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 166 of 168

to stop producing some or all drugs, according to the Senate Committee on Health. At least 48 pharmacies were found by FDA or state regulators to be producing drugs that were contami- nated or were creat- ed in unsafe condi- tions. Since DQSA, many 503Bs have had quality problems: • A Vermont pharmacy was found to be packing sterile compounds in unsanitary conditions, according to a November 2015 FDA warning let- ter. The firm also was failing to test quality, strength and purity. • Multiple locations inside the aseptic processing area at a Montana facility tested positive for bacteria and mold. The facility, FDA said in a December 2015 warning letter, "was not adequately designed for sterile drug production." The letter also noted the unusual practice of the co-owner of bringing her dogs to the facility. A pet bed was locat- ed right outside the clean room door. • A Tennessee compounding pharmacy had not validated its processes for autoclaving glass vials, for filtering drugs or for depyro- genating glassware used to mix drugs. Inspectors observed workers compounding lidocaine 2% gel for intrathecal use in a room without HEPA filtration. • An inspection of a New York pharmacy found workers preparing injectable drug products with exposed facial skin and wearing non-sterile 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 7 • WIDOWED Joyce Lovelace, who lost her husband, 78-year-old Eddie Lovelace (photo at right) to fungal meningitis, is accompanied by Rep. Edward Whitfield, R-Ky., during testimony before the House Energy Subcommittee on Oversight and Investigations hearing on the fungal meningitis outbreak. AP Photo/Susan Walsh

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