1. 1 Summary of FDA Guidance for Industry Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages www.Rx-360.org Prepared by: Barbara W. Unger March 26, 2010 This summary was prepared by the Rx-360 Monitoring and Reporting Working Group which tracks regulatory, legislative and policy developments relevant to pharmaceutical/medical device supply chain integrity. The summary is not intended to serve as comprehensive and formal interpretation or guidance (and should not replace your own review and analysis of any referenced source documents). If you have questions, please contact Maureen Hardwick, Rx-360 Secretariat, at 202.230.5133 or maureen.hardwick@dbr.com.

2. 2 Background 2007 FDAAA –Created Section 505D of FD&C Act –FDA must develop standards to secure supply chain –Includes standard numerical identifiers (SNI) Attached at point of manufacture or repackaging Package or pallet level Facilitates identification, authentication and tracking Draft Guidance published for comment in January, 2009 Final Guidance released March 26, 2010 –Addressed many industry concerns –Is not supported by national legislation or regulations –Intended to be the first of several guidances www.Rx-360.org

3. SCOPE Identifies SNI at package level only “Package” is identified as smallest saleable unit Repackager is required to add unique SNI if changing “smallest saleable unit” from that of the manufacturer Guidance does not address –how to link multiple SNIs –Pallet or case level SNIs –Implementation or application issues for SNIs 3

4. Content of SNI for Drugs Should be NDC code + unique serial number –Referred to as sNDC Serial number, < 20 alpha numeric characters Some biologics do not have NDC –Alternatively they may utilize ISBT 128 NOT required to include batch number or expiry Location on package not specified –Must not obscure FDA required information –NDC and serial number locations not required to be contiguous –Scanning / viewing should not damage package integrity 4

5. Content of SNI for Drugs Flexible in terms of data carrier technology –2-dimensional bar code –RFID –Other? Should be BOTH human and machine readable Proposed SNI (sNDC) is compatible with GTIN international standard 5

6. 6 info@Rx-360.org www.Rx-360.org For More Information Thank you