From: Dan Mullen [dan@aimglobal.org] Sent: Friday, July 12, 2002 2:08 PM To: 'fdadockets@oc.fda.gov' Cc: Karen Longe (E-mail) Subject: Comments to Docket [Docket No. 02N-0204] Comments to Docket No. 02N-0204 Bar Code Label Requirements for Human Drug Products; Notice of Public Meeting General Questions Related to Drugs and Biologics: 3. Considering current scanners and their ability to read certain symbologies, should the rule adopt a specific bar code symbology (e.g., reduced space symbology (RSS) and 2-dimensional symbology)? Should we adopt one symbology over another, or should we allow for ''machine readable'' formats? What are the pros and cons of each format? In order to make a decision on what type of bar code(s) or other machine readable technology is necessary the FDA should very specifically define the business issues that we are attempting to resolve. Once the objectives are specifically defined the appropriate technology to be used can be analyzed and decided upon. It is important to note that data structures differ from symbology (or rather data content from how it is encode). Bar code standards do exist for labeling medical devices and pharmaceuticals, for labeling blood and for use in provider facilities. Each of the three standards offer a data structure (the required data and the order to encode it). Currently the standards offer options on bar code symbology. Having a data structure standard will allow for the possibility of using other types of automatic data capture technologies such as RFID and Contact Memory. Current bar code scanner and printer technologies exist to produce and read the full range of publicly available bar code specifications. A bar code symbology that is publicly and freely available for use should be selected. The bar code symbology specifications that have been developed have undergone rigorous technical review and have been published to create an environment where bar code printing and scanning hardware and software can be developed in compliance with a common standard. The adoption of one specific symbology might be helpful but would not be necessary to accomplish the FDA's goals. In fact the solution may require the use of a 'family' of symbologies. The key will be the selection of publicly available symbologies with standard documentation that supports the creation of hardware and software from multiple vendors. Finally, In addition to improving patient safety machine readable technology will help improve their from receiving through production to shipping/distribution and reordering. As the FDA moves forward in this process, AIM would be very interested in helping to facilitate further discussion of the symbologies and related equipment that is available. Sincerely, Daniel P. Mullen Interim CEO AIM Inc. - The Trade Association for Automatic Identification and Data Capture Technologies Email: dan@aimglobal.org Web: www.aimglobal.org Phone: +1 412 963-8588 x108 Personal Fax: +1 509 479-1483 (preferred) Office Fax: +1 412 963 8753 Direct Tel: +1 412 963 9723 Mobile:: +1 412 906-0279