January 9, 2012
Division of Dockets Management
Food and Drug Administration (HFA-305)
5630 Fishers Lane - Rm 1061
Rockville, MD 20852
Re: Docket No. FDA-2011-N-0719 "Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments"
Dear Dockets Manager:
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. AABB members are located in more than 80 countries.
AABB supports the requirements of the 2004 Bar Code Rule for the use of machine readable information on labeling for blood components and cellular therapy products and appreciates the opportunity to respond to the request for comments as a part of the retrospective review. As noted in the request for review many things have changed and advanced in the years since the Bar Code Rule was published and one thing that we find impacted by the requirements of this rule is the effort to collect biovigilance data. We have utilized expertise from our Biovigilance Tissue Working Group in responding to the request for comments. In addition our comments are in support of those submitted by ICCBBA.
General comments on the ISBT 128 standard
AABB Standards for Blood Banks and Transfusion Services (27th edition) requires that labeling be in conformance with the most recent version of the US Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using the ISBT 128 coding system (with older units – labeled before May 1, 2008 – conforming to the 1985 FDA Uniform labeling Guidelines). Standards for Cellular Therapy Product Services (5th edition) contains two requirements related to the use of ISBT 128 coding system. Standard 5.9.4 requires that "Product names and descriptions on product labels shall use the terms and definitions found in the Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions.*" (*http://www.iccbba.org/standardterminology.pdf). Standard 126.96.36.199 states "The laboratory shall have a plan for implementation of ISBT 128 labeling."
AABB believes that the fundamental goal of the requirements of the Bar Code Rule should be to assure essential information encoded by manufacturer(s) can be read and interpreted correctly by facilities receiving and using products in order to ensure the appropriate product is available for the patient. Manufacturers should not be limited to the amount of information that can be encoded simply because of a limited list of recognized technologies in the regulations.
Technologies available to be used should not be limited by a list in the Code of Federal Regulations; if FDA needs to recognize acceptable technology the recognition should be made in a guidance document. FDA has recognized ISBT 128 through guidance – under the requirements of 21 CFR 601.121(c)(13); however FDA failed to recognize it in Part 201 where the European Article Number/Uniform Code Council (EAN.UCC) system, or GS1 as it is also called, and the Health Industry Business Communications Council (HIBCC) standards are listed. The ISBT 128 standard is a coding system that has been proven to provide traceability that supports recordkeeping required by the CFR as well adverse event reporting and biovigilance activities.
For this reason we encourage FDA to also recognize the ISBT 128 standard in the rule, if other systems are recognized, as it is proven in the international arena to provide coding of information when traceability from donor to patient is needed. Since the publication of the 2004 Bar Code Rule ISBT 128 has evolved to be able to manage information from 2-D and RFID data carriers.
The 2004 Bar Code Rule created requirements in 21 CFR, Part 201, for the use of a National Drug Code (NDC) for biologic products other than blood and blood components – Part 606 and 610 explain the requirements for blood. AABB and other organizations including ICCBBA attended an FDA public workshop to explain the importance of allowing the use of the ISBT 128 system for certain HCT/Ps due to its ability to provide traceability and the fact that it was already widely used with these products. The NDC requirement would not have standardized product coding as each manufacturer would have assigned its own product code to the NDC. Subsequently the March 2010
Guidance for Industry, Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Drug Packages was published acknowledging "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."
We believe this exception to use of the NDC as the SNI on the container label should be extended to any products using ISBT 128. This would also seem to be supported by 21 CFR 201.2 which states "The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer."
The ISBT 128 standard accommodates the needs of traceability and biovigilance activities by providing internationally unique product identification and standardized product nomenclature and coding that is developed by international consensus. We believe it provides an appropriate system for these activities and it is superior to the NDC for these purposes.
General comments in support of biovigilance activities
AABB is concerned that the requirement of the rule for NDC numbers, rather than allowing the use of the ISBT 128 standard for the SNI number for biologics (except blood), hinders the collection of biovigilance data. The NDC does not support biovigilance activities for products needing direct traceability between donor and recipient because it is not presented in a consistent format (format may be 4-4-2, 5-4-1 or 5-3-2) and it requires each manufacturer to assign its own product code. Lack of a common format for the NDC makes it difficult to pool data from different sources electronically. It also prevents software from being developed in a standardized manner to manage data from multiple suppliers of biological products.
Biovigilance efforts require standardization in nomenclature and coding. This allows data to be pooled to study for trends in adverse events related to a specific product or product characteristics that are low incidence but could represent the "tip of the iceberg." Recognition of problems can occur much sooner if data from multiple sources are pooled. Common usage of ISBT 128 will greatly enhance biovigilance efforts.
Responses to specific questions listed in the Federal Register Notice
Is there a need for alternative technologies to the linear bar code?
Yes. Because of the size of the container, some labels on HCT/Ps are quite small and 2-D bar codes are needed to conserve space.
Does the current linear bar code requirement meet the current needs of the healthcare industry, and healthcare providers?
No. It is too restrictive in that it does not allow use of newer, more space-efficient technologies. Currently, it takes two to four labels to encode the information that can be placed on one, smaller, 2-D label.
How has product coding technology changed since FDA issued the Bar Code Final rule on February 26, 2004?
The use of 2-D bar codes and RFID technology has become much more commonplace. Even smart phones are now able to read 2-D bar codes. Standards such as ISBT 128 have been developed to include the use of 2-D bar codes as an alternative to linear bar codes. Groups are working on proving the acceptability of RFID technology.
What factors other than those listed in question 2 should FDA take into account in considering technologies alternative to or in addition to the linear bar code?
FDA should take into consideration the size of labels used for HCT/Ps and the amount of information that is required to be on the label. While font sizes of text can be reduced to accommodate more information, the label becomes extremely difficult to read. 2-D bar codes require considerably less space than linear bar codes.
In addition, FDA should consider the unique needs for traceability and biovigilance when products of human origin are involved, as well as the need for international harmonization in regulations affecting products that may cross national borders.
What technologies or coding systems warrant FDA's consideration as alternatives or in addition to the linear bar code?
AABB believes that FDA should not specify particular technologies in the regulation; it should only require that critical information be machine readable. This allows more rapid acceptance of new technologies as they become proven. If FDA must recognize acceptable or allowable technologies the best place to do so is through guidance. We believe that at a minimum 2-D is an acceptable data carrier in addition to linear bar codes. We believe that RFID technology is close enough to being proven that FDA should find a way to make it an option without having to wait for yet another review of the regulations or publication of another guidance document.
The March 2010
Guidance for Industry, Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Drug Packages should be expanded so that ISBT 128 is allowed as an alternative to the NDC as a coding system for tissues in addition to the "certain minimally, manipulated HCT/Ps" already listed.
Does the adoption of this alternative technology have implications for other FDA or Department of Health and Human Services initiatives (e.g., SNI)?
Regulations affecting biologics that require traceability from donor to recipient should be written and harmonized in a way that allows a single coding system and data carrier that can be used for all. This would potentially affect HRSA and CDRH. (See comments above comparing use of the ISBT 128 standard to the NDC number.)
Thank you for the opportunity to offer these comments. AABB looks forward to continuing to work with the Food and Drug Administration on initiatives to improve the safety of patients and donors. Questions concerning these comments may be directed to me at
M. Allene Carr-Greer
Director, Regulatory Affairs