USP 797 Compounding Pharmacy Design in Maryland

USP 797 Compounding Pharmacy Design in Maryland

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased to announce that it has been hired to provide compounding pharmacy architectural design services for a private compounding facility in Maryland.

Bernstein & Associates, Architects will be providing compounding pharmacy design services for this project including: compounding pharmacy programming, compounding pharmacy planning, compounding pharmacy design, and compounding pharmacy equipment planning.

The compounding pharmacy design is for a new, compounding suite for a privately owned company. It will include a state-of-the-art, ISO 7 compounding suite, with both hazardous compounding and non-hazardous compounding, designed to comply with USP 797 and USP 800 regulations.

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 is well-known for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (35) hospital pharmacies in the last 10 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.

USP 800 compliant design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase which have been designed to comply with USP 800.

A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:

http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care

Pharmacy design projects by Bernstein & Associates, Architects  are featured on:
- www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
- www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
- www.pharmacydesign.org (the Pharmacy Design website)
- https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
- https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
- www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
- www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)

For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles

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/

Refining PPE Usage for HD Compounding

Refining PPE Usage for HD Compounding: Part I

This article --- written by Kate Douglass, MS, RN, CRNI, Amanda Richter, CPhT, Melanie Dorey, CPhT, and Izzat Rizvi --- reviews PPE requirements relative to USP 800.

The article focuses on gowns and shoe covers, and is a useful article for pharmacists looking to provide the optimal PPE in the new regulatory environment of USP 800.

To read the full article: https://www.pppmag.com/article/2000

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

USP 797 Pharmacy Design Project in Connecticut

USP 797 Pharmacy Design Project in Connecticut

Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased to announce that architectural and engineering construction documents for a new pharmacy project in Connecticut have been completed.

Bernstein & Associates, Architects provided pharmacy design services for this project including: pharmacy programming, pharmacy planning, pharmacy design, and pharmacy equipment planning.

The pharmacy design project is for a new, compounding suite for an inpatient, hospital pharmacy. It includes a state-of-the-art, ISO 7 compounding suite, with both hazardous compounding and non-hazardous compounding, designed to comply with USP 797 and USP 800 regulations.

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 is well-known for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (35) hospital pharmacies in the last 10 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.

USP 800 compliant design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase which have been designed to comply with USP 800.

A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:

http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care

Pharmacy design projects by Bernstein & Associates, Architects  are featured on:
- www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
- www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
- www.pharmacydesign.org (the Pharmacy Design website)
- https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
- https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
- www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
- www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)

For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles

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/

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 USP 800 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

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

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

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