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THE WORLD'S RFID AUTHORITY
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Article Link: ASD Healthcare Deploys RFID Refrigerated Drug Cabinets
FDA's Position of RF Use Around Biologics
by HENRY AMES, posted 09/26/2007
Dear Beth Bacheldor, FDA Compliance Policy Guide (CPG) Sec. 400.210, Nov 2004 “Radio Frequency Identification Feasibility Studies and Pilot Programs for Drugs” FDA excluded biological products (note: cold chain drugs are primarily biologic-based drugs) as eligible for RF pilot studies because there was - Insufficient information about the potential impact of radio-frequency (RF) on biologics. (CPG Sec. 400.210, Nov 2004, pg. 3, states: “The drugs involved will be limited to prescription or over-the-counter finished products. The drugs involved will not include those approved under a Biologics License Application or protein drugs covered by a New Drug Application.” On June 8, 2006, the FDA published the “FDA Counterfeit Drug Task Force Report: 2006 Update”. In this report, the FDA referenced the earlier 2004 CPG reiterating that they have not received sufficient information to change this policy. I believe that a major pharmaceutical manufacturer and the FDA have both begun studies with MIT to determine the potential affect RF may have (thermal and non-thermal) on biologic-based drugs but I do not beleive the findings have been published. Based on the material referenced above, could you please tell me how ASD Healthcare has obtained approval from the FDA for the use of the RFID-enabled Cubixx refrigerators? Is there some new FDA guidance that you can point me to? Have any new studies recently been published? Sincerely, Henry Ames Message threads
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