What Are Hot Issues for DSCSA Implementation? (Pt 3)


Groundhog Day was Friday, and Punxsutawney Phil saw his shadow, so we are in for 6 more weeks of winter. Haven’t we already had enough between winter and DSCSA marching forward?

Please remember that even with the FDA DSCSA 2017 Thanksgiving Grandfathering Guidance, manufacturers are down to less than 10 months until Nov. 27, 2018, based on packaging date to begin to label with product identifiers at saleable unit level.

So, it is important to maintain your hard fought victories and continuing progress to implement GS1 compliant product identifiers application, shipment notification testing, and piloting activities with manufacturer’s CMOs and 3PLs.

We recommend consultation with your Regulatory Department to interpret the net discretion and exemption effects of FDA’s “Enforcement Discretion” and “Grandfathering Exemption” which gave manufacturers a full one (1) year slack.

Now is the time to challenge all your assumptions and be crystal clear on your plans for the balance of 2018. You must build trust with your partners. Also, decide on the appropriate MOH safety stock to hold as buffer stock at your 3PL, depending on the state of readiness of your various product lines and packaging lines and CMOs.

As FDA explained to us in issuing the draft guidance for industry entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier,” a product without a product identifier would be grandfathered if there is accompanying documentation that it was packaged by a manufacturer before November 27, 2018.

For the purposes of FDA’s Guidance, a package or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was packaged by the product’s manufacturer before November 27, 2018.

The guidance provides FDA’s current thinking on how trading partners should treat grandfathered product for various activities. Most significantly, as described in the draft guidance, trading partners may engage in transactions involving grandfathered products until the product expires, regardless of when the transaction occurs within the supply chain.  FDA also reminded trading partners to be vigilant to protect patients from illegitimate drug products.

Consequently, a package or homogenous case of product that is not labeled with a product identifier is eligible for an exemption under section 582(a)(5)(A) as described in this guidance only if the product’s manufacturer packaged the product before November 27, 2018.

Also, FDA provided significant clarity for trading partners (wholesalers and dispensers) – “trading partners may engage in transactions involving grandfathered products until the product expires, regardless of when the transaction occurs within the supply chain.” This also answers questions about saleable returns in 2019.

Thus, Grandfathering will, of course, create “hybrid” scenarios for supply chain product inventories, so manufacturers need to carefully plan their timing. The FDA allowed exemptions for trading partners beyond 2018 to have serialized alongside non-serialized lots that would be grandfathered through expiry.

The ultimate DSCSA objective is the implementation of an interoperable system in 2023. So, DSCSA unit-level serialization delays to Nov. 27, 2018, require clarification of the unintended consequences and impact on subsequent phase deadlines (2019-2023). FDA Guidance on Exceptions and Exemptions remain to be issued. Requests for exceptions or exemptions may be submitted to FDA in the interim.

FDA has setup several DSCSA Public Meetings to provide for discussion and debate to progress forward with solutions and address how this impacts the Wholesaler-Manufacturer relationship and requirements in 2019.

The GS1 RxSSC DSCSA R1.2 Implementation Work Group continues to address and assess the Roadmap for successful FDA DSCSA Guidance implementation. The GS1 Work Group met F2F last week at Cardinal Health’s Tampa DC to bring together representatives to create serialization solutions.

Watch this Blog for continuing insight during Punxsutawney Phil’s Extended Winter as we watch out for FDA Guidance, GS1 WG Initiatives, and FDA Public Meetings. Feel free to contact us with your own experiences and thoughts regarding DSCSA Implementation concerns. Covectra SMEs (Subject Matter Experts) will respond and keep you posted.