Monday, October 19, 2009

USP 797 Compliance in 2009

New Article on USP 797 Compliance Published

Bernstein & Associates, Architects is pleased to announce the publication of a new article about USP 797 compliance. The article was published on USP 797 (, the website focused on design, construction and operation of USP 797 compliant pharmacies.

The article discusses the following:

- An interesting survey of USP 797 compliance in the United States in 2009 was recently published in Pharmacy Purchasing & Products magazine (
- The survey looks at various areas of USP 797 compliance.
- It begins with results of the most basic question: how many directors of pharmacy have read the USP 97 regulation
- Partial or full pharmacy compliance with USP 797 has also grown
- Full compliance with USP 797 is measured differently
- The approach of regulatory bodies towards USP 797
- State boards of pharmacy and USP 797 compliance
- JCAHO and USP 797 compliance
- Hospitals reporting a patient incident involving a compounding error during the past five years
- Continuing improvement in USP 797 compliance in pharmacies in the United States, as well as increased focus on USP 797 compliance by state pharmacy boards and JCAHO.

About the Author:

William N. Bernstein, LEED®AP, AIA is the principal of Bernstein & Associates, Architects ( and president of Equipment Planning, Inc. ( This architecture firm and equipment planning firm are well-known for pharmacy planning, pharmacy design and pharmacy architecture, including a sub-specialty in usp 797 compliant pharmacy design and construction. These pharmacy consulting firms have designed and equipment planned over twenty new pharmacies, pharmacy renovations, and pharmacy relocations in the past five years. The firm's principal --- William N. Bernstein, LEED®AP, AIA --- is a well known pharmacy architect and pharmacy equipment planner. He has written extensively on pharmacy design and pharmacy construction including usp 797 compliant pharmacies. Mr. Bernstein's pharmacy design articles can be found on, and his usp 797 articles can be found on the usp 797 website

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

Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, NY, NY 10011
T: 212.463.8200
F: 212.463.9898

For more information about pharmacy equipment planning, and pharmacy automation equipment specifications and planning, contact Equipment Planning, Inc. at:

Equipment Planning, Inc.
59 West 19th Street - 6A, NY, NY 10011
T: 212.463.08200
F: 212.463.9898

Tuesday, October 13, 2009

USP 797 Newsletter (October 2009) newsletter is a privately-owned website developed to aid understanding of the USP 797 regulation

October 2009

IN THIS ISSUE - Vendor News
- "Forward Thinking Pharmacy Design Boosts Patient Safety, Efficiency and Aesthetics"
- "CT International’s Bonric Manufacturing Facility in Malaysia is Pleased to Announce That it Has Been Certified ISO 14001"
- "EMLab P&K Supports Clients After Recent Flooding"

USP797 Seminars Being Offered - Questions and Answers - vendors
-------------------------------------------------------------------------------- - Vendor News

10/08/09: "Forward Thinking Pharmacy Design Boosts Patient Safety, Efficiency and Aesthetics"

A new hospital pharmacy design, for the Santa Barbara Cottage Hospital, has many goals, but the number one goal, from the beginning, was always clear: patient safety. The director of the pharmacy, Allan Cohen, PhD --- who signs all of his emails with the phrase “Patient Safety is Contagious – Pass It On!” --- and the Assistant Director, Sergio Castro, made sure that patient safety played a central role in the myriad decisions made in the planning and design process for the new pharmacy.

For full text of the article, go to:

10/05/09: "CT International’s Bonric Manufacturing Facility in Malaysia is Pleased to Announce That it Has Been Certified ISO 14001"

The ISO 14001 standard requires that an organization put in place and implement a series of practices and procedures that, when taken together, result in an environmental management system (EMS).

For full text of the article, go to:

10/02/09: "EMLab P&K Supports Clients After Recent Flooding"

You are probably aware of the recent flooding that took place in Georgia. In fact, many of EMLab P&K's clients are working hard to assist those in Georgia and the Southeast region. Flooding increases the need for environmental testing due to potential health risks associated with contaminated water from sewage and various waterborne agents. As a result, residents and property owners must deal with the potential for bacterial contamination, mold growth, sewage contamination and other environmental health concerns caused by flooding and water damage.

For full text of the article, go to:

USP797 Seminars Being Offered

Aseptic Processing and Compliance Tools for USP <797>
Fundamentals of Bioassay Practices
For more info go to:
-------------------------------------------------------------------------------- - Questions and Answers (latest Q&A posted on site)

RJLG Question 15: I have a question regarding the preparation of chemotherapy. I have a negative pressure glove box that is vented to the outside. It is currently in the same room as my positive pressure glove box. If I have verification from the manufacturer that the glove box does not need to be in a clean room--do I need to place the chemo glove box in a negative pressure room? Could I place it in a separate room without negative pressure. If my room does not have negative pressure--where is the appropriate area to store my chemo meds? I would appreciate any information you can send.

RJLG Answer 15: First, your glove box which is used to prepare hazardous drugs must meet the definition of a compounding aseptic isolator (CAI) or compounding aseptic containment isolator (CACI) and must be physically separated from other preparation areas (i.e., in a different room). If the CAI or CACI meets the conditions of the “Placement of Primary Engineering Controls” section of USP797 that allow usage outside of an ISO Class 7 buffer area or clean room, the room must be negative pressure (minimum 0.01 inch water column and 12 air changes per hour). If only a low volume of hazardous drugs are prepared and a closed system transfer device (CSTD) is used within the CAI or CACI, the room does not need to be negative pressure.

Regarding hazardous drug storage, please refer to RJLG Questions 12 and 14 in this Q&A section of the website.
Answer provided as a courtesy to by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor assumes any liability for the use or interpretation of this information. Please con consult your pharmacy consultant prior to taking any actions in your pharmacy.

For more USP 797 Questions and Answers, go to:
-------------------------------------------------------------------------------- Vendors

Bernstein & Associates, Architects

Analytical Testing
Aemtek, Inc.
Burgh & Schoenenberger Associates, Inc.
EM Lab P&K
EMSL Analytical Inc.
Pathcon Laboratories

Cleaning Products / Contamination Control
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Connecticut Clean Room Corporation
Contec, Inc.
CT International
Decon Labs Inc.
Dycem's CleanZone
Lymtech Scientific
Techniglove International

Cleanroom Design/Build Companies:
Clean Room Technologies, Corp.
Connecticut Clean Room Corporation
TAC Americas

Compliance Action Plans
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.

Contamination Control
Building Remediation Sciences

Environmental Monitoring
AES-Chemunex, Inc.
Building Health Check/Pure Air Control Services, Inc.
Controlled Environment Testing Association
ENV Services, Inc.
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.

Equipment Planning
Equipment Planning, Inc.

National USP 797 Testing Provider
Medical Technology Associates, Inc.

Project Management
Empire Projects, Inc.

Simplifi 797

Testing & Certification
Certco, Inc.
ENV Services, Inc.
Pure Air Control Services, Inc.
Technical Safety Services, Inc.

USP 797 Related Products
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree Laboratories Incorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems

USP 797 Related Organizations
American Society of Health System Pharmacists
United States Pharmacopeia
-------------------------------------------------------------------------------, Inc. ( is a privately-owned website developed to aid public understanding of the USP 797 regulation developed by U.S. Pharmacopoeia, and its JCAHO-mandated schedule for implementation
Contact Info for, inc.
59 West 19th Street, Suite # 6A, New York, NY 10011
T : 212-463-0800
F : 212-463-9898