Month: April 2017

California Compounding Pharmacy Faces Civil Suit over Failure to Warn Consumer Regarding Dangers of Testosterone Cream

Great Earth Compounding Pharmacy, along with a pharmacist, integrative medicine center, and two doctors, all based in southern California, are being sued by a family for unspecified damages related to a compounded testosterone cream prescribed for plaintiff Andrew Simpson. The suit alleges that Simpson’s wife and two children have all suffered serious medical consequences due …

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NECC: Judge rules pharmacy board, FDA could be found liable

  BOSTON – A Boston federal judge ruled the U.S. Food and Drug Administration and a state pharmacy board can be found at fault for the 2012 fungal meningitis outbreak that took the lives of some 77 patients, who had been injected with fungus contaminated drugs from a Framingham drug compounding company. In a nine-page …

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Countdown To The 2017 DSCSA Deadline: Serialization Strategies For Compliance

  Pharmaceutical Product Serialization Regulations and Strategies for Compliance The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers …

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Cleaning Compounding Aseptic Isolators

  Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine. Since the June 1, 2008 revision of USP general chapter 797, pharmaceutical compounding personnel have been held responsible for the cleanliness of their sterile compounding areas, including biosafety cabinets (BSCs), compounding aseptic isolators (CAIs), compounding aseptic containment isolators …

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Why Sterile Alcohol?

  FDA reminder of safe non-sterile alcohol prep pad use The FDA is reminding healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin. This reminder comes in light of the recent recall of Triad Group alcohol prep pads and swabs due to concerns of …

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PCAB Collaborates on Consensus Statement on Handling of Hazardous Drugs per USP Chapter

Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has collaborated with industry leaders to develop a consensus statement on the handling of hazardous drugs per USP Chapter guidelines. Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has collaborated with industry leaders to develop …

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FDA approves Sanofi and Regeneron’s New Eczema Drug

The US Food and Drug Administration (FDA) approved Sanofi and Regeneron’s Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids. Dupixent …

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