FDA to allow paper or electronic transaction info transfers under DSCSA

The companies have until Jan. 1 to begin preparing to exchange the information. The latest draft guidance​ establishes initial standards for the interoperable exchange of product tracing information, in paper or electronic format.

“These standards will help trading partners provide product tracing information to subsequent trading partners through the extension and/or use of current systems and processes. FDA intends to issue additional guidance to facilitate the interoperable exchange of product tracing information through standardization of data and documentation practice​,” the agency says.

Don Hsieh, director of commercial & industrial marketing for TycoIS, told In-Pharmatechnologist.com that the Jan. 1 deadline is the “very first step in a long process over the next 10 years. The major concern is that everyone is looking for as much clarity as soon as possible – a lot of implementation of timelines – the sooner they have clarity, the better.”

Under the guidance, trading partners are required to capture and maintain the applicable product tracing information for not less than 6 years after the date of the transaction. Trading partners can utilize current paper-based or electronic-based methods for the interoperable exchange of data to provide product tracing information to subsequent purchasers... Such methods could include, but are not limited to, the use of:

• Paper or electronic versions of invoices;

• Paper versions of packing slips;

• Electronic Data Interchange (EDI) standards, such as 856 Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments; and

• EPCIS (Electronic Product Code Information Services), which defines a data-sharing interface that enables supply chain partners to capture and communicate data about the movement and status of objects in the supply chain.

In issuing this guidance, FDA also considered the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the product tracing information to the subsequent purchaser of a product and to facilitate the exchange of lot level data.

“FDA intends to issue additional guidance to facilitate the interoperable exchange of product tracing information through standardization of data and documentation practices​,” the agency said.

Hsieh added that the latest guidance does not seem “that stringent​” in terms of the new requirements for industry.