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 a mixture of the medication according to directions provided by the prescriber.
Who Regulates This?
The state boards of pharmacy—not the FDA—regulate compounding practices. However, they are not as prepared as the FDA to audit pharmacies to check sterility.
What’s the Problem?
In September 2012, the non-sterile conditions at New England Compounding Center (NECC), a compounding pharmacy in Massachusetts, caused a fungal meningitis outbreak that killed dozens and injured hundreds. As a result, the pharmacy was forced to recall products, face legal issues, and shut down.
The problem was that the pharmacy had turned compounding into a large-scale business as if it was a manufacturer. Pharmacists were mixing up the needed drug in bulk in anticipation of consumers’ needs. However, compounding is supposed to take place only with an individual prescription—not large-scale. This bulk compounding caused lapses in sterility and allowed medications to be contaminated.
Due to the NECC problems, FDA Commissioner Margaret Hamburg testified twice before Congress and explained that the FDA is not allowed to regulate these compounding pharmacies. So what are they supposed to do? How can we better regulate these pharmacies?
There are several bills proposed to regulate compounding pharmacies as manufacturers. This is a problem, though, because they are not the same. When is something a pharmacy and when is it a manufacturer?
Hamburg revealed that agency inspectors are also finding appalling conditions in other compounding pharmacies. From February through April, inspections have uncovered rusty tools, bare-handed employees handling drugs, and black particles in “sterile” solutions, which cause significant risks to public health.
The FDA is inspecting compounding pharmacies for sterility and may soon adopt responsibility for regulating such pharmacies, in which case regulations will most likely become more stringent.
For more information on this issue, contact the Kulkarni Law Firm.