Regulatory requirements for ePedigree
Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, which was signed into law on Sept. 27, 2007, the Secretary of the Department of Health and Human Services (HHS) is required to develop standards and identify and validate effective technologies for purposes of "securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs." The law further requires the Secretary to develop a standardized numerical identifier to be applied to a prescription drug at the point of manufacturing and repackaging at the package or pallet level sufficient to facilitate the identification, validation, authentication, tracking, and tracing of the drug no later than 30 months from the enactment of FDAAA (1).To meet these legislative requirements, FDA sought public comment on the standards and technologies for ePedigree of prescription drugs. During the public comment period, which ended May 19, 2008, the agency requested information on radio-frequency identification (RFID) technologies, encrypting technologies, and nanotechnologies and their strengths and weaknesses for identification, validation, track and trace, or authentication. The agency also requested information on the utility of these technologies in ePedigree, the cost of their implementation and use, their interoperability, and the development of related standards (1, 2).
FDA is in the process of analyzing the information provided and is researching several options received. The agency says it is working toward meeting the March 2010 deadline for developing a standardized numerical identifier, but cannot provide specific deadlines for developing standards for validation, authentication, and track-and-trace systems as well as addressing promising technologies, but says it "will work toward meeting these goals as quickly as it can."
In addition to FDA, states such as California and Florida are moving forward with state requirements for ePedigree. California enacted a drug-pedigree law that mandated serialization, electronic pedigree, and track-and-trace systems in 2004, with an initial effective date of Jan. 1, 2007. Additional state legislation in 2006 moved the effective date to Jan. 1, 2009. Earlier this year, the California Board of Pharmacy, the state agency primarily responsible for implementing the state's ePedigree law, exercised authority delegated to it by the 2006 legislation to further extend the effective date for the implementation of the ePedigree requirements to Jan. 1, 2011 (3).
In providing comment on FDA's request for information on ePedigree technologies and standards, the California State Board of Pharmacy identified two possible technologies: 2D (data matrix) barcodes and RFID tags. The board recommended RFID be the industry standard and that 2D barcodes only be used as a backup technology (3). In terms of standards, the board recommended that the Global Trade Item Number (GTIN) developed by GS1/EPCglobal, two organizations involved in developing industry-driven standards for the electronic product code (EPC) to support the use of RFID. The board specified that GTIN is already in use and approved by the FDA for marking pharmaceutical products (4). "We particularly encourage adoption of the SGTIN-96, which is the version applicable to serialization of drug products using RFID tag technology as the data carrier," said the board in its comments (4).
In recommending RFID, the California State Board of Pharmacy said RFID tags are less easily counterfeited or duplicated than are other data carriers, including 2D barcodes. "This is true not only because the technology itself is not as easily replicated as e.g., a printable 2D barcode, but also because RFID (EPC) tags are typically given a unique identifier (e.g., Tag ID) by the tag manufacturer that confirms its authenticity and additional level of security from widespread duplication or counterfeiting," said the board in its comments (3). The board also noted that RFID is a non-line-of-sight technology, which allows unit-, case-, and pallet-level tags to be read from varying distances and through several levels of packaging (3).