Saturday, February 14, 2009

USP 797 Newsletter (February 2009 edition)

This is a summary of the February 2009 edition of the USP 797 Newsletter:
(produced by the privately-owned website - Vendor News
"EMSL analytical offers analysis for USP 797 samples", 01/14/09
"EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the US Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected..."
For the full article go to:
"New Article on Design of Pharmacy to Conform with USP 797 (2008 version)", 01/31/09
"Bernstein & Associates, Architects is pleased to announce the publication of a new article about design of pharmacies to conform to the 2008 version of USP 797. The article has been published in the February 2009 edition of Hospital Newspaper. The article discussed the latest edition of USP 797, and how pharmacists and pharmacy managers should plan, design and construct their pharmacies to conform to USP 797..."
For the full article go to:
USP797 Seminars Being Offered
• Aseptic Processing and Compliance Tools for USP <797>
• Practical Application of USP's General Chapter <797>
For more info go to:
________________________________________ - Questions and Answers (latest Q&A posted on site)
• RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?
• RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.
All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.
Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”
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 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
Project Management:
Empire Projects, Inc.
Analytical Testing:
EM Lab P&K
EMSL Analytical Inc.
Cleaning Products / Contamination Control:
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Contec, Inc.
Decon Labs Inc.
Dycem's CleanZone
Lymtech Scientific
Medical Specialties Distributors, LLC(MSD)
Techniglove International
Cleanroom Design/Build Companies:
TAC Americas
Compliance Action Plans:
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.
Environmental Monitoring:
AES-Chemunex, Inc.
Controlled Environment Testing Association
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.
Simplifi 797
Testing & Certification
Aemtek, Inc.
Certco, Inc.
Technical Safety Services, Inc.
USP 797 Related Products:
The Baker Company
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree LaboratoriesIncorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems is a privately-owned website.
For more information about usp 797, go to the usp 797 website: Or go to the USP website itself at