As 2017 heads toward the final quarter and the time intended for the Drug Supply Chain Security Act (DSCSA) to implement step 1, i.e., all pharma manufacturers distributing only serialized primary containers into the supply chain, we’ve learned a few things.
- A large portion of the suppliers are not ready.
- The FDA is not going to prosecute those who are late. The law will not be delayed, but enforcement is at their discretion. That is probably a good thing.
While there are certainly companies out there who dragged their feet, the majority of players I’ve encountered have been making a good faith effort to be ready for the deadline. There are several factors influencing whether they will be ready with the time to implement serialization solutions being the most critical. The industry learned (both manufacturers and suppliers) that serialization was quite time consuming to implement and validate. More than anticipated? I’d say not. The industry expressed their concerns about the complexity of serialized line of sight bar coding on a massive scale during the creation of the legislation in 2012 and 2013. After successfully turning back the efforts to have RFID as the carrier, the pharma industry counted on the complexity of bar coding and line of sight capture to delay or kill the legislation. They were wrong. So we are stuck with serialized bar coding for the foreseeable future and an agonizingly slow roll out of DSCSA until 2023, when pharmacies will finally acknowledge receipt of item level serialized product.
While it may seem that 2023 would be the end game, in reality it is just a beginning. The one thing we know for certain about counterfeiters is that they will find the easiest path, the low-hanging fruit. Once the prescription drug supply chain is locked up, they will simply move to the next easiest target (or already have). In this case, the over-the-counter drug market. Now to be sure, the potential profits in OTC drugs are not the same as for ethical drugs – but that hasn’t stopped counterfeiters of shampoo, toothpaste and other personal care products from pushing bogus product into our market.
The industry will eventually come to realization or have it legislated upon them that DSCSA will continue into the OTC space. There simply will be no other solution. Given what we have already seen in other markets one would conclude that consumer products would be next with foods in a close second or if we had our priorities straight might actually be ahead of our shampoos and toothpastes.
The serialized world is here to stay. We should get used to it and embrace it, for along with the basic supply chain safety it provides, it will also bring supply chain efficiencies that would have been difficult to realize otherwise. The only real question left is: How long will it take industry and Congress to come to this realization and write the next chapter of DSCSA?
The Healthcare Compliance Packaging Council is a nonprofit trade association whose primary mission is the greater use of compliance-prompting packaging to improve patient adherence and patient outcomes, leading to reduced healthcare costs.
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