Today, Joe Cabaleiro, who was a part-owner of Triangle at the time of Berg’s death and also was reprimanded by the state pharmacy board, is executive director of a national organization dedicated to improving the safety and quality of compounding pharmacies. The group, the Pharmacy Compounding Accreditation Board, conducts on-site inspections and offers voluntary accreditation to the thousands of compounders nationwide.
Cabaleiro said Berg’s death was one of the reasons he went to work for the board. “Those unfortunate events highlighted the problem, and strengthened my desire to ensure that there’s a standard of quality,” the Cary, N.C., resident said.
Whether his organization is achieving its stated goals is in dispute. Only 162 compounding pharmacies, or about 2 percent of the 7,500 total, have been accredited. New England Compounding Center, which made the tainted steroid injections linked to the recent fungal meningitis outbreak was not accredited. The death toll from that outbreak rose Thursday to 20.
Hospitals and doctors who buy compounded drugs often don’t require accreditation; many don’t even seem to know about it. “Right now, you have the option to get accredited or walk away, and there really aren’t huge consequences either way,” Cabaleiro said.
Industry officials have touted the board as a reason why compounding pharmacies don’t need increased federal regulation. “We do not need legislation to set standards, nor do we need to test our quality procedures and techniques against those standards,” wrote Kenneth Baker, a lawyer and former executive director of the accrediting board, in a May 15 op-ed in the trade publication Drug Topics. Accreditation ensures that “tough standards have been used” in preparing the compounded medications, he wrote.
Industry critics reject that idea. The board is “an industry fig leaf,” said Sarah Sellers, a former FDA official who worked on compliance issues involving compounding.
Michael Carome, deputy director of the health research group at consumer advocacy organization Public Citizen, said accreditation “is certainly not an appropriate substitute for FDA oversight and ensuring good manufacturing practices. Those are what make a drug safe.”
Cabaleiro acknowledged that the accrediting requirements are less extensive than those set by the FDA for commercial drugmakers. But pharmacists are covered by a “different set of practices,” he said. When pharmacists follow best practices, he said, “it should result in a sterile product that is appropriate and safe for the patient.”