The meningitis outbreak caused by a Massachusetts compounding pharmacy has set off a debate of whether and how regulation of compounders should be tightened.
What is Compounding?
Compounding occurs when a patient comes into the pharmacy and needs a customized formula to meet their individual needs. The pharmacist then creates an admixture of the medication according to directions provided by the prescriber. Due to recent drug shortages, compounding has also been used as a way to provide drugs in shortage to hospitals and other health care facilities. Theoretically, this “large scale compounding” is performed in anticipation of a prescription. However, there are concerns that this “large scale compounding” is actually inadequately regulated manufacturing by another name.
Who Regulates This?
There is an ongoing debate regarding the jurisdiction over compounding pharmacies. Some argue that the state boards of pharmacy—not the FDA—should continue to regulate compounding practices. However, the state boards of pharmacy are often inadequately prepared to audit pharmacy facilities to ensure that appropriate compounding sterility requirements are met.
What’s the Problem?
In September 2012, non-sterile conditions at the New England Compounding Center (NECC), a compounding pharmacy in Massachusetts, caused a fungal meningitis outbreak that killed dozens and sickened hundreds. As a result, NECC and its sister company Ameridose were forced to recall products; faced FDA, congressional, and legal scrutiny; declared bankruptcy; and shut down.
Due to the meningitis outbreak caused by NECC’s products, FDA Commissioner Margaret Hamburg, MD, was twice called to testify before Congress. She explained that the FDA is inadequately empowered to regulate these compounding pharmacies. Most recently, Commissioner Hamburg revealed that inspections by the agency have found appalling conditions in other compounding pharmacies. Inspections carried out from February through April have documented rusty tools, bare-handed employees handling drugs, and black particles in “sterile” solutions. According to the commissioner, these unacceptable conditions cause significant risks to public health.
As a result of the meningitis outbreak and subsequent findings, several bills have been proposed in Congress to improve regulation of compounding pharmacy. Some proposals would let the current structure continue as is, while others would require pharmacies to register and operate as manufacturers. While the former approach ignores the tragedies that occurred, the latter seemingly may take regulations too far.
This is the first of a 3-part series on issues relating to compounding pharmacy. The next installment will explain how compounding pharmacies can handle an FDA inspection.
—Darshan Kulkarni and Samantha Ricketts