On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”.  As the title suggests, the Guidance is part of FDA’s implementation of the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27, 2013, put in place many new requirements to aid in the tracking of pharmaceutical products in the drug distribution supply chain.  The law was enacted in response to concerns that the existing framework was vulnerable to counterfeiting and drug diversion, which put patients at risk.  Specifically, the law established Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which facilitates the tracing of products through the pharmaceutical distribution supply chain by requiring certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) to exchange transaction information, transaction history, and a transaction statement (product tracing information) when engaging in transactions involving certain prescription drugs.

The new Guidance was developed in consultation with other Federal officials and pharmaceutical distribution supply chain stakeholders, addresses the pharmaceutical security provisions.  This Guidance establishes initial standards for the interoperable exchange of product tracing information, in paper or electronic format, for compliance with sections 582(a), (b), (c), (d), and (e) of the FD&C Act.  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.

This Guidance also establishes standards to help trading partners comply with the requirements of sections 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to provide the subsequent trading partners product tracing information through the extension and/or use of current systems and processes.  Under these provisions, trading partners are also required to capture and maintain the applicable product tracing information for not less than six years after the date of the transaction.  Except as otherwise specified by the DSCSA, the product tracing information can be provided to subsequent purchasers in paper or electronic format. 

This Guidance applies to transactions involving all products that meet the definition under section 581(13) of the FD&C Act for “product.”  Under the law, a “product” is a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution).  

The definition of “product” does not include such items as blood or blood components intended for transfusion and radioactive drugs or radioactive biological products.  

Lastly, in order for any system, process, or practice to be interoperable, the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format.  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), 174 which is currently used to provide the receiving entity with advance data on shipments 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 addition to establishing standards for licensure of wholesale distributors and third-party logistics providers, the DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information to FDA annually.  As such, on December 5, 2014, FDA quietly released a web database in which wholesale distributors and third-party logistics providers can begin reporting licensure and other information to the agency, as the pharmaceutical industry gears up for the DSCSA on January 1, 2015 implementation date for its drug track-and-trace system.  Third-party logistics providers are required to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.  Annual reporting by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal, Additional information can be found here.