The 2019 HDA Traceability Seminar Briefing

October 29, 2019
Collage: Dian McDougall, Ruby Raley, and Jim Toland of Axway join Riya Cao, CEO of LSPediA at HDA Traceability 2019. Jeffery Denton speaks on Blockchain in the Pharmaceutical Supply Chain. Dr. Connie Jung provides an FDA Overview. Justine Freisleben, Shaun Z. Kirkpatrick, David Mason, Andrew Meyer, and Matt Sample speak on the challenges of DSCSA. John Dittman, Elizabeth Gallenagh, and Vidya Rajaram provide a blueprint for 2023.

The HDA held their annual forum on serialization last week in Washington DC—and LSPediA was proud to be a sponsor of the event. As anticipated, the HDA did another outstanding job in gathering the most relevant of inputs from industry leaders to keep everyone in this space aligned on what is going on, and where they should be in this journey towards securing the Rx supply chain and ensuring patient safety. That said, it was very much business as usual for this impactful forum, but in case you missed it, there were two standout items worthy of calling out in this event recap – clarity from both the FDA and industry on the upcoming November DSCSA compliance, and a bit of confusion concerning the use of GTIN’s on product packaging vs. the NDC.

Let’s zoom in and break it down.

November DSCSA Compliance

Nothing could have been more impactful than the update from the FDA ensuring clarity around the recent enforcement discretion towards saleable return goods, compliance penalties, and the expectation of industry to maintain efforts on readiness – and to focus on what is still intended to be enforced as relative to the identification, quarantine, investigation, and reporting of potential suspect and illegitimate products.

Captured below are the topical requirements that remain in force for wholesale distributors in 2019

DSCSA Wholesale Distributor Requirements and Deadlines for Suspect, Illegitimate, and Saleable Returned Products

Notably, the manufacturer requirements had already gone into effect in 2018. Captured below are the DSCSA verification requirements for manufacturers.

DSCSA Manufacturer Requirements and Deadlines for Suspect, Illegitimate, and Saleable Returned Products

The FDA has confirmed the enforcement of the requirements for wholesale distributors and manufacturers listed above. And while the wholesale distributor requirement for the verification of saleable returns has been delayed, many of LSPediA’s well-respected clients are planning to meet the original deadline. Internal deadlines and an overabundance of caution is what’s driving many of them to stay on course.

In case anyone was unclear on the FDA’s expectations ongoing, a few points were made to ensure clarity on their intent to see adherence to their requirements:

FDA DSCSA Enforcement Discretion Quote from Frank Rivera, Drogueria Betances

• The FDA will ensure requirements compliance—which could include conducting site visits to check status and progress

• Dr. Connie Jung cited the warning letter to provide insights on regulatory adherence expectations, saying, “If you are unsure of what you should be doing – read the letter.” The warning letter stated that the agency observed “failed to respond to illegitimate product notifications”, “failed to quarantine and investigate suspect product”, and “failed to keep, for not less than 6 years, records of the investigation of suspect product and the disposition of illegitimate product”. The observation precisely matches the DSCSA verification requirement 582 (c)(4)(A) – (C) listed in table above.

The compliance discretion issued by the FDA is only for saleable returns verification requirement, 582 (b)(4)(D). The rest of the verification requirement including suspect product investigation and illegitimate product handling, 582 (c)(4)(A)-(B), are on schedule to be enforced. The message from Dr. Connie Jung was loud and clear – supply chain partners must do their own part to meet compliance.

“Are there any solutions for 582 (c)(4)(A) – (B)?” you may ask.

“Yes”. LSPediA’s Investigator, part of the OneScan solution suite, provides turnkey compliance for 582 (c)(4)(A)-(C). The Investigator was used in LSPediA’s FDA VRS Pilot Program enabling all of the attributes associated with these requirements. It can be leveraged as a compliment to any competitive VRS as well as LSPediA’s. It features a collaborative workspace and workflows for facilitating suspect product investigations complete with attached documentation, photographs, and audit trails of all investigative contributions from all parties involved in the effort. The solution module also accommodates cargo theft, which was also called out by the FDA in their compliance requirements.

To GTIN, or not to GTIN – that was the question….

Can’t help but scratch my head in bewilderment on this topic, but apparently someone not paying close enough attention to DSCSA activities up to this point tried to utilize a GTIN in place of an NDC for product identification outside of an EPCIS reference. (Of course; they could not identify the product.) This confused attempt to identify a product made its way to the FDA prompting a public declaration of the obvious – that a GTIN is not a replacement for an NDC as far as product identification is concerned.

So; this need for undue clarity created some confusion for manufacturers concerned that after a decade of diligent efforts to create a GS1 designed product identifier for use in the standardized EPCIS data management schema – that they have somehow messed up in the process. We give kudos to Matt Sample (AmerisourceBergen) for trying to make a succinct and confident statement that this is not the case – the GTIN is for use in EPCIS data management and exists in human readable form next to the 2D barcode in case the barcode is not readable via a scanner. Simple stuff to many paying attention to details in this space, but not to the laymen who is not…

This is our attempt to compliment Matt’s effort;

  • The NDC and the associated linear barcode will exist on a saleable package (as it historically has as part of pre-printed package artwork) to identify a product per FDA regulatory requirements.
  • A GTIN and associated GS1 Application Identifiers for product ID, lot, expiration, and serial number needs to be right where manufacturers have been placing them – in the whitespace adjacent to the online printed 2D barcode. (Move along…nothing to see here!)
QR code used in packaging instead of 2D barcode

More notable is a problem identified by LSPediA in conducting our FDA VRS pilot, and is absolutely in need of a call out concerning the use by manufacturers of QR codes, databars, etc. These have been found on saleable packages being scanned for the pilot and is causing confusion among supply chain personnel, and likely would for other end users.  LSPediA urges manufacturers to cease this practice immediately and instead relegate the use of those non-supply chain required barcodes for inner packaging, but keep them off the salable pack.

HDA Provides Value

Thanks to the HDA for another amazing and informative event for anyone involved in this ever-evolving DSCSA space. One of the highlights for our organization and our clients included a fun and productive evening with clients and partners. Thanks to all who attended!

LSPediA clients and partners join us for dinner at HDA Traceability 2019

Another big moment was Tuesday evening’s HDA Networking Event, sponsored by Axway, which gave us the opportunity to share an announcement about the Axway/LSPediA partnership. Read more about that here.

If you didn’t make it this year, we urge you to make it a priority in 2020—it’s a valuable experience for anyone in the serialization space.

Are you struggling with DSCSA requirements? LSPediA can help ensure you meet all mandates and ensure your business and your customers see real world benefits. Contact us today. We’ll help you work smarter, reduce waste, and increase profitability.