The Impact of DSCSA on Pharmaceutical Returns and Reverse Logistics

In the last few years, the pharmaceutical industry has had to make some major changes, especially when it comes to keeping medications safe and managing logistics. The enactment of the Drug Supply Chain Security Act (DSCSA), 2013, is one such transformative step! 

All the stakeholders involved in the process, from drug distributors to independent pharmacies must be well-aware of this.

What is DSCSA and How Is it Impacting the Pharmaceutical Industry?

The DSCSA was created to improve the safety of the pharmaceutical supply chain. 

With the increase in counterfeit medications and concerns about safety, the law requires that drugs can be traced through every step of their journey, from the manufacturer to the pharmacy and ultimately to the patient. 

The Act certainly introduces multiple obligations at the different touchpoints in the pharmaceutical supply chain, and these are bound to impact the way things operate, which can be understood as follows -

Better Tracking and Tracing

The most significant change brought about by the DSCSA is the need for better tracking and tracing of medications. 

Each drug now has a unique identifier, which makes it possible to follow its journey through the supply chain. This improved tracking also affects how returns are processed. 

If a medication needs to be returned, whether due to a recall or for any other reason, companies must have precise records to confirm its journey and ensure it is genuine. This helps in verifying returns while also making it easier to act quickly if there's a problem.

More Efficient Returns Process

A smoother returns process reduces the chances of mistakes and helps prevent counterfeit drugs from re-entering the market.

Due to the DSCSA, the returns process for pharmaceutical products has become more streamlined. 

Companies now need to set up efficient systems that allow them to track returned drugs accurately. This means that when a product is returned, it can be quickly verified and processed according to the law. 

The Compliance Challenges

While the DSCSA brings many benefits, it also comes with challenges. Keeping up with the strict tracking and reporting requirements can be tough, especially for smaller companies that might not have the technology or resources in place. 

Achieving compliance means investing in better systems and training employees on new procedures to avoid mistakes. While this can be a lot of work, it is crucial for protecting patients and ensuring that drugs are safe.

Financial Effects on Reverse Logistics

The financial impact of DSCSA on managing returns can be significant. Meeting the law's requirements often leads to higher operational costs, like buying new software or hiring extra staff. 

However, having a clear and compliant returns process can actually save money in the long run. 

It helps reduce losses from counterfeit drugs and improves inventory management, allowing companies to make better financial decisions.

We're Strongly Committed to DSCSA Compliance 

We at Drugzone, take our commitment to DSCSA compliance seriously, leaving no stone unturned to ensure the safety and integrity of our pharmaceutical products. 

As a leading wholesale drug distributor in the US, we implement advanced tracking systems that provide detailed visibility of our inventory in order to ensure that every medication can be traced from manufacturer to end-user. 

Our team also undergoes regular training to stay updated on compliance regulations, and we conduct thorough audits to confirm that our processes meet all necessary standards. 

Frequently Asked Questions (FAQs)

What challenges do companies face with returns because of DSCSA?

Companies must manage more paperwork, verify product authenticity, and update their systems for compliance, which can be costly and time-consuming.

How can companies improve their return processes under DSCSA?

They can use better tracking systems, train employees on compliance, and work with experienced logistics partners to streamline returns.

What happens if companies don’t follow DSCSA rules for returns?

Not following DSCSA can lead to fines, legal trouble, and risks to patient safety, as well as damage to a company’s reputation.

Article Author

Binu .B RPH

President

With more than 20 years of experience in the pharmaceutical wholesale sector, I have Founded and managed several companies, including a pharmaceutical wholesale company, a compounding/retail pharmacy,and many more. As the president of Drugzone Pharmaceuticals Inc., I develop new business and maintain existing business relationships.