One important part of the LSPedia mission is combating misunderstandings and misinformation around DSCSA compliance. This has never been more important than in the days after the FDA's statements, though clear and unequivocal, that trading partners across the pharmaceutical industry – manufacturers, wholesale distributors, dispensers, 3PLs, and more – must be compliant by November 27, 2023 to ensure that they can fully participate in the one-year stabilization period.
Ironically, what causes much of the confusion for dispensers is a collaboration tool provided by their wholesale distributors: EPCIS-compliant data portals. Many distributors who have already onboarded EPCIS took the step of providing these portals, which allow them to track orders, exchange EPCIS data, and investigate potential problems. To a dispenser partner, these are useful for everyday product receiving, support quick electronic transactions, and are overall a terrifically convenient tool. They seem like they fully cover DSCSA transactions. And they do...for the distributor.
Don't let these create a false sense of security. There are a number of obligations dispensers need to fulfill under DSCSA that are fully outside the data exchange with their own distributor. And even if this weren't the case, from a practical standpoint, it's simply never a good idea to make a trading partner responsible for your own business' ability to comply with the law.
For just one example, the ATP requirement means dispensers need to confirm and ensure that their distributor is authorized before doing business with them. ATP verification must be carried out individually by any company doing business in the pharmaceutical supply chain, and attempting to rely on a trading partner to fulfill it is both outside FDA compliance rules and risky at a business level.
DSCSA states that dispensers must have protocols in place to verify applicable state laws for licensure and registration for trading partners. As well, it mandates that they must have protocols for regular audits to verify the status of their trading partners. It’s an aspect that is essential for compliance and everyday business – yet can be automatic and frictionless with a system like OneScan Pharmacy Pro.
Yes, it's incredibly useful if your distributor can verify suspect products to discover whether they’ve been recalled, redirected, or are otherwise illegitimate, since this helps them find problems before they can reach you. (And, as we know, EPCIS errors only become harder to solve the further down the supply chain they get.)
However, DSCSA requires dispensers to have this ability as well. The purpose of this is distinctly practical: Exceptions can be unusual or unexpected, proceeding through multiple steps in the supply chain before detection; products may be recalled after changing hands; new issues can crop up in the exchange with the distributor itself.
If you don’t have this capability, not only are you vulnerable to regulatory audits, you’re making the security of your business and the health of your patients completely reliant on someone else’s system working perfectly, and when problems do occur, you won’t have the visibility or tools to resolve them.
Under DSCSA, every business in the pharmaceutical supply chain must have systems and processes for handling suspect or illegitimate products. Further, the Enhanced Security requirement states that discrepancies in transaction information must be resolved within three business days.
Again, this is not something a partner can do for you – if there’s any reason to believe that there’s an issue, it’ll be up to your team to look into the matter and report it to partners and the FDA.
OneScan Pharmacy Pro makes all these processes quick and easy to manage: your team can mark products as quarantined until they can be cleared to dispense or removed from the supply chain; use Investigator to resolve discrepancies in data; receive automated alerts to EPCIS errors; and report findings to the FDA via Form 3911.