Dear FDA Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
AABB wishes to amend the comments originally submitted February 9, 2009 to the draft “Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages” to include the following recommendation.
Section III. STANDARDIZED NUMERICAL IDENTIFIERS, A. What should be designated as a package-level SNI? (page 4): “In addition, hematopoietic stem cells derived from peripheral and cord blood use the ISBT 128 standard for product package identification. Using these standards, a unique identification number is created for each individual product package. Therefore, for such products that do not use NDC numbers, FDA is considering use of ISBT 128 or Codabar as the SNI.”
Recommendation – The phrase “hematopoietic stem cells derived from peripheral” should be expanded to include all cellular therapy products. Reword the sentence to read, “In addition, cellular therapy products and cord blood use the ISBT 128 standard for product package identification.”
Background – The current draft guidance limits the type of cellular products that could utilize ISBT 128 or Codabar as the standardized numerical identification (SNI) to peripheral blood progenitor cells and cord blood. There are many other cellular products (i.e., marrow and other somatic cellular therapy products such as donor lymphocytes and dendritic cells) that use ISBT 128 or Codabar and should be permitted to use these labeling conventions as an alternative to SNI. The SNI will not replace the need to use ISBT 128 and the requirement to track using two different labeling conventions will ultimately have a negative impact on patient safety and open the manufacturing processes to many opportunities for error.
AABB appreciates the opportunity to comment on the draft guidance. Should you have any questions regarding these comments or would like additional information, please contact me at 301-215-6515 or email@example.com.
Joseph L. Giglio, MS, MT(ASCP)SBB, CSQE(ASQ)CQA
Deputy Director, Regulatory Affairs