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Questions and Answers on USP 797
Questions and
Answers on USP 797 Provided by American Society of
Health-System Pharmacists, 7272 Wisconsin Avenue,
Bethesda, MD 20814, 301–657-3000:
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A3 Question: Does USP Chapter 797 provide all I
need to know about compounding sterile preparations?
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A3 Answer: No. USP Chapter 797 sets forth
standards, guidance, and examples for compounding
sterile preparations, but it does not provide specific
and comprehensive information describing how to meet
those standards. Persons who compound sterile
preparations should exercise their professional judgment
to obtain the education and training necessary to prove
their competence in managing sterile compounding
facilities and in sterile compounding processes and
quality assurance. Such education and training is
available from a variety of sources, including ASHP.
This answer provided by ASHP on
www.Ashp.org. The subject of this
question-and-answer session is constantly evolving because
of ongoing research, changes in legal and regulatory
requirements, and improvements in technology, and are
subject to the professional judgment and interpretation of
the practitioner due to the uniqueness of each pharmacy's
role in compounding sterile preparations. The author,
reviewers, editors, ASHP, and Baxter have made reasonable
efforts to ensure the accuracy and appropriateness of the
information presented. However, any reader of this
information is advised that the author, reviewers,
editors, ASHP, and/or Baxter are not responsible for the
continued currency of the information, for any errors or
omissions, and/or for any consequences arising from the
use of the information in the interview in any and all
practice settings. Any reader of this document is
cautioned that ASHP and Baxter make no representation,
guarantee, or warranty, express or implied as to the
accuracy and appropriateness of the information contained
in this interview, and will bear no responsibility or
liability for the results or consequences of its use
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