Key Takeaways:
· The Drug Supply Chain Security Act (DSCSA) is in full effect, and many packaging professionals are now figuring out how to manage and exchange fragmented data.
· There is a growing demand for more robust packaging solutions that balance safety with regulatory compliance.
· Serialized packaging provides a unique identifier needed to track a product consistently, verify authenticity, and reconcile discrepancies when products change hands.
Now that FDA’s Drug Supply Chain Security Act (DSCSA) is in full effect, many packaging professionals are figuring out how to manage and exchange fragmented data, implement connected technology, and ensure patient safety. DSCSA outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain. This helps prevent harmful drugs from entering the U.S. drug supply chain, detect them if they do enter the supply chain, and enable rapid response to remove harmful drugs from the supply chain to protect patients.
A healthcare professional presenting an NFC‑enabled autoinjector designed for product authentication and improved patient adherence.MM Pharma & Healthcare Packaging
The regulation creates the framework, but success depends on how well organizations integrate packaging data into their day-to-day workflows and how effectively partners collaborate across the supply chain.
Michael Hadjisavas, chief operating officer, Life Sciences and Healthcare at p-Chip, agrees, “The DSCSA is well-intentioned, but it has been challenged by a lack of truly integrated solutions that solve the end-to-end technological needs of these very complex supply chains. The urgency of these solutions is growing.”
Fluchel says that smart and connected packaging plays a critical role because it serves as that consistent reference point across the entire supply chain. “The most significant trend is the shift from compliance-driven implementation to operational integration,” she says.
Thus, there is a growing demand for more robust packaging solutions that balance safety with regulatory compliance. A “DSCSA-compliant” solution should aim to integrate serialized, tamper-evident, and traceable packaging for improved data exchange and unit-level tracking and verification.
“We have to recognize that we are entering a megatrend fueled by new classes of therapeutics,” says Hadjisavas. “These include cell and gene therapies, tissue and engineered regenerative medicines, and individualized therapies. I anticipate that these therapies will require advanced digital process control to ensure Chain-of-Identity and Chain-of-Custody, and they will likely integrate with DSCSA regulations.”
Fragmentation Leads to Vulnerability
No matter the therapy, when it comes to traceability, a clear pain point that plagues the pharmaceutical supply chain is fragmentation. “Drug traceability often breaks down when products move across different systems, partners, or lifecycle stages,” says Fluchel. “Manual processes, inconsistent data standards, and limited visibility into returned or diverted products create risk.”
“Each entity across the drug supply chain does not have the ability to verify they are receiving a trusted or authenticated product from their upstream supplier and its original source,” says Hadjisavas. “This disconnection of data creates an operational gap that causes supply chain entities’ inability to authenticate a product. Additionally, each entity usually operates with their own distinct and proprietary identification system that is attached or associated with the ID assigned by the preceding organization. This creates a massive data logistics challenge that requires association of a drug product to multiple ID systems and matched metadata sets. This has caused less than 20% compliance with this DSCSA for drugs supplied in the U.S. since its ratification in 2013.”
Hadjisavas says this fragmentation exposes the drug supply chain to vulnerabilities that allow non-compliant or counterfeit products to enter the logistics system and ultimately cause patient harm. The p-Chip microtransponder (MTP) aims to address vulnerabilities – such as easily copied barcodes and easily removable adhesive labels – by being embedded or directly attached to packaging such as vials, pill containers, vaccines, syringes, or clinical consumable. The MTPs can also be injection molded or heat-staked into the packaging or drug container to ensure permanence and tamper-proof tagging. The MTP can be read by a handheld reader that activates the chip with modulated laser light and decodes the emitted ID signal, enabling unit-level serialization.
Serialization Enables Unit-Level Tracing
Industry experts say that unit-level serialization can pull together a fragmented supply chain. Under DSCSA requirements, manufacturers and downstream partners must be able to verify package level identifiers before determining if a product is compliant, recalled, should be returned, or wasted. In practice, many organizations struggle with incomplete packaging data, disconnected systems, or manual reconciliation processes that introduce friction and increase risk.
Serialized packaging provides the unique identifier needed to track a product consistently, verify authenticity, and reconcile discrepancies when products change hands or reenter the system. Inmar integrates serialized packaging data into its RxTransparent and Returns infrastructure, allowing products to be verified. This enables clients to make consistent, compliant decisions while reducing unnecessary waste, preventing counterfeit reentry, and improving efficiency, says Fluchel.
“Inmar ingests and verifies serialized data associated with individual products and reconciles transaction history as products move through the supply chain, applying verification and decision logic at the package level to determine the optimal route the product could travel through the supply chain,” says Fluchel. "By linking serialized identifiers embedded in packaging to returns processing and verification workflows, Inmar helps identify counterfeit products, supports DSCSA compliance, and brings greater consistency and confidence to how products can be most effectively utilized.”
NFC Facilitates Interoperability
Smart or connected packaging serves as an active participant in the healthcare supply chain rather than a passive container. It enables seamless data capture and sharing, verification, and communication across the lifecycle of a drug, from manufacturing through dispensing and returns. Connected packaging requires a data infrastructure that can ingest, normalize, and exchange serialized product data across multiple stakeholders. “Interoperability is essential because no single entity owns the entire lifecycle of a drug,” says Fluchel.
One type of smart packaging technology is near-field communication (NFC), which is garnering interest from a safety perspective, says Tiffany Overstreet, global innovation director, MM Pharma & Healthcare Packaging. NFC technology helps patients confirm product authenticity and gives them confidence that what they are taking is genuine and safe to use. MM is adding NFC-enabled inlays to cartons and labels, which can be used on injectable devices or vials to empower patients to verify product authenticity. “Additionally, built-in security verifies the chip is genuine and provides data to the pharma company confirming the product reached its intended destination.”
Seamless connectivity: the phone reads the NFC tag embedded in the MM autoinjector label and displays a landing page instantly.MM Pharma & Healthcare Packaging
“The complexity went beyond simply adding a smart feature,” she says. “The label needed to function as a standard label when the smart technology wasn’t activated, ensuring complete flexibility in their operations. This required us to completely reimagine the physical label design and our entire quality process. We integrated readers directly into our manufacturing line to capture data from the smart technology, verify its accuracy as a digital quality check, and generate comprehensive reports for the client. Critically, we implemented multiple validation checkpoints to ensure that only products meeting specifications, both physically and digitally, were shipped. The result was full implementation with zero changes to the client's packing process and no impact on its line speed or output. The customer gained advanced authentication capabilities while maintaining complete operational continuity.”
AI Identifies Data Inconsistency
MM Pharma & Healthcare Packaging has also added an AI-powered security feature to its security solutions. The technology combines print with an AI-enabled app that can confirm a product package is genuine. “In its current form, it’s best suited for use by authorities and authorized personnel to verify product authenticity,” explains Overstreet. “This technology helps keep brands safe by enabling brand owners to quickly and easily verify authenticity at minimal cost. Because of its digital nature, it also alerts brand owners if someone attempts to counterfeit their feature and scan it with the app. When a counterfeit scan is detected, the brand owner receives the exact geographic location of the scan, making it easier to identify and locate the counterfeiter.”
Fluchel adds, “In the context of traceability, AI can help identify inconsistencies in serialized data, flag potential diversion or fraud, and improve decision making around returns and recalls. Rather than replacing existing systems, AI strengthens them by helping organizations interpret large volumes of packaging and transaction data more efficiently and accurately.”
p-Chip microtransponders are the size of a grain of salt and enable secure digital identities for physical items, enabling traceability, authentication, and data-driven supply chains.p-Chip Corp.
Tracking and interpreting transaction data is at the core of a recently launched two-year trial from p-Chip, whose MTP takes advantage of AI innovation. The trial aims to trace drugs for more than 1,000 patients across several therapeutic areas. The trial will involve labeling drug packages and vials by direct attachment or directly embedding the MTPs. In Phase 1, Hadjisavas says drugs will be scanned upon receipt from wholesalers, distributors, and logistics providers through to warehousing, insurance authorization, patient scheduling, packaging and shipping to healthcare providers. IDs will be captured and integrated into software that ingests patient IDs and various transactional data, such as physician notes, diagnostic data, prescription data, insurance authorization data, scheduling and logistics data. Subsequent phases will integrate diagnostic transactional and bio-manufacturing data, with outcomes for personalized and individualized therapies. These end-to-end traceability capabilities will be implemented across all 50 states, with initial roll-out in Florida.
“This is an exciting time where new technologies are enabling the vision of Chain-of-Identity to realize its potential,” says Hadjisavas.
The potential of combining smart technology and packaging results in a data source that can inform supply chain decisions.
“Connected packaging plays a role beyond regulatory compliance,” says Fluchel. “When packaging data is integrated thoughtfully, it becomes a strategic asset that supports patient safety, operational efficiency, and trust across the healthcare ecosystem. Over time, the value of smart packaging will be determined by how well organizations operationalize connectivity across the supply chain and use that data to reinforce integrity, consistency, and confidence at every point of product movement.”
