According to the March 20th issue of the Federal Register, the FDA is requesting comments and information on technologies that can be used for the identification, validation, tracking and tracing, and authentication of prescription drugs.
Legislation was passed in 2007 to require standards to be developed and to identify effective technologies to protect against counterfeit, substandard, misbranded, or expired drugs. These technologies can include RFID, nanotechnology, encryption technologies, and other track and trace or authentication technologies.
The FDA wants further information on:
- The strengths and limitations for technologies to be able to identify, validate, track and trace, or authenticate drug transactions
- The costs to implement and use these technologies
- Benefits to the public health
- Feasibility for widespread use for these technologies
- Developing the standards necessary for the supply chain use of the technology
Comments must be submitted by May 19, 2008. Submit comment to the Division of Dockets Management (HFA305), FDA, 5630 Fishers Lane, Room 1061 Rockville MD, 20852, Room 1061. Submit electronic comments to http://www.Regulations.gov. For more information, phone 301-827-3360 or email ilisa.bernstein@fda.hhs.gov.
