DSCSA – The final Countdown
All serialization mandates including the Drug Supply Chain Security Act (DSCSA) incorporate change. Knowing that we have many changes and many complex ones at that, the first step we can take is to break the US Food and Drug Administration (FDA)’s program down into more manageable pieces. In the case of the Drug Supply Chain Security Act we can actually use some of the FDA timelines as clean dividers to required functionalities.
Serialization deadline for the American Market: November 2017
November 2017 is arguably the most widely known of the deadlines. Unless an exception or waiver has been granted by the US Food and Drug Administration, pharmaceutical companies and CMOs alike will have to have an operational serialization solution in place by the end of the year. Concerned are all prescription medicines, also known as RX products. They must be serialized at the unit of sale level. Furthermore, all homogeneous cases must be serialized as well. While aggregation is not required in the November 2017 deadline, many people miss the requirement of serializing the cases and how to implement that in a less impactful manner.
The devil is in the detail: liability transfer
2019 is an important date to note. At first read of the law, it seems to only really affect the distribution network for resalable products. However, the law is based on liability. Liability transfers at the transaction stage of what has become known as the 3 Ts (transfers, transactions, and trading partners). This creates challenges for trading partners that will force changes and requirements to be implemented outside of the “letter of the law”. 2019 is a perfect example of this issue. The requirement being placed on the distribution network has put them in a quandary of how to fulfill this requirement. It appears now that the solution to this will be to require full aggregation and transfer of that aggregated data far ahead of the scheduled 2023 timeline.
Full unit level traceability and data exchange
In 2023 full unit level traceability with data exchange will be mandatory. This is the final stage. However, just as in the 2019 scenario discussed above, the impact on other participants in the extended supply chain network can have cascading effects. All the way back to the point of packaging based on liability!
Clarifications and guidance documents related to the DSCSA
If we factor in the six guidance documents the FDA is scheduled to deliver on the Drug Supply Chain Security Act, we see lots of potential changes or clarifications that could create new or accelerated requirements to trading partners.
The scheduled guidance documents are:
1. DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third- Party Logistics Providers
2. DSCSA Implementation: Products Eligible for Grandfather Status
3. DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
4. DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
5. DSCSA: Verification Systems for Prescription Drugs
6. DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
Serialization: Ready, steady, go!
Most, if not all currently available guidance documents are still in draft mode. However, even if not all guidelines are available yet, requirements for 2017 are sufficiently clear to be mandatory. There are only 6 months to go, and most of your trading partners will want to test with sufficient time before the deadline! With generally 3 – 6 months implementation time, depending on which serialization solution you choose, there is no time to lose. If you cater for the American market, you need to start putting together a serialization implementation strategy now if you want to be compliant and operational in time.