Healthcare Business News
Rep Rosa DeLauro D Conn

Bill would make drug compounders register with FDA

By Paul Barr
Posted: December 5, 2012 - 5:15 pm ET

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.

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DeLauro sits on the Appropriations subcommittees overseeing HHS and the FDA, according to the release. “I wish this legislation were not necessary, but recent, tragic events have proven that it is,” DeLauro said in the release.

Rep. Edward Markey (D-Mass.) in early November introduced a bill to ramp up oversight of compounding pharmacies. Markey's bill would preserve states' regulatory authority for traditional small compounding pharmacy activities; ensure that compounding pharmacies that operate as drug manufacturers are regulated by the FDA; and allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so, according to a Markey news release. The bill is called the Verifying Authority and Legality in Drug Compounding Act, or the VALID Compounding Act.

The FDA is holding a meeting Dec. 19 with state officials to discuss a number of related issues, including whether or not states are currently able to provide enough oversight of compounding pharmacies and what the federal government's role should be in regulating those pharmacies, according to the Federal Register notice.

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