Saturday, November 5, 2016

Proposed Revisions to USP 797 – Overview and Current Status

Proposed Revisions to USP 797 – Overview and Current Status , see:   


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Hospital project management services, see: http://empireprojects.com/healthcare-project-management-hospitals/
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Friday, November 4, 2016

USP 800 Pharmacy Design – New Article Published by Pharmacy Architect

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.

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USP 800 Architecture and Design: http://bernarch.com/healthcare-design-usp-800-compliant-pharmacy-design-and-consulting/
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Healthcare project management services, see: http://empireprojects.com/healthcare-project-management/
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To reach USP800.guru:
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W: www.usp800.guru