September 24, 2014
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New single-dose antibiotic could help patients with compliance problems
The Pharmaceutical Journal
A new single-dose antibiotic could benefit patients, such as intravenous drug users, whose lifestyle makes it difficult to comply with a week-long course of vancomycin. The new antibiotic, oritavancin, has just been approved by the U.S. Food and Drug Administration, and in a trial of 787 patients with skin infections, it was no less effective than vancomycin.
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Insourcing IV sterile compounding
Pain Medicine News
Determined to cement access to reliable and safe sources for crucial IV drug admixtures, a growing number of hospitals are bringing production of compounded sterile products (CSPs) in-house and turning their backs on external compounding pharmacies. Such far-reaching decisions reflect the lingering distrust of outsourced CSPs, according to several administrators from hospitals that have made this move.
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FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
Medical News Today
Food and Drug Administration is reminding healthcare professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. The FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired.
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Industry groups take issue with FDA draft guidance on outsourcing facilities
in-Pharma Technologist
The FDA's draft guidance, released in July, recognizes the differences between outsourcing facilities and commercial drug manufacturers and looks to tailor the cGMP requirements to the unique needs of the compounding industry. However, both BIO and GPhA call on the FDA to make a distinction within cGMP requirements between (a) sterile drug products that are compounded by the aseptic combination of licensed, commercially manufactured sterile drug products under aseptic conditions and (b) sterile drug products that are compounded from non-sterile bulk active pharmaceutical ingredients "since the risks associated with the compounded drug product differs between these two types of products, necessitating different controls."
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EMA guideline on pharmacovigilance inspections comes into effect
in-Pharma Technologist
As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved , the agency is still implementing a number of the individual modules that make up the over-arching law. Among those modules recently implemented is Module III - Pharmacovigilance Inspections, which includes guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the E.U. and outlines the role of different parties involved.
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