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July 1 compliance deadline is looming large; half of surveyed pharmacies are unaware of implementation services
The Drug Supply Chain Security Act, passed in 2013, set a rolling timetable for implementing its requirements to trace the movement of drugs from manufacturer to wholesaler to dispensing pharmacy. With the January 1, 2015 deadline for wholesaler-distributors approaching last December, the Healthcare distribution Management Assn. petitioned FDA for regulatory discretion—and got a postponement until May 1. Now, community pharmacists are seeking a comparable postponement, with their July 1 implementation deadline only a week away.
In a letter to the office of Compliance at FDA, the National Community Pharmacists Assn., the American Pharmacists Assn. and the National Alliance of State Pharmacy Assns. state that despite an “ongoing and robust educational campaign,” their members won’t be ready to provide DSCSA documentation to FDA inspectors by the deadline. In fact, a recent NCPA survey of its members (the owners of 23,000 independent community pharmacies) found that half of them are unaware that their distributor suppliers can store the data for them; less than 15% have entered into a contractual arrangement to enable this storage; and less than 20% are aware of how similar arrangements can be performed with secondary wholesalers (often the backup source for drugs in short supply). Not mentioned was whether any pharmacies have set up their own internal data-storage and reporting capabilities. (DSCSA only requires the data to be verified and available; not that pharmacies themselves maintain the database.)
Notably absent from the letter is the National Assn. of Chain Drug Stores; presumably their members are ready to go.
NCPA is a relatively powerful trade association in Washington—its members are usually prominent community business people in every Congressional district across the country—and it is likely that it will get a postponement. Not clear is whether it will be for the four months that wholesaler-distributors got, or longer. And the current requirement—for the “3Ts” (lot-level transaction information, transaction history and transaction statement)—is only the first step; traceability for individual pharmaceutical packages is the eventual goal in 2023.