STAT+: FDA delays enforcement of a pharmaceutical supply chain law to stop counterfeit drugs
The FDA has postponed its plans to enforce a law designed to thwart counterfeit or diverted medicines passing through the pharmaceutical supply chain.
In response to growing complaints, the U.S. Food and Drug Administration has postponed its plans to enforce a law designed to thwart counterfeit or diverted medicines passing through the pharmaceutical supply chain. The law was supposed to be fully enforced in late November, but the agency now says it will not take action until November 2024.
At issue is the Drug Supply Chain Security Act, which has been implemented in steps over the past decade. The law requires pharmaceutical manufacturers, wholesalers, and pharmacies to install the equivalent of electronic health records to track transactions in hopes of making it easier to detect phony medicines and, crucially, identify the point at which they enter the supply chain.
Bottles, for instance, will have serial numbers. There must be complete transaction histories that track product movement and each business will be required to verify that any medicines received are, in fact, legitimate. The idea is to make it possible for law enforcement agencies to shut down companies or individuals who exploit weaknesses in the vast U.S. distribution network.
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