The U.S. Food and Drug Administration issued guidance for the Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, and Prescription Drugs. The document establishes initial standards for the interoperable exchange of product tracing information (transaction history (TH), transaction statement (TS), transaction information (TI) in paper or electronic format.
#1: Track and Trace
Title II of the Drug Supply Chain Security Act requires manufacturers, repackagers, wholesale distributors, and dispensers to track drug products as they move through the supply chain. The product-tracing requirements go into effect Jan. 1, 2015, for manufacturers, repackagers, and wholesale distributors, and July 1, 2015, for dispensers.
Trading partners are required to provide the subsequent purchaser with the product-tracing information. Trading partners are also required to capture and maintain the product-tracing information for six years. The FDA notes that although third-party logistics providers are also considered trading partners, the product-tracing requirements are not applicable.
According to the document, trading partners can use current paper-based or electronic-based methods for the interoperable exchange of data. 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.
The methods to do this include (but are not limited to):
- 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.
What 3PLs Need to do Right Now
Talk to your clients about the new track-and-trace requirements and ask them how they will be providing this information to you by Jan. 1, 2015. Based on the guidance issued in November, the exchange of this information through the supply chain is open. The track-and-trace requirements present a new opportunity for 3PLs to add value to clients by building out a warehouse management system to store this information.
The FDA intends to issue additional guidance in the future to facilitate the interoperable exchange of product-tracing information through standardization of data and documentation processes. Stay tuned for updates.
All 3PLs are deemed licensed, as the FDA has yet to issue its federal licensing standards. The FDA plans to issue these standards Nov. 27, 2015.
State licensing standards have been pre-empted by the DQSA since it was enacted into law last year. Most states have not repealed their licensing laws to reflect the new federal laws. There are two exceptions to the licensing: Florida, and by Jan. 1, California. If you are located in Florida or California or if you ship products to these states you must have a state license. As far as we know, no other states are considering a licensing program.
The FDA placed licensing requirements on manufacturers, wholesalers, dispensers and repackagers well before DQSA came into law. By Jan. 1, 2015, 3PLs need to verify that their partners are properly licensed with the FDA. And, if you plan to ship any prescription drugs in or out of California, you need to obtain a state license by the first of year.