In response to stakeholder requests, the FDA has delayed the enforcement date only for dispensers under the Drug Supply Chain Security Act (DSCSA) until November 1, 2015. FDA states that it “does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act. This compliance policy does not extend to the requirements under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history, as required by section 582(d)(1)(A)(ii).”
The full text of the Compliance Policy Guidance can be found on the DSCCA page on FDA’s website, , which can be found here.
