Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. Among the injectable allergen extracts, some are standardized; for these products there is an established method to determine the potency (or strength) of the product on a lot-by-lot basis. For the other injectable allergen extracts there is no measure of potency, and these are called "non-standardized."
Vaccines, Blood & Biologics
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Avenue
Building 71 Room 3103Silver Spring, MD 20993-0002