"See if they're receptive to you being there," she adds. "Onsite visits
might be the only way to get a true feel for a compounder."
4. Is it willing to be audited?
It's also a good idea to conduct more in-depth audits of a com-
pounder's services, according to Greg Rockers, RPh, who has operat-
ed 2 503B outsourcing facilities and assisted organizations in navigat-
ing multiple FDA inspections. He says your audits should mimic what
FDA inspectors cover during their on-site visits — everything from
the physical condition of the building's exterior and clean room to the
policies for developing formularies, establishing beyond-use dates and
testing the sterility of finished products.
Conducting your own audits can be a valuable exercise because
some FDA-registered 503B facilities have not yet been inspected,
according to Mr. Rockers. Audits should give you a sense of how com-
pounding facilities handle customer complaints and investigations.
Effective audits typically span 2 to 3 days and should be conducted at
least annually, says Mr. Rocker, but it would be ideal to conduct 2
audits each year: the first unannounced and the second about 9
months later.
5 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 • A U G U S T 2 0 1 8
• CLEAR VIEW A compounding phar-
macy should be willing to share the
results of FDA inspects and any correc-
tive steps they've taken to address iden-
tified deficiencies.
