|
 |
 |
|
House Dem writes bill tightening rules for drug compounders
Rep. Edward Markey (D-Mass.) is preparing to introduce a bill that would impose stricter regulations on drug compounders.
Markey's district includes the Framingham-based New England Compounding Center (NECC), the pharmacy operation linked to 28 meningitis deaths around the country.
The spate of illnesses has prompted questions about the NECC and other compounders, which reprocess drugs on a large scale to meet patients' special needs. The firms are not obligated to follow many rules that apply to drug makers, and congressional Democrats have blamed the meningitis outbreak on lax regulations.
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.
