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The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Bulk drug substances are the raw active ingredients most compounded medications are made from.
Implementation of GFI #256 Earlier this year, the FDA finalized regulatory guidance for compounded medications, known as GFI #256. If GFI is affecting your practice’s ability to get compounded medications for office use, partnering with a trusted 503B outsourcing facility can help you eliminate risks of limited ordering.
We host several webinars on a variety of topics that our sales team and customers enjoy and learn from. There still is a knowledge gap of what 503B means to the veterinary industry and the differences between a compoundingpharmacy and an outsourcing facility. Do you have any plans to create more education around that?
On November 1, 2023, long-awaited revisions to the United States Pharmacopeia (USP) Chapters <795>: Pharmaceutical Compounding – Nonsterile Preparations and <797>: Pharmaceutical Compounding – Sterile Preparations became official. Chapters <795> and <797> present the standards for preparing compounded medications.
I worked with Emmett and Michael in retail pharmacy in the 90s before they purchased Stokes Pharmacy. My first job here with Stokes was as a sales rep selling human compounded medication. Going into compounding was challenging because compounding is different than traditional retail. It was challenging.
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