A new law - the "Compounding Quality Act (CQA)," Title 1 of the larger "Drug Quality and Security Act" - was signed into law by President Obama on November 27. The law aims to do what existing federal laws and a mishmash of conflicting state laws couldn't: make the drugs coming from compounding pharmacies safer for patients.
Prior to the passage of the CQA, the federal Food and Drug Administration (FDA) had little authority to regulate compounding pharmacies. The lack of federal oversight wouldn't be an issue but for the lack of consistent state laws to regulate the facilities. Unfortunately, some states have no laws at all on the books addressing these pharmacies, others have laws with no real "teeth" and still more have laws that are thorough but only cover the pharmacies in their states, not the medication that might be brought in from other areas.
Though the issue of compounding pharmacies being largely unregulated has existed for years, the current push for additional regulation began after last March's massive, nationwide meningitis outbreak (tied to steroid injections prepared by a Massachusetts compounding facility) that sickened more than 750 people and killed 64. The CQA is designed not only to give the FDA more oversight authority, but also raise awareness in the medical community about the potential damage that unsafe compounding pharmacies can do to patients.
What does the new law do?
While the law does dramatically increase the amount of possible federal oversight of compounding pharmacies and the newly created category of "outsourcing facilities," the facilities must themselves voluntarily register with the FDA in order to be regulated. Some lawmakers had pushed for a more stringent version of the CQA, one that mandated FDA compliance, but the version passed doesn't include such language.
Instead, facilities may decide to register with the FDA to have their operations overseen. The hope is that hospitals, pharmaceutical companies, government providers and other purveyors of massive amounts of medications will want the security added by regulation and will primarily purchase their goods from those facilities that have registered, thus forcing the industry to, in essence, regulate itself. If that happens, theoretically there should be no further instances of mass personal injury or death linked to unregulated compounding pharmacies.
The law also sets forth criteria that compounding pharmacy operations must meet before being allowed to call themselves "outsourcing facilities." These businesses must follow strict "good manufacturing practices" (as established by existing federal regulations and industry standards), submit to FDA inspection based upon the level of risk posed by the medications they prepare and meet other specified conditions, including providing the FDA with information about the types of drugs handled at their facilities and report any adverse events caused by their products.
Are you a victim?
Tragically, this new law is "too little, too late" for hundreds of people sickened by the now-closed New England Compounding Center and other compounding pharmacies that failed to exercise proper safety precautions. If you or a loved one has been injured by a compounded medication, you may be entitled to compensation; speak with an experienced personal injury and products liability attorney in your area to learn more about possible legal avenues to pursue recovery.