The FDA’s DSCSA-related public meeting on October 14 was a platform with two major goals: 1) It gave the FDA a chance to assess the industry’s implementation progress, and 2) it provided industry representatives a forum for advocating their opinions and positions.
Industry movers and shakers were allowed to present their work and give updates on their progress toward implementing the product identification requirement – aka, serialization. Presenters included:
In addition to sharing challenges and achievements, these companies were also present to ask the FDA for guidance and clarification, and to consider new proposed deadlines.
Below I’ve recapped some of the important topics we discussed.
‘‘GRANDFATHERING PRODUCT.— ‘‘(A) PRODUCT IDENTIFIER.—Not later than 2 years after the date of enactment of the Drug Supply Chain Security Act, the Secretary hall finalize guidance specifying whether and under what circumstances product that is not labeled with a product identifier and that is in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of this section shall be exempted from the requirements…
Dr. Connie Jung, Acting Associate Director for Policy and Communications of the Office of Drug Security, Integrity, & Recalls from the FDA, acknowledged the need for grandfathering guidance and assured the audience that, although she can’t announce the publish date, the grandfathering guidance is in the works and will be released soon.
The DSCSA requires trading partners to only do business with authorized partners, “in the case of a third-party logistics provider, having a valid license under State law or section 584(a)(1), in accordance with section 582(a)(7), and complying with the licensure reporting requirements under section 584(b);”
However, this was adopted at the state level with slightly different interpretations. For example, California now requires 3PL businesses to obtain licenses from their operating states, including the states that don’t issue 3PL licenses.
The problem? None of the products from India are following the SNI format. India has its own GTIN standard, which does not contain the NDC number.
Let me reiterate that the DSCSA does not require aggregation until 2023. Just in case there was any confusion, this was confirmed by Dr. Ilisa Bernstein, Deputy Director of the FDA’s Center for Drug Evaluation and Research’s Office of Compliance. “Aggregation is not a 2017 regulatory requirement” said Dr. Bernstein.
Several participants offered fixes. Optel Vision asked the FDA to require aggregation in 2017, but delay enforcement until 2018. McKesson, taking another angle, recommended the FDA pull forward its 2023 aggregation requirement to 2019. And Generic Pharmaceutical Association, protecting the interest of its generic pharmaceutical members, asked the FDA to clarify to the industry that aggregation is not a 2017 requirement.
We’re all left wondering if the FDA will consider any of these recommendations. More than likely, they’ll take a middle road – as they have on many DSCSA issues – let the players figure out the game as it's being played.
Serialization is not a simply undertaking. Serialization plus aggregation is incredibly more complex. As a leader in DSCSA and serialization implementation, LSPediA can help in strategy, solutions, line execution, QA, and validation.
Here are just some of the ways our clients are benefiting from LSPediA Services:
To find out how we can help you meet compliance requirements on time, and gain a competitive edge, contact us today.