Debut of compounding committee delayed

The Food and Drug Administration was inundated with so many top-quality nominations for its Pharmacy Compounding Advisory Committee that the selection committee is having trouble narrowing the pool to 15. That's why the FDA cancelled the July 9-10 date for what would have been the committee's first meeting.

It then tried to reschedule that meeting for late July, but that looks like it will fall by the wayside. So, the first meeting likely won't take place until September, which will really create some pressure. That will give the committee just two months to advise the FDA on a couple of issues on which the agency must make preliminary decisions by November.

The key decision is which chemicals to put on a list of those that are "demonstrably difficult" to compound. The FDA Modernization Act of 1997 requires the FDA to start publishing that list by November 1998 and authorizes the advisory committee to help the FDA make decisions on that list, two others and a host of other compounding questions the FDA will have to resolve.

One of the 15 seats is set aside for a representative of pharmacy trade groups. But, there will undoubtedly be other pharmacists on the committee, most likely those with academic or technical backgrounds, according to Tom McGinnis, deputy associate commissioner for health affairs at the FDA.

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