Last year Alabama-based Medaus Pharmacy withdrew 11 sterile drug products after the FDA raised questions about the lab it was using to test for sterility. The FDA now says the compounder has sterility issues in its own facility which raise questions about the safety of its products.
During a March review of the Birmingham facility by the FDA and state health regulators, the FDA inspectors found the pharmacy was selling drugs without prescriptions, a violation that under a new law gives the FDA authority to inspect the compounder. When it did, it found unsanitary conditions, including the fact that employees were not wearing sterile clothing, hair or beard nets or face covers while filling vials with sterile drugs. The observations were put into a warnig letter posted Tuesday to the FDA website but refuted by Medaus in its response.
The FDA also said the the ISO 5 area where sterile drugs were being filled was not "suitable for aseptic processing" because ceiling panels were not sealed, it didn't have HEPA filters and the hoods had not been shown to be adequate. Airflow in the area was a problem and so could lead to contamination. The warning letter also said the company had not established proper stability testing.
In an email Hube Dodd, general counsel for Medaus, said the company told he FDA in its response that its ISO-7 and ISO-8 rooms operate on a separate air filtration system with their own HEPA filters and that it has upgraded to MAC 10" units. He also said the ceiling tiles, were designed, along with other features of the facility to ensure air quality and the the tiles have the advantage of being removable for cleaning during routine maintenace and that employee clothing meets required standards.
"I think it is important to note that out of the millions upon millions of product units that Medaus has compounded during its existence, there has not been a single adverse patient outcome as a result of any failure in our production or safety assurance protocols. Not one," Dodd said.
Medaus Pharmacy in September voluntarily recalled 11 products, including lipo injections with lidocaine, because it was unable to confirm testing "was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients."
Last year, Congress gave the FDA broader authority over compounding pharmacies after a fatal outbreak of fungal meningitis in 2012--tied to a contaminated drug made by a compounding pharmacy--infected hundreds and killed dozens of people. But instead of giving the agency absolute powers, the new law allows compounders to volunteer for FDA oversight, to set themselves apart from the pack. The law also makes clear the FDA can inspect and take action against companies that don't volunteer if it believes there is a safety issue. Congress created the voluntary program with the idea that hospitals would want to buy from regulated companies with an FDA seal of approval.
- here's the warning letter
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