On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. This law is updates the federal drug tracing and tracking system and outlines Federal Drug Administration (FDA) authority over compounding pharmacies.
In 2012, a large outbreak of meningitis was linked to unsanitary conditions at a compounding pharmacy. Historically, the FDA had limited authority over compounding pharmacies, leaving oversight of the pharmacy to the states.
This new law gives the FDA authority over compounding pharmacies to ensure product safety. Compounding pharmacies that are mass producing medications are asked to register with the FDA as an Outsourcing Facility. This registration is voluntary at this time and opinions regarding the effectiveness of the law are mixed.
Under the law doctors and health systems are encouraged to purchase compounded medications from a registered pharmacy, however there is nothing stopping providers from purchasing these same medications from any pharmacy they choose, registered or not. With an initial $15,000 registration fee, pharmacies may decide that it is not worth it and try to sell without registering. Clearly, voluntary registration will have an impact on the number of pharmacies the FDA is able to regulate.
The second part of this law modernizes drug tracing and tracking. Current medication tracking systems are terribly outdated. New systems will keep track of medications, ensuring that they are not counterfeit or created by a junk pharmacy.
The new track and trace system will take years to implement, with the hopes that the system will be fully functional within the next ten years. Once implemented, the track and trace system would allow medications to be traced down to the package level. It will be up to the legislation to create serial numbers for medications within the tracking system.
What do these changes mean for the United States drug supply?
In the beginning, not very much. With the changes to tracking and tracing drugs taking place slowly, it will take time for counterfeit drugs to be eliminated from the system. This law is a good first step for the tracking and tracing of medications, but it will probably take further legislation to get compound pharmacies to register and be regulated by the FDA.