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Home  >  References References General References Used Throughout Stability References Painful Injection From 50% Glycerin FDA Standardization Major Allergen And Standardization Regional Relevance Of Allergens Cross-Reactivity Management Of Anaphylaxis Coring & Syringe Technique Skin Testing USP 797 References – Beyond Use Date, Pharmacy Compounding Rules Allergen Information General References Used Throughout Cox, L, et al.… read more

Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For non-standardized products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk… read more

Formulation Concern – Alum Does aluminum (alum) have a negative impact on patient health? Aluminum has been used as an adjuvant in numerous vaccines for over 70 years with no severe adverse effects reported. Despite suggestions, made decades ago, that alum may contribute to conditions such as Alzheimer’s disease or other neurological disorders, there has… read more

Potency Labeling The biologic strength (potency) of an allergenic extract can be expressed in a variety of ways. In general, all allergenic extracts are divided into 2 categories: Standardized (BAU /AU) The FDA has mandated standardization testing for a limited number of extracts. The purpose of standardization is to minimize the amount of variability between… read more

Extract Formulations Allergen extracts are available in a variety of formulations. An extract’s formulation directly impacts the stability of the allergenic proteins in solution and therefore the shelf life of the product. The FDA has determined maximum expiration dates for each formulation based on the estimated loss of potency over time. All extracts can be… read more