NACDS comments to FDA on track-and-trace technologies

ALEXANDRIA, Va. The National Association of Chain Drug Stores submitted comments yesterday to the Food and Drug Administration in which the association highlighted questions and technical challenges that suggest track-and-trace and related technologies are still in their “nascent” stages and their mandatory use inappropriate.

NACDS submitted two sets of comments, on the issues of “Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication,” and “Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs.”

“We are proud of the systems and initiatives that our members have developed with other industry stakeholders to improve the integrity of the U.S. drug supply chain,” NACDS wrote. “Our members have and continue to work diligently to undertake efforts to secure the pharmaceutical supply chain from counterfeit drugs.

“Prescription drug tracking and tracing technologies, although promising, face a number of challenges before they could be considered reliable and acceptable, and could be deployed across the drug distribution system, particularly down to the level of pharmacies and other dispensers,” NACDS wrote. “Significant industry wide challenges must be addressed and overcome before these technologies can be determined to be an integral and cost-effective part of the prescription drug distribution supply chain.”

NACDS said implementation challenges are diverse and numerous. They range from developing a reliable method for “identifying” products with a designation that contains all appropriate information, to varied and emerging frequencies used in RFID tags and the multiple readers that would be needed for each, to the unknown impact of radio frequency energy on biologics, to the impacts on existing relationships between trading partners.

In response to a question about blocking counterfeits, NACDS emphasized the safety of the U.S. drug distribution system and urged a focus on evaluating potential entry points of counterfeits and addressing any deficiencies.