Last week I covered the likely impact of the recent draft compliance policy currently under a 60-day public comment period (see “DSCSA and RxTrace: The Song Remains The Same“). This week, I will take a look at its likely impact on downstream trading partners, including repackagers, wholesale distributors and dispensers.
Under the Drug Supply Chain Security Act (DSCSA), these organizations have specific obligations to only engage in transactions with product that has the DSCSA-mandated product identifier (serial number) on it (see “The DSCSA Product Identifier On Drug Packages“). And when investigating suspect product or receiving saleable returns, they must verify those drugs with the manufacturer using the standardized numerical identifier (SNI) (see “Drug Verification: EU Vs US” and “DSCSA: Saleable Returns Verification“). These obligations kick-in on November 27, 2018 for repackagers, 2019 for wholesale distributors and 2020 for dispensers. These are what I call the “cascading” deadlines.
But now, when the draft compliance policy becomes final, the manufacturer’s one year serialization delay will result in cascading delays at each of these downstream trading partners. The manufacturer’s enforcement delay will cause non-serialized product to legally enter the supply chain between November 27, 2017 and November 26, 2018. Because the FDA would not enforce the manufacturer’s deadline for one year, it would be unfair for them to enforce these cascading deadlines on downstream trading partners.
The manufacturer’s delay is for exactly one year, but notice how the delay in enforcement for downstream trading partners does not have a specific end date. The reason is that no one can predict how long it will take all of the those non-serialized drugs that enter the supply chain from the manufacturers between November 27, 2017 to November 26, 2018, to exit the supply chain. As long as they are still in the supply chain, they would continue to get a pass on the serialization requirements.
Instead of a specific end-date, the FDA expects downstream trading partners to determine for themselves if the non-serialized product they are dealing with (buying, selling, returning, investigating) entered the supply chain from the manufacturer during that magical year when the FDA used enforcement discretion to allow that to occur.
After your original cascading deadline, if the product does not have the DSCSA product identifier on it, and it originally entered the supply chain from a manufacturer before November 27, 2017 or after November 26, 2018, you should not buy it, you should not return it to saleable inventory (for returns) and if you are conducting an investigation into suspect product, you should strongly consider labeling it illegitimate product. But if it originally entered the supply chain between November 27, 2017 and November 26, 2018, you can treat it as you treat non-serialized product today.
The compliance policy leaves it up to you to “…take steps to determine that the product was introduced in a transaction into commerce by the manufacturer in this timeframe.” But don’t despair. The FDA recommends two ways of doing it:
- “At least one of the transaction information documents that compose the transaction history for the product describes an initial transaction date from the manufacturer that occurs between November 27, 2017, and November 26, 2018; or
- “There is other documentary evidence created by a trading partner in the ordinary course of business and containing a product description that matches the package or homogenous case of product that is not labeled with a product identifier. In addition, this other documentary evidence should contain a date from which it can be determined that the product was introduced in a transaction into commerce by the manufacturer between November 27, 2017, and November 26, 2018. Examples of such documents may include, but are not limited to, bills of lading, commercial invoices, and shipping invoices.”
(See “DSCSA: Transaction History“.) The draft compliance policy makes it clear that, if the drug has a DSCSA product identifier on it, you should follow the un-modified DSCSA when acting on it.
There is one more thing to say about the impact of this compliance policy on repackagers (see “Who Is A DSCSA Repackager?“). Repackagers will not get a delay in their November 27, 2018 requirement to apply the DSCSA product identifier to their own packages–at least not from this guidance document. That means the first date that 100% of drugs entering the supply chain will be serialized, will not change. It will still be November 27, 2018 as it would have been before the compliance policy.
Of course, the FDA could modify the policy at any time, based on evidence supplied by stakeholders or the public. If you feel strongly about that, you still have 6 weeks to submit comments on this draft.