Serialization Pharma: Resources for Understanding DSCSA Compliance

Serialization & DSCSA Compliance

Several years ago, more than 500 manufacturers, distributors, and consultants met to discuss the issues in the US healthcare supply chain. This meeting would tackle the issue of counterfeit drugs in the supply chain and how to reduce their number.

This meeting introduced the idea of product serialization and discussed the need to enhance traceability in the healthcare supply chain. Here’s what all of this means.

What Is Product Serialization?

Product serialization is the unique identification of products, which goes down to the level of individual items, rather than only at the batch level. Serialization pharma is the identification of individual packs of medications, that is, assigning them a globally unique two-dimensional code, and marking it on the packaging.

With the implementation of product serialization, a proper system for tracking and tracing products in the entire supply chain must be integrated. That kind of a comprehensive system will enable US wholesalers to verify the products, as well as exchange data with other wholesalers in the supply chain.

This initiative is called DSCSA compliance, and every pharmaceutical manufacturer, re-packager, wholesale distributor and dispenser in the US must adhere to the regulatory requirements. The mandated deadline for pharmaceutical manufacturer and re-packager was November 27, 2018.

What Is DSCSA Compliance?

DSCSA (Drug Supply Chain Security Act) compliance is the U.S. initiative to prevent the introduction and distribution of counterfeit drugs.

The main goal of this compliance is to enable pharmaceutical manufacturers, re-packagers, wholesale distributors, pharmacies, and third-party logistics to exchange information about every single medication package and see exactly where it has been in the supply chain.

This will help them verify the products, identify illegitimate products anywhere in the supply chain, and make recalls of drug products more efficient.

All of this is made possible with the introduction of serialization and traceability technology. All of the product data will be stored in a secured cloud-based repository.

How to Be DSCSA Compliant?

To be DSCSA compliant, every pharma business affected by the DSCSA compliance laws must capture transaction information (TI), transaction history (TH), and transaction statement (TS) from the previous owner, and provide it to the subsequent owner of each product.

They must maintain their TI, TH, and TS for every transaction for six years. They must only ship legitimate products, and they can never change the transaction history in any way.

Pharmaceutical serialization and traceability will modernize the pharma industry. The initiative will revolutionize the industry and, hopefully, eliminate all the counterfeit drugs from the supply chain.

If you need a reliable solution for tracking and tracing products in the healthcare supply chain, rfxcel is here for you. We can help you meet all the needs of product serialization and become DSCSA compliant in no time. Contact us today to find out more about how we can be of help.

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