Patient Safety Demands that Drug Compounders Comply With Law

“When compounded products are not made according to strict quality standards appropriate for their scale of production, the results can be deadly.”  Six public health organizations wrote this to FDA Commissioner Hamburg to voice strong support on FDA’s robust enforcement of the federal law on compounding.

PhRMA joined with the American Public Health Association, Biotechnology Industry Organization, the Generic Pharmaceutical Association, the Pew Charitable Trust and the Trust for America’s Health to support FDA’s efforts to enforce its authority to regulate compounders of prescription drugs, pursuant to the new compounding law, which was promulgated to ensure that we do not have another public health crisis due to unregulated compounding. The situation in 2012-2013 led to a nationwide outbreak of fungal meningitis that was linked to contaminated compounded injections.

As a consequence of this outbreak that resulted in more than 60 deaths, Congress passed the Drug Quality and Security Act of 2013 (DQSA) which amended the Federal Food, Drug & Cosmetic Act to give FDA greater authority over compounding activity, especially over large-scale compounding activity.  This Act is working to protect patient lives.

Unfortunately, efforts are under way by some stakeholders to carve out exemptions to the law that could allow compounding of prescription drugs without prescriptions, or outside of limited amounts in anticipation of a prescription, by pharmacies that do not comply with FDA regulations and do not meet appropriate drug quality standards.  Such efforts undermine the carefully crafted DQSA, which was designed to balance access to compounded medicines with the need for updated oversight to make sure these drugs are safe and meet high quality standards.

The letter further stated “While the new regulatory paradigm for compounding will take time and resources for stakeholders to implement, FDA should be commended and supported for its continuing, robust efforts to realize the potential of this law. Doing so will help protect patients for years to come.” 

Patient safety demands that the FDA enforce the federal law on compounding in a risk-based manner. Such enforcement will allow the Agency to keep the prescription drug supply safe, no matter how such drugs are manufactured.