Drugs will have to be tracked every time they change hands from the factory to the pharmacy under provisions of an 18-year-old law the government is just now ready to enforce.
The Food and Drug Administration had long put off enforcement of the provisions in response to concerns from secondary wholesalers that the tracking requirement could put them out of business. The slow pace in the adoption of enabling technology led to further delays. The regulatory agency now says those concerns have either dissipated or no longer justify staving off enforcement any further.
The FDA believes that radio-frequency identification (RFID) technology is the most promising way to track drugs as they move through the supply chain. However, the FDA said Friday it will hold off on requiring drug manufacturers and distributors to use the technology. The agency said it was disappointed in the lack of progress in adopting the electronic track-and-trace tags across the drug supply chain.
Health officials have long sought ways to establish the so-called "pedigree" of a drug as a means of keeping counterfeit medicines out of the drug supply. The pedigree includes details of each sale of a drug in the wholesale market.
The rule will take effect when the most recent holds expire Dec. 1.
Pedigree information is expected to be passed along by wholesalers in paper form until RFID technology enters wider use. Authorized distributors — wholesalers with an "ongoing relationship" with a manufacturer — are not required to supply pedigree information for drugs. Secondary wholesalers, however, will have to obtain and provide pedigree information to sell a drug.
Enforcement efforts will focus on high-value drugs and those that are either vulnerable to counterfeiting or have been counterfeited previously, the FDA said.
The prevalence of counterfeit drugs is very low, according to the agency. The most commonly counterfeited drugs include Viagra, Tamiflu, Lamisil, Cialis and Procrit.