Prevention of Reuse of Genuine Packaging Components for Counterfeit Products

“Prevention of Reuse of Genuine Packaging Components for Counterfeit Products” addresses the growing threat of counterfeit pharmaceutical products entering the legitimate supply chain through the reuse of genuine packaging components. Counterfeiters often retrieve discarded packaging—such as vials, bottles, and labels—and refill them with fake or substandard drugs, posing serious risks to patient safety.

Key Topics Covered:

• Case Study: Gilead HIV medications were counterfeited using reused genuine bottles, highlighting the real-world dangers of packaging reuse.
• Supply Chain Security: Recommendations span the entire supply chain—from printers and component suppliers to manufacturers, distributors, and healthcare providers. Emphasis is placed on:
  • Protecting intellectual property (e.g., molds, dies, artwork)
  • Secure handling and destruction of packaging waste
  • Contractual safeguards and documented procedures
• Tamper-Evident Packaging: The paper categorizes tamper-evidence solutions into four levels (L0–L3), with L3 offering the highest protection. It provides detailed tables outlining tamper-evident technologies for:
  • Primary packaging (vials, syringes, blister packs)
  • Secondary packaging (cartons, clamshells)
• Technology Integration: Advanced solutions such as RFID/NFC, void labels, and destructive seals are recommended to prevent reuse and ensure authenticity.
• Regulatory Overview: A global summary of relevant regulations and guidelines from ISO, FDA, EMA, TGA, and others is included to support compliance and best practices.

Rx-360’s Supply Chain Security Working Group developed this paper to put forth a combination of secure processes, technological innovation, and regulatory adherence to support the pharmaceutical industry in its efforts to protect patients and maintain trust in the supply chain.

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