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April 2018 : State of Pharmacy Compounding - Vol. 15 No. 4 - Page #1

Remaining abreast of all the developments regarding the current recommendations, requirements, and best practices in hospital pharmacy compounding is a tall task given the amount of regulatory activity in play. Yet, safe and accurate compounded preparations remain vital to emergency treatment and ongoing therapy.

Therefore, it is best to gain a solid understanding not only of the new regulations themselves, but also the underlying reasons for their introduction. Consider, for example, the new requirements in USP <800> for air pressure; the regulation clarifies that the negative pressure room for HD compounding must meet both a minimum and maximum pressure requirement. “The C-SEC used for sterile and non-sterile compounding must be externally vented...and have a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas.”

The first takeaway from the new regulation may be to ensure its execution and recognize the importance of installing a properly placed gauge to monitor air pressure in the C-SEC. But equally important is understanding why this regulation has been enacted: If the air pressure in the compounding engineering control is too negative, this raises the risk that turbulent and potentially contaminated air will be drawn into the room every time the door is open.

At Pharmacy Purchasing & Products, we know how important the integrity of compounded preparations is to the overall efficacy of the patient encounter. PP&P seeks to support hospital pharmacy’s efforts to ensure this integrity, and in doing so, we are proud to present the results of our 11th annual State of Pharmacy Compounding survey. The data herein will help you measure your practice against that of your peers. A primary goal at PP&P is to always focus on moving the conversation forward. By engaging pharmacy experts to help explain the reasoning behind new regulations and by sharing your peers’ best-practice approaches to compliant compounding practices, we hope to assist you in building a safe and effective compounding practice.

All the best,

R. Mitchell Halvorsen

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