qualify him to run Kraft Foods."
In the end the only effective way to regulate compounding may be
caveat emptor. Hospital and surgery center workers may have to act
as the last line of defense for patients.
"NECC did a fantastic job of obfuscating what they were doing and
positioning themselves to look like they were competent," says John
Voliva, RPh., the executive vice president of the International Academy
of Compounding Pharmacies.
Before doing business with a compounder, Mr. Voliva suggests a
site visit. "See the site, see the procedures with your own eyes, see
the cleanliness, see the clean rooms. If that's not possible, request all
the records you can think of. Reports regarding sterility testing, envi-
ronmental monitoring of hoods [and] personnel testing." Since 503Bs
are supposed to comply with Current Good Manufacturing Practices,
ask for documentation of that, he adds. If a compounding lab isn't
staffed with people experienced in CGMP environments, it's not
uncommon for them to hire outside experts to bring them into com-
pliance.
Compounding labs fill a need. They are necessary. And there may
simply not be enough regulatory horsepower to effectively police
them. Surgical professionals have to hope that compounding pharma-
cies have patients' best interests at heart and that they know how to
help protect them. Blind trust isn't enough, however. As they go for-
ward in the world post-NECC, surgery professionals would do well to
observe the Russian proverb of which Ronald Reagan became so
fond.
Trust, but verify.
OSM
J U L Y 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 1 6 9