Physical Environment Provisions of USP <797> “Pharmaceutical Compounding – Sterile Preparations”

USP 797 cover

By Benjamin Leutze

General Chapter <797>, “Pharmaceutical Compounding-Sterile Preparations,” of the U.S. Pharmacopeia addresses policies and practices for preparation, packaging, and storage of compounded sterile preparations (CSPs) before they are administered to patients. The standard applies to all places where CSPs are prepared (e.g., hospitals, clinics, pharmacies, and emergency rooms) and to all persons, regardless of profession, whose work involves preparation of CSPs. Contact is the most likely source of clinically significant microbial contamination during pharmaceutical compounding, and proper hand hygiene is critical. The standard also stresses the need for environmental sampling as part of comprehensive quality management. This ASHE monograph discusses only the physical environment aspects of USP <797> and is intended for the use of health care facility managers.
 

  • Defining CSPs
  • Explaining enforceability
  • Describing environmental quality and control
  • DDiscussing physical environment considerations including HVAC layout
  • Reviewing initial certification process and ongoing compliance requirements
  • Providing an operational checklist

Digital Version

 Members click here Members can download a PDF of the monograph

Click here for USP 8000 resources

 

Print Version

Catalog number: 055955
Member: $25.00
Nonmember: $35.00

Purchase Now

 

Related Resources

Standards/Guidelines
ANSI/ASHRAE/ASHE Standard 170 offers guidance, regulation and mandates to designers and operators of health care facilities. The revised 2021 edition…
Webinar Recordings
Just Ask ASHE: Q1 2021 Webinar Speaker: ASHE
Compliance Tools
Webinar Recordings
Just Ask ASHE: Q2 2020 Webinar Speaker: ASHE