keeping an eye out for any dust bunnies, bugs and water damage, all
of which can lead to contamination, says Mr. Rockers.
While he says most surgical facilities will stick with a pharmacy
that's proven itself to be reliable, it's still a good idea to regularly
check in with your compounder, says Mr. Rockers, who recommends
doing so at least once a year. "A lot can change in a year," he says.
If your lab has registered with the FDA, but has yet to be inspected,
take extra precautions. "I used to say that pharmacists could graduate
on a Monday and work at a sterile compounding lab on a Tuesday,"
says Mr. Rockers. "Same thing goes with the FDA. Once you register
with the FDA and pay your fee, you're registered as an outsourcing
facility." But that doesn't mean that a new facility is getting inspected
right away. Depending on the number of outsourcing facility regis-
trants and other inspection priorities, the FDA expects to inspect
newly registered outsourcing facilities within 2 months of initial regis-
tration.
One major one to look out for is whether your facility is sending you
sterility and stability test results of the products being sent your way.
"If not, that is a deal breaker," says Mr. Rockers. Before the product is
shipped to you, you should always have its sterility and stability test
results in your hand. If your lab isn't sending you those results? "I
would walk away immediately," says Mr. Rockers.
You should also validate that your pharmacy has the proper licen-
sure to ship to your facility, which varies by state, and check that
every product it ships you has a number to contact the com-
pounder on it. "This is an absolute requirement," says Mr. Rockers.
Both of these factors could indicate to you whether your lab might
be skirting the system.
OSM
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