Outpatient Surgery Magazine

Compounding Disaster - July 2016 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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Page 168 of 168

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

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