FDA has once again extended a compliance policy guide for radiofrequency identification tagging of pharmaceuticals in a bid for more time to implement legislation for ensuring quality control.

The policy guide, which offers firms considerable flexibility in using anti-counterfeiting technology, would have expired at the end of 2010; it is now extended until the end of 2012.

RFID is a method of communication by radio waves that allows automatic tracking of tagged products. The FDA has viewed it as a solid tool for combating the growing menace of counterfeit medicines, which threatens the supply of quality products.

In a Dec. 23 notice, FDA explained that the agency needs more time to implement aspects of the Food and Drug Administration Amendments Act of 2007 governing authentication and shipping of pharmaceuticals. The FDAAA had called for a creation of a new section - 505D - on standards of authentication and tracking in the Federal Food and Cosmetic Act. And this section in the FD&C act specifies that RFID is a promising technology.

"In implementing section 505D of the FD&C Act, FDA is currently addressing issues, such as promising technologies, that are relevant also for the CPG," the notice states. "In addition, FDA is considering further the experience of stakeholders and the Agency under the CPG. As we consider all of these issues, the CPG will remain in effect until December 31, 2012."

Therefore, the compliance policy guide on "Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs" which was published in 2004 will remain in place for another year ([A#0066047011]).

The guide, which already had been extended in 2007 and 2008, covers RFID tags (chips and antennae) attached to "immediate containers, secondary packaging, shipping containers, and/or pallets of drugs that are being placed into commerce."

The policy as it stands now leaves manufacturers relatively free to develop their own quality control systems, commented Peter Pitts, former associate commissioner at the FDA at the time the guidance was published and who was involved in an agency task force on combating counterfeiting. In Pitts' view, the delay of implementation of the aspects of FDAAA pertaining to tracking pharmaceuticals is "good for industry, the agency, and the public."

A range of technologies are available beyond RFID. The approach was at the cutting edge a few years ago but technologies have been evolving rapidly, he said. It makes sense for the FDA to carefully consider all of the issues, examine what technologies are now in use by industry, and draft comprehensive guidance implementing the 2007 legislation.

"We don't want guidance that is outdated the minute it is published," Pitts said.

Most likely a range will be needed, including overt and covert tracking, as counterfeiters are very skilled at overcoming barriers.

-Emily Hayes (e.hayes@elsevier.com)

FDA Delays Implementation Of Radiofrequency Identification Standards

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