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STATEMENT OF HDMA PRESIDENT AND CEO JOHN M. GRAY ON STANDARDIZED NUMERICAL IDENTIFIER GUIDANCE ISSUED BY FDA
ARLINGTON, Va., March 30, 2010 – John M. Gray, President and CEO of the Healthcare Distribution Management Association (HDMA), issued the following statement regarding the Food and Drug Administration’s recent guidance for industry regarding standardized numerical identifiers (SNI):
“The FDA’s recent guidance will help supply chain participants implement measures to enhance the efficiency and security of the healthcare supply chain. A standardized SNI – a serial number that can uniquely identify prescription drugs at the unit level – sets the stage for implementation of electronic systems that are interoperable across the supply chain.
“This is a promising step towards maintaining and enhancing the safety and security of the prescription drug supply, and one that HDMA wholeheartedly applauds. Many of HDMA’s distributor members are active participants with manufacturer trading partners in pilot programs to test technologies that support the electronic identification of products. This guidance clarifies the direction those programs will take.
“In addition, development of a standard for the SNI is a significant milestone toward the establishment of a single, uniform federal pedigree law, which would eliminate the existing 50-state patchwork of individual state pedigree requirements. HDMA supports federal legislation to provide FDA with additional authority in this area and streamlining of the current system.”
About HDMA
HDMA is the national association representing primary healthcare distributors, the vital link in the healthcare system. Each business day, HDMA member companies ensure that more than nine million prescription medicines and healthcare products are safely delivered to more than 165,000 pharmacies, hospitals, nursing homes, physician offices, clinics and others nationwide. HDMA and its members work daily to provide value and contain costs, saving the nation’s healthcare system an estimated $32 billion per year.
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