Accuracy, Access and Assurance: The New Priorities in Pharmaceutical and Consumer Packaging

Gary L. Parish is a leading authority in secure data encoding and document authentication, with decades of experience supporting law enforcement, regulated manufacturing and government technology development. He earned a Bachelor of Science in Business Administration from the University of Maryland and began his career as a Detective with the Bureau of Criminal Investigations in the Prince George’s County Police Department, Maryland. Parish has authored numerous technical articles and received multiple awards for his contributions to security, authentication and innovation.

The Shift Toward 2D Codes and New Packaging Risks

Pharmaceutical packaging is undergoing accelerated transformation as manufacturers face rising regulatory expectations, increasing product complexity and new global standards for how product information is delivered. One of the most significant changes is the GS1 Sunrise 2027 initiative, in which GS1 is recommending manufacturers convert from a 1D UPC or EAN Code to a 2D QR Code for billions of products worldwide.

Sunrise 2027 is a global GS1 initiative recommending that manufacturers transition from traditional 1D UPC and EAN barcodes to 2D QR Codes. The goal is to modernize packaging by enabling each product to carry more detailed information—such as batch data, expiration dates, and regulatory content—directly within the symbol. Unlike 1D barcodes, 2D QR Codes can store richer data and support digital interactions, making them more suitable for today’s supply chain, retail, and consumer information needs. Sunrise 2027 represents a shift toward packaging that delivers more accessible, accurate and digitally connected product information.

While this shift enables richer data and digital engagement, it also introduces new vulnerabilities. The recommended 2D QR Code is a public, open format symbol that anyone can generate, creating a more fertile environment for counterfeiting, code replacement and redirection—risks that are especially concerning for pharmaceuticals, where accuracy and authenticity are non negotiable.

Traditional QR codes also depend on external websites and internet connectivity, complicating quality control processes that require offline verification against approved master labels. As packaging evolves from a printed surface into a carrier of critical safety information, authentication data and regulatory content, manufacturers must evaluate how these symbols will perform in environments where data integrity is essential.

Lessons From Decades in Packaging Safety

My approach to packaging accuracy and product safety was shaped by early experiences in environments where a single labeling error could have serious consequences. Early in my career, I assisted McNeil Pharmaceuticals—maker of Tylenol—in designing security features that became industry standards following the Tylenol tampering crisis. That work underscored the importance of secure, verifiable packaging.

Later, while developing inspection systems for pharmaceutical companies, I saw firsthand how misprints, incorrect artwork or outdated labels could halt production or compromise patient safety. Leveraging imaging technology, I created the first automated image comparison system that allowed FDA regulated companies to verify approved regulatory documents against incoming printed labels, cartons and inserts before they reached the packaging line.

These experiences reinforced a principle that guides my work today: packaging must deliver information that is accurate, verifiable and accessible to every user.

HD InfoCode+: A High Density, Dual Layer Code for Safety, Accessibility and Security

As CEO of HD Barcode LLC and co inventor of HD InfoCode+, I have focused on advancing packaging technology beyond the limitations of traditional QR Codes. HD InfoCode+ is not a replacement for QR Codes; it is a high density, dual layer data symbol designed to store complete, offline “directions for use” that every consumer and patient can access — including blind, visually impaired and reading challenged individuals. Where Braille can only provide the product name and dosage, HD InfoCode+ delivers the full “directions for use” exactly as printed on the label or carton, ensuring universal access to critical information.

In the same symbol, HD InfoCode+ also includes a secure, encrypted authentication layer readable only by authorized smartphones, enabling manufacturers to verify product authenticity and prevent counterfeiting, diversion and unauthorized relabeling. This approach allows packaging to deliver both public access to essential information and manufacturer level security without relying on external websites or internet connectivity.

Balancing Speed with Regulatory Precision

Production lines are optimized for speed, yet regulatory frameworks—such as 21 CFR 211.122—require meticulous verification of every label and packaging component. Quality teams must confirm that each printed element matches the approved master label and that no incorrect materials enter the line.

This tension between speed and precision has driven adoption of automated inspection systems, offline verification tools and data rich codes that reduce reliance on external databases.

The GS1 transition adds another layer of complexity. While the new QR format supports consumer engagement and expanded data capacity, it does not inherently guarantee accuracy, authenticity or offline access. Manufacturers must evaluate how 2D codes will function within GMP environments, how they will be verified during incoming inspection and how they will support accessibility requirements for blind, visually impaired or reading challenged individuals.

Accessibility Case Example: A Blind Consumer Using Enhanced Packaging

A blind consumer receives an over the counter product. The printed label contains critical instructions, but reading it independently is impossible. Traditional QR codes offer limited help—they require internet access, link to external websites and often provide generic marketing content rather than actionable directions.

With an enhanced high density code such as HD InfoCode+, the experience changes:

• A tactile locator mark guides the user’s fingers to the code.

• Their smartphone scans the symbol and immediately reads embedded, offline instructions aloud—dosage, timing, warnings and storage requirements.

• Optional features provide sign language videos, large print text, or audio only guidance tailored to the user’s needs.

• Authentication data stored in the secure portion of the code confirms the product is genuine.
This scenario demonstrates how packaging can become an accessibility tool—not just a regulatory requirement.

Emerging Solutions and Advice for the Field

HD InfoCode+ represents one of the emerging solutions addressing these challenges. Its high density 2D architecture can store complete directions for use, authentication data and accessibility features directly within the symbol. Accessibility content can be provided through a public code, while authentication data remains protected—readable only by authorized devices.

Digital printing platforms are enabling serialized and variable data at scale. Accessibility focused innovations—such as tactile locator marks, audio enabled codes and sign language based instructions—are expanding the definition of “complete labeling” for diverse consumer and patient populations.

For professionals entering pharmaceutical manufacturing and packaging, the guidance is clear: understand regulatory requirements, learn how packaging lines and quality systems operate, evaluate new technologies through the lens of practicality and compliance, and remember that every improvement ultimately serves the same purpose—protecting the consumer or patient.

Closing Perspective

As the GS1 Sunrise 2027 transition approaches, the industry will continue to evolve. The companies that succeed will be those that treat packaging not as an afterthought, but as a critical component of product integrity, regulatory compliance and consumer trust.