This implementation guideline is intended to support compliance with the Drug Supply Chain Security Act (DSCSA) of 2013, Title II of the Drug Quality and Security Act. (Public Law 113-54).
This version includes information to identify transfer of ownership, including ship to, buyer, ship from and seller information. The guidelines support the Direct Purchase Statement and Transaction Statement, and include updated Business Examples. It provides a streamlined format for the exchange of Transaction Information (TI), Transaction History (TH) and a possible Transaction Statement (TS), and like previously published HDMA implementation guidelines for the 856 Ship Notice/Manifest, it also provides manufacturers with a systematic way to advise their distributor trading partners with advance information on shipments to better plan and automate the receipt of goods process. In the December 2014 update, HDMA created additional business examples for the July-released ASN guideline to support compliance with DSCSA. All examples are based on the HDMA Transaction Scenarios, and begin on page 106 of the document.