Pharmaceutical Labels 

The pharmaceutical labeling industry is known far more for functionality than flash. From growing complexities to increasing regulations, pharma labels must also perform in a wide range of challenging environments. 

Unlike many other labels, pharmaceutical labels carry critical information such as dosage instructions, warnings, lot numbers, and expiration dates. The information contained on the label must remain accurate and legible throughout the product’s lifecycle to be successful.

“At its core, a pharmaceutical label needs to do three things well: protect patient safety, remain compliant, and communicate clearly,” explains Stacy Falconer, VP, Healthcare and Commercial Strategy, Premium Label & Packaging Solutions (PLPS). “The label also has to perform. Whether it’s exposed to refrigeration, moisture, sterilization, frequent handling, or even cryogenic storage conditions, it needs to maintain its integrity from production through end use. At PLPS, we view the label as an extension of the product itself. If the label fails, the product experience fails.”

“Given the pivotal role pharmaceutical labels play in patient safety, accuracy and legibility are non-negotiable,” adds Simon Halsey, product development manager, MM Pharma & HC Packaging. “The label must clearly communicate the product name, dosage, ingredients, and instructions for use, often across multiple languages, in a way that leaves absolutely no room for misinterpretation.”

With patient safety at a premium, security is one of the key functions of this labeling segment. “Security is an important consideration,” comments Lisa Ivey, R&D manager, Fedrigoni Self-Adhesives. “For many pharmaceutical applications, the label can help provide evidence of tampering, support authentication, and protect against counterfeiting. In this market, the label is part of a larger system of protection. It needs to perform reliably while also supporting the integrity of the product and the confidence of the patient, provider, and brand owner.”

“As regulatory scrutiny intensifies and serialization requirements expand, organizations are recognizing that control over labeling is effectively control over risk,” adds Laura Johnson, senior sales director, Life Sciences, Loftware. “What once might have been a localized issue can now ripple across the entire system, putting patient safety and business continuity at risk.”

Compliance and regulatory requirements can be complex, though. There are numerous tasks the label – and overall packaging – must achieve. “At a minimum, pharmaceutical label materials must comply with food safety regulations, however, the requirements extend well beyond that,” says Yasmine Pierre, product manager, Pharma and Healthcare Label Solutions, UPM Adhesive Materials. “For plastic packaging, it is essential to ensure that no harmful substances from the label can migrate into the primary package. This creates a strong focus on low migration inks, varnishes, and especially adhesives, since the adhesive is in direct contact with the container. This is particularly important for liquid pharmaceuticals in plastic containers, although concerns have also been raised regarding potential migration into solid dose products.”

When it comes to developing new products, a pharmaceutical label should be tailored exactly to the requirements of the specific customer application. “Ideally, the label should feature additional functionalities that enhance product and patient safety while improving processes in healthcare settings,” remarks Stefan Wiedemann, senior director, Strategic Marketing and Business Development, Schreiner MediPharm. “Examples here include integrated hangers for infusion bottles, detachable documentation labels or multi-layer designs for extended product information. Ultimately, the pharmaceutical label’s design must ensure smooth processability for the pharma manufacturer.”

According to PLPS, a converter that specializes in pharmaceutical labeling, this sector requires significant traceability, change control, documentation, and quality assurance oversight throughout the labeling process. Artwork revisions, multilingual content requirements, serialization data management, and strict approval workflows also add additional layers of complexity that must be carefully managed while maintaining production efficiency and speed to market.

The industry must also adapt incredibly well to rapid change. According to Avery Dennison, bringing a new drug product to market takes on average 10-15 years, with a development cost between $1.3 to $2.8 billion. 

“In addition to being purpose-built for pharmaceutical applications, pharma labels differ from standard label materials by providing more robust change management,” notes Cory Keller, senior product manager, Pharmaceuticals, Avery Dennison. “In the case of Avery Dennison, we minimize component changes in the pharma label portfolio, and when we do, we provide advance notification (typically 12 months) to facilitate end-user qualification.”

“A formal change management process protects business continuity,” adds Pierre. “This process ensures that any modifications to the material are controlled and communicated in advance in an agreed timeframe. Standard label materials, in comparison, are not pretested for pharmaceutical applications and are not included in such change control frameworks, making them unsuitable for regulated pharma use. 

“Converters expanding into the pharma and healthcare end-use sectors must consider that standard materials they currently run for other applications, although may seem adequate, are not likely suited for pharma applications,” continues Pierre. “Most dedicated pharmaceutical label solutions carry a higher price tag, but they lower the risk of regulatory non-compliance and their change management process will help to avoid unannounced changes that could result in costly and time consuming requalification.”

Pharmaceutical labels also carry several inherent challenges not evident in other segments. “The physical constraints of the application add further challenges, as many containers, vials, syringes, and devices are small with very limited surface area, yet with substantial information requirements,” states Halsey. “Solutions such as extended content labels (ECL) are essential in addressing this, but they require real expertise to execute well.”

“Pharma labels face a much lower tolerance for error than many other labeling applications, because an incorrect or unreadable label can affect patient safety,” adds Wiedemann. “There is no tolerance for mix-ups, print defects, unreadable codes, or material failures. The level of performance is what separates true pharma packaging expertise from standard label production: every detail must be designed and controlled with product and patient safety in mind.”

Environmental demands are equally stringent. “Labels must perform through cold-chain storage down to -196°C for cryogenic applications, sterilization processes, extended product service life, and where required, must incorporate tamper-evident or anti-harvest properties,” notes Halsey. “Moreover, the materials themselves must frequently meet pharma-grade standards. With all this in consideration, fitness for purpose in the application is only the starting point.”

When designing pharma labels, disconnected labeling systems introduce fragmentation across product data, processes, and governance. This could inevitably lead to inconsistency and operational risk.

“When artwork management, regulatory content, and production labeling operate in silos, organizations lose the ability to ensure version integrity and real-time accuracy,” states Johnson. “This often results in manual interventions, delayed change implementation, and avoidable errors that can escalate into recalls or compliance breaches. For example, analysis of FDA drug recall data from 2012-2023 shows that labeling and packaging issues account for approximately 19% of all drug recall events, making it one of the leading root causes of recalls in the pharmaceutical industry. The broader implication is that disconnected systems undermine trust – not just in the label but in the entire downstream supply chain that depends on it.”

There is also a significant demand for risk management in pharma labeling. Managing risk associated with drug package system approvals and/or changes is of utmost concern for pharmaceutical companies since ensuring efficacy and safety is the number one priority.  

“Sometimes, changes to label materials will trigger stability testing at the pharmaceutical company, which can take many months,” says Keller. “Avery Dennison is mindful of these unique qualification requirements, which is why we minimize component changes and provide extended change notification when elective changes are made. Additionally, Avery Dennison’s ISO 17025 certified analytical lab can be leveraged to support converters and end users to test pharma label materials in real-world conditions to provide support data to facilitate packaging qualification testing.”

Ultimately, the most successful pharmaceutical label accomplishes multiples tasks. 

“For converters serving this market, the strongest label constructions are those that balance several requirements at once: print clarity, durability, dimensional stability, adhesion performance, conformability, and compatibility with the intended print platform,” says Diane Merzbach, PPG strategic market manager, PPG Teslin Substrate Products. “Pharmaceutical labels leave very little room for variability, so materials must deliver consistent performance, from production through end use.”

A Changing Industry

Security is critical in pharmaceutical labeling, especially as counterfeit products are more prevalent than ever before. Changing legislation and regulations also significantly impact companies’ operations.

Regulations are an important aspect of pharmaceutical labeling because labels are not only branding or identification tools, they are part of the product’s safety and quality system. 

“In the EU, the Falsified Medicines Directive requires safety features such as a unique identifier and an anti-tampering device on all prescription drug packs, while the US DSCSA continues to push unit-level traceability and interoperable verification across the supply chain,” explains Schreiner MediPharm’s Wiedemann. “These rules are evolving toward more digital, data-driven requirements. For a specialist such as Schreiner MediPharm, this means developing customized security labels that combine clear tamper evidence with analog and digital authentication features. We recommend a comprehensive, multi-level approach involving different stakeholders within the pharma supply chain to ensure product integrity and anti-counterfeit protection.

“These requirements are helping drive the need for labels that can carry durable, scannable data throughout the entire product supply chain,” adds PPG’s Merzbach. “At the same time, growth in biologics, specialty medications, clinical trials, home healthcare, and at-home testing is expanding the types of containers, environments, and use conditions labels must support.”

In addition, smart labeling technologies are impacting the pharmaceutical market like never before. “Digitalization is transforming what labels are expected to do,” comments MM Pharma & HC Packaging’s Halsey. “The increasing use of electronic labeling, from e-leaflets to smart packaging, means that today’s label is no longer a static or passive information carrier. It is an active component in a broader digital ecosystem, and the regulatory landscape is evolving to reflect that. Perhaps most significantly, the integration of smart packaging technologies, such as NFC and UHF RFID, has opened up new possibilities for traceability, inventory control, authentication, and direct patient engagement.”

“Regulatory requirements have helped drive broader adoption of serialization and 2D DataMatrix codes, while QR codes, RFID, and other smart label technologies are becoming more important for traceability, authentication, inventory management, and access to digital product information,” adds PPG’s Merzbach. “This added functionality places new demands on print quality and durability.”

According to MM Pharma & HC Packaging, the changing nature of popular pharmaceuticals is impacting the industry, as well. For example, the rapid growth of GLP-1 therapies and other injectables has driven a corresponding increase in the volume of supporting secondary packaging, including labels, cartons, and patient information leaflets alike.

“Pharmaceutical packaging is becoming more varied,” says Fedrigoni’s Ivey. “Applications can range from OTC and prescription bottles to injectables, vials, syringes, refrigerated products, blood bag labeling, hang tags, and secondary packaging. Each of these applications can require a different balance of adhesion, flexibility, durability, printability, and security. That has pushed the industry toward more application-specific solutions rather than one-size-fits-all material choices.

“There is rarely a one-size-fits-all solution,” she adds. The container, diameter, surface energy, storage environment, sterilization or handling process, print method, converting requirements, and security needs can all influence the right construction.”

There are other considerations to take into account such as issues with light sensitivity. Drugs requiring labels that address this have been a key innovation area for Avery Dennison. “Exposure to light is an increasing concern with numerous medications due to the potential for photodegradation or other chemical reactions that affect drug stability (effectiveness),” states Keller. “This is driven by the growth of biologic drugs, a global market that Grandview Research values between $400 and $600 billion, with projections estimating it to exceed $1 trillion by 2030. Additionally, many synthetic drugs, like the newly introduced oral GLP-1 medications, are also light sensitive.”

To address the growth of light sensitive drug products, Avery Dennison recently introduced a new UV Barrier Label Portfolio, which includes high opacity materials that block over 99% of UV light. This portfolio also features a clear overlamination film with a greater-than 95% UV light blocking feature.  

“These barrier materials help maintain the effectiveness and shelf life of medications that are sensitive to UV light,” comments Keller. “The clear overlamination film provides the added benefit of visual inspection, an important quality step in the manufacturing of many injectable drug products.”

Sustainability is making its mark here, too. While patient safety will always be the top priority, pharmaceutical companies are starting to adopt sustainable packaging design concepts in new drug launches and redesigns.  

“Early implementation has been focused on secondary packaging such as moving from plastic to paper trays/inserts,” says Keller. “There is also a movement from single use to multi-dose auto injectors, which will help reduce the number of devices going to landfill. 

“With respect to sustainable pharma label materials, Avery Dennison recognizes there is no one-size-fits-all approach,” adds Keller. “Instead, our pharma label portfolio provides a ‘menu’ of options depending on each end user’s specific goals.”

In Compliance with Regulations

There are numerous regulations that impact the pharmaceutical labeling space, and they’re ever-changing. Regulations influence nearly every aspect of this critical converting market – from FDA requirements to global serialization mandates, compliance is built into the process from the beginning.

“Requirements can influence what information must appear on the package, how that information is presented, how products are identified through the supply chain and, in certain cases, how tampering or product authentication is addressed,” states Fedrigoni’s Ivey. “These requirements continue to evolve as the pharmaceutical supply chain becomes more digital, more global, and more focused on end-to-end traceability. Serialization, product tracing, and machine-readable codes have increased the need for labels that can support consistent print quality and reliable scanning. 

“Regulations, guidance, and customer expectations continue to shift, so material selection has to account not only for today’s package, but also for the way that package moves through the supply chain and how information may need to be verified, scanned, or protected at different points,” continues Ivey.  

As regulations continue to evolve, there are several mainstays in this arena. “What we’ve seen over the past several years is a growing focus on traceability, product security, and patient communication,” says PLPS’ Falconer. “Requirements continue to evolve as supply chains become more global and products become more specialized. As a result, pharmaceutical manufacturers need greater visibility and control over variable data, serialization, and label verification than ever before.

“The industry continues to evolve,” Falconer says. “New regulations, emerging therapies, global supply chains, and increasing security requirements are driving greater demand for flexible labeling solutions that can adapt quickly while maintaining compliance.”

According to UPM, pharma labels require increased scrutiny on chemical composition. “PFAS is one recent area of focus,” states Pierre. “Medical device regulations also require biocompatibility of materials, which applies to labels as well. It’s worth noting that there’s a growing regulatory focus on packaging efficiency and environmental considerations, driven by regulations such as PPWR in Europe and EPR laws in various US states, although pharmaceutical labeling remains partially exempt from these laws.”

Regulatory expectations are also influencing how converters and brand owners think about label performance over time. “It is no longer enough for a label to look good when it leaves the press,” says PPG’s Merzbach. “The printed information must remain readable and the label construction must remain intact throughout the product’s expected life. As regulations continue to advance, converters need materials that can help reduce uncertainty and regulatory risk. A label can contain the correct information when it is printed, but if barcode readability degrades, variable data becomes compromised, or the label fails during distribution or use, the result can still be a compliance concern.”

Utilizing the Right Technology

Due to the critical nature of patient safety involved with pharmaceutical labeling, utilizing the right technology is paramount. The right formula involves the combination of printing capabilities, inspection systems, and quality processes working together.

“Substrate, adhesive, and ink selection also play a critical role because pharmaceutical labels may be exposed to refrigeration, sterilization, frequent handling, and even cryogenic storage conditions,” notes Falconer. “Selecting the right materials helps ensure the label remains legible and functional throughout the product’s lifecycle.”

UPM Adhesive Materials has developed PharmaSure adhesives and products to drive converter confidence when choosing label materials for prescription, OTC, and healthcare applications. This portfolio has also been optimized for digital printing, supporting this shift without compromising performance.

“At UPM, we have focused on addressing pharma labeling requirements, such as migration risk, by developing our UPM PharmaSure adhesives, which enable compliance with strict pharmaceutical standards,” explains Pierre. “Tamper evidence, brand protection, and track-and-trace have become increasingly important. Material solutions within the UPM PharmaSure portfolio are designed to support these needs with reliable, compliant constructions that offer the aforementioned security features.”

Meanwhile, PPG Teslin facestock has been engineered for demanding applications where printed information needs to remain clear, durable and secure, adds PPG’s Merzbach. “Its microporous structure absorbs inks, toners, adhesives and coatings, helping lock them into the material structure for long-lasting performance. For pharmaceutical applications, where barcodes, GS1 DataMatrix codes and variable data must remain readable throughout the product lifecycle, this embedded print anchorage can help reduce compliance risk while supporting traceability and patient safety.”

Schreiner MediPharm’s highly functional solutions show how much added value can be included in a label, notes Wiedemann. “These include Needle-Trap labels with integrated needle protection for prefilled syringes, and smart RFID/NFC labels enabling a wide range of digital applications, including automated inventory management in hospitals, NFC labels for digital tamper evidence and authentication, and patient support via smartphone,” he says. “Other recent developments include special labels with integrated UV/light protection or gas barrier properties for novel sensitive drugs. In addition, sustainable label solutions have been playing a growing role in reducing environmental footprint along the pharma supply chain.”

Software plays a vital role in the process, as well. Organizations are moving away from standalone tools toward integrated ecosystems that unify labeling, artwork, and product data within a single controlled framework. This enables real-time synchronization of regulatory updates, reduces duplication of effort, and ensures consistency across manufacturing sites and trading partners.   

“At Loftware, we see this evolution as essential to modern supply chain resilience, where connected data flows are as critical as physical product flows – an approach that has directly informed the development of Loftware Connect through ongoing customer feedback and evolving industry requirements,” states Loftware’s Johnson.

Flexibility is one of the most significant advantages a label supplier can offer the pharmaceutical sector. “At MM Pharma & HC Packaging, our label capabilities span traditional printing techniques, such as flexographic and screen printing, as well as digital and hybrid options,” says Halsey. “This flexibility enables us to meet a genuinely wide range of customer requirements and is particularly valuable when developing label solutions at the forefront of what the technology can currently achieve.”

As in other markets, collaboration is paramount in the pharma space. “This is where Fedrigoni Self-Adhesives brings real value,” says Ivey. “Our Applications Development team works closely with converters to evaluate the specific requirements of the application and engineer the right material solution for the package, process, and performance demands. That may include tamper-evident and anti-counterfeiting labels, tight mandrel applications, OTC and prescription packaging, refrigerated storage or a custom construction developed for a specific pharmaceutical use. The goal is not simply to choose a material from a list, but to create a solution that is built for the application.”

Inspection tools go a long way in guaranteeing efficacy in this market. “To support these requirements, PLPS utilizes advanced vision inspection systems that not only verify print quality and label construction but also inspect and validate variable data printing for accuracy,” remarks PLPS’ Falconer. “This enables our quality team to identify and replace non-conforming labels while maintaining complete traceability throughout the manufacturing process, effectively providing a 200% inspection process for variable data pharmaceutical applications.

“Ultimately, technology is only part of the equation. The real advantage comes from pairing the right equipment with experienced people, strong quality systems, and a deep understanding of pharmaceutical requirements,” states Falconer. “That’s what ensures consistency, compliance, and patient safety.”

PLPS Launches MyClinicalSuite

Premium Label & Packaging Solutions (PLPS) has announced the launch of MyClinicalSuite, a clinical-only label and packaging production environment designed to help clinical research organizations maintain the highest standards of quality, compliance, and data integrity while providing faster turnaround times.

Operating from PLPS’ Lakewood, NJ, facility, MyClinicalSuite combines in-house variable data printing (VDP), robust quality procedures, including inline vision inspection systems, and a dedicated team of clinical packaging experts to create a more agile and responsive production model.

The launch of MyClinicalSuite reflects the continued growth of PLPS’ healthcare segment. It includes the addition of industry veterans Stacy Falconer, Bill Kougelis, and Stephanie Wydra. Together, the team brings decades of healthcare experience across clinical trial labeling, packaging operations, commercial strategy, variable-data management, specialty applications, and regulated pharmaceutical environments. 

Their combined experience supporting national and global market leaders and managing large-scale healthcare packaging programs helped shape the development of MyClinicalSuite. The environment addresses the increasing demand for speed and flexibility in clinical markets.

“Healthcare label and packaging programs require specialized expertise, operational precision, and rapid responsiveness,” says Chris Payne, CEO of PLPS. “Our investment in this clinical-first operating structure and our growing healthcare team reflects the increasing importance of PLPS’ capabilities across regulated healthcare markets.”

Unlike traditional production environments, where clinical work competes with larger commercial production schedules, MyClinicalSuite supports the unique demands of clinical trial programs. By separating clinical production workflows from commercial operations, PLPS can shorten timelines, offer greater operational flexibility, and ensure smaller-batch clinical programs receive the same level of responsiveness and priority as larger production runs.

“Sponsors are under enormous pressure to move faster while navigating increasing complexity, tighter timelines, evolving trial designs, and heightened regulatory expectations,” says Falconer. “MyClinicalSuite was built to address those realities directly. The unique production environment is managed by an experienced team focused solely on clinical trials, allowing us to deliver speed without compromising quality, compliance, or control.”

“MyClinicalSuite reduces risk, improves patient-level tracking accuracy, and secures trial administration,” adds Bill Kougelis, Clinical Product Line director, PLPS. “By managing in-house VDP and label/booklet production within a clinical-focused environment, we can execute late-stage changes more efficiently, improve turnaround performance, and help sponsors maintain complete data integrity and patient control throughout the trial process.”

PLPS’ Lakewood ISO-certified facility follows cGMP standards and has been producing clinical trial labels and packaging since 2008. The site offers a wide range of clinical trial labels and packaging applications. These include booklets, extended content, and specialty labels such as cryogenic and pattern adhesive. Integrated vision systems and 200% inspection processes validate both bar codes and human-readable data throughout production.