FDA Seeks Input On The Future Format of the National Drug Code

Last week the FDA published a notice of a public hearing and request for comments regarding the impact of any future changes made to the length and format of the National Drug Code (NDC).  The current format of the NDC has been around since the early 1970s (see “Anatomy Of The National Drug Code”).  It has served the FDA, healthcare professionals and patients well since that time, but it is showing its age.  I call its affliction, “Identifier Failure” and I point out all of the symptoms for the aging NDC system in my essay “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”.

It appears that the FDA recognizes these problems—or at least, they recognize that there might be problems—introduced by changing the NDC definition.  So they want to hear from stakeholders to help them better understand what they should do.  Should they expand the NDC from 10- to 11-digits?  Should they start over with a totally new way of identifying drugs?

In fact, back in 2016 the FDA made the Labeler Code a 4, 5 or 6 digit number.  Before that, in was either a 4 or a 5 digit number, thus making the NDC a fixed length, 10-digits long identifier (4-digit Labeler Codes were adjusted by adding a zero to the beginning to make the NDC a fixed length identifier).  By adding the potential for 6-digit Labeler Codes, the NDC would either have to be redefined as an 11-digit, fixed length code, or a 10- or 11-digit variable length identifier.  Back at that time, FDA said they would initiate a public discussion of future formatting options in the near future.  That “near future” has finally arrived.  See the public notice here.

As I pointed out in my earlier essay, this could be catastrophe for the industry if it isn’t handled properly.  And I have been outspoken about how to solve this approaching problem (see “UDI And The Approaching End Of The NDC”, “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1” and particularly “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”).  In fact, that last essay—the open letter to the FDA—contains my proposal for fixing the NDC by converting it to the same approach the FDA used in the definition of the Unique Device Identifier (UDI) system just a few years ago (see “FDA Proposed UDI: A Revolution In Number Assignment”).

The biggest benefit for taking that approach is that all existing NDCs would fit into the new definition without changing, and new NDCs could be defined with any GTIN (as long as it is registered with the FDA), not just those that fit within the old “Labeler Code” model.  The GTIN identifier would become the new “NDC”, and other identifier organizations who follow the same ISO standards required by the UDI system would qualify to become “number issuing agencies”.  Their standard identifiers would be acceptable too, as NDCs, once accredited by the FDA.  For the full explanation, see the open letter essay.

Anyway, the FDA will hold a public hearing to collect ideas from stakeholders on November 5, 2018 at their headquarters in Silver Spring, MD.  If you have ideas or concerns about how the FDA might “fix” the NDC system, I encourage you to register to attend (see the announcement for registration and webcast details).  Comments may be submitted to the docket until January 5, 2019.  I have registered to attend the meeting and I have requested a five minute timeslot to make a brief presentation of my thoughts on fixing the NDC system.

Why only five minutes?  I don’t consider myself as a “stakeholder” (except as a patient who consumes pharmaceuticals).  I expect the Healthcare Distribution Alliance (HDA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the National Association of Chain Drug Stores (NACDS), the Healthcare Supply Chain Association (HSCA) and other true industry stakeholders to make lengthier presentations.  I just need a few minutes to make the case for the UDI approach.  And I will be very interested to hear what those industry associations have to say about the problem and the solution.

I hope to see you there.