Part 2 of 2: DSCSA: What's to Come?

Return product processing

The next two segments of the DSCSA will regulate the processing of returned products. These are anticipated to go into effect on Nov. 27, 2019. After which, if nothing changes, it will become illegal to return non-verified products into inventory that are designated for re-sale, unless, they are either verified or grandfathered in (see later).

This has serious potential ramifications as the total value of returned products equates to over $4 billion in saleable products per year. Doing this poorly, at the very least, will result in inventory issues and, even worse, could be cause for perfectly good products being scrapped. All of which primarily results from badly implemented new processes and poor or slow verification router service (VRS) systems. In the end, neither are good for the most important person in the supply chain, the patient.

Dispenser conformance

Following this, on Nov. 27, 2020, dispensers will need to appropriately process serialized product. When this occurs, the serialization process will have reached further down the supply chain. Right now, it is clear that most actors at this level, despite the DSCSA being published formally on Nov. 27, 2013 (at the time of this writing, nearly five and a half years ago), have not yet considered what to do. This can only result in one of two things, further acts of leniency by the FDA or panic/chaos. Again, the person suffering will be the patient.

Fully interoperable supply chain

The final step in the existing DSCSA regulation is scheduled to come to fruition during 2023 with the unveiling of the era of “Fully Interoperable Supply Chain”. There are still many schools of thought as to the meaning of the Nov. 27, 2023 cutover into the Fully Interoperable Supply Chain. With numerous groups and public hearings gathering information, its currently anyone’s guess as to how this will work or what additional steps will be needed to comply.

When the DSCSA was first signed into law late Nov. 2013, the year 2023 was a decade away (obviously). Since then, five and a half years have passed and we are really no further enlightened into the meaning of the endpoint of our journey.

But what is readily apparent from our experience thus far is that, if additional systems and technologies are required, the definition needs to be settled very soon. If not, serious thought should be given to delaying this final milestone, especially if you consider how fundamentally under-prepared the industry was for the Nov. 27, 2017 date—a deadline that prompted the one year grace period. Four and a half years will pass in the blink of an eye.

Grandfathering

In a long-awaited move, the FDA released its grandfathering guidance earlier this year by intimating that any product entering the U.S. pharmaceutical supply chain on or before Nov. 27, 2018 and not labeled with a serial number would be considered, “Grandfathered In.” This guidance appears to be fairly clear and presents the distribution supply chain with a small challenge.

Nowhere will this be more apparent than in the returns department. An example, if you will, is to put yourself in the shoes of a returns associate operating inside a warehouse. You have just opened a returned package to find that the product inside is not serialized. What do you do? This raises many issues, including:

• You are unable to use a VRS system to check its validity;

• You cannot easily check to see if the item has been returned from where it was shipped;

• You cannot check to see if this item has ever been in your own or indeed any of your company’s facilities before.

So, how can you check to see if the item is grandfathered in? There is not going to be a centralized list of grandfathered products. So it is off to the races. First, the in-system search is used to check Item and Lot Numbers manually to see when it was received in the hope that this can answer the question, if not, then it’s a paper records search.

The moral of this story is as follows, if you are not already receiving your T3 data electronically and storing it for easy Returns-Team retrieval, then for a period of time, potentially three to five years, you will need to have an excellent filing system or be prepared to up-scale your Returns Department. If an FDA audit finds systematic returns to stock of potentially non-grandfathered product or poor returns process quality, then that’s a 483 in waiting.

Ian Parsonage

#Serialization