What are some of the hot issues in DSCSA Implementation?
Serialization partnering teams should stay focused and continue to make good progress with testing and piloting to meet the new upcoming November 27, 2018 serialization deadlines. While FDA 2017 Guidance may have some added “breathing room,” we still need to maintain our momentum for testing & piloting given the potential for the key Big 3 and HDA Trading Partners to maintain their schedules.
In July 2017, after stakeholder feedback, FDA issued DSCSA Guidance, announcing its effective one-year delay using its enforcement discretion, as follows:
Product Identifier Requirements Under the Drug Supply Chain Security Act–Compliance Policy; Draft Guidance for Industry; [Docket No. FDA-2017-D-2232] Under this compliance policy, FDA does not intend to take action against manufacturers who do not affix, or imprint a product identifier to their packages and homogenous cases of product that are intended to be introduced in a transaction into commerce between November 27, 2017, and November 26, 2018.
The DSCSA law is not changed. Yet FDA’s enforcement discretion allows a “grace period” for manufacturers so they can push out to Nov. 27, 2018:
…in affixing, or imprinting a product identifier to Pharmaceutical Rx packages and homogenous cases of product (expected by wholesalers to be in GS1 compliant bar codes).
Nonetheless, FDA also recognizes that things have now become more complex, with a mixture of serialized and non-serialized product in the supply chain. So while the DSCSA Enforcement deadline for manufacturers’ unit-level serialization has been delayed for one year to Nov. 27, 2018, clarifications are still needed on the impact of that notice on subsequent phase deadlines (2019-2023).
The anticipated companion Grandfathering Guidance was delayed until Thanksgiving, which eventually 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. In that guidance, FDA intends to address the relationship of the compliance policy set forth in this guidance with “grandfathered” products.”
The GS1 RxSSC DSCSA Implementation Work Group continues to address and assess the Roadmap for successful FDA DSCSA Guidance implementation. The GS1 RxSSC R1.2 Implementation Guideline Work Group brings together representatives from across Pharmaceutical manufacturers, wholesalers, dispensers, GS1, consultants, and Track & Trace serialization solution providers. We still have to debate and determine how this impacts the Wholesaler-Manufacturer relationship and requirements in 2019.
Watch the COVECTRA Blog for more future insights on the FDA Guidance and Public Meetings. In subsequent articles, we will continue to explore DSCSA hot issues and themes in more detail. In the meantime, feel free to contact us with your own experiences and thoughts regarding DSCSA Implementation concerns.