Pharmacy inspections sporadic at best — and some pharmacists would welcome more
CHAMPAIGN — How many compounding pharmacies there are in Illinois is unknown. There are 3,316 licensed pharmacies in Illinois, and any of them could be compounding, according to the state Department of Financial and Professional Regulation.
"Every pharmacy can be a compounding pharmacy," department spokeswoman Sue Hofer said.
The state inspects each pharmacy, on average, once a year, with a staff of six licensed pharmacist inspectors, she said.
The Food and Drug Administration also has the authority to inspect pharmacies, but because the state conducts routine inspections and pharmacies are exempt from federal registration if they meet certain conditions, the FDA lacks a full inventory of U.S. compounding pharmacies, FDA spokeswoman Sarah Clark-Lynn said.
The agency conducts inspections in response to complaints or when it has reason to believe a violation has occurred, and then works with states to take appropriate action, she said.
Some compounding pharmacists say they don't always see state inspectors annually.
"In the old days, you saw a state inspector every year, but that isn't the case now," said Doug Higgins, owner of Doug's Compounding Pharmacy in Paxton.
Kathy Munday, owner of St. Joseph Apothecary, said the state comes in and inspects "whenever they choose to, sometimes it's been as long as three months, sometimes it's two years."
Inspections aren't announced, she said.
"You're always on your toes, and you should be," she adds.
Peoria compounding pharmacist Mike Minesinger said state inspections have averaged less than once a year for his two pharmacies.
But he'd like to see the state hire more qualified inspectors so they could inspect compounders on a quarterly basis, he said.
"It would be nice to have someone come around and help us comply with the laws," he said.
If inspections were done quarterly, bad practices could be caught much sooner, contends Minesinger, owner of Alwan Pharmacy and Compounding Center.
"If a patient is harmed, and then there's an inspection, that's a broken system," he said.
The state does investigate all complaints, Hofer pointed out.
"The only assurances we can give is that we do inspect them, and should we get word that there is an issue, we will take what action we deem necessary up to a suspension of their license," she said.
Meanwhile, compounding pharmacists advise customers ask them some questions. Some suggested by Higgins: How much compounding do you do? What kinds of things do you do to ensure the quality of your products? Do you have them independently tested? What professional affiliations do you have?
Higgins and Minesinger have pharmacies that are among five in Illinois to be accredited by the Pharmacy Compounding Accreditation Board, a voluntary accreditation process that's been available for compounding pharmacies since 2006. Higgins' pharmacy was newly accredited at the end of October.
The International Academy of Compounding Pharmacists estimates there are 7,500 pharmacies doing drug compounding. Only a handful of them, 165, are accredited, according to PCAB board Executive Director Joe Cabaleiro.
Accreditation standards are tough to meet, he says.
Pharmacies must pass inspections every three years and meet nationally recognized quality standards.
The board generally has 20 to 30 pharmacies in the accreditation process, but since the meningitis outbreak, has seen a big surge of interest, Cabaleiro said.
"Maybe now folks are seeing it's worth the time and interest to do it right," he said.