New so-called track-and-trace rules for drugmakers, wholesalers and logistics companies went into effect Jan. 1, requiring them to be able to provide full documentation of lots of prescription drug products all along the chain of custody. They did, but--and it is a significant but--the FDA at the very last minute said it would not enforce all of the new rules before May 1.
The day before the rules were to take effect, the agency announced in the Federal Register that it had updated the guidance for the Drug Supply Chain Security Act Implementation and "does not intend to enforce these requirements against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required," by the act for "certain human, finished prescription drugs."
The agency for years pushed for track-and-trace rules that would allow it to more easily locate recalled products and to protect against counterfeits, and so many companies are ready to go. But the FDA said it had heard from plenty of companies that had "unforeseen complications" that would disrupt shipments if the requirements were imposed and leave some patients unable to get their meds.
"To minimize possible disruptions," the FDA said it decided to delay enforcing the new rules. It did not let companies off the hook for other provisions of the act, like verifying suspect and illegitimate products, and requires that they only do business with authorized companies.
The FDA did not indicate the delay would have any effect on the timeframe for dispensers, who are supposed to begin collecting data by July 1 and it did not indicate that the delay would change the requirement in 2017 that companies begin assigning serial numbers to individual "saleable units" of every prescribed product sold in the U.S.
The Act, passed in 2013, is two-pronged. In addition to setting up a timeline that will eventually lead to a fully electronic U.S. drug tracking system, it gave the FDA limited powers to oversee the compounding pharmacy industry, which has spawned a cottage industry of small, specialty drug manufacturers. That part of the law sprung from the 2012 fungal meningitis outbreak tied to New England Compounding Center that killed 64 and sickened more than 750. A federal indictment unsealed in Boston last month charged 14 owners, executives and employees of the now defunct compounding company with 131 charges, including two who were indicted on 25 counts of second-degree murder for the deaths of some of those patients.
- here's the Federal Register notice