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
Friday, October 28, 2016
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
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
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
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
Friday, November 27, 2015
Vendors Listed 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
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