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Pharmacy Resource Center

Learn about USP 797 and your pharmacy! 

New trends are emerging in safety around both processes and equipment for the pharmacy.  United States Pharmacopeia has released a new chapter (USP 797, copies of which may be ordered from the USP web site) covering compounded sterile preparations, and other organizations are reviewing guidelines for preparation of hazardous drugs.

To help you stay current on the latest issues about aseptic preparation of parenteral drug products, The Baker Company has assembled the following set of links to online articles and references.

Return to the pharmacy products index or select a topic below for more information:

Compounded Sterile Preparations
Hazardous Drug Preparation
Guidelines and Standards
Barrier Isolator Technology

Compounded Sterile Preparations (CSPs)

• The Baker Company; Put Your Trust in Baker for Compliance with USP <797> Pharmaceutical Compounding - Sterile Preparations; May 2004
  
  Whitepaper from The Baker Company explains the requirements of USP <797> and assists in the selection of equipment to come into compliance.
  
  
• Thompson, Cheryl A; USP Publishes Enforceable Chapter On Sterile Compounding; ASHP web site release; September 4, 2003
  
  This article compares the ASHP guidelines to the new USP Chapter 797.  There is also a discussion of the regulatory impact for the FDA, JCAHO, and state boards of pharmacy.
  
  
• Wenzel R, Edmond M; The Impact of Hospital-Acquired Bloodstream Infections; Emerging Infectious Diseases, Vol. 7 No. 2, March-April 2001
  
  This report assesses the scope and cost of bloodstream infections in the hospital, underscoring the importance of maintaining sterile conditions during preparation.
  
  
• Kastango E; The Cost of Quality in Pharmacy; International Journal of Pharmaceutical Compounding, Vol 6 No 6, November/December 2002
  
  The benefits of maintaining high standards of quality in the pharmacy are discussed, citing real examples from recent incidents in California and Missouri.

Hazardous Drug Preparation

• Gebhart F; Watch out! Secondhand Chemo Alert Due From NIOSH; Drug Topics 2002;10:HSE1
  
  In this article, the author provides an update on an expected alert from the National Institute for Occupational Safety & Health regarding the potential for occupational exposure to chemotherapy and other hazardous drugs.
  
   
• Kiffmeyer TK, Kube C, Opiolka S, Sessink P, et al; Vapour Pressures, Evaporation Behaviour and Airborne Concentrations of Hazardous Drugs: Implications for Occupational Safety; Pharmaceutical Journal 9/Mar/2002, Vol 268 no 7188 pp331-337
  
  This paper reviews the findings of a study indicating that cytostatic and other hazardous drugs may evaporate and form a gas phase, and discusses the implications for designing appropriate safety measures.
  
   
• Connor TH, Anderson RW, Sessink PJ, Broadfield L, Power LA; Surface Contamination with Antineoplastic Agents in Six Cancer Treatment Centers in Canada and the United States; Am J Health Syst Pharm 1999 Jul 15;56(14):1427-32 [abstract only]
  
  This study provides evidence from a sample of facilities indicating that antineoplastic agents were detected on surfaces in pharmacy drug preparation and administration areas in cancer treatment centers, and includes a brief overview of the potential risks of exposure.
   

Guidelines and Standards

• ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, issued 2000
  

The American Society of Health-System Pharmacists provides a set of best practice guidelines for preparation of sterile products. 

• ASHP Submits Testimony at Senate Hearing on Compounding, ASHP Online News Release, October 23, 2003
  
  ASHP representatives gave testimony regarding the role of government, professional organizations, and pharmacists in regulating compounding.
  
  
• DeSorbo, Mark A; USP Releases Sterile Compounding Regulations; Cleanrooms, January 2004

Provides a summary of the environmental conditions stipulated by USP 797, and discusses the use of barrier isolators (gloveboxes) to meet the requirements.

Barrier Isolator and Glovebox Technology

• Tillet, L; Barrier Isolators as an Alternative to a Cleanroom; Am J Health Syst Pharm 1999 Jul 15;56(14):1433-6 [abstract only]
  
  This case study uses barrier isolators to insure sterility and containment in the preparation of cytotoxic and other hazardous agents. Relative to a cleanroom, the analysis found a reduction in costs attributable to reduced gown and glove use. 
   
• Cazin JL, Gosselin P; Implementing a Multiple-isolator Unit for Centralized Preparation of Cytotoxic Drugs in a Cancer Center Pharmacy; Pharm World Sci 1999 Aug;21(4):177-83 [abstract only]
  
  Another case study, this article details the selection process of equipment for an area within the pharmacy for the preparation of cytotoxic drugs. In addition to explaining the reasons for use of barrier isolators, this article also underscores the importance of a safety and quality standards.
   
• Farris J; Barrier Isolators and the Reduction of Contamination in Preparation of Parenteral Products; Cleanrooms, February 2002
  
  This study concludes that preparation of parenteral drug products may potentially generate airborne concentrations of antineoplastic agents, and that barrier isolators are effective as an engineering control to reduce the risk of exposure.