FDA Unveils Compliance Policy Guide for RFID Technology in Pharmaceuticals

Strategic Insights -

The US Food and Drug Administration (FDA) has released a Compliance Policy Guide for implementing radio frequency identification (RFID) technology feasibility studies and pilot programs in the pharmaceutical supply chain. The agency aims to enhance the safety and security of the drug supply through this initiative. The FDA is also creating an internal RFID Workgroup to monitor the adoption of RFID technology and proactively identify regulatory issues.

Key Takeaways:

  • The FDA has issued a Compliance Policy Guide for RFID feasibility studies and pilot programs to enhance the safety and security of the pharmaceutical supply chain.
  • The agency is creating an internal RFID Workgroup to monitor RFID adoption and identify regulatory issues.
  • Industry initiatives, such as those announced by Pfizer, GlaxoSmithKline, and Purdue Pharma, are welcomed by the FDA.
  • Companies like Johnson & Johnson are setting RFID technology standards and participating in pilot studies.
  • RFID technology creates an electronic pedigree, or record of the chain of custody, from manufacture to dispensing, aiding in the identification and investigation of illicit transactions.
  • The FDA encourages industry to take advantage of RFID technology to gain experience with data transfer, storage, and security.

Statistics:

  • By 2007, the FDA aims for the widespread use of RFID technology throughout the industry (Marketletter, March 1).
  • Pfizer plans to place RFID tags on all bottles of Viagra intended for US sale as expeditiously as possible in 2005.
  • GlaxoSmithKline plans to begin using RFID tags in the next 12-18 months on at least one product susceptible to counterfeiting.
  • Purdue Pharma is placing RFID tags on bottles of OxyContin and Palladone to facilitate authentication, tracking, and tracing.
  • The FDA considers electronic pedigrees to be a type of electronic safety net, utilizing technology to rapidly identify and transmit illicit transactions.

Sources:

1. Marketletter, "Combating Counterfeit Drugs" (March 1)

2. FDA news release (exact date not specified)

3. FDA Compliance Policy Guide for implementing RFID technology feasibility studies and pilot programs.