Outpatient Surgery Magazine

Compounding Disaster - July 2016 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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Page 167 of 168

gowns. The pharmacy was also selling domperidone and Brilliant Blue G, even though neither is FDA-approved. • A San Francisco pharmacy had to recall all its compounded prod- ucts produced over a one-year period. The reason: Drugs labeled as biotin did not contain biotin, but rather contained 4-aminopyridine, which can cause seizures. • An inspection of a Virginia firm, triggered by a report of particu- lates in hydroxyprogesterone caproate injectable solution, revealed brown stains on the surface of the HEPA filter on the ISO 5 laminar hood. The company was processing phenyl eph rine HCl injection at the time of the observation. The company was not using sporicidal disinfectant to clean the ISO 5 or ISO 7 areas. • A Dallas 503B failed to use sporicidal disinfectants even after drugs it produced flunked sterility tests. The company's ISO 5 sterile hood was visibly soiled. It failed to investigate after 22 instances of positive tests for soiled gloves and 52 for soiled clothing. The air filtering system for the clean room did not produce positive pressure. Experts say FDA has been aggressive in policing 503Bs. But some doubt that the agency can prevent all the problems that might crop up. Ed Timm, president and CEO of Mobius Therapeutics, maker of a mitomycin-C kit called Mitosol, believes "another NECC is almost inevitable. And it will not be on same scale. It will be far worse." Mr. Timm says one problem is volume. "Prior to DQSA, you needed pre- scriptions. The volume jamming through these labs is exponential: 7 million injections of Avastin last year." He says compounders are not equipped to handle it. Even com- pounders who are "brilliant pharmacists" simply don't know what they're doing when it comes to manufacturing. "It's outside of their bandwidth," he says. "Mario Batali is an exquisite chef. That does not 1 6 8 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J U L Y 2 0 1 6

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