Quality Control: Lessons Learned from a Trimix Stability Study in a 503A Compounding Pharmacy

Author(s):  Rhoads Rick

Issue:  Mar/Apr 2018 - Volume 22, Number 2
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Abstract:  Changes in California regulations regarding beyond-use dates of sterile preparations have prompted many compounders to consider stability studies for their formulas. Traditionally, 503A compounders have relied on published data and professional experience to determine stability. However, due to these new regulations, stability studies are now required for California resident and nonresident licensees to extend the beyond-use date of sterile preparations. Conducting studies for the first time can be costly and difficult for compounding pharmacists. This article shares several lessons learned from the author’s experience performing stability studies on Trimix injection, a sterile preparation for erectile dysfunction. Avoiding easily made errors can save the compounder unnecessary time and expense.

Related Keywords: compounded sterile preparations, sterile compounding, beyond-use dates, stability studies, Trimix injection, erectile dysfunction, California Code of Regulations, time-point testing, bracketing, concentration, starting material potency, pharmacy staff, training

Related Categories: LEGAL, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, QUALITY CONTROL, ENDOCRINOLOGY/HORMONES/ MENOPAUSE/ANDROPAUSE

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