Allergenic products are regulated by the CBER. Currently, there exist 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, used by physicians to determine the specific causes of contact dermatitis. They are manufactured from natural substances or chemicals that are known to cause contact dermatitis.
Allergenic Extracts are used for the diagnosis and treatment of allergic diseases such as allergic rhinitis, allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. They are injectable products that are manufactured from natural substances known to elicit allergic reactions. Food extracts are only used to diagnose food allergies, but other types of extracts can be used for the diagnosis and treatment of allergic disease.
Allergenic extracts are currently manufactured in two forms: standardized and unstandardized. Standardized allergenic extracts are compared to U.S. reference standards for potency, prior to their release. These reference standards are maintained and distributed to manufacturers by CBER. Currently, 19 standardized allergenic extracts exist. Unstandardized extracts are those extracts for which there are no U.S. reference standards.
Further information: http://www.fda.gov/cber/allergenics.htm
