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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:

  • A3 Question: Does USP Chapter 797 provide all I need to know about compounding sterile preparations?
     

  • 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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