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FDA Issues Last Minute Draft Guidance to Address Human Readable Identifiers

Christian Souza

TrackTraceRx Conferences

Before jumping into today's article we wanted to thank everyone that visited us at the HDA conference in Washington D.C. and everyone that we met in Europe during the and Web Sub Summit. More to come on this on our future blogs.

TrackTraceRX team at the HDA conference in Washington D.C.

Our very own CEO Brian Sanz at the Web Summit in Europe.

Web Summit was very busy!

Now on to our post:

As the November deadline for the DSCSA serialization quickly approaches, pharmaceutical manufacturers and other stakeholders within the drug supply chain have been working hard to ensure that they meet compliancy standards, especially considering that the approaching deadline is the cumulation of a year long extension granted by the FDA.

While things have been rolling along smoothly, the FDA recently threw a bit of a wrench into the implementation process for many drug supply chain entities. Just a matter of weeks before the approaching deadline, the FDA has issued a Draft Guidance that recommends a human readable format for product identifiers – a format which happens to be different from what many manufacturers and distributors have been using as they work towards compliancy.

Considering that this Draft Guidance comes so late in the game, drug supply chain members understandably have plenty of questions about the new recommendations and what it all means to their current compliancy process.

“Before jumping to any conclusions about what the new Draft Guidance means, it’s important to understand the key differences between what is stated within the document and the way that manufactures and distributors have been preparing for the impending deadline. ”

Understanding the What’s Contained Within the New Draft Guidance

The Draft Guidance, titled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers” was issued in September as a way of answering many of the questions regarding the human readable part of product identifiers required under the DSCSA.

The information and recommendations contained within the Draft Guidance are considered rather controversial, primarily because they are so different from what pharmaceutical manufactures and distributors have implemented in the absence of formal guidelines. With the November deadline just a matter of weeks away, these difference have sent many drug supply chain members into a flurry of frustration and panic.

Before jumping to any conclusions about what the new Draft Guidance means, it’s important to understand the key differences between what is stated within the document and the way that manufactures and distributors have been preparing for the impending deadline. After reviewing the document, there are three major differences that stand out.

FDA showing reservation on GTINs.

Moving Away From GTIN

One of the most notable differences within the Draft Guidance is that while many manufactures and repackagers have implemented their serialization processes according to GS1 standards, including a GTIN which is imbedded with the NDC number, the FDA has shown reservation in using GTIN.

The FDA has said that the need to separately print the NDA as an element separate from the GTIN is essential for patient safety reasons. This is a hard point to argue, however, many drug supply chain members have gone forward with their serialization process according to GS1 standards.

While this presents an issue for manufactures and repackagers immediately, one can see how the benefits of a separately printed NDC number apply to drug safety and back up the overall intention and purpose of the DSCSA. The main concern of using the GTIN as a stand alone in the human readable product identifier is that it carries a higher potential for improperly identifying the NDC and the associated pharmaceutical.

Alternately, those in the drug supply chain have recently expressed concerns that the NDC alone is not enough to ensure proper identification. Considering that there are multiple GTINs for every NDC number, industry members feel that moving away from GTIN can have the opposite effect and potentially lead to an increased incidence of misidentification.

New Expiration Format

While this  next recommendation isn’t nearly as problematic for manufactures and distributors as the shift away from GTIN toward NDC, the new recommended date format listed under the Draft Guidance is one that is different not only from what supply chain entities have been doing, but also different from the format discussed in a previous Draft Guidance from 2013 that covered safety considerations with container labels.

It’s important to remember that when the FDA publishes a new DSCSA Draft Guidance, that they are simply communicating their current scope of thought with industry members. At this point, recommendations like the one for dating formats are just that – a recommendation. However, this Draft Guidance does illustrate the current thought trajectory on implementation, so it’s best to start making moves toward what the FDA is currently recommending.

Textual Field Names Vs Application Identifiers

The final aspect of significant value within the latest Draft Guidance is less of an issue to many of the operating entities of the drug supply chain. The FDA has recommended textual field names, which many companies have already been attempting to add in addition to GS1 application identifiers when there has been sufficient room on the label to do so.

This recommendation doesn’t really come as surprise considering the patient safety benefits of including a textual name. The struggle here would be for product identifying labels with limited available space.

What to Do Moving Forward

While it might be hard to present a valid argument against all the recommendations in the latest Draft Guidance, there are definitely some frustrations that come with the timing of the document. It was evident to the FDA last year when they extended the deadline that the implementation process for serialization standards was more complex and time consuming than many businesses anticipated. Presenting these recommendations now leaves many of those companies wondering how they will need to further adapt their serialization process once the guidelines for human readable identifiers become set in stone.

To help alleviate pain points for drug supply chain members, the FDA is currently asking for comments and recommendations from stakeholders. Granted, the deadline to submit comments comes in at a mere week before the serialization deadline hits the books. Still, by submitting their comments, stakeholders can help uncover a viable solution for potentially finding a middle ground between the FDA’s new recommendation and the standards that so many drug supply chain members have followed thus far concerning human readable identifiers.

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