Congress Strengthens FDA Oversights of Compounding Pharmacies

Congress Strengthens FDA Oversights of Compounding Pharmacies | Pintas & Mullins Law Firm

Compounding pharmacy lawyers at Pintas & Mullins Law Firm report on a rare feat of bipartisan agreement for a new bill that will increase federal oversight of compounding pharmacies. Leaders in the House and Senate announced the new legislation, which calls for a new tracing system to track prescription drug sales from manufacturing through distribution.

The Democratic chairman of the Committee on Health, Education, Labor and Pensions stated that the new bill would allow the FDA to monitor compounding pharmacies in much the same way as it does for large drug makers, such as Pfizer and Johnson & Johnson.

The new bill is titled the Drug Quality and Security Act, and its main objective is to further improve drug safety and help prevent all future public health crises like the 2012 outbreak of fungal meningitis that killed 60 people and injured over 700 others. The compounding pharmacy responsible for the outbreak, the New England Compounding Center, has since closed.

The new tracking and tracing program will prevent counterfeits from entering American supply chains and maintain and strengthen the already-existing regulatory system. The FDA will have official, far-reaching oversight of large-volume compounders. Due to the recent boom in the pharmaceutical industry and Americans’ consequent reliance on medications, large-volume compounders are becoming more and more prevalent.

Currently, each individual state’s Pharmacy Board oversees compounding pharmacies, including those that mix specific medications for unique patients. Federal and state laws regarding compounding pharmacies are notoriously lax, and the implementation of this new bill will clarify the pharmacy-specific laws and resolve the patchwork of regulations by establishing uniform standards nationwide, instead of from state-to-state.

Federal and state laws were so unclear, for example, that between 2002 and 2012 the FDA had to obtain 11 warrants to inspect facilities involved in drug compounding. These facilities denied FDA access to their facilities upon initial request, challenging their authority due to conflicting court rulings. The FDA used to only conduct investigations when adverse events or complaints were reported. After the fungal meningitis outbreak, the agency began an effort to inspect facilities that may pose risks to public health.

This increased effort led to the discovery of a vast array of inadequate sterile drug production practices, which resulted in dozens of recalls and warnings just this year alone. A full list of these recalls and official warnings can be found here.

Compounding pharmacies will have to choice to register as outsourcing facilities, like traditional drug manufacturers, which would place them exclusively under federal law. Lower-scale pharmacies may also choose to remain traditional compounding facilities, and will continue to be regulated primarily by state boards, though FDA oversight will still be present.

Despite classification, federal regulators will have the authority to conduct safety inspections, announced or otherwise, receive reports on problems with any drugs, and, as stated, track what each pharmacy is producing. Compounding pharmacies manufacture about four billion prescriptions in the U.S. each year. 

The second section of the bill creates an entirely new system for tracking drugs from manufacturer to pharmacy. There is currently no system like this in place, making recalls and reports of contaminations or illnesses extremely difficult to trace. The new standards will create a uniform framework for tracking these drugs, meaning any that are stolen or counterfeit will be detected before reaching patients.

Compounding pharmacy lawyers at Pintas & Mullins Law Firm will continue to report on this new legislation as it is officially signed into law by President Obama and implemented throughout the country. If you or a loved one was seriously injured or sickened by a medicine produced by a compounding pharmacy, you may be entitled to significant compensation for your medical bills and lost wages, and should contact a qualified attorney as soon as possible for a free legal consultation.