Aggregation in 2017, 2019, or 2023? Industry Advises FDA at Public Meeting

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:

• Healthcare Distribution Alliance
• AmerisourceBergen
• McKesson
• Generic Pharmaceutical Association
• Pharmaceutical Distribution Security Alliance
• LSPediA
• The LinkLab
• Johnson & Johnson
• Optel Vision

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 products: Many in attendance asked the FDA to publish guidance on grandfathering, which the DSCSA required them to do before November. 27, 2015.

‘‘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.

• State licensure: Several presenters asked the FDA to work with state governments to harmonize licensing requirements.

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.

• Standardized numerical identification on imported drug products: The DSCSA requires drug products to be serialized with the Standard Numerical Identification (SNI) standard, issued by the FDA on March 2010 in the FDA’s SNI Guidance The SNI format is illustrated below:

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.

• Serialized data and cGMP: This sounds straightforward but has huge implications. Current Good Manufacturing Practice (cGMP) systems are required to undergo computer system validation under the CFR 21 Part 11 regulation, something that is not familiar to many virtual manufacturers, WDDs, and 3PLs. Even for manufacturers, validating the serialized data system is a challenge. Many of these systems are hosted in the cloud and, to make matters more complex, very commonly in the public cloud. My blog on August 10, “Understanding Serialization and the Cloud,” discussed the complexity of validating in the cloud.

• Aggregation in 2017, 2019, or 2023: It is a perpetual tug of war. On one hand, WDDs need inference data to gain visibility of units inside cases. Inference is only available when manufacturers aggregate. On the other hand, aggregation demands double the investment from manufacturers, adding burdens of cost, resources, and the risk of missing the 2017 compliance deadline. Voices representing these views were heard loud and clear at the public meeting.

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.

LSPediA Takeaways

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:

• Meet DSCSA compliance deadline by deploy tried and true serialization methodology
• Lower overall serialization spendingby reducing the number of redesigns
• Mitigate compliance risks with comprehensive, gapless coverage tailored to your specific needs
• Shorten your project timelineby removing trial-and-error process

To find out how we can help you meet compliance requirements on time, and gain a competitive edge, contact us today.