Vaccines, Blood & Biologics
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.
Report of Scientific and Medical Literature
- Federal Register Notice: Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease; Extension of Comment Period
- Federal Register Notice: Center for Biologic Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease, September 26, 2011
Panel on Review of 'Allergenic Extracts Category IIIA Reclassification, Final Report, December 1983(PDF - 3.4MB) Allergenics Advisory Review Panel Reports
- Federal Register Proposed Rule: Biological Products: Allergenic Extracts; Implementation of Efficacy Review, January 23, 1985 (50 FR 3082)