Physical Environment Provisions of USP <797> “Pharmaceutical Compounding — Sterile Preparations” Third Edition Cover 460x595

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

By Benjamin Leutze

General Chapter <797>, “Pharmaceutical Compounding — Sterile Preparations,” of the U.S. Pharmacopeia addresses policies and practices for the preparation, packaging and storage of compounded sterile preparations (CSPs) before they are administered to patients. USP <797> 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. The chapter emphasizes individual training and evaluation of those who compound sterile preparations. 

This monograph discusses only the physical environment aspects of USP <797>, and is intended for the use of health care facility managers. It will aid those preparing for compliance with USP <797> by:

  • Defining CSPs
  • Explaining enforceability
  • Describing environmental quality and control
  • Discussing physical environment considerations including HVAC layout
  • Reviewing initial certification process and ongoing compliance requirements
  • Providing an operational checklist
 Access PDF Members can download a PDF of the entire monograph
Order Digital Version Catalog Number (Digital): P055959
 Member: click "Access PDF", Nonmember: $35.00                         
Order Print Version Catalog number (Print): 055959
 Member: $25.00, Nonmember: $35.00                         

Related Resources

Resources
Ensure compliance with associated regulatory requirements in a way that ensures patient care and safety is the foremost priority.
Book
This guide focuses on the design, construction, and operation of decarbonized new hospital buildings and major renovations.
Resources
The sustainability competency calls on health care facilities managers to act as good stewards of resources and actively reduce the field’s impact on…
Press Releases
CHICAGO — The American Society for Health Care Engineering (ASHE) of the American Hospital Association has announced the winners of its 2024 Energy…
Compliance Tools
This tool helps determine the appropriate special locking arrangement to permit compliant egress in the event of a fire alarm activation.
Monograph
This eBook features a collection of articles describing extreme weather events that have affected health care facilities across the country.