April 15, 2011
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
RE: Docket No. FDA-2010-N-0633 Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop, 15-16 February 2011.
Dear FDA Dockets Manager:
Founded in 1962, America's Blood Centers is North America's largest network of community-based blood programs. Seventy-five blood centers operate more than 600 collection sites in 45 U.S. states and Canada, providing half of the United States, and all of Canada's volunteer donor blood supply. These blood centers serve more than 180 million people and provide blood products and services to more than 4,200 hospitals and health care facilities across North America. ABC's U.S. members are licensed and regulated by the U.S. Food & Drug Administration. Canadian members are regulated by Health Canada.
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. Members are located in more than 80 countries.
We appreciate the opportunity to provide comments to the docket established for this public workshop. The workshop attempted to explore approaches for achieving an effective and feasible track and trace system for finished prescription drug products, and to obtain views on system attributes and standards that would facilitate identification, authentication, and tracking and tracing of prescription drug packages. One particular area of concern noted by the Food and Drug Administration is with potential introduction of counterfeit products into the US market.
Blood and blood components and hematopoietic progenitor cells (HPCs) sourced from peripheral blood and the umbilical cord are the particular focus of our comments. We believe that the US blood industry already accomplishes the intents/goals of this initiative.
- Blood is tracked and traced from collection all the way through to final disposition. This allows for infectious disease lookback as required by 21 CFR 606.160, 606.165, 610.46, 610.47, and 610.48.
- Standardized numbering systems and bar code symbology approved by the FDA (21 CFR 606.121(c)(13)) are used on all products. The identification numbering system used uniquely links all components produced from the donation to the donor. The FDA Guidance released March 2010 "Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages" discusses the use of package-level SNI and determined the following for certain biological products that do not use NDC numbers:
"Some prescription drugs approved under Section 351 of the Public Health Service Act, such as blood and blood components and certain minimally manipulated human cells, tissues, and cellular and tissue-based products (HCT/Ps), do not currently use NDC numbers. Examples of HCT/Ps that do not use NDC numbers include allogeneic placental/umbilical cord blood, peripheral blood progenitor cells, and donor lymphocytes for infusion. Instead, such products currently use other recognized standards for identification and labeling, such as ISBT 128, which creates a unique identification number for each product package. See http://iccbba.org/about_gettoknowisbt 128.html, "Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels," (http://www.fda.gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/Guidances/Blood/ucm073362.htm.) The SNI for these products should be the unique identification number created for each package under these other recognized standards, such as ISBT 1285.
This guidance does not address standards for prescription drug SNI at levels other than the package-level including, for example, the case- and pallet-levels and ponders how the SNI number could be transferred to individual components if lots are divided and notes that the SNI does not include the expiration date or lot number. The ISBT 128 labeling system widely in use for blood components (now required by the AABB Standards) incorporates expiration date and the ability to make divided product, all of which retain the original unique identifier plus suffix. Case- and pallet-level requirements are not a requirement for blood components. Each donation is a unique lot; cases and pallets are not created.
5FDA currently also recognizes Codabar as a standard for blood and blood component container labels. We note that ISBT 128 is becoming the more widely-used industry standard."
- Authentication of systems in place to prevent product mislabeling is required by current Good Manufacturing Practices outlined in 21 CFR Parts 211 and 606.
- Counterfeit products have not been an issue, we believe, due to the fact that
- blood and blood components are generally delivered to hospital inventories within 72 hours of the donation (following infectious disease testing and record review),
- finished packaging is the blood bag,
- products have relatively short shelf lives – 5 days for platelets, 42 days for red blood cells, 1 year for frozen plasma (but it is generally used much sooner), and
- the delivery system from supplier to end user is most often door to door.
Establishments that manufacture HPC products in the US are also utilizing the barcode symbology referenced above and have received the same acknowledgement in the March 2010 guidance document. The Cellular Therapy Coding and Labeling Advisory Groups is working to standardize ISBT terminology on an international level so that imported HPC products will meet this same standard.
We do understand that there are likely some pharmaceutical products that would benefit from additional steps that would further improve the security of the drug supply chain. However, blood centers in the US effectively accomplish the intent of track and trace in the least burdensome manner and it would be unduly burdensome to add or change requirements to the robust track and trace system that currently exists. We believe we have outlined the reasons that the current system being used for blood components, and increasingly used for HCT/P products, is sufficient to meet the goal of protecting these products from fraudulent labeling.
If you have questions about these comments please contact M. Allene Carr-Greer at email@example.com.
Director, Regulatory Affairs
|M. Allene Carr-Greer|
Director, Regulatory Affairs