FDA issues draft guidance on key product tracing provisions of Drug Supply Chain Security Act
ARLINGTON, Va. — The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by industry by Jan. 1, 2015.
According to the guidance, 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 standards, such as 856 Advance Ship Notice (ASN), which is currently used to provide the receiving entity with advance data on shipments; and
EPCIS, or 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.
"While we are still in the process of evaluating this guidance, and will provide a more comprehensive response to the FDA during the 60-day comment period, it does appear to give the supply chain a degree of flexibility in preparing for the Jan. 1 deadline to have in place processes and protocols to capture transaction data from suppliers and have the capacity to pass that information along to downstream customers," the Healthcare Distribution Management Association released in a statement.
HDMA expressed concerns last week about the pharmaceutical supply chain’s ability to comprehensively meet the implementation deadline for key product tracing provisions of the Drug Supply Chain Security Act.
"As you know, HDMA has been a long-time champion of the DSCSA as it represents the best solution for enhancing supply chain security, creating uniformity across the country and ensuring the safety of our nation’s drug supply," John Gray, HDMA president and CEO, expressed in an email to the agency. "This is, however, a learning experience for all involved, and at this time, we expect continued development through at least the first quarter of 2015, particularly as distributors expand their focus to also include on-boarding dispenser customers."