The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently two types of allergenic products licensed for use: allergen patch tests and allergenic extracts. Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by physicians to determine the specific causes of contact dermatitis, and are manufactured from natural substances or chemicals, such as nickel, rubber, and fragrance mixes, that are known to cause contact dermatitis.

Allergenic extracts are used for the diagnosis and treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Allergenic extracts are injectable products that are manufactured from natural substances, such as molds, pollens, insect venoms, animal hair, and foods, known to elicit allergic reactions in susceptible individuals. Food extracts are only used to diagnose food allergies, but other allergenic extracts may be used for both diagnosis and treatment of allergic disease.

Allergenic extracts are currently manufactured in two forms: standardized and unstandardized. Prior to release standardized allergenic extracts are compared to US reference standards for potency. CBER maintains these reference standards and distributes them to manufacturers. There are currently 19 standardized allergenic extracts. Extracts for which there are no US reference standards are called unstandardized extracts.

Updated: February 20, 2007