A compounding pharmacy in Utah was faulted by federal investigators for unsanitary conditions, and for not adequately testing some of its mixed-to-order drugs to ensure their sterility, potency and safety.
University Pharmacy Inc. in Salt Lake City was visited five times in February by U.S. Food and Drug Administration (FDA) inspectors who found equipment and utensils used to mix injectable drugs were not sanitized frequently enough to prevent contamination.
“Spills and splatters of amber and white colored residue were observed” in and around the equipment, their inspection report says.
Safety testing was done on whole batches of drugs — gel eye drops and injectable hormones prescribed for erectile dysfunction, hormone imbalances and to stop preterm labor in women — but not on the finished product, inspectors said.
Following a 2012 deadly meningitis outbreak involving drugs mixed at a compounding center in New England, the FDA has scrutinized dozens of specialty pharmacies.
But the agency isn’t following up to see that problems identified are fixed, says the D.C.-based consumer advocacy group Public Citizen, which is pressing for tighter enforcement.
The FDA publishes inspection reports only after identifying “significant objectionable conditions,” said Michael Carome, a doctor and director of Public Citizen’s health research group.
But it’s not clear from the agency’s web site whether University Pharmacy, or dozens of others with inspection findings, have fixed problems or recalled their products, Carome said.
University Pharmacy owner Richard Rasmuson said he welcomes the scrutiny but down-played inspectors’ findings.
“We’ve made some changes, small things,” he said.
Under political pressure by the drug industry, Rasmuson said, the FDA has for years fought to eliminate the compounding industry, which produces made-to-order drugs that aren’t commercially available — often for pennies on the dollar. “We were on their shortlist because we had been inspected before.”
He said inspectors are now unfairly holding pharmacies to manufacturing standards required of large drug makers, which are responsible for far more patient injuries and deaths than compounders.
“We send our drugs out for batch testing by an independent firm and haven’t had anything fail a sterility test in 15 years,” he said, stressing that inspectors swabbed the pharmacy’s equipment and found no pathogenic, or disease-causing, bacteria.
“University Pharmacy is a small pharmacy, a local pharmacy. We have a good reputation with our patients and doctors,” Rasmuson said.