Should You or Must You?

October 2019 : Cleanrooms & Compounding - Vol. 16 No. 10 - Page #1

The dichotomy between the shoulds and the musts in USP <800> presents quite a conundrum: It may seem evident that the easiest approach is to sort the chapter by recommendations and requirements and then concentrate on the latter—if only to ease the efforts required to demonstrate compliance by the December 1st deadline.

Yet, just as USP Chapter <797> has evolved over time, we can safely assume that Chapter <800> will follow suit. As pharmaceutical agents continue to grow in complexity, and in some cases, toxicity, augmented safeguards are sure to be on the horizon.

Given what we know about the dangers presented by HD exposure, we also can assume that Chapter <800> will only become stricter with the passage of time. As such, the requirements therein are likely to expand. Therefore, it is prudent to consider recommendations as precursors to eventual requirements.

Because the full application of USP Chapters <797> and <800> is a complex endeavor, a comprehensive, step-wise implementation plan is in order. However, as these measures are intended to protect you and your employees from harm, what should be done and what must be done will likely merge together.

All the best,

R. Mitchell Halvorsen


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