Illinois pharmacists are worried that the recent, deadly U.S. outbreak of fungal meningitis could hurt the compounding pharmacy industry. This comes after the Massachusetts company Ameridose LLC was linked to a tainted steroid injection.
Pharmacist Larry Freeder has owned The Compounder in Aurora for 20 years. He says his company does regular in-house and off-site testings on their products.
“Whether [Ameridose] did or not, I have no idea how they handle their business,” he said. “But the guidelines in the USP 7-97 are pretty clear about when we should test and what we should be testing for.”
It’s up to states to regulate pharmacies and compounds. The Department of Professional Regulation supervises all pharmacies and pharmacists in the state. However, it’s the federal Food and Drug Administration who regulates the drugs these compounds use to formulate specialized prescriptions. Illinois regulators say whenever something like the fungal meningitis outbreak happens, an investigation must be launched to determine what caused the problem.
“I think that we’re still getting answers to what happened,(in the fungal meningitis outbreak) what went wrong, where there might have been lapses,” said Sue Hofer from the Department of Professional Regulation. “I think it’s too soon to judge any one entity is at fault.”
Hofer said the department conducts semi-regular inspections of all pharmacies in Illinois.
State and federal regulation have been questioned with the meningitis outbreak. Illinios pharmacists have mixed opinions about whether there should be a change and if those changes would even make a difference. Pharmacists, like Freeder, think that if officials increase regulation standards, that would mean higher costs for their companies and patients.
“I’m not confident that you could put another level of bureaucracy, another level of guidelines, rules and regs in place that would make a difference,” Freeder said.