Bill would give FDA clearer authority over drug compounders

Published on December 7, 2012 at 9:11 AM · No Comments

The bill, introduced in Congress, would also direct the Food and Drug Administration to train state regulators -- whose oversights may have contributed to the meningitis outbreak that sickened more than 500 and killed at least 36.

Modern Healthcare: Bill Would Make Drug Compounders Register With FDA
A bill that would require compounding pharmacies to register with the Food and Drug Administration was introduced in the House, according to a news release from the two sponsors of the bill, Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.). The bill, called the Supporting Access to Formulated and Effective Compounded Drugs Act, or SAFE Compounded Drugs Act, would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders, according to the news release. In addition, it would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators. A compounding pharmacy in Massachusetts is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths (Barr, 12/5).

CQ HealthBeat: DeLauro, Lowey Bill Would Give FDA Authority Over Compounding Pharmacies
Two House Democrats introduced a bill to give the Food and Drug Administration clearer authority over compounding pharmacies, although any action on the issue probably will have to wait until the next Congress. The bill, from Democrats Rosa DeLauro of Connecticut and Nita M. Lowey of New York, would give the FDA more authority and also try to build more collaboration between state and federal regulators (Ethridge, 12/5).

In other Capitol Hill news --

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