Impact of United States Pharmacopeia chapter 797: Results of a national survey

Timothy A. Candy, Philip J. Schneider, Craig A. Pedersen

Research output: Contribution to journalReview articlepeer-review

18 Scopus citations


Purpose. The initial response of the pharmacy profesion to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied. Methods. A stratified random sample of 600 hospital pharmacy directors across the nation were surveyed by mail. Results. A total of 251 surveys (41.8%) were returned. Larger hospitals (≥200 staffed beds) were more likely than smaller hospitals (<200 staffed beds) to have read USP chapter 797 (80.0% versus 45.8%, respectively) and have a copy of the chapter (94.6% versus 78.0%, respectively). Overall, respondents felt that chapter 797 would negatively affect workload and pharmacy's ability to provide sterile preparations in a timely manners. Conversely, respondents replied that the new standards would have a positive effect on the quality of care provided by the hospital. Overall, 45.3% of respondents reported plans to build a cleanroom, and 21.7% reported plans to obtain new equipment to comply with chapter 797. Furthermore, 42.3% of respondents had decreased the quantity of high-risk compounding. Respondents also reported that their pharmacy's budget had increased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. Conclusion. USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall.

Original languageEnglish (US)
Pages (from-to)1336-1343
Number of pages8
JournalAmerican Journal of Health-System Pharmacy
Issue number14
StatePublished - Jul 15 2006


  • Aseptic areas
  • Automation
  • Budgets
  • Compliance
  • Compounding
  • Control, quality
  • Data collection
  • Disinfectants
  • Equipment
  • Pharmacists, hospital
  • Pharmacy, institutional, hospital
  • Quality assurance
  • Standards
  • Sterile products
  • United States Pharmacopeia
  • Workload

ASJC Scopus subject areas

  • Pharmacology
  • Health Policy


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