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FDA’s Late Recommendation on Human-Readable Format

What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in advance of the November deadline.

Just 10 weeks before the Drug Supply Chain Security Act (DSCSA) requires drug manufacturers to begin applying a serialized product identifier in barcode and human-readable form to drug packages and homogeneous cases, the FDA has recommended a human-readable format that differs from what the majority of  manufacturers have already chosen. What’s going on here? What options do manufacturers have?

I’ve been talking about this issue for a few years. Here is the trail of RxTrace essays that have focused on it (the more recent essays are the most pertinent for today):

• May 4, 2015, “The DSCSA Product Identifier On Drug Packages

• July 27, 2015, “I’ve Changed My Mind, Follow GS1’s HRI Specification

• April 25, 2016, “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1

• May 2, 2016, “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

• February 19, 2018, “Human Readable Text Controversy

A reoccurring theme in most of these essays is that the FDA had not yet provided guidance for the human-readable part of the DSCSA product identifier. As of September 20, 2018, we now have that guidance, in draft form at least (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document.”)

The new draft guidance is controversial in the industry because it differs from the practices that drug manufacturers adopted in the absence of guidance as they prepared for their November 27, 2017, and then 2018 serialization and verification deadline. The three most notable differences are:

  1. FDA says NDC, majority using GTIN
    For regular readers of RxTrace, this is no surprise. Those who are only occasional readers or are new to RxTrace are probably surprised. Notice this is not just a “recommendation,” FDA uses “…must…”. Unfortunately, the industry pays closer attention to not violating GS1 standards than they do to not violating the DSCSA when it comes to the human-readable portion of the product identifier. The DSCSA is pretty clear about the need to print the NDC (as one element of the Standardized Numerical Identifier, SNI) and there are solid patient safety reasons to do that. Those reasons trump the supply chain benefits of following the historical GS1 Human Readable Interpretation (HRI) standard to a tee. The FDA, in this draft Q&A, is simply telling us what the DSCSA has always said. But I believe there are ways to meet both (see “Human Readable Text Controversy.”)


  1. FDA recommends textual field names, majority using GS1 application identifiers (AI)
    Again, no surprise here. More and more, companies have been moving to AIs plus text on products that have enough room for both. That certainly meets the spirit of the FDA’s recommended approach, but it takes a lot of space. Again, the reason is patient safety, and again, I believe there is a solid middle-ground.


  1. FDA recommends new format for expiration date, majority doing something else
    This draft Q&A offers a new date format that I’ve never seen before in FDA documents. In fact, it differs pretty significantly from the date format discussed in the 2013 draft guidance “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” that most companies were probably trying to follow, and which is even used as a reference in this new draft guidance. OK, they are both “draft,” but the one that just came out reflects the FDA’s “current thinking,” so companies should probably gravitate toward it. That older draft guidance is probably worthy of being updated for other reasons, too, now that the DSCSA is a reality.

Speaking of the concept of a “draft” guidance, be aware that the FDA is currently asking for stakeholder comments on this new one. You have until November 19, 2018 to submit your comments. You know, less than a week before the serialization and verification deadline! Until the guidance is finalized (if it ever is–there is no schedule), it is marked “Draft – Not for Implementation,” but it still reflects the FDA’s “current thinking.” Even if/when a draft guidance is finalized, it will still be marked as “Contains Nonbinding Recommendations,” except where they use words like “must” or “shall,” which is normally only done when referring to a requirement directly from the original law or rule, rather than “may” or even “should.”

What makes this new draft guidance frustrating for everyone is that it didn’t come three, or even two years ago when companies were still designing their solutions. It was published after every drug manufacturer has finished configuring, testing, deploying and validating their serialization solutions in advance of the November deadline. That means, if they want to conform to this guidance, they will need to make changes that will likely trigger some amount of re-validation.

Two of the three things I list above are just FDA recommendations. No big deal. Make those changes the next time you do something else to your solution that triggers re-validation—even if it takes a few years. But the GTIN/NDC issue (#1 above) is not just a recommendation. It is based closely on text found in the DSCSA itself. Even so, I don’t think anyone should drop everything and try to cram this change into their systems before the end of November. Hold tight for now.

I expect this part of the draft guidance to generate lots of written responses. I predict the responses will be overwhelming in support of the GTIN, and there is probably a chance (a very slim chance) that FDA may make some kind of exception to allow it (if they even can—the DSCSA is an Act of Congress after all). Those responses should be really interesting to read. Once they are all posted later this year I will write a review of the ideas expressed in them and analyze the implications.

BTW, while researching this essay I discovered that the FDA has significantly changed CFR 21 Part 207, Subpart C, National Drug Code (formerly referred to as CFR 21 Part 207.35) at some point in the last two years. I have added a note on one of my earlier essays that extracted the obsolete text from this section.

Editor’s note: This article was originally published Oct. 1, 2018 on It is used here with permission by author Dirk Rodgers, Regulatory Strategist for Systech International and founder of RxTrace.


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