UPS EXPRESS MAIL & FACSIMILE
Allergy Laboratories, Inc.
1005 SW 2nd Street
Oklahoma City, OK 73109
Dear Ms. Johnson:
The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the United States Food and Drug Administration (FDA) has reviewed your Internet website www.allergylabs.com. Your website promotes mixtures of allergenic extracts for indications including skin diagnosis and treatment (immunotherapy) of patients with seasonal and perennial allergies. Your website refers to these as “custom mixes.” These mixtures are described on your Internet website as “2, 5, 10, 30, or 50 mL extracts custom mixed to your specifications using up to 12 allergen parts.” Copies of the pertinent Internet website pages are enclosed for your reference.
The mixtures of allergenic extracts referenced above are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)].
You currently hold approved biologics license applications (BLAs) for numerous allergenic extracts; however, these BLAs do not include provisions for manufacturing these “custom mixes.”
Please be reminded that licensed biological products may not be combined with other licensed biological products, either therapeutic, prophylactic or diagnostic, except as a license is obtained for the combined product [21 CFR 610.17]. The mixtures of allergenic extracts described on your Internet website are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your distribution of mixtures of allergenic extracts for which a valid license or IND is not in effect appears to violate the FD&C Act and the PHS Act and may result in FDA seeking relief as provided by law.
We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville, Maryland 20852-1448.
If you have any questions regarding this matter, you may contact Dr. Jessica Kostick at (301) 827-6201. Please be advised that only written communications are considered official.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research