By November 1, 2015, pharmacies must be compliant with certain requirements of the Drug Supply Chain Security Act (DSCSA) that were previously delayed. On June 30, the Food & Drug Administration (FDA) announced that it would give drug dispensers an additional four months (until November 1, 2015) to comply with the following federal track and trace requirements that were to take effect July 1:
Only accept product if the previous owner providers the “3Ts” (Transaction History, Transaction Information, and a Transaction Statement). Information can be provided in paper or electronic format (e-mail or Web-based).
Trading partners, including pharmacists, capture and maintain the 3Ts for 6 years from data of transaction. Pharmacies may contract out for capture and maintenance function of 3Ts with wholesale distributor(s) or other third-party vendor(s). Make sure to review contractual terms (e.g., are there costs to access 3Ts, charges associated if no longer a customer, etc.).
APhA has created a checklist (PDF) to help pharmacies comply with DSCSA provisions. Since January pharmacies have been required to verify that trading partners have a valid licensure and/or registration per federal and/or state law and develop systems regarding suspect/illegitimate product identification and notification. As of July, pharmacies are expected to provide product tracing information to a subsequent owner, which includes pharmacy-to-pharmacy transfers, except for a specific patient need. The next set of deadlines most relevant to pharmacists are slated for November 2017 (manufacturer product identifier deadline), November 2020 (dispenser product identifier deadline), and November 2023 (unit-level traceability).