Friday, November 4, 2016

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: https://www.facebook.com/usp797

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

Friday, October 28, 2016

USP 797 - Update on Current Status of Revisions

As is well known, USP is in the process of updating USP 797.

A brief history and update on the current revisions to USP 797 is listed below. This update is current as of the date of this article, October 2016.

Initially, the revision to USP 797 General Chapter was proposed in September 2015 for public comment. The public comment period for the proposed ended on January 31, 2016 and the Compounding Expert Committee is currently reviewing all of the public comments received.

The chapter is currently being revised based on the input USP received. USP does not yet have an anticipated date for the publication of the chapter due to the volume of comments during the public comment period. Based on the nature and significance of the public comments received, the Committee in charge of the revisions will determine whether the chapter will be republished in the Pharmacopeial Forum for another round of public comments.

Additional Resources:

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 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 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: https://www.facebook.com/usp797

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

Saturday, May 14, 2016

Proposed Revisions to USP 797 - Overview and Current Status

This article is an overview, including current status, of the proposed revisions to USP 797.

Brief History of USP 797 and the Current, Proposed Revisions:

USP 797 was first published in 2004.

The last official revision to USP 797 became official on June 1, 2008.

The Compounding Expert Committee of USP began a new set of revisions in July 2010, and on September 25, 2015, USP issued a set of proposed revisions to USP 797 for public comment. The public comment period ran through January 31, 2016.

Currently, as of May 14, 2016, USP is evaluating the comments received through the public comment process.

You can download the proposed revisions that were published on September 25, 2015, from the following link: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf

Key Components of the Proposed Revisions per USP:

According to USP (per http://www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision), the major revisions of the General Chapter include:

1. Reorganization of existing sections and placement of procedural information in boxes

2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.

3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings

About USP:

Go to: http://www.usp.org/about-usp

Additional Private Resources About USP 797: (not affiliated with or endorsed by USP)

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

Sunday, May 8, 2016

Pharmacy Design Commission in Ohio Awarded to Bernstein & Associates, Architects

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) has been selected to provide pharmacy design services for a new, USP 797 compliant compounding suite for a hospital pharmacy in Ohio. See http://www.usp797.org/pharmacy-design-commission-in-ohio-awarded-to-bernstein-associates-architects/

Pharmacy design consulting services include: pharmacy programming, pharmacy planning, pharmacy design, pharmacy architecture, pharmacy engineering, and pharmacy equipment planning.

About Bernstein & Associates, Architects (www.bernarch.com):
Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm’s founding in 1990. This architecture firm has an international reputation for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (25) hospital pharmacies in the last 5 years, which have included USP 797 compliant pharmacy design and construction. The firm’s principal — William N. Bernstein, AIA — is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies.

For more information about pharmacy design and usp797 architectural and engineering design, please see the pharmacy design page for Bernstein & Associates, Architects: http://bernarch.com/healthcare-design-pharmacy/

Additional ways to follow Bernstein & Associates, Architects, include:
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/

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

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

For more information about healthcare and hospital design and construction, including pharmacy design, pharmacy equipment planning, planning for pharmacy automation equipment, and pharmacy construction, contact Bernstein & Associates, Architects at:
New York (Headquarters)

Bernstein & Associates, Architects
1201 Broadway – #803
New York, NY 10001
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles

Saturday, November 28, 2015

List of Vendors on the USP797.org Website

Architects

Bernstein & Associates, Architects - www.bernarch.com

Analytical Testing

Aerobiology Laboratory Associates - www.aerobiology.net

Associates of Cape Cod, Inc. - www.acciusa.com

EMSL Analytical, Inc. - www.pharmaceuticaltestinglaboratory.com

Cleanroom Products / Contamination Control

Acute Care Pharmaceuticals - www.Pharma-Choice.com

Berkshire Corporation - www.berkshire.com

Clean Air Essentials - www.isotechdesign.com

IsoTech Design - www.isotechdesign.com

Cleanroom Connection, Inc. - www.CleanroomConnection.com

Connecticut Clean Room Corporation - www.ctcleanroom.com

Contec, Inc. - www.contechealthcare.com

Criti Clean Cleanroom Products - www.Criti-Clean.com

Decon Labs Inc. - www.deconlabs.com

Hutchins & Hutchins, Inc. - yourcleanroomsupplier.com

IsoTech Design - www.isotechdesign.com

Cleanroom Design/Build Companies

Connecticut Clean Room Corporation - www.ctcleanroom.com

Hutchins & Hutchins, Inc. - yourcleanroomsupplier.com

IsoTech Design - www.isotechdesign.com

Micro Filtrations, Inc. - www.mficertify.com

Environmental Monitoring

ENV Services, Inc. - www.envservices.com

IsoTech Design - www.isotechdesign.com

Micro Filtrations, Inc. - www.mficertify.com

Technical Safety Services, Inc. - www.techsafety.com

Equipment Planning

Equipment Planning, Inc. - www.equipmentplanning.org

Healthcare Design and Construction Resources

ENV Services, Inc. - www.envservices.com

Micro Filtrations, Inc. - www.mficertify.com

Pharmacy Design

Pharmacy Design - www.pharmacydesign.org

Project Management

Empire Projects, Inc. - www.empireprojects.com

Testing & Certification

ENV Services, Inc. - www.envservices.com

Medrep Technologies, Inc. - www.medrep.us

Micro Filtrations, Inc. - www.mficertify.com

USP 800

USP800 Guru - www.usp800.guru

List of Vendors on the USP797.org Website

Architects

Bernstein & Associates, Architects - www.bernarch.com

Analytical Testing

Aerobiology Laboratory Associates - www.aerobiology.net

Associates of Cape Cod, Inc. - www.acciusa.com

EMSL Analytical, Inc. - www.pharmaceuticaltestinglaboratory.com

Cleanroom Products / Contamination Control

Acute Care Pharmaceuticals - www.Pharma-Choice.com

Berkshire Corporation - www.berkshire.com

Clean Air Essentials - www.isotechdesign.com

IsoTech Design - www.isotechdesign.com

Cleanroom Connection, Inc. - www.CleanroomConnection.com

Connecticut Clean Room Corporation - www.ctcleanroom.com

Contec, Inc. - www.contechealthcare.com

Criti Clean Cleanroom Products - www.Criti-Clean.com

Decon Labs Inc. - www.deconlabs.com

Hutchins & Hutchins, Inc. - yourcleanroomsupplier.com

IsoTech Design - www.isotechdesign.com

Cleanroom Design/Build Companies

Connecticut Clean Room Corporation - www.ctcleanroom.com

Hutchins & Hutchins, Inc. - yourcleanroomsupplier.com

IsoTech Design - www.isotechdesign.com

Micro Filtrations, Inc. - www.mficertify.com

Environmental Monitoring

ENV Services, Inc. - www.envservices.com

IsoTech Design - www.isotechdesign.com

Micro Filtrations, Inc. - www.mficertify.com

Technical Safety Services, Inc. - www.techsafety.com

Equipment Planning

Equipment Planning, Inc. - www.equipmentplanning.org

Healthcare Design and Construction Resources

ENV Services, Inc. - www.envservices.com

Micro Filtrations, Inc. - www.mficertify.com

Pharmacy Design

Pharmacy Design - www.pharmacydesign.org

Project Management

Empire Projects, Inc. - www.empireprojects.com

Testing & Certification

ENV Services, Inc. - www.envservices.com

Medrep Technologies, Inc. - www.medrep.us

Micro Filtrations, Inc. - www.mficertify.com

USP 800

USP800 Guru - www.usp800.guru

New USP 797 Compliant State-of-the-Art Pharmacy for Prominent Teaching Hospital in New York Completed

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/Healthcare-Design-Pharmacy/) is pleased to announce that a new inpatient pharmacy design that was designed by Bernstein & Associates, Architects, for a prominent New York teaching hospital, has been completed. The hospital size is over 700 beds. The project was a complete gut renovation of existing hospital space to create a completely new, state-of-the-art, inpatient hospital pharmacy.

Pharmacy design consulting services included: pharmacy programming, pharmacy planning, pharmacy design, and pharmacy equipment planning.

The project included all new: receiving/storeroom, distribution, USP 797 compliant compounding suite, compounding lab, purchasing, administrative support, and staff support.

Another feature of the pharmacy was the extensive use of pharmacy automation equipment.
**************
About Bernstein & Associates, Architects (www.bernarch.com):

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm has an international reputation for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (25) hospital pharmacies in the last 5 years, which have included USP 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies.

Pharmacy design projects by Bernstein & Associates, Architects are featured on http://bernarch.com/Healthcare-Design-Pharmacy/.

USP 797 articles can be found on: the USP 797 website www.usp797.org, the USP 797 blog http://www.usp797org.blogspot.com/, USP 797 Twitter account www.twitter.com/usp797, http://www.linkedin.com/company/usp797-org-inc-, and
https://www.facebook.com/usp797/

USP 800 articles can be found on the USP 800 website www.usp800.org, the USP 800 blog http://www.usp797org.blogspot.com/, USP 800 Twitter account www.twitter.com/usp800, http://www.linkedin.com/company/usp-guru, and https://www.facebook.com/usp800/

Pharmacy design articles can also be found on the pharmacy design website www.pharmacydesign.org.

For more information about healthcare and hospital design and construction, including pharmacy design, pharmacy equipment planning, planning for pharmacy automation equipment, and pharmacy construction, contact Bernstein & Associates, Architects at:
Bernstein & Associates, Architects
1201 Broadway - #803
New York, NY 10001
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles