USP 797 Compounding Guidelines

There has been some controversy over applying the United States Pharmacopeia (USP) shelf-life rules for compounded pharmaceutical products to allergen extract mixes.

These rules require that all compounded (mixed) materials be disposed of every 28 days due to sterility concerns. The allergy industry has successfully challenged this requirement and provided evidence that allergen extract mixes are an exception to this rule.

It has been agreed that the manufacturer’s assigned expiration dates apply to compounded allergen extracts so long as appropriate sterility procedures are utilized in your facility and the extracts contain a preservative, such as phenol (0.4%), that inhibits microbial growth.

Besides following appropriate aseptic techniques, compounding personnel are also required to pass a “Media Fill Test” annually. This is a test of aseptic technique. A written test is also recommended. ALK does not sell nor specifically endorse any Media Fill Test product on the market but can make suggestions upon request.

The written test, as well as the guidelines for handling allergen extracts, are available from www.JCAAI.org. An abbreviated list of guidelines is also printed in the most recent update of the Allergen Immunotherapy Practice Parameters (2011).