The information a drug pedigree should contain is codified in 21 CFR 203.50, but FDA does not have the statutory authority to implement a uniform requirement that would supersede state requirements.
And, it cannot mandate a universal requirement that includes all wholesalers. This means stakeholders may have to meet federal
as well as multiple state pedigree requirements, and there may be pedigree gaps unless Congress passes legislation in these
Data management. E-pedigree implementation also depends on the data management that enables information sharing among all members of the supply
chain from a central database or a distributed system where information is stored on various company servers. Data security
is imperative. The Task Force expressed no preference between a centralized or distributed data storage system and noted that
a hybrid environment may be the optimum solution. The report goes on to say, "We do believe that it is essential that every
entity in a drug product's chain of custody have access to the product's pedigree data all the way back to the manufacturer,
in order to verify and authenticate the pedigree. It is also important for FDA to have access to the information in matters
of suspect illegal activity" (1).
Some assistance with data management may be generated by a collaborative effort between the HDMA Foundation, the research arm of the Healthcare Distribution Management Association (Arlington, VA,
http://www.healthcaredistribution.org), and the Rutgers Center for Supply Chain Management (New Brunswick, NJ,
Privacy concerns. The Task Force stated that privacy issues must be addressed and noted that "consumer education is necessary" regarding the
presence and purpose of RFID. Toward that end, it recommends the agency support the industry's education efforts and "work
with manufacturers and other stakeholders in their efforts to develop appropriate messages, symbols, or statements for labeling
of drug products and packaging that contains an RFID tag" (1).
Another privacy issue to be worked out is whether to deactivate or remove an RFID tag and at what point in the supply chain
this should be done. Tag deactivation may be addressed in the standards-making process or may have to wait until the e-pedigree
process is more mature. "We believe that this issue warrants further discussion among stakeholders, technology experts, and
consumers, about the viable options," states the report (1).
The stay on pedigree requirements will expire in a few months, so members of the pharmaceutical supply chain must accelerate
their pedigree data collection efforts now. The report concludes, "With the implementation of the PDMA [pedigree] regulations
in December 2006, we expect that supply chain stakeholders will move quickly to adopt electronic track and trace technology,
implementing RFID in a phased-in approach . . . companies should continue to tag drug products, build infrastructure across
the supply chain for using an e-pedigree, and remain vigilant to their responsibility to provide a safe and effective drug
product to the patient" (1).
1. US Food and Drug Administration, FDA Counterfeit Drug Task Force Report: 2006 Update (FDA, Rockville, MD, June 2006), http://
http://www.fda.gov/oc/initiatives/counterfeit/report6_06.html, accessed July 11, 2006.
2. FDA, Draft Compliance Policy Guide 160.900, Prescription Drug Marketing Act: Pedigree Requirements under 21 CFR Part 203 (FDA, Rockville, MD, June 2006), http://
http://www.fda.gov/oc/initiatives/counterfeit/cpg.html, accessed July 11, 2006.