A unique role in the supply chain leads to complex DSCSA requirements.
Repackagers are one of the four business types named under the Drug Supply Chain Security Act (DSCSA) – along with manufacturers, wholesale distributors, and dispensers – who have tracing, serialisation and verification requirements to help improve the safety of prescription medicines as they travel through the supply chain.
DSCSA regulations – which are triggered in part by change of ownership from one supply chain partner to another – impact on repackagers as they purchase originally manufactured product, and then transform it into a new entity for resale by repackaging or relabelling it. DSCSA first impacted repackagers in 2015 at the lot-level, and will enter phase two in November 2018 with serialisation mandates. Because the nature of repackagers’ business involves both manufacturing and selling product, their role in compliance is particularly complex: in effect, they need to master the requirements facing both manufacturers and wholesale distributors.
When serialisation takes effect for manufacturers in November 2017, repackagers will begin to receive serialised product. Twelve months later, they will need to begin generating new serial numbers for their repackaged product, and the relationship between the parent and repurposed products will need to be archived.
Under DSCSA, repackagers face many new challenges, including:
- Storing lot-level transaction documentation received from the original manufacturer for the required archiving period.
- Creating lot-level transaction documentation to send with repackaged, resold product.
- Generating serial numbers.
- Apply unique identity and a unique product identifier, add it to saleable units at the sealed homogeneous case level for every drug product that will be sold.
- Tracking relationships between original and repackaged products, associating the original product identifier from the original source product to the product identifier of the new product.
- Storing a high volume of data and transactions.
- Managing the documentation flow between all of their suppliers and customers.
- Respond to verification requests.
Like other business types subject to DSCSA, repackagers have an opportunity to parlay compliance data into a meaningful information stream for their business, offering value beyond compliance.