Originally Published PMPN January 2005
NEWS
FDA Announces New RFID Initiatives |
FDA has upped the ante in its bid to make RFID the main focus of its anticounterfeiting efforts. The agency recently announced the publication of a Compliance Policy Guide (CPG) for the implementation of RFID feasibility studies and pilot programs. FDA has simultaneously created an RFID work group charged with monitoring RFID adoption in the pharmaceutical supply chain. The work group is also expected to identify regulatory issues and develop processes for handling those issues.
At a press conference introducing the two initiatives, FDA said the work group will improve communication with members of the supply chain and should facilitate both the performance of pilot studies and the collection of data needed to formulate policy.
FDA has stressed that the CPG should clear a path for more pilot programs involving RFID tagging of packages. The agency said that the scope of the guide is based on information FDA obtained concerning ongoing and planned RFID feasibility studies that examine use of the technology. “FDA is determined to protect the public,” said FDA acting commissioner Lester Crawford at the press conference. Referring to recent pharmaceutical RFID pilot studies, he said the use of RFID and other technologies “is exactly the type of bold leadership we expect to see more of. We hope that other manufacturers, wholesalers, and retailers will follow this example by also becoming early adopters of RFID.”
To encourage more studies, FDA intends to exercise enforcement discretion if studies falling within the CPG’s parameters trigger certain regulatory requirements. In addition, the CPG will go into effect immediately upon its publication in the Federal Register.
Those interested in commenting on the CPG may submit comments at www.fda.gov/dockets/ecomments.
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