The Senate passed the Drug Quality and Security Act in November, legislation aimed at strengthening the safety of compounded prescription drugs in Michigan and around the country in the wake of a deadly meningitis outbreak.
It has been more than one year since the public became aware of what quickly became a far-reaching fungal meningitis outbreak affecting citizens in 20 states including Michigan.
Following an investigation by the Centers for Disease Control and Prevention and the Food and Drug Administration along with local health departments, it became clear the outbreak was caused by contaminated steroid injections produced by the now defunct New England Compounding Center, a compounding pharmacy in Massachusetts.
According to the CDC, more than 750 Americans seeking pain relief were affected by tainted NECC steroid injections. More than 260 of these victims live in Michigan. Sixty-four of the victims, including 19 Michiganians, lost their lives.
This tragedy brought a spotlight to bear on the opaque regulation of what are known as mass-compounding pharmacies — facilities that produce large amounts of custom-formula drugs.
On a bipartisan basis, members of the Senate and House of Representatives worked through this issue to produce legislation that strengthens federal authority to regulate mass-compounding facilities and will lay the groundwork for a nationwide system to track prescription drugs. Though not as far-reaching as some might have intended, it is an important and necessary step forward.
It is important to draw a distinction, as this legislation does, between so-called “traditional compounding” —when a pharmacist tailors a particular drug to meet the unique needs of a patient, such as removing a certain dye or altering the dosage level of an adult medication to be suitable for a child — and the mass compounding of drugs for wholesale distribution.
Compounding pharmacists have long been regulated by state boards of pharmacy. As made clear in the meningitis outbreak investigation, NECC, a mass compounding pharmacy, was operating in a regulatory gray area.
Neither the state nor the federal government took full responsibility for ensuring the NECC facility and its compounding practices were safe and sterile.
The Drug Quality and Security Act President Barack Obama signed into law aims to address this regulatory gray area by clarifying the FDA’s oversight role with mass compounded pharmaceuticals.
Under this law, mass compounding pharmacies can choose to register as “outsourcing” facilities that would be subject to new FDA regulatory oversight similar to that of other pharmaceutical manufacturers. The law also calls for detailed labeling of compounded drugs and directs the FDA to make a list of FDA-regulated facilities available on its website.
Importantly, this law will implement a new system for tracking drugs from the manufacturer to the pharmacy to help ensure accountability at every step along the way.