Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management. Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data. But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to do some extra work.
The DSCSA Transaction Information (TI) and Transaction History (TH) both require the use of the 10-digit NDC (TS does not contain references to product codes), which is the real, true NDC so I will drop the qualifier “10-digit” in front of “NDC” and just refer to it as the NDC. The FDA created the NDC back in the early 1970’s (see “Anatomy Of The National Drug Code”) and has used it solely to refer to the drugs they regulate. Yes, the NDC has problems, but until the FDA replaces it with something else, that’s the code the FDA will use (see “UDI And The Approaching End Of The NDC”), and that’s the safest code you should use in your TI and TH.
Last week, industry veteran Bill Fletcher posted a good explanation for where the 11-digit code came from (members of the “Food and Drug Serialization Professionals” LinkedIn group, see “Potential confusion with Drug Supply Chain Security Act [DSCSA] 10-digit NDC and HIPAA 11-digit pseudo-NDC”). For some additional background from the FDA on this difference, see “Old NDC Database Information”. Bill raises some great questions at the end, and a suggestion to GS1 to establish an application identifier (AI) to support the 11-digit number as the U.S. national reimbursement number, just like it has for Brazil, Germany and perhaps others. That’s a good idea.
But in the short term, companies that have set up their inventory management and/or warehouse management systems (WMS) to key off the 11-digit code might need to rethink that approach and make some kind of adjustment.
What about those who have set up their systems to use a GTIN as their primary product reference number? They are probably in better shape since it is straightforward to convert between the NDC and either form of GTIN and back (see “Depicting An NDC Within A GTIN”).
Interestingly, the FDA only recently fulfilled another mandate from Congress by promulgating the Unique Device Identification (UDI) final rule (see “FDA Proposed UDI: A Revolution In Number Assignment”). Once it is fully implemented throughout the U.S. medical device industry UDI should go a long way toward resolving a bunch of problems of varying degrees of seriousness, all resulting from the mis-identification of devices.
Because commercial inventory management and WMS systems are almost always designed to be used in all industries and supply chains, the type of product code they recognize that supports the most functionality is likely to be the GS1 GTIN. Most probably treat the NDC or the 11-digit reimbursement code as a blind 10- or 11-digit “number” without any recognition of the structure and rules for those numbers without custom coding. Under the UDI rule now in place for devices, a 14-digit GS1 GTIN can be registered with the FDA as a valid UDI number (so can codes constructed using HIBCC and ICCBBA rules), but that’s not the way the NDC system works for drugs (see how the NDC system works in “Anatomy Of The National Drug Code”).
So in the case of UDI for devices, the GTIN is one-in-the-same as the registered regulatory code, but in the case of the NDC for drugs, the GTIN is not exactly the same as the registered regulatory code. Should the DSCSA TI and TH only list the true registered regulatory code—the NDC—or is it acceptable to use a GTIN instead? How about the 11-digit reimbursement code that is based on the NDC? As Bill points out, differences in usage by different companies in the supply chain could lead to confusion by downstream trading partners and may hinder smooth supply chain operations, let alone investigations into suspicious drugs.
Once manufacturers and repackagers need to begin applying Standardized Numerical Identifiers (SNIs) (also known as a “serialized NDC”, or, “sNDC”) to their products, it is clear that the FDA will accept a “serialized GTIN”, or “sGTIN” as a depiction of the SNI (see “FDA Aligns with GS1 sGTIN For sNDC”), even though the registered regulatory number will remain the NDC. As Bill points out in his post, you cannot create a GTIN from the 11-digit code that is based on the NDC. And, consequently, you also cannot create an sGTIN from that code either, and so you also cannot create an SNI.
Hopefully this situation will result in alignment in the supply chain at least away from the use of the 11-digit reimbursement code. On the other hand, the farther down the supply chain you get, the more important and entrenched the use of that reimbursement code is. These are the companies that need that number to get paid, or reimbursed (thus the name). Most of these folks truly believe (mistakenly) that the “NDC” is an 11-digit number. So when you talk with them, make sure you clarify what number—which “NDC”—you will use in your DSCSA data exchange and be prepared for some potential push-back if you plan to give them the true 10-digit NDC.
NEW FDA DRAFT DATA EXCHANGE GUIDANCE IS DUE THIS WEEK
The FDA is due to publish their draft guidance on standards for data exchange for use in meeting the DSCSA paper and electronic transaction data requirements that start on January 1 for manufacturers, repackagers and wholesale distributors, and on July 1 for dispensers. If the FDA is on time, the draft will be published on Thanksgiving day. If they are early, as they predicted last spring (see “The 2014 FDA DSCSA Workshop”) but seemed to back away from at the recent HDMA Traceability Seminar, they will publish before that day. I’m still not holding my breath.
Companies should not be waiting for this draft guidance because there will not be enough time to implement if you have not started preparing for one of the approaches that are well known in the industry (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”, “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”, and “The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1”). I also don’t think the FDA will accept the excuse that you were not ready because you waited until the draft guidance was published…and then did not have enough time to implement. But I suppose we will hear that excuse from some.
UPDATE ON LAST WEEK’S RxTRACE ESSAY
Last week I mentioned a conversation I had with one of the ten largest generic drug manufacturers in the world in which they said they had only recently heard about the DSCSA and had not yet done anything to prepare (see “Will The DSCSA Cause Drug Shortages After January 1?”). Well, I heard from a knowledgeable source who said that they knew for a fact that that particular company has had a team working on preparing to meet the DSCSA for nearly a year now. So apparently the group I ran into was a different group of folks who were simply unaware of their own company’s work in this area. I suppose I should not be surprised. The teams deployed by each company to meet this law are usually pretty small and if you so not get to just the right person, it is sometimes very hard to make contact with anyone who knows that DSCSA activity is underway. Apparently that is what happened in this case. Hopefully this is a good sign and we will not see any major shortages as the result of the DSCSA.