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Compounding in the News Update...

By CarolAnn Giovando.

'Compounding Act' Stalls in Senate

The congressional effort to expand the FDA's regulation of pharmacies that customize drugs stalled in late spring as Senator Pat Roberts (Republican, KS) distanced himself from the proposal. The bill, sponsored by Roberts and Senate Health, Education, Labor and Pensions Chairman Ted Kennedy (Democrat, MA) and Senator Richard Burr (Republican, NC) proposes that the FDA have strict authority over compounding pharmacies.

Sources close to Roberts clarified he does not explicitly support the proposal even though the draft was distributed with his sponsorship. Sarah Little, a Roberts spokesperson had no comment on the Senator's support for the proposal. She did stress that the draft is meant only as a starting point.

Major pharmacy associations, compounding pharmacy groups, compounding pharmacies including Bellevue Pharmacy, and some patient groups have raised red flags--all concerned that the proposal would eliminate patient access to crucial medications.

The draft proposal began circulating in early 2007 and would threaten patient access to compounded medications if passed, according to Jim Rock, a lobbyist for compounding proponents. The bill would prohibit the use of non-sterile ingredients to make sterile products. "For someone who doesn't know compounding, it sounds like it would make sense," Rock said.

Of note, many treatments for autism, cancer, severe pain management and nearly every intravenous bag hospitals use all are compounded from non-sterile ingredients, which are sterilized before the medication is finished.

Last month, nine pharmacy groups, including the American Pharmacists Association, the National Community Pharmacists Association, and the International Academy of Compounding Pharmacists sent letters to senators that in part stated provisions to allow FDA to determine when compounding is appropriate and what drugs can be customized would have a chilling effect.