The pharmaceutical labeling space presents a host of challenges and opportunities for converters. From the supplier perspective, significant R&D is required to stay ahead of the curve to ensure the products making their way to consumers are safe and effective.

Regulations play a key role in pharma labeling. For example, there are regulatory and compliance requirements that are essential, including the FDA New Drug Application (NDA) process and adherence to standards like REACH, RoHs, and FDA 175.105.

“Pharmaceutical labels are designed for challenging technical applications, such as small diameter tubes and vials, and must withstand ultra-low temperatures and resist chemicals and sterilization processes,” explains Cory Keller, senior product manager, Specialty, Avery Dennison. “This market distinguishes itself from other prime labels due to the critical importance of change management, as stability testing for packaging modifications can exceed 12 months.”

To manage risk and the many challenges associated with pharmaceuticals, Avery Dennison boasts an ISO 17025 certified analytical lab that can be leveraged to support converters and end users to test pharma label materials in real world conditions. This service helps provide support data to facilitate packaging qualification testing. 

“Managing risk associated with drug package system approvals and/or changes is of utmost concern for pharmaceutical companies since ensuring the efficacy and safety is the number one priority,” remarks Keller. “Sometimes, changes to label materials will trigger stability testing at the pharmaceutical company, which can take many months. 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.”

Avery Dennison has developed numerous products to meet demand in this challenging application. Avery Dennison’s Pharmaceutical and Healthcare Collection features a core portfolio ideal for various OTC, prescription drug, and medical device applications, centered on four key adhesives with a strong change notification commitment. Additionally, Avery Dennison offers application-specific portfolios that feature purpose-built solutions for challenging pharma applications like tight mandrel syringes and cold chain needs, with ultra-low temperature labels for biological and pharmaceutical products. These labels suit various containers, including plastic, glass, and aluminum, and can endure extreme temperatures.

There are a wide range of products for this market, too. “Blood and IV bag label solutions ensure safe collection, storage, and transport, with primary and secondary labels that withstand high-temperature sterilization and freezer storage, featuring low migration adhesives to prevent contamination,” states Keller. “Meanwhile, pharma security labels provide tamper-evident protection, featuring options like fiber tear, voids, sharp tear, and frangible designs to maintain product integrity and brand security. Finally, medical device labels meet IEC 60601-1 standards for safety testing of electrical medical devices, with UL-certified materials applicable to substrates like aluminum.”

Security is becoming more prevalent than ever, and Avery Dennison has instituted RFID technology to help spur innovation in this field. According to Keller, this will serve as one of the key markets to watch in the future, especially in the pharmaceutical space.

“RFID is transforming the pharma labeling market by enhancing patient safety through improved visibility from manufacture to point of care,” says Keller. “It also offers automated protection against counterfeiting and diversion, ensuring the integrity of pharmaceutical products. Avery Dennison, the largest UHF RFID partner, leads the digital transformation with integrated RFID solutions, including UHF, HF, and NFC, widely adopted in pharma packaging for patient safety.”

In addition to RFID, sustainability will make its mark in the pharma space. While patient safety will always be the top priority, pharmaceutical companies are in the early stages of setting ambitious 2030 and 2050 corporate sustainability goals. 

“This will drive the need in the industry to provide label and packaging solutions that can help reduce the carbon footprint (Greenhouse Gas Emissions) in the value chain, along with using more recycled content and/or recyclable materials,” comments Keller. “In response to this, Avery Dennison – in early 2025 – will be introducing a new 1.2M 90% rPET liner and expanding our FSC-certified paper facestock options to include Lightweight Pharmaceutical Litho FSC.  Converters and end users can also leverage the AD Circular program that can divert matrix and liner waste from landfill.”