Revisions to Compounding Guidance?  Where Will That Take Us?

It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities.  Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities […]

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FDA Takes Injunctive Action Against Pharmacy Compounding Outsourcing Facility

FDA has given new notice to registered pharmacy outsourcing facilities that it is prepared to take aggressive enforcement action against serious violators. In one of its first major enforcement actions of 2016, a Consent Decree of Permanent Injunction was entered on January 8th against Downing Labs (formerly NuVision), a Dallas, Texas outsourcing facility manufacturing both non-sterile drug products and injectable drugs.

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