Part 1 of 2: DSCSA: Post-Serialization Depression
Updated: Aug 6, 2019
Over 18 months since the DSCSA (Drug Supply Chain Security Act) came into effect, manufacturers continue to struggle with Post-Serialization Depression (PSD).
Even with the FDA providing one additional year of grace period—over 18 months since the DSCSA (Drug Supply Chain Security Act) came into effect for manufacturers—many pharmaceutical companies suffer from Post-Serialization Depression (PSD) or, amazingly, have still not completed their implementation projects.
With respect to the former, unfortunately, PSD does not refer to the cognitive state of the internal project team. All too often, PSD symptoms manifest through losses in productivity of 5%, 10%, and even 30% due to the introduction of the serialization factor.
So, why are so many companies suffering from PSD? Isn’t serialization just another add-on automation regulation? Haven’t these companies overcome the same types challenging scenarios before? Shouldn’t this just be a matter of putting in place competent project managers and choosing reputable system providers? Unfortunately, the answer is not as easy as it looks due to some of the following factors that may be affecting your operations.
Business Process Change
Was serialization seen as a major paradigm shift in the way your company handles batch production?
Did the Quality Team embrace the inevitable changes to the release process?
Did Operations and Maintenance release enough staff to be properly trained on the new systems?
Did you aggregate out of the gate?
Master Data Management:
Did you give priority to Master Data Quality?
Did you build a new infrastructure to embrace the data explosion at the shop floor?
Partner Data Exchange:
Did you check that your existing trading partners were gearing up adequately to take your data?
Did you ensure that your partners are, or would be, EPCIS message compliant?
Did you understand the impact of the T3 in down-stream trading?
Did you think about the later aspects of Returns or Repackaging?
If the answer to any one of these was NO; then you may be limping along with a ticking time bomb. If you said NO to three or more; then you are most likely losing substantial amounts of margin.
FDA guidance--NDC usage
To add fuel to the fire, the FDA issued regulatory guidance in late Q3 of 2018 on the use of the National Drug Code (NDC) as a primary part of the “Unique Identifier.” In doing so, the guidance not only ignored the way in which the industry has been implementing track-and-trace systems, but also ignored the spirit/text of the DSCSA, which clearly states that the coding of packs should be done using a Globally Recognized standard.
While not said directly, 99% of organizations interpreted this to mean the GS1 global standards and, in turn, quickly set a course to build systems that encoded serial numbers as an attribute of the GTIN (Global Trade Item Number).
In fact, there isn’t a serialization system available today that could manage NDC/Serial numbers without the serial number actually being linked to the GTIN. Wherein, the unit level GTIN-14, at least for the U.S., is derived from the NDC (by adding a ‘003’ in front and a check digit (using GS1’s rules) at the rear (3 + 10 + 1 = 14), but has a major differentiating component that the NDC does not have.
Specifically, the Unit Pack, Bundle, and Homogeneous Case all have the exact same NDC. Whereas each of these have a unique GTIN by virtue of the first digit, which is a Packaging Level Indicator (and the obvious resulting change to the check-digit).
By way of example, using a fictitious NDC, the following GTINs could be produced:
Note: The bold 1234567890 is the fictitious NDC used as a model, ‘03’ is the current USA Pharma Conversion ‘filler’ of the NDC to GTIN-14. The underlined first character is the packaging level indicator and, the double-underlined last character is the check digit.
As a result, under the FDA’s guidance, it is possible for multiple packs to have the same NDC/Serial number combination (which, by the way, is really bad). However, in contrast, when using the GTIN/Serial combination, uniqueness is guaranteed.
In response, the industry’s reaction was swift and consistent, “We are using GTIN, Serial, Expiry and Lot Number and we will show the NDC on the same panel as the license plate.” Unfortunately, the industry is still awaiting the final view/opinion from the FDA. But one thing is clear… to change that which has been done for the last five years would not be easy and in many cases could require additional equipment; particularly if the end result is a request to print the NDC as a fifth line of human readable text.
All of that said, the existing NDC issued guidance does potentially give latitude to companies for the use of the third segment for different packaging levels, as well as for different dosage forms. If manufacturers began to use this segment to indicate the packaging level, then the NDC would become unique in each of the four examples above, thus removing the risk of an NDC/SN commonality.
The trouble here is that I’m not aware of any manufacturer using the NDC in this way—so it wouldn’t help immediately. Plus, changing to this usage would cause for the need of a reissuance of GTINs with resulting changes to artworks, so this may be a non-starter anyway.
Guidance: serial number & expiry date format
Other aspects of recent FDA guidance have also served for cause of concern. The main two examples being guidance for human readable text describing the Serial Number, “SERIAL” and guidance for the presentation of the Expiry Date.
For the serial number text, most of the industry has coalesced around using “SN”, “S/N”, or “21”). For the expiration date, the FDA recommends a structure of ‘YYYY-MM-DD’ or ‘YYYY-MMM-DD’ (including hyphens) or in print regions with limited space, suggests dropping the ‘-DD’. The industry has largely followed guidelines offered by the Healthcare Distribution Alliance (HDA—who have been active in this space for many years) that make use of ‘DD MMM YYYY’ or simply, ‘MMM YYYY’ or ‘MM/YYYY’.
In any case, following this new guidance after thousands of products have already been serialized according to HDA suggestions is problematic at the least. That said, if a manufacturer followed GS1 guidance to the letter and thus have included the AI or Pre-Text, I suspect you have right on your side. Once again though, an updated response to the industry’s inquiry is eagerly awaited from the FDA.
In summary, the recent guidance is generally regarded as just that… “guidance.” The law is the law and following it is critical. By using GS1 structures and rules for how to print the pre-text for the four core data elements, you are arguably complying with the law.
However, in doing so, I have one recommendation… make sure that your rationale for how you are coding is well thought out. This is because, at some point, the FDA inspector may have a question or two for you.
... See the remainder of the article in Part 2.