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Quality Digest

FDA Compliance

Report: RFID on Packaging Secures Pharmaceutical Supply Chain

Published: Tuesday, May 24, 2005 - 22:00

According to research from the Pharmaceutical Research and Manufacturers of America, the use of an electronic system that authenticates individual packages while they’re on the supply chain protects both the industry and patients. The use of radio frequency identification chips (RFID) on pharmaceutical packaging has been identified by the Food and Drug Administration as the most promising technological approach to deterring counterfeit drugs. PhRMA recently released a position paper that strongly recommends advancing technology that would check if a pharmaceutical package originated with the manufacturer before it’s dispensed to a patient.

“Making double sure that a drug is authentic before a patient gets it and takes it home is vitally important,” says Billy Tauzin, PhRMA president and CEO. “And we’re close to having the technology to do it.”

According to Tauzin, this could be accomplished through mass serialization, bar coding or radio-frequency identification tags. However, the PhRMA paper determined that fully operational trace-and-track technology likely won’t be implemented for another five or more years. It supports implementing the paper pedigree requirements as outlined in the Prescription Drug Marketing Act as an interim step until a broad-based electronic system is established. It also recommends requiring that packages, pallets and cases of certain prescriptions contain a machine-readable serial number.

“America’s biopharmaceutical companies are deeply concerned that the drugs they produce not be compromised by breakdowns in the distribution system,” says Alan Goldhammer, PhRMA associate vice president for regulatory affairs. “PhRMA is prepared to collaborate with federal and state policy makers to set uniform electronic track-and-trace standards throughout the United States.”

The pharmaceutical industry has been holding discussions with wholesalers, pharmacies, and federal and state regulators on the feasibility of a nationwide electronic pedigree system to stymie counterfeiters. Pharmaceutical companies currently use a variety of counterfeit-resistant technologies. These include color-shifting inks, holograms, microprinting and chemical agents embedded in the drugs. They need to be changed regularly because some can be duplicated by counterfeiters as quickly as 12–18 months after they come out.

For more information, visit www.phrma.org.


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