According to the Drug Supply Chain Security Act ("DSCSA"), effective January 1, 2015, manufacturers and wholesale distributors that transfer ownership of a product will be required to provide the subsequent owner with transaction history, transaction information, and a transaction statement in a single document in paper or electronic format. Last month, the U.S. Food and Drug Administration ("FDA") released a draft guidance entitled "DSCSA Standards for the Interoperable Exchange of Product Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information," which is intended to help trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) comply with the track and trace requirements outlined in the DSCSA "through the extension and/or use of current systems and processes."
As the January 1 effective date approaches, some trading partners have expressed concern that "unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and ultimately could impact patients' access to needed prescription drugs." As such, the FDA has issued a Compliance Policy indicating that it "does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by [the DSCSA]." Please note that this Compliance Policy does not extend to other requirements in the DSCSA, such as "verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners."