On November 18, the U.S. Senate passed H.R. 3204, the Drug Quality and Security Act, a bill to enhance regulation of compounding pharmacies. The bill has already been passed by the U.S. House of Representatives and it will now go to the President. This bipartisan and bicameral compromise bill is in response to the fatal outbreak of fungal meningitis last year.
The bill would create a new category of compounders known as outsourcing facilities. Under the legislation, compounding pharmacies may elect to register with the Food and Drug Administration (FDA) as outsourcing facilities. As part of the registration, the outsourcing facility voluntarily agrees to subject itself to certain requirements similar to those that currently govern traditional drug manufacturers.
Under the new regulatory structure, the FDA will have information regarding where outsourcing facilities are located and what drugs are being compounding. Additionally, the FDA will receive adverse event reports about compounded drugs, and will have the authority to conduct risk-based inspections.
Compounders that decline to register as outsourcing facilities will not be penalized under this legislation.
The proponents of this new framework argue that this market-based approach to regulation will allow hospitals and other end users the opportunity to purchase from an FDA-regulated outsourcing facility or a facility that has elected not to register with the FDA.
Authors of the legislation claim it is crafted to maintain the status quo in regards to physician offices.
ASA will continue to closely monitor this legislation.
Review the Drug Quality and Security Act.
House Energy and Commerce Committee Fact Sheet.