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Below is the guidance we received from the FDA concerning how to barcode non-licensed products that are prepared at our facility but do not have codabar numbers assigned. Hope this helps. Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding the bar code rule. CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products. Local product Codabar codes may be assigned to blood products for which there are no assigned product Codabar codes. These products are usually products that have not been licensed by the FDA since data has not been submitted to prove that the product is effective and safe. Local Codabar product codes may be picked from anywhere in the range of 29600 through 29999. After you have selected a product code, you can assign your own product name to the code, e.g., Red Blood Cells Leukoreduced Additive Solution Removed and Platelets Pheresis Leukoreduced Saline Added. I hope this helpful. Adrienne Hornatko-Munoz Branch Chief, Manufacturers Assistance & Technical Training Branch (MATTB) OCTMA/CBER/FDA HFM-41 301-827-2000 phone 301-827-3843 fax This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. -----Original Message----- Subject: Guidance concerning labeling products I am trying to determine the proper way to label 2 products that are manufactured by a transfusion service. These products are not shipped to other facilities. I am hoping you can provide some guidance. I can not find bar code numbers for the following non-licensed products: Additive Solution Removed, Leukoreduced Red Blood Cells and Saline suspended Leukoreduced Pheresis Platelets. We are trying to ensure that we comply with the Bar Code Label Requirements for Human and Biological Products; Final Rule (Docket number 2202N-0204) and am unsure how to handle these two products. Thanks for your help, Kris Michelle Precourt LIS Coordinator The Children's Hospital of Philadelphia 215-590-5466 _______________________________________________ meditech-l mailing list [email protected] http://mtusers.com/mailman/listinfo/meditech-l
