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  • Oct122018

    Pharmacy Inspection Podcast Episode 31 – Melissa Stefko

    This week we welcome Melissa Stefko, from Wells Pharmacy Network to the podcast. Melissa Stefko, Senior Director of Quality for 503B…

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    Pharmacy Inspection
  • Sep242018

    A Compounder’s Guide to Prevention of Contamination in Compounding Industry

    LIVE Webinar: October 19th 2018, 1 PM EST  – $99 – Limited Seats Available (purchase includes recording viewable for 1…

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    Pharmacy Inspection
  • Jun152018

    Warning: Stability Studies for extending BUDs will be enforced

    Not a new standard I’ve written about this in the past: when extending beyond use dates we need to do…

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    Pharmacy Inspection
  • May102018

    Getting an FDA “Close Out Letter”

    “Closing out” an FDA Form 483 An FDA Inspection So you’ve been visited by the FDA and whether you’re a…

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    Pharmacy Inspection
  • Jan312018

    BD vs FDA: only the PATIENT loses in this battle.

    Known Knowns In 2015, the FDA alerted the public to a loss of potency of medications if they’ve been compounded…

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    Pharmacy Inspection
  • Jan192018

    FDAs 2018 Compounding Policy Priorities Plan

    Yesterday the FDA released their 2018 priority plan for compounding compliance and enforcement (click to read whole plan). They’re consistent in…

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    Pharmacy Inspection
  • Jan162018

    FDAs Top 10 Inspectional Observations of 2017

    A new year; a new top 10 list from the FDAs Inspectional Observations! Honestly, there are quite a few repeats…

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    Pharmacy Inspection
  • Nov062017

    Too difficult; you’ll fail – The difficult to compound list

    Difficult to compound There’s an initiative that’s been underway, for both 503A and B’s abilities to be limited. If you’re…

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    Pharmacy Inspection
  • Oct272017

    Veterinary Compounders – Is the FDA easier on you?

    Questions I had a couple questions this past week, specifically about veterinary compounding, as this is what we do at…

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    Pharmacy Inspection
  • Sep282017

    FDA: what say you Dr. Gottlieb about USP 800 – does this make sense?

    USP 800 and the FDA Every now and then I comb through 483s on the FDA website. I came across…

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    Pharmacy Inspection