The FDA's inspection sweep through the largest compounding pharmacies in the country continues to document operators that are not too careful about cleanliness and sterility. The meningitis outbreak that prompted the FDA campaign may have focused attention on the U.S. compound pharmacy industry, but it turns out it is not the only place confronting issues.
Canadian officials report that chemotherapy drugs from an Ontario compounding pharmacy given to nearly 1,200 patients failed strength specifications because they contained too much saline solution, Canadian Broadcasting reported. The government-run Cancer Care Ontario said a lab technician discovered the problem and tests found doses of cyclophosphamide and gemcitabine to be 3% to 20% under specified dosing levels, CNN reported.
The drugs came from Marchese Hospital Solutions, a retail and compounding pharmacy in Hamilton, Ontario. A spokesman for Marchese said it is "deeply concerned" that questions have been raised about the quality of its drugs and that a preliminary investigation indicated "we have met the quality specifications of the contract we are honored to have been awarded." Cancer Care Ontario's Dr. Carol Sawka, vice president of clinical programs and quality initiatives, said the agency is evaluating its controls to learn from the episode, according to CNN.
|FDA Commissioner Margaret Hamburg|
Compounding pharmacies made up an obscure niche of the drug manufacturing industry until a compounder was tied to last year's meningitis outbreak in the U.S. that infected 730, dozens fatally. About 1,440 patients in 23 states had been injected with the steroid made by a Massachusetts compounder that was found to be contaminated. FDA Commissioner Margaret Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders but in the meantime launched inspections of the largest U.S. operations earlier this year. It has posted 30 reports to its website that sprang from those inquiries that detail lax controls and poor practices. They list problems like drug residue of multiple medications in HEPA filters and pharmacies that have no clear process for sterilizing vials. Three of the compounders have recently recalled their sterile injectable drugs after the FDA found issues with contamination.
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