The Compounding Pharmacy Debacle

NOVEMBER 9, 2012 | POSTED BY BRUCE WHITE, PHD

Almost everyone now must have heard about the New England Compounding Pharmacy tragedy that has been unfolding over the past month. The Centers for Disease Control and Prevention in Atlanta (CDC) numbers the present death toll at 28 and total reported cases at 377 from 19 states. Untold thousands of patients may have been injected with contaminated medicines. The New York Times has called this situation “one of the worst public health drug disasters since the 1930s.” 

Already there are more calls for stricter regulations and controls for compounded medicines that enter interstate commerce. The New York Times reported on November 2, 2012, that Representative Edward J. Markey (D-Mass.) will be introducing a bill to oversee compounding pharmacies with wide-scale operations be regulated as “manufacturers” by the Food and Drug Administration (FDA). Calls for greater regulation of compounding pharmacies are not new; the FDA has been attempting greater control for at least the last 20 years.

However, the real question remains: would federal oversight have made any difference? Some may think that federal government regulation rather than state government regulation may have prevented this unfortunate episode. Federal oversight – to the amazement of some – may have made little difference. There are certainly not enough FDA inspectors at the present time to make periodic visits to the registered manufacturers facilities. Moreover, if this situation turns on ordinary negligence – someone or some persons at the pharmacy failing to meet the standard of care – the number of applicable regulations will have made little difference, right? Really, isn’t it common sense that a “sterile product” be sterile and free of bacterial or fungal contamination? If a purported sterile product – whether manufactured or compounded – is not sterile, the medicine is failing to meet labeled standards, period.

Moreover, federal regulations – if crafted for compounding pharmacies specifically – would probably not be that dissimilar from what is now prescribed by state boards of pharmacy. State regulation can be just as extensive and rigorous as federal regulation, in some cases far more strict.

Perhaps the question then is not whether or not the federal versus the state regulators may do a “better” job of enforcing clear standards?   Continue reading here