FDAnews Drug Daily Bulletin

ROTECH HEALTHCARE RESPONDS TO FDA WARNING LETTER

Aug. 17, 2006
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Rotech Healthcare Inc. reported that on August 10, 2006, it received a warning letter from the Food and Drug Administration (FDA) relating to its subsidiary, Pulmo-Dose, Inc. The warning letter states that Pulmo-Dose's compounding of formulations of budesonide, albuterol/ipratropium, and formoterol/budesonide exceeds the scope of the practice of pharmacy and that Pulmo-Dose is operating as a pharmaceutical manufacturer and not a pharmacy engaged in extemporaneous compounding. Business Wire (http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20060814005689&newsLang=en)