The International Academy of Compounding Pharmacists, which has long opposed additional regulation, released a statement Sunday noting that existing law gives the FDA and states authority over compounders. Federal and state regulators can inspect any pharmacy at any time, the statement said.
“Now we must make sure that happens,” the IACP said. The “vast majority” of the 7,500 compounding pharmacies “do not fear inspections; they expect them.”
On Sunday, Massachusetts health officials said that they had shut down another compounding pharmacy, Infusion Resource, last week after concerns about the sterility of medications given to about 40 patients. They didn’t identify the drugs except to say that they were for patients following hospital discharge.There was no evidence of contamination, they said. The company also was cited for administering intravenous treatments on-site without a proper license.
A state commission is being established to look at best practices, and new rules are being developed to require more frequent reporting from compounding pharmacies. The state is adding five inspectors at the Board of Pharmacy, and officials had begun a round of unscheduled visits. The board also is looking into possible conflicts of interest between a board member who is also a pharmacist at Ameridose, a sister company of NECC.
Some of the minutes “call into question” whether the board member recused herself from Ameridose and NECC matters, said Lauren Smith, interim health commissioner.
The NECC knew that its sterile-drug operations were extensively contaminated by mold and bacteria but took no corrective action, the FDA said last week. State regulators inspected the facility in 2011 in connection with a proposed expansion. A newly released report of that inspection said the pharmacy met sanitation standards, according to media reports.
After the outbreak, a state inspection found that the NECC repeatedly failed to follow standard safety and quality standards and was violating its license by shipping high volumes of medications without individual patient prescriptions.
In the congressional report, Markey’s staff assessed the FDA’s actions by searching publicly available data on the agency’s Web site and media reports. It found problematic compounding pharmacy practices that resulted in 23 deaths and at least 86 serious illnesses or injuries in at least 34 states. Those figures are a conservative estimate, the report said, and do not include fatalities and illnesses from the meningitis outbreak.
The FDA sent warning letters to pharmacies in Illinois and Michigan about nicotine lollipops without patient prescriptions; about medications containing a drug linked to cardiac problems in Maryland, New Jersey and Wyoming; and about contaminated magnesium sulfate solution from Texas and Mississippi facilities that caused the death of a South Dakota patient.
To assess state performance, Markey’s staff searched publicly available documents at each state pharmacy board. Only Arizona, California, Missouri, New York, North Carolina and Rhode Island took enforcement action against compounding pharmacies. Violations included improper dosages, expired drugs and lapses in sterile compounding.
When Missouri began conducting annual potency and sterility tests of some compounded drugs, it found that 11.6 to 25 percent of drugs tested had unsatisfactory results. But the state didn’t list which pharmacies were responsible, the report said.
More typically, state enforcement centered on billing and other traditional violations, the report said.
Most state board Web sites also prevent consumers from easily locating or downloading enforcement records for specific pharmacies.They don’t allow for keyword searches. Consumers would have to know the date of the enforcement action or the name of the pharmacy to obtain useful information, the report said.
Howard Schneider contributed to this report.