A new article on creating a USP 800 compliant pharmacy, by William N. Bernstein, AIA, has just been published in Health Facilities Management.
Entitled “USP 800 Brings New Regulations to Hospital Pharmacies”, the article is a comprehensive guide to designing clean room environments for sterile compounding and non-sterile compounding in accordance with the new USP 800 guidelines.
The full pharmacy design article can be found at
http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care
Below are some of the topics covered in this USP 800 article:
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History of USP 800
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Deadline for compliance with USP 800
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Relationship of USP 797 and USP 800
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Changes in guidelines on sterile compounding of hazardous drugs relative to previous guidelines in USP 797
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What does USP 800 mean when it refers to “hazardous drugs”
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Latest list of USP 800 hazardous drugs
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Frequency of review of list of USP 800 hazardous drugs
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Introducing new hazardous drugs in a USP 800 compliant facility
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Exceptions to list of USP 800 hazardous drugs
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Discussion of investigational drugs in USP 800 guideline
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Under what circumstances do hazardous drugs fall outside of USP 800 guidelines
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Discussion of “assessment of risk” in USP 800 guidelines
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Areas governed by USP 800
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How does USP 800 address storage of hazardous drugs
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How does USP 800 address compounding of hazardous drugs
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When is a negative pressure room required under USP 800
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How many air changes does USP 800 require
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What additional space does USP 800 require
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How does USP 800 address refrigeration of hazardous drugs
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Locations of refrigerated storage of hazardous drugs in USP 800
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Location of exhaust relative to refrigerator in USP 800
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Discussion of details of storage room shelving in USP 800
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Seismic considerations discussed in USP 800
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Discussion of which drugs go into the USP 800 storage room
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Storage of sterile and non-sterile hazardous drugs in USP 800
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Under what circumstances can sterile and non-sterile drugs be stored in the same room in USP 800
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Discussion of compounding vs. fixed formulations in USP 800
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Types of controls related to the compounding process in USP 800
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C-PEC in USP 800
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C-SEC in USP 800
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Closed-system, drug transfer device in USP 800
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When is an ISO-5 environment required in USP 800
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When is an ISO-7 environment required in USP 800
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When is a negative-pressure room required in USP 800
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USP 800 discussion of loss of power
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USP 800 discussion of emergency power
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Discussion of worker safety in USP 800
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Types of Biosafety Cabinets discussed in USP 800
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USP 800 eliminates available options that existed in USP 797
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USP 800 discussion of signage
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Location of spaces discussed in USP 800
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Receipt and unpacking of hazardous drugs as discussed in USP 800
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Water column measurements in USP 800
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What has to be externally vented in a USP 800 compliant pharmacy
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Air exchange rate requirements in USP 800
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USP 800 discussion of maintaining power to ventilation systems in a power outage
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Different USP 800 requirements for sterile compounding vs. non-sterile compounding
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Definition of non-sterile compounding in USP 800
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Definition of sterile compounding in USP 800
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Under what circumstances does USP 800 permit both sterile and nonsterile compounding in the same room
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Under what circumstances does USP 800 permit sterile compounding in a non-ISO space
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USP 800 discussion of segregated compounding area (C-SCA).
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USP 800 requirements for non-sterile compounding
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Carry-over of certain requirements from USP 797 in terms of cleanroom design in USP 800
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Discussion of USP 795, Pharmaceutical Compounding — Nonsterile Preparations, in USP 800
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Under what circumstances does USP 800 permit sterile and nonsterile compounding in the same room
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Relationship of storage and compounding spaces in USP 800
Author of this USP 800 article is William N. Bernstein, LEED AP, AIA, the principal of Bernstein & Associates Architects. His firm has been at the forefront of designing USP 797 and USP 800 compliant pharmacies across the US. He can be reached at
info@bernarch.com.
Follow Bernstein & Associates, Architects:
Pharmacy Architecture and Design:
http://bernarch.com/healthcare-design-pharmacy/
USP 797 Architecture and Design:
http://bernarch.com/healthcare-design-usp-797-compliant-pharmacy-design-and-consulting/
USP 800 Architecture and Design:
http://bernarch.com/healthcare-design-usp-800-compliant-pharmacy-design-and-consulting/
Bernstein & Associates, Architects on Twitter:
https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger:
http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn:
https://www.linkedin.com/company/bernstein-&-associates-architects
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https://www.facebook.com/bernsteinarchitects/
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