Constructing an Oncology Pharmacy
May 2017 - Vol. 14 No. 5 - Page #10

To ensure compliance with USP <800> Hazardous Drugs—Handling in Healthcare Settings and USP <797> Pharmaceutical Compounding—Sterile Preparations, health system pharmacists must have a comprehensive understanding of the chapters and the changes that must occur in their compounding practices to meet the requirements. In particular, the facilities requirements described in USP <800> require many organizations to undertake pharmacy renovations or new pharmacy builds to facilitate compliant compounding practices.

Compliant sterile compounding is a challenge for many organizations. The board of pharmacy permitting process for sterile compounding is lengthy, often spanning several months. State boards of pharmacy may require the submission of USP <797> certification reports, as well as viable and non-viable testing of the buffer and anterooms, prior to initial inspection for a sterile compounding permit. Construction delays due to misinterpretation or misunderstanding of federal regulations by inexperienced contractors can contribute to delayed pharmacy openings and increase construction costs. Thus, it is critical to develop a comprehensive pharmacy construction plan, guided by sound practices and regulatory compliance.

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