In response to the deadly incidents with a compounding pharmacy in Massachusetts that is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths, potential federal legislation has been introduced in the U.S. House of Representatives. Two bills have been introduced in the U.S. House of Representative that require more oversight on the federal level and tighter regulations.
The first bill introduced by Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.). would require compounding pharmacies to register with the Food and Drug Administration (“FDA). 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.
The second bill introduced by Rep. Edward Markey (D-Mass.) in early November would ramp up oversight of compounding pharmacies. Rep. 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.
Per the Federal Register notice (77 Fed. Reg. 71009) on November 28, 2012, in addition, The FDA is holding an intergovernmental meeting Dec. 19, 2012 with state officials to discuss a number of related issues, including (i) whether or not states are currently able to provide enough oversight of compounding pharmacies; (ii) what the federal government’s role should be in regulating those pharmacies, such as compounding high-volumes of drugs for interstate distribution; (iii) whether there is a way to re-balance Federal and State participation in the regulation of pharmacy compounding that would better protect the public health; (iv) what strategies should be developed to further strengthen Federal/ State communications; and whether there is a role for the States in enforcing a Federal standard for ‘‘non-traditional’’ compounding? if so, what role?
A public meeting document will be held after the intergovernmental meeting.