You’ve probably read the news stories about a recent outbreak of meningitis in 19 states. So far this outbreak has caused 25 deaths as well as 354 cases of serious illness. The Centers for Disease Control traced the outbreak’s origin to contaminated steroids from a Massachusetts-based compounding pharmacy.
The contamination resulted from the compounding pharmacy’s attempt at high-volume drug production using inadequate facilities, equipment and practices. As more information about compounding pharmacies’ practices comes to light, I’m wondering why better standards and operating procedures, supported by clear documentation, are not in place at these facilities.
Compounding pharmacies don’t follow industry best practices
Compounding pharmacies are supposed to be small enterprises that make up batches of specialized prescription drugs for individual physicians and hospitals, or specialty products like creams and ointments. Their facilities, equipment, and processes aren’t meant for large-scale manufacturing. They’re not classified as drug manufacturers, so they aren’t required to follow many of the pharmaceutical industry’s best practices—not even when they ramp up their production to unsafe levels and start shipping products all over the country.
But should it really matter that they aren't required to follow best practices? When best practices can ensure public safety, it makes sense to follow them whether or not you’re required to do so. It’s simply the right thing to do.
Drug manufacturers must follow GxP’s—why not compounders?
Large-scale pharmaceutical manufacturing is all about following best practices. Called “GxPs,” (Good “x” Practices) they apply to every phase of drug development, testing and manufacturing processes. Frequent FDA audits ensure that everyone follows GLPs (Good Laboratory Practices), GCPs (Good Clinical Practices), GMPs (Good Manufacturing Practices) and other guidelines for producing safe, untainted products.
Considering the grievous consequences of releasing contaminated drugs, I think these robust, rigorously applied GxPs make a lot of sense for all drug manufacturers.
Best practices for compounding pharmacies could save lives
It’s time for the compounding industry to recognize the need for best practices that will help avert more tragedies like this meningitis outbreak. The good news is that many of these best practices already exist. Adopting appropriately modified versions of the large-scale manufacturers’ GxP’s would help safeguard the public while helping compounders operate safely and efficiently.
Do you agree that the compounding industry must adopt and adhere to best practices similar to those followed by the larger manufacturers? Let us know your thoughts.