Frequently Asked Questions
What is VerifyReg™?
VerifyReg™ is a data integrity checkmark created to
support compliance with companies that
work within the US FDA Drug Supply Chain Security Act (DSCSA). Acquiring
a VerifyReg™ checkmarks indicates
that the company’s linear barcodes and
2D Data Matrix codes are adhering to the proper code structure of the mandated
and preferred data markers used on pharmaceuticals. When a company properly
upholds the accuracy and integrity of these data markers, this prevents the
introduction of counterfeit, damaged or illegitimate products into the
pharmaceutical supply chain.
Who are the users of VerifyReg™?
Pharmaceutical manufacturers, wholesalers, dispensers, and packagers.
Who benefits from VerifyReg™?
Manufacturers, wholesalers, dispensers, and packagers.
Manufacturers benefit by being able to quickly promote their adherence to DSCSA compliance with the VerifyReg™ checkmark. This can help create new business and promote their organization in general.
Wholesalers, dispensers, and packagers benefit by having more confidence in the products they distribute and dispense; because they know that the companies they are getting product from have declared compliance.
What business challenges does VerifyReg™ address?
VerifyReg™ addresses several business challenges.
For a manufacturer or packager, it is a quick and easy way to highlight that they understand, and have shown the ability to create codes that follow DSCSA rules and regulations.
For wholesalers, it is a less time-consuming way to vet
potential suppliers. By checking to see if a company has a
VerifyReg™ checkmark, they will know immediately the company has
created verified data elements to adhere
to all DSCSA mandated and preferred data markers.
Although further vetting will be needed, it is a great first step that significantly reduces the time it takes to find the best supplier.
How long does my verification last?
Product verification is for one-year from the time verified. A renewal notice will be sent to you 60-days prior to expiration.
What Standards Does VerifyReg™ Utilize?
• ISO/IEC 15416:2016 – Automatic identification and
data capture techniques — Bar code print quality test specification — Linear
symbols
ISO/IEC 15416:2016 sets out the procedure for measuring
specific attributes of barcode symbols. It also establishes a process for
assessing overall symbol quality based on these measurements. Additionally, the
standard offers insights into potential causes of deviations from optimal
grades to guide users in corrective actions. While primarily designed for
symbologies with defined reference decode algorithms and intended for linear
scanning, the methodology can be applied, in part or in full, to other symbologies.
• ISO/IEC 15415:2011 – Information technology —
Automatic identification and data capture techniques — Bar code symbol print
quality test specification — Two-dimensional symbols
ISO/IEC 15415:2011 outlines two methodologies for measuring
specific attributes of two-dimensional bar code symbols, tailored to multi-row
and matrix symbologies respectively. It also establishes procedures for
evaluating and grading these measurements to determine overall symbol quality.
The standard provides insights into potential causes of deviation from optimal
grades to aid users in corrective actions. While primarily designed for
symbologies with defined reference decode algorithms, the methodologies can be
applied, in part or in full, to similar symbologies. For direct part marks,
combining ISO/IEC TR 29158 with ISO/IEC 15415:2011 may yield more accurate
correlation between measurement results and scanning performance.
• ISO/IEC 29158:2020 – Information technology —
Automatic identification and data capture techniques — Direct Part Mark (DPM)
Quality Guideline
This engineering document is aimed at verifier manufacturers
and application specification developers. It introduces modifications to the
symbol quality methodology outlined in ISO/IEC 15415, along with a symbology
specification. The changes encompass alternative illumination conditions, new
terms and parameters, adjustments in measurement and grading of specific
parameters, and the way grading results are reported. The document's primary
purpose is to evaluate the symbol quality of direct marked parts, particularly
those where the mark is directly applied to the item's surface and a
two-dimensional imager is used for reading. Additionally, this method can be
extended to symbols produced by other means, especially in scenarios where both
direct part marked (DPM) symbols and non-DPM symbols are scanned in the same
environment, with the reported grade being in the DPM format rather than
ISO/IEC 15415.
What are the fees and requirements to apply?
The fee to verify each product label is:
AIM Members: $189*
Non-Members: $249
*AIM member pricing is available to AIM Global and AIM Chapter members. Contact a VerifyReg™ Program Manager or
For each product label you wish to review, please send the label/package ONLY to:
The label/package ONLY should be mailed to:
AIM Global
100 Allegheny Drive
Suite 105C
Warrendale, PA 15086 USA
Terms of Use
VerifyReg™ customers agree to the Terms and Conditions of the VerifyReg™ program.
When will I know if my product label is approved?
Customers will be notified within three (3) business days whether their product label qualifies for the VerifyReg™ checkmark designation.
Other Questions?
If your questions are not addressed above, please contact a VerifyReg™ Program Manager or +1 724.742.4470.