat bacterial upper and lower respiratory infections in pediatric populations and for other uses. As a result of shortages, there is an urgent need to increase the supply of beta-lactam, especially as we enter winter months, when upper and lower respiratory infections often peak.

The FDA issued the guidance to help make sure appropriate steps are taken during the preparation of compounded beta-lactam oral antibiotic suspension products, using approved tablets and capsules that are currently in shortage.

Beta-lactam Cross Contamination Risks

The guidance highlights steps that reduce the risk of cross-contamination between beta-lactam products and non-beta-lactam products. Beta-lactam drugs can cause life-threatening allergic reactions in some patients.

Amoxicillin is prepared as an oral medication from a beta-lactam powder. Beta-lactam products must be prepared with comprehensive separation from non-beta-lactam products. This is especially necessary to prevent cross-contamination and prevent hypersensitivity or allergic reactions. Cross-contamination can occur with other products, like penicillin, to which many people have severe allergies.

Preparation must be done by a licensed pharmacist in a State-licensed pharmacy or federal facility.

The FDA will prioritize regulatory and enforcement actions related to unsanitary conditions during the preparation of beta-lactam products. The agency will focus on compounding pharmacies that do not use FDA-approved products, do not use dedicated equipment, or appropriate personal protective equipment, or follow proper cleaning procedures.

The FDA indicates it is working with drug makers to resolve the amoxicillin oral suspension shortages.