Medical Device Link.

Originally Published PMPN March 2004

Regulatory Focus

Security Technologies Database Unveiled

The Product Surety Working Groups Initiative issues its final report.

Ben Van Houten

The Product Surety Working Groups Initiative has issued its final report, which announces a new database that provides a catalog of security technologies related directly to specific drug packaging types.

The initiative is a collaboration between FDA’s Office of Regulatory Affairs, New Mexico State University’s Physical Science Laboratory, and three independent companies. The group evaluated counterfeiting and tampering vulnerabilities and security solutions for food, pharmaceutical, and biological products over a two-year period. It focused on risk areas throughout the supply chain and identified opportunities for enhanced security measures.

“The final report identified a range of weaknesses and potential weaknesses in America’s pharmaceutical distribution system. It stimulated a good deal of communication between different players, including supply chain members, the government, and others,” says Lewis Kontnik, an author and lawyer who served as a consultant on the initiative. He adds that the database is set up in a user-friendly interactive system that “could be and probably should be made publicly available. The report was also timely in providing a good baseline for some of the work and analysis by FDA in its Counterfeiting Task Force.”

The initiative’s project team, consisting of the Physical Science Laboratory, Reconnaissance International, Axess Technologies Ltd., and Sigma 4 Inc., drew input from government agencies, law enforcement, and the food and drug industries. The team then identified opportunities for the use of technologies, management practices, and industry cooperation to fight counterfeiting and tampering. 

The database, formally titled A Secure Web-based Database to be Populated with Security Technologies Categories and their Applications (PST), is meant to be used as a security planning tool by FDA-regulated companies. It will enable employees of FDA or an authorized manufacturer to associate certain risk categories and packaging types with appropriate technologies.

For example, a carton might be printed with special ink containing a chemical taggant. This would allow the manufacturer to carry out forensic tests on the packaging, providing proof of authenticity. The carton could also be the carrier for a holographic label used as a public authentication device, as well as a tamper evident seal.

All package types designated by FDA for use in the supply and distribution of drug products are included. A special package search option allows users to select a specific package type or component and material of choice and to follow the same one-step decision for the remainder of the selection process.

The initiative, formally known as the “Evaluation of Anti-counterfeiting/Anti-tampering Countermeasure Devices and Technology and Track-and-Trace Systems and Technologies for Enhancing Regulatory Product Security and Targeting Import Examinations,” also accomplished the following objectives:

• Assisted FDA in its relationship with industry and other agencies, so that resources can be better used to detect and safeguard compromised FDA-regulated products.
• Identified product-preserving industry practices, such as efforts made in reporting counterfeits within the international marketplace.
• Assembled information on the latest technologies and systems, including product tracking and container integrity. 
• Encouraged public/private partnerships to enhance security of FDA-regulated products.

The report also identified potential areas of collaboration that might enhance security in the pharmaceutical supply system, such as:

• Authentics Database. A suggestion was made that an independent organization, such as the United States Pharmacopeia, might be an appropriate organization to operate such a system
• Forensic Analysis of Fakes. The credit card industry operates a forensic database containing detailed component analyses of all fake credit cards. A similar approach was suggested for pharmaceutical packaging
• Sharing of Best Practices. Such a system could apply to distributors, buying groups, pharmacists/boards of pharmacy, and manufacturers.

The full report can be found at www.productsurety.org.  

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