Every rule and requirement within the Drug Supply Chain Security Act (DSCSA) points back to one fundamental goal: patient safety. The law was created as a direct response to the growing threat of counterfeit, stolen, and contaminated drugs entering the U.S. market. By establishing a national system for tracing and verifying medications, the DSCSA creates a powerful defense that protects public health. Understanding this “why” is crucial, as it transforms compliance from a simple business obligation into a shared responsibility. This guide explains not only what the law requires but also how your role contributes to a safer supply chain for everyone.
Key Takeaways
- Master the core compliance actions: Your responsibilities under the DSCSA focus on three key areas: serializing each product with a unique identifier, documenting every transaction electronically, and verifying the authenticity of the drugs you handle.
- Invest in an integrated technology solution: Manual processes and generic software create significant risk. A purpose-built serialized ERP is the foundation for compliance, as it automates the complex data sharing, verification, and record-keeping required by the law.
- Understand that non-compliance threatens your entire operation: The consequences of failing to meet DSCSA standards go beyond fines. They include operational shutdowns, license revocations, and legal action that can halt your business completely.
What is the Drug Supply Chain Security Act (DSCSA)?
If you work in the pharmaceutical industry, you’ve definitely heard of the Drug Supply Chain Security Act, or DSCSA. It’s a foundational piece of legislation that has reshaped how prescription drugs move through the country. At its core, the DSCSA is all about creating a safer, more transparent supply chain for everyone, from the manufacturer to the patient.
Think of it as a digital handshake at every step of a drug’s journey. The law establishes a national system to trace and verify prescription drugs as they are distributed across the United States. For businesses like yours, this means new requirements for product serialization, transaction documentation, and verification. Understanding these rules isn’t just about avoiding penalties—it’s about protecting patients and securing your place in the supply chain.
Understanding Its Purpose and Background
The DSCSA was signed into law back in 2013 as part of the larger Drug Quality and Security Act (DQSA). Its primary purpose is to protect consumers from counterfeit, stolen, or otherwise harmful drugs. Before the DSCSA, the system for tracking drugs was fragmented, making it difficult to spot and remove dangerous products from the market. The law was created to build a single, electronic, and interoperable system to track certain prescription drugs from the moment they’re made to the moment they reach a dispenser. This framework helps ensure that the medications patients receive are authentic and safe.
Breaking Down the Core Objectives
The main goal of the DSCSA is to enable unit-level traceability for prescription drugs throughout the entire supply chain. This is achieved through a few key objectives. First, the law aims to prevent harmful or illegitimate drugs from entering the U.S. market. Second, it helps stakeholders quickly identify and remove those drugs if a breach does occur. Finally, it facilitates a more efficient and secure recall process. To meet these goals, the law requires trading partners—including manufacturers, distributors, and dispensers—to share specific transaction information in a secure, electronic format, ensuring full compliance at every handoff.
Why Was the DSCSA Created?
The Drug Supply Chain Security Act wasn’t created in a vacuum. It was a direct and necessary response to serious vulnerabilities that threatened the integrity of our nation’s drug supply and, most importantly, patient safety. Understanding the “why” behind the DSCSA helps clarify its requirements and underscores the importance of compliance. At its core, the law was established to tackle three major issues: the rise of counterfeit drugs, the need for stronger patient protections, and the inherent weaknesses in a fragmented supply chain.
The Threat of Counterfeit Drugs
The infiltration of counterfeit medications into the legitimate supply chain posed a massive risk to public health. Before the DSCSA, it was much harder to detect and prevent these dangerous products from reaching pharmacies and patients. The legislation was specifically designed to stop fake, contaminated, stolen, or otherwise harmful prescription drugs from reaching consumers. These illegitimate products can contain the wrong ingredients, incorrect dosages, or even toxic substances, turning a potential treatment into a serious threat. By creating a more secure and traceable system, the DSCSA provides a powerful defense against those who would profit from endangering lives.
Putting Patient Safety First
Ultimately, the DSCSA is all about protecting people. The primary goal is to ensure that every patient receives safe and effective medication every single time. According to the FDA, the law was created to stop dangerous drugs from entering the U.S. supply and to enable the quick identification and removal of these products if a problem is detected. This focus on patient safety is critical for maintaining public trust in the pharmaceutical industry and the healthcare system as a whole. When patients can be confident that their medications are authentic and have been handled properly from manufacturer to pharmacy, it leads to better health outcomes for everyone.
Addressing Supply Chain Weaknesses
The pharmaceutical supply chain is incredibly complex, involving manufacturers, repackagers, distributors, and dispensers. Historically, the lack of a unified system made it difficult to track products effectively, creating blind spots that bad actors could exploit. The DSCSA addresses this by mandating an electronic, interoperable system to track each package of a prescription drug. This connects the physical product to its digital information, usually through a barcode, allowing trading partners to share data seamlessly. This level of transparency strengthens the entire supply chain, making it more resilient and secure against diversion, theft, and counterfeiting.
What Does DSCSA Compliance Actually Involve?
Getting compliant with the DSCSA isn’t a one-and-done task. It’s a set of ongoing practices that create a secure, transparent, and accountable pharmaceutical supply chain. Think of it as building a system of checks and balances that protects products from the moment they’re made until they reach the patient. At its core, compliance breaks down into four key responsibilities: serialization, documentation, verification, and handling exceptions. Mastering these areas is essential for protecting your business and, more importantly, the people who rely on your products. Let’s look at what each of these involves.
Identifying and Serializing Products
The first step in securing the supply chain is giving each drug package a unique identity. Under the DSCSA, manufacturers must place a unique product identifier on the smallest saleable units of prescription drugs. This identifier, usually in a 2D barcode, contains the product’s serial number, lot number, expiration date, and national drug code. This process, known as serialization, essentially gives every bottle or box its own digital fingerprint. This allows any trading partner to track and trace that specific unit throughout its entire journey. A robust serialized ERP system is the foundation for managing this data, ensuring every product is accounted for from production to dispensation.
Documenting Transaction Histories
Every time a drug changes hands, that movement must be recorded. The DSCSA requires trading partners to provide, receive, and maintain documentation for each transaction. This includes Transaction Information (TI), which details the product, quantity, and parties involved, and a Transaction Statement (TS), which affirms the seller is authorized and the information is accurate. You must keep these records for six years, creating a complete electronic pedigree for every product. This creates an unbroken chain of custody that can be audited at any time. Having a system that automates and stores this information is critical for maintaining compliance and responding to inquiries without disrupting your operations.
Verifying Your Products
Compliance isn’t just about creating and passing along data—it’s about actively using that data to confirm products are legitimate. All trading partners have a responsibility to verify the product identifiers on the packages they handle, especially for returned products or any time a transaction seems suspicious. This means you need a reliable process to check a product’s serial number against the manufacturer’s data to ensure it’s authentic. This verification step is a crucial defense against counterfeit or diverted drugs entering the supply chain. Your operational features should include tools that make this verification process fast and seamless, integrating it directly into your receiving and returns workflows.
Handling Suspect and Illegitimate Products
Even with strong safeguards, you need a clear plan for when things go wrong. If you identify a product you suspect is counterfeit, diverted, or otherwise illegitimate, the DSCSA outlines specific steps you must take. First, you must quarantine the product to prevent it from moving any further. Next, you need to investigate to confirm whether it is illegitimate. If a product is confirmed to be illegitimate, you are required to notify the FDA and your immediate trading partners, often within 24 hours. This rapid response protocol is vital for containing potential threats to public health. A well-defined process, supported by your ERP system, ensures you can act decisively and correctly.
A Timeline of DSCSA Implementation and Deadlines
The DSCSA wasn’t implemented overnight. Instead, it was rolled out in a series of carefully planned phases over a decade. This approach gave the pharmaceutical industry time to adapt its processes, technology, and partnerships to meet the new requirements. Think of it as building a house one floor at a time—starting with a solid foundation and adding more complex structures as you go. Each phase introduced new responsibilities, moving the entire supply chain closer to the ultimate goal: a fully electronic, interoperable system for tracking and tracing prescription drugs throughout the United States. This gradual rollout was intentional, recognizing the massive operational shifts required from manufacturers, distributors, and dispensers alike.
This phased implementation began with lot-level tracking and progressed to the much more granular requirement of unit-level serialization. The final phase ties everything together, mandating that every transaction for every single package is captured and shared electronically. Understanding this timeline is key to appreciating the scope of the law and ensuring your own operations are aligned with current expectations. It helps clarify not just what you need to do, but why these specific steps were put in place to build a safer, more transparent drug supply chain. It’s a story of evolution, from broad strokes to fine details, all designed to protect patients.
Phase 1: Enhanced Drug Pedigrees (2015)
The first major step in the DSCSA journey began in 2015. This phase focused on establishing lot-level traceability. Instead of tracking individual drug packages, companies were required to track products by their batch or lot number. This meant that whenever a batch of a specific drug was sold, the transaction information, history, and statement—often called the “3Ts” (Transaction Information, Transaction History, and Transaction Statement)—had to be passed along to the next partner in the supply chain. This was the foundational move away from unreliable paper pedigrees and toward a more standardized, electronic system for documenting a drug’s chain of custody.
Phase 2: Product Serialization (2017)
Starting in 2017, the DSCSA took a significant leap forward with the introduction of product serialization. This phase required manufacturers to place a unique product identifier on individual drug packages. This identifier, typically in the form of a 2D barcode, contains the product’s national drug code (NDC), a unique serial number, lot number, and expiration date. Essentially, every single saleable unit of a prescription drug received its own “fingerprint.” This shift from tracking entire lots to tracking individual packages was a critical step toward achieving the full traceability that a modern serialized ERP system can manage.
Phase 3: Unit-Level Traceability (2023)
The final phase, with a key deadline of November 27, 2023, brings all the previous efforts together. It requires full, unit-level traceability across the entire supply chain. Now, every time a serialized package changes hands—from manufacturer to wholesaler, wholesaler to pharmacy—that transaction must be electronically recorded and shared. This creates a complete, interoperable electronic record for each individual package from its point of origin to the dispenser. This final step ensures that partners can verify products at any point, making it much harder for counterfeit or illegitimate drugs to enter the supply chain and solidifying the industry’s compliance framework.
Who Needs to Comply with the DSCSA?
The DSCSA creates a chain of responsibility that connects every trading partner in the U.S. pharmaceutical supply chain. It’s not just for one type of company; everyone from the manufacturer to the local pharmacy has a specific and vital role to play. Understanding your specific obligations is the first step toward ensuring your operations are fully compliant and that you’re contributing to a safer drug supply for everyone.
Responsibilities for Manufacturers
As the starting point of the supply chain, manufacturers carry the foundational responsibility of product serialization. You must affix a unique product identifier to each package and sealed case of a prescription drug. This isn’t just about printing a barcode; you also have to provide detailed electronic data about the drug’s journey as it moves to the next trading partner. Maintaining these precise records is essential for traceability and is a core requirement for preventing counterfeit products from ever entering the market. A robust serialized ERP system is critical for managing this complex data flow from day one.
Obligations for Wholesale Distributors
Wholesale distributors are the critical link between manufacturers and dispensers. Your primary duty under the DSCSA is to verify the product data you receive with every shipment. This means confirming that the product identifiers are authentic and that you have the required transaction information before you accept the products into your inventory. You must also maintain these records and pass them along as you distribute the drugs. By ensuring the legitimacy of the products you handle, you play an active role in securing the supply chain and making sure only safe, verified medications move forward. This is a key function for all wholesale distributors in the network.
Requirements for Repackagers
If you’re a repackager, your obligations closely mirror those of a manufacturer. When you take a product out of its original packaging, you must assign a new, unique product identifier to the new package and maintain all the original serialization data. This ensures that the drug remains traceable even after it has been repackaged. You are responsible for making sure the new labels are correct and that all relevant transaction data is accurately recorded and maintained. This step is crucial for preserving the integrity of the track-and-trace system and requires meticulous attention to detail and data management.
Duties for Dispensers
Dispensers—like pharmacies, hospitals, and clinics—are the final checkpoint before a medication reaches a patient. Your duties are centered on verification and vigilance. You must confirm the legitimacy of the products you receive from distributors and only accept those with the proper DSCSA-required documentation. If you encounter a suspicious or illegitimate product, you are required to quarantine it immediately and report it to the FDA and your trading partners. This final verification step is the last line of defense in protecting public health and is a cornerstone of the DSCSA’s mission to ensure patient safety and supply chain compliance.
Common Challenges in DSCSA Compliance
Achieving full DSCSA compliance is a significant step forward for patient safety, but it’s not without its difficulties. Many pharmaceutical businesses, from manufacturers to dispensers, run into similar roadblocks when updating their systems and processes. The core of the DSCSA is creating a fully interoperable and secure electronic system to trace prescription drugs across the country. This requires a major operational shift, involving new technology, updated workflows, and dedicated team training. Understanding these common challenges is the first step toward building a clear and effective compliance strategy for your organization.
Overcoming Interoperability Hurdles
One of the biggest challenges is interoperability—making sure the systems used by manufacturers, distributors, repackagers, and dispensers can all communicate with each other. The goal of the DSCSA is to create a seamless electronic system for sharing data, but that’s tough when each trading partner might use different software with unique data formats. This can lead to information gaps and inefficiencies, slowing down verification processes. A truly effective solution requires a platform that can easily integrate and exchange data with others, ensuring that every package’s journey is visible and verifiable from start to finish. A purpose-built serialized ERP can solve this by centralizing data and standardizing communication.
Managing Implementation Costs
Adopting the technology needed for DSCSA compliance represents a significant investment. The costs go beyond just software licenses; they include new hardware like scanners, system integration expenses, and the resources needed to overhaul existing workflows. While it can be tempting to cut corners by patching together different generic systems, this approach often leads to higher long-term costs and greater compliance risks. It’s better to view these expenses as an investment in operational excellence. A compliant system not only protects your business but also improves efficiency and strengthens relationships with your trading partners. Streamlining your operations with tools like financial automation can also help offset some of these initial costs.
Meeting Training and Education Needs
New systems and regulations are only effective if your team knows how to use them correctly. DSCSA compliance touches multiple roles within an organization, from warehouse staff handling products to pharmacists verifying them before dispensing. Each person needs to understand their specific responsibilities and the importance of following the new protocols to ensure patient safety. The complexity of the law means that training can’t be a one-time event; it requires an ongoing commitment to education as your team and the regulations evolve. Choosing intuitive systems with features like an AI-powered chat can simplify complex tasks and reduce the overall training burden on your staff.
Addressing Data Security Concerns
The DSCSA mandates the exchange of sensitive transaction data throughout the supply chain. Protecting this information is critical. Companies must ensure they are sharing transaction details and product identifiers through secure, encrypted electronic systems that can communicate effectively. A data breach could compromise the integrity of the supply chain, erode patient trust, and expose your business to significant liability. That’s why it’s so important to partner with technology providers who prioritize data security and have robust measures in place. Your compliance tools should not only meet DSCSA requirements but also safeguard your data against potential threats.
How to Overcome DSCSA Compliance Hurdles
Meeting the requirements of the DSCSA can feel like a major undertaking, but you don’t have to go it alone. With the right strategies and tools, you can build a clear path to compliance. Breaking down the process into manageable steps makes it much easier to tackle these hurdles effectively and protect your business.
Implement Electronic Systems for Data Sharing
The foundation of DSCSA is electronic, interoperable data exchange. To comply, every partner in the supply chain needs a system that can track each prescription drug package from end to end. This isn’t just about slapping a barcode on a box; it’s about creating a digital thread that follows the product. A purpose-built serialized ERP is designed for this, facilitating the seamless sharing of information between manufacturers, distributors, and dispensers. This ensures everyone has the data they need, creating the transparency and accountability the law requires.
Use Verification Router Services
When you receive a product, you need to be able to verify its authenticity. Likewise, you must be prepared to respond when a trading partner sends you a verification request. A Verification Router Service (VRS) is a crucial tool that simplifies this process. It acts as a secure hub, routing verification requests to the right manufacturer’s database and returning a response almost instantly. Integrating a VRS into your workflow removes manual work, reduces errors, and helps you handle verification requests efficiently without disrupting your operations.
Keep Accurate Trading Partner Records
Under the DSCSA, you are required to maintain detailed records of every transaction for a minimum of six years. This includes Transaction Information (TI) and Transaction Statements (TS) for every product you handle. Manually managing this volume of data is not just impractical—it’s risky. Using a system with robust compliance features ensures these records are captured accurately, stored securely, and are easily accessible for audits or investigations. This creates a clear, traceable history for every drug’s journey, which is a core principle of the act.
Lean on Industry Partnerships
You don’t have to interpret every line of the DSCSA regulations by yourself. Industry groups like the Partnership for DSCSA Governance (PDG) exist to help the entire pharmaceutical supply chain adopt these new standards together. Collaborating with industry partners and technology providers who specialize in pharma gives you access to shared knowledge and best practices. Leaning on this collective expertise can give you the confidence that your compliance strategy is sound and aligned with industry-wide efforts, helping you successfully adhere to the law.
The Right Tech for DSCSA Compliance
Meeting DSCSA requirements isn’t just about updating your standard operating procedures; it’s about having the right technology to back them up. The law was designed around the idea of a fully electronic, interoperable system, which means manual, paper-based methods simply won’t cut it. Trying to manage serialized data, transaction histories, and verification requests with spreadsheets and binders is a recipe for errors, delays, and non-compliance.
The good news is that the right technology can transform DSCSA from a regulatory headache into a strategic advantage. By implementing systems that provide end-to-end visibility and automation, you not only ensure compliance but also create a more efficient, secure, and transparent supply chain. These tools are designed to handle the heavy lifting, allowing you to focus on getting life-saving medications to the people who need them. From tracking every single package to sharing data securely with your partners, the right tech stack is the foundation of modern pharmaceutical distribution.
End-to-End Traceability Systems
At its core, the DSCSA is all about traceability. The FDA’s goal is to create an electronic system that can follow each prescription drug package from the moment it’s made until it reaches the dispenser. This requires a system that provides a complete, unbroken chain of custody. An end-to-end traceability solution, like a serialized ERP, connects every point in the supply chain, capturing and storing data for each product at the unit level. This gives you a bird’s-eye view of your entire inventory, making it easy to track movement, identify bottlenecks, and respond instantly to any inquiries or investigations.
Electronic Data Exchange Platforms
Compliance isn’t a solo sport. You need a secure and standardized way to share transaction data with your trading partners. The law mandates that companies must track prescription drugs electronically and exchange information in a secure format. This is where electronic data exchange platforms come in. These systems ensure that transaction information, history, and statements are passed seamlessly between manufacturers, wholesalers, and dispensers. Using a platform that supports industry standards, like EPCIS, guarantees that your data is interoperable and that every partner in your supply chain can receive and process it correctly, keeping everyone in sync and compliant.
Real-Time Verification Tools
Under the DSCSA, you must be able to verify the products you handle. This means you need tools that can check the unique identifier on any package to confirm it’s legitimate, especially when dealing with a suspect product or a saleable return. Real-time verification tools allow your team to scan a 2D barcode and instantly query the manufacturer’s database to confirm the product identifier is authentic. This process needs to be fast and reliable to avoid disrupting your workflow. Integrating these tools into your daily operations is essential for protecting your business and your patients from counterfeit or illegitimate drugs.
Automated Inventory Reconciliation
With serialization, every single package has a unique identity. This makes manual inventory counts and reconciliation nearly impossible. An automated system is the only practical way to manage this complexity. A purpose-built inventory management module that is fully integrated with DSCSA features can track every serialized unit in your facility. It automates reconciliation by matching the physical products you have on hand with the electronic data you’ve received. This provides real-time visibility, flags discrepancies immediately, and ensures your inventory records are always accurate and ready for an audit, which is fundamental for maintaining compliance.
The Risks of Non-Compliance
Ignoring DSCSA requirements isn’t just a minor oversight; it’s a significant business risk with serious consequences. The regulations are in place to protect patient safety and secure the supply chain, and the FDA takes enforcement very seriously. For pharmaceutical companies, non-compliance can lead to a cascade of problems, from hefty fines that drain your resources to operational shutdowns that bring your business to a standstill. It can even result in criminal charges for individuals.
Think of compliance not as a burden, but as a fundamental part of your operational license. Failing to meet these standards puts your company’s reputation, financial stability, and future on the line. The stakes are simply too high to leave to chance or manage with inadequate systems like spreadsheets or a patchwork of generic software. A proactive approach to compliance is the only way to safeguard your business and ensure you can continue to serve patients safely and effectively. The consequences are real, and they can impact every part of your organization. Let’s break down exactly what you could be up against if you fall short of DSCSA standards.
Facing FDA Enforcement Actions
When it comes to DSCSA, the FDA has broad authority to act. If your company fails to comply, you could face a range of enforcement actions that directly impact your ability to do business. This isn’t just a warning letter. The FDA can impose significant fines and penalties, and in more severe cases, they can issue injunctions that halt your operations entirely. Imagine being legally barred from distributing products simply because your traceability data isn’t in order. These actions are designed to be disruptive because the goal is to ensure a safe drug supply chain. The resulting legal fees, remediation costs, and damage to your brand’s credibility can be devastating.
Potential for Criminal Charges
The consequences of non-compliance can extend beyond corporate penalties and impact individuals personally. In cases of willful or repeated violations, the Department of Justice can pursue criminal charges. The penalties are severe: failure to comply with DSCSA requirements can lead to fines of up to $250,000 and imprisonment for up to 10 years. These charges underscore the gravity of the situation, particularly in the context of public health crises. The government is cracking down on any weak links in the supply chain that could allow counterfeit or dangerous drugs to reach patients, linking compliance directly to the fight against issues like the opioid crisis. This level of personal liability makes robust compliance an absolute necessity for company leaders.
Dealing with Financial Penalties
The financial fallout from non-compliance can be crippling. Fines from the FDA are just the beginning. You also have to consider the indirect costs, which can quickly multiply. These include expensive legal battles, the cost of implementing emergency corrective actions, and the loss of revenue from operational downtime. Furthermore, a public record of non-compliance can damage your relationships with trading partners, who may be hesitant to do business with a company deemed high-risk. A solid financial automation system can help manage your core business, but it can’t protect you from penalties if your compliance processes are weak. These financial hits can threaten the long-term viability of your business.
Restrictions on Business Operations
Beyond fines and legal trouble, non-compliance can lead to direct restrictions on your daily operations. For example, wholesale distributors and third-party logistics providers (3PLs) are required to report their licenses and other critical information to the FDA annually. Failure to do so can result in the suspension or revocation of those licenses, effectively putting you out of business. Without the proper credentials, you cannot legally handle or distribute products. This is where a purpose-built serialized ERP becomes essential. It ensures that all your product data and partner information is tracked accurately, helping you meet reporting requirements seamlessly and keep your operations running without interruption.
Best Practices for Staying Compliant
Staying compliant with the DSCSA isn’t about checking a box once; it’s about building solid, repeatable processes into your daily operations. The right habits and tools make all the difference, turning complex requirements into manageable tasks. Here are four key practices to keep your operations smooth and fully compliant.
Scan 2D Barcodes for Verification
Every DSCSA-compliant product package has a 2D barcode containing a unique product identifier. Your team should be scanning these barcodes at every critical point, especially at receiving. This action verifies the product’s legitimacy and ensures it belongs in your inventory. If you encounter a suspect or illegitimate product, you must quarantine it immediately and begin an investigation. A reliable serialized ERP system is essential for managing this process, allowing you to track, trace, and verify each item efficiently.
Maintain Clear Transaction Records
Documentation is your best friend in the world of DSCSA. For every drug you handle, you must keep its Transaction Information (TI) and Transaction Statement (TS) for six years. This data creates a clear chain of custody that regulators can review during an audit. Keeping these records organized, secure, and easily accessible is non-negotiable. An integrated system that automates record-keeping saves you from manual data entry and reduces human error, ensuring your compliance data is always ready for inspection.
Prepare for Verification Requests
Your trading partners will send requests to verify the product identifiers on the drugs you’ve sold them. You need a system in place to respond to these requests quickly and accurately. Many companies use a Verification Router Service (VRS) to manage this communication. Being prepared means having the technology to receive a request, instantly check the product’s status in your system, and send a response. A slow or inaccurate verification process can create bottlenecks and damage trust with your partners.
Stay Up-to-Date on Regulatory Changes
The DSCSA is not a static regulation. The FDA periodically provides updates, clarifications, and new guidance. For instance, the FDA introduced a stabilization period for the final requirements to give trading partners time to refine their systems, not an extension. Make it a priority to follow FDA announcements and work with partners who are knowledgeable about the regulatory landscape. Staying informed helps you anticipate changes and adapt your operations before you fall out of compliance.
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Frequently Asked Questions
What’s the difference between lot-level tracking and unit-level serialization? Think of it this way: lot-level tracking, which was the first phase of the DSCSA, was like tracking a whole case of water bottles using one batch number. Unit-level serialization, which is the current requirement, is like giving every single bottle in that case its own unique serial number. This much more detailed approach allows any trading partner to trace and verify one specific package throughout its entire journey, rather than just tracking the general batch it came from.
I already use an ERP system. Isn’t that enough for DSCSA compliance? While a general ERP is great for managing core business functions, it typically isn’t designed to handle the unique demands of pharmaceutical traceability. DSCSA compliance requires specific capabilities, like managing millions of unique serial numbers, exchanging data in a standardized format with all your trading partners, and processing verification requests in real time. A purpose-built serialized ERP has this functionality integrated from the start, which removes the risk and complexity of trying to adapt a generic system.
What’s the first step I should take if I receive a product that seems suspicious? Your immediate responsibility is to prevent that product from moving any further down the supply chain. You must physically separate it from your other inventory and place it in a secure quarantine area. This ensures it cannot be accidentally sold or dispensed. Once the product is quarantined, you can begin your investigation to confirm if it is illegitimate and follow the required steps for notifying the FDA and your trading partners.
The November 2023 deadline has passed. What should I do if my business isn’t fully compliant yet? The most important thing is to take decisive action now. While the FDA has provided a stabilization period to help companies finalize their systems, this time is meant for actively working toward compliance, not delaying it. Your first step should be to identify your specific gaps and partner with a technology provider who understands the regulations. Showing that you have a clear plan and are making a good-faith effort to get compliant is critical.
Do these rules apply to all drugs, or just certain types? The DSCSA applies specifically to certain prescription drugs intended for human use. It generally does not cover over-the-counter medications, veterinary drugs, blood products, radioactive drugs, or certain medical gases. Because the definitions are very specific, it’s essential to know for sure which of your products fall under the law’s requirements. A robust compliance system can help you properly categorize and manage your inventory according to these rules.
