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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 B32: Packing
and Transporting Compounded Sterile Preparations - We
are an "outsourcing pharmacy" compounding admixtures for
local hospitals. What safeguards are needed for
packaging and transport to hospitals?
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Answer B32: Compounding
personnel are expected to select packing containers and
materials that maintain physical integrity, sterility,
and stability of CSPs during transit. Packaging must
protect CSPs from damage, leakage, contamination, and
degradation (e.g., from heat exposure) and protect
transit personnel from harm (if hazardous drugs are
transported). Compounding personnel should ascertain
that temperatures of CSPs during transit will not exceed
the warmest temperature specified on CSP labeling. This
means communication directly with couriers to learn
shipping durations and exposure conditions. Compounding
personnel must include handling and exposure
instructions on the outside of containers and obtain
assurance of compliance from transporters. Compounding
personnel must periodically review the delivery
performance of couriers to ascertain that CSPs are
transported efficiently and properly.
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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