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FDA, EC Considering RFID for Drug Pedigrees
The FDA and the European Commission are each seeking input on technologies and methods for pharmaceutical serialization and tracking. The FDA is required to develop track-and-trace identification and technology standards, while the EC is broadly reviewing options to improve the drug supply chain.
Apr 15, 2008—This article was originally published by RFID Update.
April 15, 2008—The US Food and Drug Administration (FDA) is accepting public comments through May 19th to guide development of technology and identification standards to track prescription drugs. The agency is specifically asking for comment about RFID's suitability for identifying pharmaceuticals, verifying their authenticity, and the practicality of RFID use in the pharmaceutical supply chain. Separately, the European Commission issued a Notice for Comment to help guide its drug anti-counterfeiting efforts. The European comment period ends May 9th.
The FDA requests for information were published in a pair of Federal Register notices last month. The first, docket number FDA-2008-N-0120, seeks input "on issues related to standards for identification, validation, tracking and tracing, and authentication for prescription drug products." The second, FDA-2008-N-0121, seeks input about technologies, and seeks comment specifically about RFID.
The FDA was charged with developing the standards when the Federal Drug Administration Amendments Act of 2007 (FDAAA) passed last September. The act directs the FDA to develop an identification standard to uniquely identify pharmaceuticals at the unit-of-use level within 30 months. The FDA is further directed to develop a standard compatible with "promising technologies." The notice goes on to list RFID as a promising technology, along with nanotechnology and encryption, but notes other technologies are not excluded.
Judging by the emphasis in the Federal Register notices and from previous comments, the FDA appears to view RFID more favorably than bar code for drug pedigree and track-and-trace applications. However, bar coding has many champions within the pharmaceutical industry, in part because it is viewed as less expensive to implement. In comments to RFID Update last week, pharmaceutical industry consultant Dr. Adam Fein questioned whether RFID is capable of accurately and efficiently handling the large amounts of data necessary to provide drug traceability from manufacturer to consumer (see California Not Ready for Drug Pedigrees -- Is RFID?).
However, the Healthcare Distribution Management Association (HDMA), a distributor organization whose members handle approximately 80 percent of all prescription medicines sold in the US, has long advocated RFID to provide pedigrees and track-and-trace capabilities in the pharmaceutical supply chain. The HDMA has issued a statement in support of the FDAAA's standards goals. The HDMA has been actively involved in RFID trials and other projects, and specifically recommends the use of RFID technology standardized by EPCglobal.
The EPC system appears very well suited to meeting the FDA's requirements because it has standards for a numbering system and technology. EPC codes provide unique serial numbers that can be applied to individual pharmaceutical doses or other packaging levels. EPC's technology standards, including Gen2, support widely used, interoperable RFID technology. EPCglobal also created a standard specifically for the pharmaceutical supply chain (see E-Pedigree Standard Ratified, Supports RFID).
The FDA's efforts to create drug ID and tracking technology standards come 20 years after it created pedigree requirements. Pedigree requirements were established when the Prescription Drug Marketing Act (PDMA) was signed into law in 1988, but implementation has been stayed numerous times, most recently in 2006 (see Injunction May Slow Momentum for RFID E-Pedigrees).
While federal enforcement languished, many states developed their own pedigree requirements. Today only 15 states have no drug pedigree laws in place or in development, according to this analysis by the HDMA. RFID, bar code, and other techniques have been used to comply with various state requirements. California has perhaps the most sweeping pedigree law, which requires unit-of-use serialization, but the deadline for compliance was recently pushed back two years because organizations needed more time to prepare.
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