House Dem writes bill tightening rules for drug compounders

{mosads}”Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Markey said in a statement Thursday.

His bill would require compounders that distribute medications on a large scale to register with the Food and Drug Administration (FDA) as drug makers, subjecting them to tougher rules.

Small compounding pharmacies would be exempt from some FDA regulations under the measure — if they compound drugs for an identified patient with a valid prescription, for example.

On Thursday, the National Community Pharmacists Association (NCPA) praised Markey’s bill for its goal of rooting out firms like the NECC.

But the group also said the measure could be hazardous for patients and pharmacists.

“As currently drafted, the legislation would grant new powers to an already stretched Food and Drug Administration to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications that they have been making safely and effectively for decades,” NCPA senior vice president John Coster said in a statement.

The meningitis outbreak has been linked to tainted steroid injections distributed by the NECC. As of Thursday, the Centers for Disease Control had been notified of 386 cases in 19 states.

Markey will introduce his bill Friday, according to a press memo.