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DQSA Title I Cited in Warning Letter to Pharmacy Compounder

A warning letter issued to Triangle Compounding Pharmacy is the first to cite Title 1 compounding provisions of the Drug Quality Security Act (IPQ December 28 2013). The letter, issued in the wake of a Feb./March 2013 inspection states that the sterile drug compounder does not “qualify for the exemptions in section 503A of the […]

Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz

The wave of recalls of contaminated preparations and FDA-483s is continuing as FDA’s extensive inspection blitz of compounding pharmacies across the US hits the four-month mark....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

FDA Releases Final Guidance on PET Drug Media Fills; Application Filing Deadline Extended

FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June....

Recent PET Drug Inspection Findings Shed Light on Upcoming FDA Focal Points

Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time....

FDA Unapproved Drugs Initiative Orders Hundreds of Cough/Cold Products off the Market

FDA is taking another significant step in its unapproved drug enforcement initiative by ordering that hundreds of oral prescription (Rx) drugs used to treat coughs and colds be taken off the market....

CBER Releases Updated Compliance Program Guide on Inspection of Biological Drug Products

The Center for Biologics Evaluation and Research (CBER) released in June a revised version of its Compliance Program Guidance (CPG) 7345.848, “Inspection of Biological Drug Products,” which combines and replaces previous versions of CPGs covering related biological products and provides inspectional guidance to investigators for conducting biennial or for-cause inspections across the biologics spectrum....

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CLICK HERE  for the IPQ Monthly Update – March 2021 in Review


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