What Are Hot Issues for DSCSA Implementation? (Pt 2)


This is another update in a series of blog articles from the DSCSA experts at Covectra, Inc., dedicated to the art and science of supply chain integrity and US FDA DSCSA compliant solutions implementation. We invite you to share your thoughts with us as DSCSA’s challenging compliance mandates continue to require 2018 action and implementation in the pharmaceutical supply chain from manufacturers and their trading partners.

…So where did we leave off last week on hot issues in DSCSA Implementation?

Ah, yes, Thanksgiving 2017, when FDA Released its 2017 Thanksgiving “Turkey”…

Fortunately, FDA released the two-year long delayed/awaited Grandfathering Guidance at Thanksgiving time. It outlined FDA’s current thinking on the “grandfathering product” provision of section 582(a)(5)(A) of the FD&C Act regarding products not labeled with a product identifier that are in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of section 582. View the FDA’s DSCSA Guidance email here.

Manufacturers get a full one (1) year Grandfathering exemption – to Nov. 27, 2018 – based on packaging date, not sale/shipping date!

Please consult with your regulatory department on interpreting this exemption. If you are not currently holding large amounts of MOH buffer stock at your 3PL, the net effect of “Enforcement Discretion” and “Grandfathering” will be similar.

Grandfathering will create “hybrid” scenarios for supply chain product inventories.

Though FDA would allow exemptions, manufacturers could inconvenience trading partners in 2018-2019 by having serialized alongside non-serialized lots that would be grandfathered through expiry. We still have to debate and determine how this impacts the Wholesaler-Manufacturer relationship and requirements in 2019.

DSCSA unit-level serialization delays to Nov. 27, 2018 require clarifications on the unintended consequences and impact on subsequent phase deadlines (2019-2023). Nonetheless, please maintain progress with GS1 compliant product identifiers and shipment notification testing and piloting activities with CMOs and 3PLs.

As I said last week, the GS1 RxSSC DSCSA R1.2 Implementation Work Group continues to address and assess the Roadmap for successful FDA DSCSA Guidance implementation. They are meeting face-to-face this week at Cardinal Health’s Tampa DC to bring together representatives to create serialization solutions.

Watch this blog for more future insights on the FDA Guidance, GS1 WG Initiatives, and FDA Public Meetings. In the meantime feel free to contact us with your own experiences and thoughts regarding DSCSA Implementation concerns.

Covectra will keep you posted…stay tuned for more in this series.

Note: Here is the full length version of the FDA’s grandfathering guidance.