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
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