Question: Can you explain the ideal process for drug product authentication?

Answer: There continues to be great debate from legislators regarding best practices and continually changing deadlines for implementation. However, the primary focus currently is for an e-pedigree solution for drug product identification, authentication, and traceability.

FDA has identified three primary processes and layers of drug authentication:

1. Covert identifiers - Hidden marks directly on the package to provide authentication of the package such as micro text, color shifting inks, or printed patterns that are unseen by the human eye.
2. Overt identifiers - Tamper-evident devices placed on the package to prevent theft such as tamper-evident labels, holograms, or package design features that destroy the package if tampered with.
3. True product authentication. The ability to confirm authenticity and track the drug back to the original manufacturing source and forward through the entire supply chain to the end user.

While the first two layers of authentication deal primarily with authenticating the packaging, the true product authentication must occur at the product level. Within the next few years, pharmaceutical manufacturers, distributors, and retailers will be required by federal and state laws to ensure authenticity of drugs passing through the entire supply chain. These mandated processes will most likely involve:

(a). An e-pedigree for the drug (electronic pedigree).
(b) - Mass serialization that utilizes EPC (electronic product code).
(c) - RFID (radio-frequency identification) technologies.

Question: Would drug manufacturers provide tools for every pharmacy or supply-chain partner to use, or would drug manufacturers perform their own field audits?

Answer: Most manufacturers partner with other companies in some form for the process. However, the manufacturer is the creator and owner of the information. The most common methods currently being employed to enhance pharmaceutical product security throughout the supply chain are:

1. The pharmaceutical company would create and populate a database with the related product information with an EPC.
2. All downstream partners in the supply chain would scan the bar codes or RFID tags with scanners during receipt, shipping, and final dispensation of the drugs.
3. There are various companies and methods that could then provide real-time information stored about the serial number that was scanned. That process can then provide verification that the EPC was actually issued to that specific drug and that the product was valid and safe for the consumer.

Question: Do you have any customers who have reported success with either scenario?

Answer: Again, until the legislation is implemented, most drug manufacturers are either moving forward, in some fashion, with current technologies listed above or consulting with their package providers to implement covert and overt methods. As a printed packaging provider to the pharmaceutical industry, we have implemented several proprietary security methods with many clients. In addition, we do have the ability to support all e-pedigree initiatives from a packaging perspective.