FDA gives pharmacies more DSCSA compliance time

Following last week’s letter to FDA from a group of community-pharmacy and —pharmacist organizations saying that they wouldn’t be ready for the July 1 deadline for accepting drug-tracking data under the Drug Supply Chain Security Act (DSCSA), FDA has granted the same postponement period—four months—that it gave to wholesalers who were uncertain of their ability to meet a Jan. 1 deadline early this year.

In a three-page guidance note posted on the FDA website, FDA writes, “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information…” However, if a dispenser (i.e., a pharmacy) sells product to another dispenser, it must meet the transaction data requirement now.

"The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the U.S. pharmaceutical system," said National Community Pharmacists Assn. president, B. Douglas Hoey. (NCPA was one of the signatories to last week's letter.)

The big question is, will four months be enough of a delay? In the letter sent to FDA last week, NCPA noted that barely half of its members were even aware of what their reporting and data-storage options are. (Many community pharmacies are being steered toward an ongoing relationship with their primary suppliers—the wholesalers—who could store the transaction data for them.)