Can we share Stability Studies?
I received this question this week: What do you think about sharing a stability study with another pharmacy? Would that be acceptable? I tried to…
Category: Sterile Compounding
FDA 483 #8 – Using ungraded ingredients
Learning Objectives Discuss the use of USP graded ingredients in pharmaceutical preparations and the importance Explain what prompted the FD&C act of 1938 to be…
483 Friday #7 – Viable Air Sampling
Learning Objectives Explain the purpose of viable air sampling Discuss how conclusions can be made from the results of viable air sampling Happy Friday! This…
Does your Sterile Compounding CPE need improvement?
Compliance with standards is of great importance, not just because of the consequences of non-compliance with regulatory authorities, but truly for the safety of our…
WARNING: Hazardous Drug Spill; HOW TO CLEAN UP
Hazardous Cleanup I’ve had a few people contact me about the process for cleaning up a hazardous drug per <800>. It’s slightly different than what…
Cleaning up Confusion; correctly cleaning your room
Before we get started… I actually have an entire video series on cleaning and disinfection in the Sterile Compounding Course. I go over a number…
483 Friday #5 – Potency Testing
The learning objectives for this week’s 483: Explain the typical out of specification range of potency for many compounded formulations Discuss a type of testing…
Save $500K; Hacking USP
USP <800>: Looming Compliance Deadline Less than a year away pharmacies will be expected to comply with USP’s newest standard pertaining to the handling of…
Ending confusion – Endotoxins to Endospores
Endotoxins or Endospores? At one point I was a little mixed up by these two very different terms. They start with the same prefix; they’ve…
What the…what’s Water Activity (Aw)?
There’s been a “new” term that’s been introduced with the revision of USP <795>, Water Activity. There’s an entire 2 page USP Chapter about water…