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Questions and Answers on USP 797
Questions and
Answers on USP Chapter 797 with Clyde Buchanan:
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Question B4: Sterile
Compounding Personnel - Our sterile compounding
personnel watch a video and take a test annually. Do
they also need to perform media fill testing?
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Answer B4: All
sterile compounding personnel must have not only
didactic review and exams but also annual media fill
testing of aseptic skills, initially and annually
thereafter for low- and medium-risk compounding, and
semi-annually for high-risk compounding. Compounding
personnel who fail written tests or whose media fill
test vials show gross colonization must be immediately
re-instructed and re-evaluated by expert compounding
personnel to assure correction of all aseptic practice
deficiencies.
Answer provided by E. Clyde
Buchanan, MS, FASHP, Senior Director of Pharmaceutical
Services for Emory Healthcare. He is also Adjunct
Professor at the Mercer University, Southern School of
Pharmacy. He received his B.S. Pharmacy degree from the
University of North Carolina and MS/Residency from The
Ohio State University. For six years he was Assistant
Director of Pharmacy at Duke University Medical Center,
then served as Director of Pharmacy at St. John's Hospital
in Springfield, Illinois for 11 years before going to
Emory.
He has served the American
Society of Health-System Pharmacists as Chair, Special
Interest Group on Administrative Practice; Vice Chair,
Council on Legal and Public Affairs; and member of the
House of Delegates, as wel as on several committees and
task forces and invited writer for several ASHP
publications, including
Compounding Sterile
Preparations, 2nd edition.
Mr. Buchanan has authored many
papers, book chapters, and two books, and he has spoken on
a national and international level on a variety of
clinical and administrative pharmacy topics.
All opinions expressed in the
following interview are those of Mr. Buchanan. When
evaluating specific recommendations regarding compounding
practices, practitioners are strongly encouraged to rely
on a wide array of sources, including state and local
authorities, accrediting bodies such as the Joint
Commission on Accreditation of Healthcare Organizations,
and organizations such as the United States Pharmacopeia,
as well as experts such as Mr. Buchanan.
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