DSCSA Exemptions: What You Need to Know for Compliance

October 21, 2024 Christian Souza Leave a comment

The Drug Supply Chain Security Act (DSCSA) is designed to enhance the safety and traceability of pharmaceutical products. Recent FDA guidance, issued on October 9, 2024, introduced temporary exemptions from certain DSCSA requirements, offering businesses more time to comply. DSCSA Exemptions: What You Need to Know for Compliance is essential for understanding these exemptions’ implications and ensuring companies take the necessary steps to remain on track with compliance efforts.

The Significance of DSCSA Exemptions

The DSCSA mandates the use of Electronic Product Code Information Services (EPCIS) to ensure accurate and secure transaction data exchange across the pharmaceutical supply chain. Many businesses, however, have struggled to implement these systems due to technological challenges or data issues. In response, the FDA has offered temporary exemptions to give companies more time to refine their systems and work toward full compliance.

Although these exemptions can ease immediate pressure, businesses must recognize that the FDA continues to closely monitor compliance progress. Companies failing to show significant progress could still face penalties, even if they qualify for exemptions. A partially functioning system is better than none—delaying efforts could expose your organization to serious risks.

Key Dates and Eligibility for Exemptions

The FDA exemptions apply to businesses actively working toward DSCSA compliance, specifically those who have already made strides in establishing electronic data connections by November 27, 2024. The exemption timelines for various sectors are as follows:

Manufacturers and Repackagers: Exempt until May 27, 2025
Wholesale Distributors: Exempt until August 27, 2025
Dispensers (26+ employees): Exempt until November 27, 2025
Small Dispensers (<26 employees): Exempt until November 27, 2026

No formal notification to the FDA is required to take advantage of these exemptions, but businesses are expected to use the time to finalize compliance preparations.

Why Immediate Action Remains Crucial

Despite these exemptions, waiting until the last minute to establish DSCSA compliance systems is a risky approach. Regulatory authorities will continue to assess progress, and the extended timelines shouldn’t be seen as an excuse for inaction.

Beyond regulatory concerns, failing to implement DSCSA solutions could impact key business relationships. Major trading partners like AmerisourceBergen, McKesson, and Cardinal Health require that compliance data be transmitted electronically through EPCIS.

Image to represent: Drug Supply Chain Security Act (DSCSA) is designed to enhance the safety and traceability of pharmaceutical products

Developing Strong SOPs for Compliance

In addition to implementing technology for compliance, businesses need to have clearly defined Standard Operating Procedures (SOPs) for managing DSCSA requirements. During an audit, one of the first things an auditor will request is your SOP. Not having one in place could significantly increase your compliance risks.

Your SOP should outline how your company handles serialized data, transaction verification, and real-time data exchanges. Ensuring that your SOP is comprehensive and audit-ready is key to avoiding compliance issues in the future.

What Does This Mean for Different Sectors?

The FDA’s exemptions give businesses additional time, but companies in all sectors must continue working toward full compliance to avoid negative consequences. Here’s how the exemptions impact various types of organizations:

Pharmacies and Dispensers: The extra time allows you to stabilize your systems, but ensuring proper serialized data exchange is essential to maintain business relationships with suppliers and customers.
Manufacturers and Wholesalers: If your electronic systems are still under development, the exemption period allows you to refine them. However, failing to meet compliance could result in the loss of major trading partners.

Steps to Ensure DSCSA Compliance

With enforcement deadlines fast approaching, here are some critical actions businesses should take to ensure they meet DSCSA requirements:

Audit Current Systems: Evaluate your existing systems to determine whether they are capable of handling serialized data exchanges.
Upgrade Technology: If your current system is outdated or not equipped to manage real-time EPCIS data exchange, consider upgrading it now to avoid penalties.
Ensure Data Accuracy: Setting up the infrastructure is only the first step. Make sure that the serialized data you’re exchanging with trading partners is accurate and reliable.
Train Your Staff: Your employees need to understand how to manage serialized data exchanges and work with your DSCSA compliance solution effectively.
Develop or Update Your SOP: If you don’t already have a clear SOP in place, now is the time to create one. A well-documented SOP will not only help you meet regulatory requirements but also streamline your operations.
Monitor Your Trading Partners’ Compliance: Be proactive in ensuring that your trading partners are also compliant. This will help avoid potential disruptions in your supply chain.

Final Thoughts

The FDA’s temporary exemptions offer a brief respite, but achieving full DSCSA compliance is essential for protecting your business from regulatory penalties and operational setbacks. It’s not just about meeting legal requirements—compliance also plays a crucial role in maintaining strong business relationships and ensuring the smooth operation of your supply chain.

By acting now and ensuring that both your technology and procedures are up to standard, your business can avoid the risks associated with non-compliance and continue to thrive in a tightly regulated industry.

DSCSA, Uncategorized

FDA’s Firm Stance on DSCSA Compliance: No More Delays

June 6, 2024 Christian Souza

The FDA recently emphasized the urgent need for compliance with the Drug Supply Chain Security Act (DSCSA), impacting the pharmaceutical industry significantly. At the 2024 FDLI Annual Conference, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), confirmed that there will be no further extensions to the compliance deadline. This announcement marks a critical step in the FDA’s ongoing efforts to secure the pharmaceutical supply chain.

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DSCSA, FDA

FDA Official Will not extend the 2023 deadline

August 18, 2021 Christian Souza

Deadline will not be extended

As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have a full interoperable electronic track and trace system in place by 2023.

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DSCSA, FDA

The FDA’s New Guidance for 2021 Explained

August 10, 2021 Christian Souza

As the premier regulatory body for ingestible products in the United States, the FDA (Food and Drug Administration) is responsible for safeguarding public health through safety measures, guidance, and regulations. The importance of the FDA’s job cannot be stressed enough, and in the current global health crisis we find ourselves in, this responsibility is even more critical.

The FDA’s annual guidance schedule is often more aspirational than strictly practical, but it does a good job in providing useful insights into what areas the FDA’s CDER (Center for Drug Evaluation and Research) has given priority for that particular year.

You can find updated lists for the FDA’s guidance for 2021 here. In this article, we’ll focus on the guidance as it relates to the DSCSA (Drug Supply Chain Security Act).

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FDA, FSMA

FDA’s Food Safety Modernization Act (FSMA), Explained

May 24, 2021 Christian Souza

One of the most important things for a country to safeguard is the health and safety of its residents. Hazards don’t always arrive in plain sight and are most often hidden in things we trust and consume on a daily basis. The biggest example of this is the food we eat.

Food has the ability to nourish us and provide us with the energy to thrive in our existence, but it can also severely damage our health if not mandated properly. This is the main reason why the FDA’s Food Safety Modernization Act (FSMA) was enacted in 2011 by President Obama.

The specifics of the act are complicated, and the nature of the subject matter requires extensive regulations to be upheld. In this article, we’ll give you an overview of everything worth knowing about the FSMA guidelines. We’ll show you the importance of food regulation standards, we’ll get into each aspect of the FSMA in more detail and we’ll end with what’s changed for 2021.

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DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

April 19, 2021 Christian Souza

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join.

The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements for the DSCSA for 2023. The PDG is a 501(c)(6) nonprofit business association requiring a yearly membership fee to join.

The other is the Healthcare Distribution Alliance, or HDA, which is a long-running organization that represents many members of the pharma supply chain in a quest to advocate for public policy that supports patient access to medical products through safe, efficient, and effective distribution. The HDA also requires a yearly membership fee.

Today’s post will look at both organizations, profile what they do, and then let you know why joining them is crucial for getting the most out of the DSCSA.

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CBD, Hemp, Marijuana

Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated?

March 8, 2021 Christian Souza

The Drug Supply Chain Security Act was enacted in 2013 to put protocols into place for the serialization and traceability of pharmaceuticals that move through the drug supply chain – from manufacturer through to the distributors until they reach the hands of the patient. The goal being to ensure the safety and purity of each medication.

With medical marijuana being legalized in more states, this brings up the important question of if and how medical use marijuana should be handled under the guidelines of the DSCSA. Currently, the only states where medical marijuana is prohibited for all uses are Nebraska, Idaho and South Dakota. For the rest of the country, there are circumstances in which marijuana can be legally dispensed and consumed with a doctor’s prescription. Obviously, there’s the need for strict regulations, but the process for putting these regulations into place remains a little cloudy.

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DSCSA, EPCIS

EPCIS GUIDE for your organization

February 23, 2021 Christian Souza

*NOTE – We are including a Free Trading Partner Integration template for you to download at the end of this article.

The 2023 DSCSA requirement looms in the near future and pharma companies are frantically working together to create and implement the technological goals that create the interoperable system by November 27, 2023. To achieve the three areas of interoperability as defined by the PDSA—exchange, verification, and tracing—these companies must also land on a common informational framework.

In other words, to create a system that allows for the DSCSA vision of “fully interoperable, electronic tracing of products at the package level,” the industry needs to pick a common standard and use it throughout pharma. I discuss the challenges in my previous article: Drug Supply Chain Security Act, Phase II: Here’s what you MUST know.

Gary Lerner, the president at Gateway Checker Corporation, explained what it would take to make this happen. In short: “Capturing and exchanging information at this level of specificity requires a common information framework.”

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…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance