VerifyReg Offers Validation of Prescription Drug Labels

Published: November 5, 2023

The AIM Global initiative will confirm the appropriate marking of printed labels and QR codes, as well as NFC and RFID tags used in the supply chain from manufacture to patient.

On November 23, the FDA’s Drug Supply Chain Security Act (DSCSA) will require supply chain traceability of prescription drugs as they move through the supply chain. That’s in addition to the currently mandated printed identifiers. So, drug companies and those who manage, ship, or sell those goods are creating labels and technology-based solutions to meet the looming new requirements. To ensure DSCSA compliance is met through validated functional identifiers – whether a company uses 2D barcodes, nearfield communication (NFC), radio frequency identification (RFID), or another identifying technology – AIM Global has released a solution it calls VerifyReg.

Currently, companies face a variety of data schemes, as well as technology options and challenges, to create a system that complies with the FDA requirements. The DSCSA requirements outline 2D data matric codes or linear codes, while NFC or RFID could also meet the identification needs but are not required. The VerifyReg program, released in October, provides data integrity validation for labels used on pharmaceuticals as they move through the supply chain. Label providers and packaging companies can use the system to ensure that the correct data is printed appropriately and legibly on each label. Still, as companies adopt the technology, an NFC or RFID chip is encoded and operating correctly as well.

Pharmaceutical providers can then use the DSCSA-compliant labels and retailers, as well as other constituents in the supply chain, to prevent counterfeiting, ensure the integrity of a product, and do so in a standardized way. Guidelines determine the data requirements for packaging of pharmaceuticals uniformly, explains Scott Austin, AIM Global board member and director of consulting company Zugang Technologies Connections.

While DSCSA does not require the use of NFC or RFID, the RF-based technology enables automatic capture of data according to FDA’s requirement, as well as offering supply chain management for constituents from manufacturers to retailers. Whichever data marker is used, “If it doesn’t work, then you have a breakdown in the supply chain. It’s as simple as that,” Austin says.

Ensuring Interoperable Data Exchange

Scott Austin, AIM Global board member and director of consulting company Zugang Technologies Connections

The FDA issued the most recent DSCSA standards requirements in September this year for secure, interoperable electronic data exchange among the distribution supply chain. Prescription drug authentication and transparency have been a focus of the FDA for more than five years. In November 2018, manufacturers and re-packagers were required to place DSCSA-compliant product identifiers on prescription drug products.

A year later, wholesale distributors were mandated to accept and manage only products with the DSCSA-compliant product identifier (unless the product was grandfathered or subject to a waiver, exception, or exemption under the law), explains Austin.

The product identifier must include its numerical identifier (composed of the national drug code number and a unique alphanumeric serial number), the product’s lot number, and expiration date in both human- and machine-readable formats. That machine-readable format could be a 2D barcode, NFC, or RFID tag. In some cases, these identifiers don’t work, and AIM is targeting that challenge with VerifyReg, Austin says. “A simple unreadable barcode can have a huge impact on the objectives of the FDA’s system and a potential recall in the future.”

AIM Global is a 50-year-old industry standards group for automatic identification technologies that offers an independent voice in supporting the verification of identification markers. In the case of VerifyReg, AIM intends to work with the various participants in the supply chain to ensure their chosen identifiers are legible in the field.

How it Will be Used

To leverage the VerifyReg tool for code structure and data marking validation, users log into the platform online and proceed to register their products.

RFID or NFC label providers can use the system not only to validate their printed data markers but also the functionality and legibility of the chips embedded in the labels or tags.

They would then send their products to AIM Global’s Pennsylvania laboratory to verify the RFID tag code structure. The program can then include checking the tag’s functionality with the packaging it is being used with, including more challenging materials such as foil packaging. The group will only check the data format, however, rather than the read distance under specific conditions.

Initially, those employing the VerifyReg tool include suppliers of pharmaceutical products such as manufacturers and distributors, as well as label and packaging suppliers; however, Austin adds that “we expect the unexpected, and other stakeholders will appear who can utilize the data quality validation in their day-to-day business.”

How VerifyReg™ works


One benefit of traceability will be easily tracking medications in the supply chain when there has been a recall. The data will also aid in preventing counterfeits from being sold or consumed in the market. Greater data collection can also be used to help companies understand the distribution of a drug and optimize the supply chain according to that insight. A better understanding of the supply chain could reduce the risk of drugs expiring before they are used, for instance.

Pharmaceutical and supply chain companies experienced the need for drug traceability with the COVID-19 pandemic caused not only by supply chain shortages and labor challenges but also by greater demand for specific medications.

With that greater demand on those in the pharmaceutical industry, Austin says, “it’s serendipitous that we have the government policy aligning with market conditions. I think that the benefits from this program – if the companies leverage them – are far more significant than the original intent of the FDA.

To meet the needs of those registering with VerifyReg, AIM has conducted training to help representatives complete validation, including testing barcode code scans, NFC, or RFID reads. That has also meant acquiring the necessary technology to simulate data capture events.

Although DSCSA is a U.S. requirement, AIM Global will also support companies internationally, such as manufacturers that sell products in the U.S.

For AIM Global, the end game is reliable data quality, transparency, and trust across the pharmaceutical industry. In the long term, the association intends to offer the verification solution for other markets beyond pharmaceuticals. That could include fresh foods, for instance. “We will start with the pharmaceutical supply chain,” says Austin. “We’ll see how the industry values this service, and then if it is valued, we’ll take it into other verticals with similar requirements.”

The food industry could be a target for AIM Global since food faces similar issues when it comes to health risks and recalls if a problem occurs. Total recalls of food have heavily impacted both producers or manufacturers and consumers.

In the meantime, however, DSCSA standards for pharmaceuticals are the focus, and AIM intends to see how well its service is adopted.

Key Takeaways:

  • AIM Global offers VerifyReg service for those making or using drug identification labels that meet the DSCSA standards.
  • The association will confirm the appropriate display of data on the printed label on barcodes while also testing the functionality and proper encoding of FNC and RFID labels.