House and Senate committees have agreed on legislation that would give the FDA greater authority to regulate companies that compound sterile drugs and ship them across state lines.
The legislation would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.
The bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Mass.
The legislation is expected to pass quickly through the full House and Senate.
Traditionally, pharmacists who compound medication mix tailored doses for individual patients in response to specific prescriptions. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC that 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.
Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.
Previous attempts to create national standards to track and trace drugs have foundered amid complaints from companies that they would be too costly to implement.
But concerns over counterfeit drugs have been growing. Last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.
The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.
In the United States, dozens of states have some type of regulation designed to track a drug's pedigree, but the rules are inconsistent. The bill is designed to resolve the current patchwork of federal regulation by applying a uniform standard nationwide.
First published September 26 2013, 5:26 AM