USP 800 and USP 797: What is New and What is the Same

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:

• History of USP 800
• Deadline for compliance with USP 800
• Relationship of USP 797 and USP 800
• Changes in guidelines on sterile compounding of hazardous drugs relative to previous guidelines in USP 797
• What does USP 800 mean when it refers to “hazardous drugs”
• Latest list of USP 800 hazardous drugs
• Frequency of review of list of USP 800 hazardous drugs
• Introducing new hazardous drugs in a USP 800 compliant facility
• Exceptions to list of USP 800 hazardous drugs
• Discussion of investigational drugs in USP 800 guideline
• Under what circumstances do hazardous drugs fall outside of USP 800 guidelines
• Discussion of “assessment of risk” in USP 800 guidelines
• Areas governed by USP 800
• How does USP 800 address storage of hazardous drugs
• How does USP 800 address compounding of hazardous drugs
• When is a negative pressure room required under USP 800
• How many air changes does USP 800 require
• What additional space does USP 800 require
• How does USP 800 address refrigeration of hazardous drugs
• Locations of refrigerated storage of hazardous drugs in USP 800
• Location of exhaust relative to refrigerator in USP 800
• Discussion of details of storage room shelving in USP 800
• Seismic considerations discussed in USP 800
• Discussion of which drugs go into the USP 800 storage room
• Storage of sterile and non-sterile hazardous drugs in USP 800
• Under what circumstances can sterile and non-sterile drugs be stored in the same room in USP 800
• Discussion of compounding vs. fixed formulations in USP 800
• Types of controls related to the compounding process in USP 800
• C-PEC in USP 800
• C-SEC in USP 800
• Closed-system, drug transfer device in USP 800
• When is an ISO-5 environment required in USP 800
• When is an ISO-7 environment required in USP 800
• When is a negative-pressure room required in USP 800
• USP 800 discussion of loss of power
• USP 800 discussion of emergency power
• Discussion of worker safety in USP 800
• Types of Biosafety Cabinets discussed in USP 800
• USP 800 eliminates available options that existed in USP 797
• USP 800 discussion of signage
• Location of spaces discussed in USP 800
• Receipt and unpacking of hazardous drugs as discussed in USP 800
• Water column measurements in USP 800
• What has to be externally vented in a USP 800 compliant pharmacy
• Air exchange rate requirements in USP 800
• USP 800 discussion of maintaining power to ventilation systems in a power outage
• Different USP 800 requirements for sterile compounding vs. non-sterile compounding
• Definition of non-sterile compounding in USP 800
• Definition of sterile compounding in USP 800
• Under what circumstances does USP 800 permit both sterile and nonsterile compounding in the same room
• Under what circumstances does USP 800 permit sterile compounding in a non-ISO space
• USP 800 discussion of segregated compounding area (C-SCA).
• USP 800 requirements for non-sterile compounding
• Carry-over of certain requirements from USP 797 in terms of cleanroom design in USP 800
• Discussion of USP 795, Pharmaceutical Compounding — Nonsterile Preparations, in USP 800
• Under what circumstances does USP 800 permit sterile and nonsterile compounding in the same room
• 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
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/

Follow Empire Projects, Inc.:
Healthcare project management services, see: http://empireprojects.com/healthcare-project-management/
Hospital project management services, see: http://empireprojects.com/healthcare-project-management-hospitals/
Empire Projects, Inc. on Twitter: https://twitter.com/empireprojects
Empire Projects, Inc.on Blogger: http://empireprojects.blogspot.com/
Empire Projects, Inc. on LinkedIn: https://www.linkedin.com/company/empire-projects-inc.
Empire Projects, Inc. on Facebook: https://www.facebook.com/empireprojectsusa/

Follow USP.org:
USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia

Follow USP797.org:
USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: http://www.facebook.com/usp797org/

Follow USP800.guru:
USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook: https://www.facebook.com/USP800

Follow PharmacyDesign.org:
PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/

To reach USP797.org:
USP797.org
1483 York Avenue – #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org