Drug counterfeiting is a global problem that costs pharmaceutical companies billions of dollars and threatens the health of millions of consumers. The National Association of Boards of Pharmacy reports that an estimated 1 percent to 2 percent of drugs in North America are fraudulent. The World Health Organization (WHO) cites similar statistics for European and other industrialized countries, but says the percentage of counterfeit drugs is much higher in many African countries and in parts of Asia and Latin America.
Countries worldwide have been working to stem the flow of counterfeit drugs in their supply chains. For many years, the pharmaceutical industry has been considering radio frequency identification technology to combat drug diversion and counterfeiting, as well as to improve manufacturing and distribution efficiencies. Indeed, pharmaceutical providers in South Korea and several other countries have piloted or deployed RFID solutions (see RFID Makes Order Out of Chaotic Distribution Chain, Gador to Track Drugs in Argentina and Nigerian Drug Agency Opts for RFID Anticounterfeiting Technology).
So when the California State Board of Pharmacy issued an electronic-pedigree law, with an initial 2007 deadline, drug manufacturers and wholesalers began considering using RFID to meet the mandate, and RFID providers began offering e-pedigree solutions. The law stated that bar codes or RFID could be used to create an electronic record for tracking the movement of prescription drugs through the supply chain.
Florida, Nevada and several other states also passed e-pedigree laws, each with different requirements. Then, in 2008, the U.S. Food and Drug Administration stepped in, and the push for a drug-authenticating e-pedigree system moved from the state to the federal level.
In September, the U.S. House of Representatives passed the Drug Quality and Security Act (H.R. 3204), and in November, the bill passed in the Senate. The legislation creates a uniform national standard for drug supply-chain security that would supersede all state e-pedigree initiatives. H.R. 3204 has many provisions directed at the drug distribution supply chain. These include encoding most prescription drug products at the smallest salable unit and sealed homogenous case level with a unique product identifier. Serialization provisions designed to identify products are combined with product tracing and verification requirements.
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