The DSCSA: What You Need to Know

 

November 27, 2023, is coming and it will be here before we know it. What’s so important about this date? It’s the date that the Drug Supply Chain Security Act (DSCSA) will be completely phased in. As pharmaceutical companies work to reach full compliance, here’s a quick refresher on the DSCSA.

 

What is the DSCSA?

 

The Drug Supply Chain Security Act lays out the requirements that everyone involved in the pharmaceutical supply chain must follow. This includes all manufacturers, repackagers, distributors, dispensers, and trading partners. The purpose of the DSCSA is to provide an interoperable system that will be able to track and trace prescription drugs as they are manufactured and distributed across the United States.

 

What are the benefits?

 

The DSCSA provides the FDA with the resources to better protect consumers against counterfeit drugs by tracking those drugs through the various stages of production. By building a system to track prescription drugs, the FDA and manufacturers will be better equipped to detect and remove potentially hazardous drugs before they get to the consumer.

 

What do I need to do?

 

The first step is to be familiar with the law. After you are familiar with your responsibilities laid out in the DSCSA, work with your trading partners to ensure that they know their roles.

A great way to make sure you are compliant with all the new regulations is to partner with a company that specializes in compliance and validation. RemTech consultants are experts in DSCSA laws and know what it takes to make sure you are compliant. Our consultants work to make you compliant through project management, staff augmentation, validation.

 

Don’t let the DSCSA deadline sneak up on you. We would love to answer any questions you may have and set you on the right path. Contact us today.

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