Next steps

Implementation for USP ‹467› was pushed back from July 1, 2007 to July 1, 2008 to allow the industry time to prepare. But even so, analysts worry it may not be enough time. "The regulations have been changed so much and it's been so drawn out that I've got a feeling that a lot of people are behind on this and they are going to be in scramble mode real soon," predicts Schumacher.

FDA plans to issue a Federal Register notice that would clarify when compliance with the USP ‹467› specifications should be reported. A draft is in the works and is currently undergoing the approval process. For products that are already marketed under an NDA or ANDA, manufacturers would report their compliance with USP ‹467› in the next annual report. "I don't think we will require them to include a lot of analytical detail in the annual report," says Ouderkirk. "For example, they may have developed methodologies to comply with ‹467›, and rather than having supplements filed we're just looking to an annual report for them to notify us that they are compliant. We are trying to avoid triggering a lot of supplements from the industry." New NDAs should take ‹467› requirements into consideration. "If I were filing something today, I would want to note that I am complying with ‹467› no later than July 1," says Ouderkirk.

Reference

1. Lancaster Laboratories, internal publication on USP ‹467›, available at http://www.lancasterlabs.com/pharmaceutical/residualsolvents.pdf.