Blog Compounding Documentation 
The FDA Law Blog
FEBRUARY 2, 2025
This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process.
Omnicell
JANUARY 10, 2023
So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? It’s well documented that manual processes are archaic and inaccurate, and organizations like ISMP, ASHP, and many others agree things need to change.
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The FDA Law Blog
SEPTEMBER 11, 2024
FDA says that highly potent compounds – again, as defined in ICH M7(R2) – pose risks below that limit. We note that the other FDA guidance document on nitrosamines addresses NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5
Omnicell
SEPTEMBER 5, 2022
Mark Neuenschwander Founding Director, THRIVCoalition.org Seminal research from 1997 on IV compounding discovered that 9 percent of manually compounded sterile preparations had incorrect ingredients and/or volumes. Worst yet, 74% of all respondents were aware of at least one pharmacy compounding error in the last 12 months.
ISPE
MARCH 16, 2023
In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. ISPE Good Practice Guide on Containment for Potent Compounds 4. Environmental monitoring is another important aspect of Annex 1.
Omnicell
JANUARY 10, 2023
Compounding these challenges is that each vaccine brand requires different storage requirements with regard to temperature and beyond-use date (BUD) for each temperature type (frozen, refrigerated, and room temperature). The good news is that there may already be solutions embedded in your health system.
Omnicell
SEPTEMBER 5, 2022
” This CE-accredited session for pharmacy and nursing discussed how COVID-19 is compounding complications of Substance Use Disorder, and shared best practices for diversion monitoring in order to refocus resources and revise schedules amidst COVID-19.
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