mary responsibility over a particular pharmacy.
The NECC catastrophe exposed a failure in drug safety, says Ms.
Axelrad. Lax oversight essentially let NECC operate as manufacturer
by shipping tens of thousands of vials of drugs.
"It was a wakeup call to everybody that they had to do more," says
Ms. Axelrad.
Vetting your pharmacy
It should come as no surprise that Ms. Axelrad suggests you use a
compounder from the FDA's list of registered outsourcing facilities
(osmag.net/RWb5Vh). You should then review the more than 4,500
compounded products you'll find on the FDA's outsourcing product
report database, a spreadsheet you can download at
osmag.net/3WJYkm. Finally, she suggests you review the FDA's web-
site (osmag.net/E7teCY), which lists inspections, recalls and warning
letters.
"Look for people who've been inspected, who weren't cited and
are making the product you need," she says, adding you should ask
to see the reports from an inspection by the FDA, the state or by an
outside auditor. If a pharmacy you're considering has received a
warning letter, ask to see the facility's response letter to the FDA's
warning letter.
It would be good to visit the pharmacy yourself — "Call a few and
ask if they'd be willing to let you inspect their facility," says Ms.
Axelrad — but you could also hire an auditor who knows what to
look for to examine the pharmacy for you.
Should you visit the pharmacy, Greg Rockers, RPh, who operated 2
503B compounding facilities before he cofounded the Williamson
Rockers Group, a pharmacy consulting firm, says you'll get a sense of
how long the leadership has been in place for and what their experi-
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