Before the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January. But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law. From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”). Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
That extension in enforcement is a blessing to a few companies who were having trouble getting ready fast enough, but most companies were ready by the original date and by now are supplying Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) to their customers on a “routine” basis. (Routine is in quotes only because everyone has just started passing this data and it will take a few months before it can rightly be considered routine.)
So now that the data exchange requirements are behind us, drug manufacturers and repackagers need to return their attention to serializing their drug packages and homogeneous cases—this time aiming for the November 27, 2017 (for manufacturers) and 2018 (for repackagers) deadlines of the DSCSA.
The Healthcare Distribution Management Association (HDMA) helped align companies around a standard approach to data exchange through Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”) and through their transaction scenarios (see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”). Fortunately, the HDMA has also published some information about applying barcodes on drug product (see “Updated HDMA Bar Code Guidance: A Must Read”) but that publication predates the passage of the DSCSA. Watch for an update to that important guidance in 2015.
We also need new guidance from the FDA to answer questions about the continuation of the existing linear barcode, mandated since 2006 on drug packages. And, whether or not the human readable lot and expiration date that is printed as part of the new 2D barcode is sufficient as the only printing of that information on the package. In my view, the FDA needs to tell everyone what is necessary about that printed data to make it usable for supply chain operations, healthcare workers and patients.
The problem is that the GS1 General Specifications say that the human readable data next to the barcode should include the Application Identifiers (AIs) to identify the type of data contained in each field encoded in the barcode. But to make use of the human readable lot and expiration date fields to fulfill the technical and the regulatory requirement, the AIs should be replaced with the text “Lot:” and “EXP:”, or something comparable. That is, don’t follow the GS1 General Specification on this. GS1 US Healthcare has covered this issue well in their guidance (see “The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1”), but the FDA should provide this kind of guidance so companies can be confident in their compliance. Interestingly, South Korea actually requires the use of the AI’s on drug packages rather than text that would be understandable to the local population.
There are a myriad of other technical challenges that companies are facing in order to find a serialization solution that is simultaneously fast, reliable and produces the necessary print quality. You can usually get two of those requirements, but to meet all three is very difficult, depending on what point you are starting from.
Serial number data management, including any randomization, must also be figured out soon (see “Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations”). Manufacturers have a number of serialization solution vendors they can choose from. Some are better at the low end (L1-L3) and some are better at the higher end (L4-L5 and even enterprise-to-enterprise…the “data exchange” solution providers). A complete solution will almost certainly require an integration of equipment and software from multiple vendors.
Riya Cao of LSPediA and I have recently begun working together to offer integration and other consulting services aimed at meeting the U.S. and global serialization requirements of pharma and biotech manufacturers, repackagers, wholesale distributors and dispensers. Contact us to line up a conversation with no cost and no obligation.
Beyond that, I recommend the Pharmaceutical Traceability Forum to be held on March 30 through April 1, 2015 in Boston. Use PTF_RXTRACE in the discount code field on the registration page and receive a 20% discount off the normal fee. Early-bird pricing ends on January 9, 2015 so don’t delay.
Dirk.
