March 3, 2015
To the Editor,
Rena Steinzor’s recent column (“Bad Feds, Deadly Meds,” February 28, 2015) points to shortcomings in the Food and Drug Administration’s management and oversight of the compounding pharmacy profession, and she uses the case of New England Compounding Center and the meningitis outbreak that it spawned as an example.
There is no debate about the FDA’s failure to act in the case of NECC, which was clearly a manufacturing operation intentionally disguised as a compounding pharmacy to evade oversight. There is never any excuse for waiting 684 days to follow-up on an inspection, which is what occurred in this case.
Steinzor, however, seems to leave off much progress that has been made in the two years since the NECC tragedy, and she gives the misimpression that compounding pharmacies are not regulated. In fact, it is hard to imagine a more regulated profession than compounding pharmacies. States across the land – including Massachusetts, home of the now-shuttered NECC – have dramatically tightened laws, regulations and inspection protocols.
While registration with the FDA is voluntary, a provision we opposed, the federal Drug Quality and Security Act was designed to require large-scale compounders shipping sterile medications across state lines to hospitals and large medical practices to register with the FDA. Compounding pharmacies filling one prescription at a time for individual patients are licensed and regulated by state boards of pharmacy.
The regulations are rigorous as they adhere to United States Pharmacopeia standards, and those that do not comply or follow procedures lose their license.
We should all be outraged by the actions of NECC and the fact that the FDA and the Massachusetts Board of Registration in Pharmacy, at the time, failed to do their job. They knew what was going on in that facility hard by the waste recycling center.
To state that little progress has been made in the two-plus years since, however, is not accurate and it needlessly alarms the public.
David G. Miller, R.Ph
Executive Vice President & CEO
International Academy of Compounding Pharmacists