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The only thing that stays the same is that everything changes. This is true even when it comes to nonsterile compounding and USP <795>. PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, addresses notable changes of the new USP guidelines and provides some considerations regarding implementation.
Eagle's own Dylan Herr, discusses how the sanitary conditions for sterile and non-sterile drugs at compounding facilities are regulated and how those regulations can affect you.
"Do you have questions about what it means to be compliant with various parts of USP <800>?" "Do you have the equipment you need?" Matt Martin, PharmD, of PCCA's Clinical Services provides an in-depth checklist of considerations you need to have while trying to navigate USP <800>.
Amy Shank, PCCA's Director of Government Relations, provides an update to the state of legislative affairs in the world of compounding. Specifically, she provides a report on the Seventh Annual ACT Legislative Conference that took place in Washington D.C., earlier this month. She also provides steps you can take to contact your own Congressional Representatives serving your district.
PCCA is proud to announce its updated USP<800> educational page. This new, streamlined experience offers answers to the questions PCCA has received regarding the new guidelines set for December 1, 2019.
PCCA's VP of Clinical Services A.J. Day and Matt Martin, PCCA Clinical Compounding Pharmacist, discuss how to navigate compounding with bulk drug substances while remaining within the FDA's guidelines.
An overview of bases with Daniel Banov, potency and stability studies with Eagle's Dylan Herr, and Eagle President Ross Caputo discusses the before, during and after of FDA inspections. Come check out what's new with PCCA Play!
FDA Updates with A.J. Day. An interview with the author of The Hormone Fix, Dr. Anna Cabeca, and a special interview with Cheri Kraemer, that and so much more from the Mortar & Pestle this month!
Jeff Gloyer is an engineer I with Eagle. He has experience working with multidisciplinary teams to implement the engineering design process. Here he discusses considerations that compounding pharmacies need to take in order to ensure they are USP <797> and <800> compliant.
On July 27, 2018, the Compounding Expert Committee of the United States Pharmacopeial Convention published proposed revisions to USP chapter <797> Pharmaceutical Compounding – Sterile Preparations. The proposed chapter is open to public comments until November 30, 2018, and is expected to become official on December 1, 2019.