Outpatient Surgery Magazine

Did Skin Prep Fuel This Fire? - February 2017 - 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 89 of 146

received from their local vendor to make sure they hadn't come from the New England Compounding Center (NECC), the Massachusetts pharmacy at the center of the 2012 deadly fungal meningitis outbreak, the deadliest medication contamination case in U.S. history. Fortunately for them and their patients, they hadn't. State and federal regulators say NECC mixed and sold contaminat- ed vials of steroids that sickened 778 unsuspecting patients, killing 76 of them. In the wake of the NECC tragedy, government oversight of compounding facilities has increased, but you still have to do your homework when choosing a compounder. How can you be sure your lab takes medication safety as seriously as you do? You can start by asking these 7 questions. Is it licensed? Each state in the country is home to a state board of pharmacy, an association of pharmacists who develop, implement and enforce public safety standards for pharmacists. Every U.S. com- pounding facility should be licensed by the relevant state board of pharmacy. In some cases, when a lab ships compounded medication over state lines, licensing is required by more than one board of phar- macy. This information — who's current and who's not — is often available on a State Board of Pharmacy website. Otherwise, you may need to dig a little deeper; experts recommend calling a state board to ask about any licensure revocations or suspensions. 503A or 503B? While the Food and Drug Administration's oversight of compounders has historically been a murky area, regulation has increased since the 2013 passage of the Drug Quality and Security Act (DQSA), following the NECC scandal. Under this law, compounders are classed according to 2 categories: traditional pharmacies that dispense patient-specific compounds only with a prescription (503A); and bulk 9 0 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J A N U A R Y 2 0 1 7

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