Enough already. In one week we’ve seen three recalls at three separate compounding pharmacies. Two of which are in the state of Massachusetts; the other is in Georgia.
Earlier this week it was revealed that Pallimed Solutions, a compounding pharmacy in Woburn, MA was being asked to recall products made in their small facility. It was cited for the use of less-than-sterile procedures and/or materials though there have been no reports of illnesses or injury at this point.
Pallimed is still trying to address problems dating back to last year. The state Department of Public Health issued a statement Monday (March 25, 2013) saying the state pharmacy board issued a cease-and-desist order to Pallimed Friday “after foreign matter was observed in vials of injectable drugs."
State regulators called in the US Food and Drug Administration Friday after waiting months for Pallimed to submit acceptable plans to correct the problems uncovered at the facility in November, which included substandard equipment for producing sterile medications. Each submission, nine in total, was “very flimsy,” said Dr. Madeleine Biondolillo, the state’s director of health care safety and quality.”
Biondolillo goes on to express general concern about Pallimed, what it was producing, how it were producing it, and if it was using standards in accordance with the regulations. Expressing concern is all fine and well but what results can we expect? What is the state of Massachusetts planning to do about compounding pharmacies – i.e., fixing the problem? What about the FDA?
ABC News reports that the company is concerned about the safety of its customers. "By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations. "
Pallimed says it is sorry. I imagine it said that when it screwed up last year with the production of too potent doses of the painkiller, Lidocaine, and then again last November when it had to stop production of generic Viagra and now it is expressing its sincere concerns for our safety because it was caught again.
I have to agree with FDA Commissioner Margaret Hamburg, who stated in her blog on FDA Voice, “There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate. FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations. Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting.”
Hopefully, no one is going to die this week due to Pallimed’s ineptitude. But this could have been another tragic incident like the New England Compounding Center of Framingham.
Whether we’re talking about steroid injections, erectile dysfunction medicine, or painkillers—it seems the time has arrived to demand stricter standards for the "compounding" of sterile drug products in this country. This loophole in the federal regulations should be closed. The consequences of not doing so are too severe, as we have seen and, unfortunately, are likely to continue seeing.
For more information, read my article on drug compounding legislation at: /fda-and-prescription-drugs/drug-compounding-legislation-introduced-in-congress-but-will-it-go-anywhere.aspx?googleid=305902