Bipartisan Compounding Pharmacy Legislation Announced: “Drug Quality and Security Act”

On September 25, 2013, a bipartisan group of House and Senate members reached agreement on legislation to help ensure the safety of compounded drugs by giving the Food and Drug Administration greater authority to regulate companies that compound sterile drugs and ship them across state lines.

The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC which ship sterile products across state lines. These larger organizations, to be known as "outsourcing facilities," would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies. An outsourcing facility is free to choose whether it will (i) be state licensed as a pharmacy or not; and (ii) obtain prescriptions for identified individual patients and/or prescribe for unlimited office use. A potentially-critical prohibition, however, is applied to outsourcing facilities, in that will only be permitted to compound from bulk API, as opposed to commercially available drugs, that appear on an affirmative, finite list to be established by HHS.

For full text of the Drug Quality and Security Act, please click here.

For more information, please click here.

The act passed the House on September 28, 2013, but has not yet received a Senate vote.

If you would like more information, please contact Laura Tepich at ltepich@kdlegal.com.