Compliance Policy Guide: RFID Studies and Pilot Programs for Drugs

FDA is extending the expiration date of the compliance policy guide (CPG) Sec. 400.210 entitled ‘‘Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs’’ to December 31, 2012.

FDA has identified RFID as a promising technology to be used in the various efforts to combat counterfeit drugs. The CPG describes how the Agency intends to exercise its enforcement discretion regarding certain regulatory requirements that might otherwise be applicable to studies involving RFID technology for drugs. The goal of the CPG is to facilitate performance of RFID studies and to allow industry to gain experience with the use of RFID technology and its effect on the longterm safety and integrity of the U.S. drug supply.

Please find additional information at: http://edocket.access.gpo.gov/2010/pdf/2010-32274.pdf

Source: FDA Press Release

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