USP Chapter 797 Frequently Asked Questions
- What is USP Chapter 797?
- How do I get a copy of USP Chapter 797?
- Does USP Chapter 797 provide all I need to know about compounding sterile preparations?
- What is a "Compounded sterile preparation" according to USP Chapter 797?
- Is USP Chapter 797 applicable just to pharmacies that compounding sterile products?
- Are enforceable sterile compounding standards necessary?
- What can I do now to meet the requirements of USP Chapter 797?
- What can I do if I have questions about USP Chapter 797 that aren't answered in the ASHP Compounding Resource Center?
1. What is USP Chapter 797?
USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. For more information, see the ASHP Discussion Guide on USP Chapter 797 [PDF].
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2. How do I get a copy of USP Chapter 797?
USP Chapter 797 is published in the 2004 edition of the United States Pharmacopeia 27—National Formulary 22 (USP-NF). The USP 27—NF 22 version contains both old and revised text of the chapter, which is confusing to some readers. A "clean" version with just the new text was published in the First Supplement to USP 27--NF 22 in February 2004. Because several other important chapters are referenced in Chapter 797, some experts have advised that the complete USP—NF reference be purchased.
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3. Does USP Chapter 797 provide all I need to know about compounding sterile preparations?
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.
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4. What is a "compounded sterile preparation" according to USP Chapter 797?
A "compounded sterile preparation" (CSP) is defined in USP Chapter 797 as a dosage unit that 1) is prepared according to manufacturer's labeled instructions; 2) contain nonsterile ingredients or employ nonsterile components and devices that must be sterilized before administration; or 3) is biologic, diagnostic, drug, nutrient, or pharmaceutical that possesses either of the two previous characteristics and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powder for injection, irrigations, metered sprays, and ophthalmic and otic preparations. For more information, see the ASHP Discussion Guide on USP Chapter 797.
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5. Is USP Chapter 797 applicable just to pharmacies that compound sterile products?
No. USP Chapter 797 requirements must be met in all health care settings in which sterile compounding takes place and by all disciplines involved in sterile compounding, including physicians, nurses, pharmacists, and pharmacy technicians. For more information, see the ASHP Discussion Guide on USP Chapter 797.
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6. Are enforceable sterile compounding standards necessary?
The FDA has long expressed concern about the quality of compounded preparations. Recent deaths caused by microbial contamination of injectable steroids have prompted several state boards of pharmacy to strengthen compounding regulations. Although ASHP published the profession's first sterile compounding standards in 1992, a 2002 survey of sterile compounding practices revealed low compliance with those voluntary standards. The lack of enforceable standards has allowed budget-driven health-system administrators to avoid making the investment necessary to construct and operate safe compounding facilities. ASHP believes that enforceable standards will improve compliance, enhance patient safety, and ultimately enrich the practice of pharmacy.
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7. What can I do now to meet the requirements of USP Chapter 797?
The first steps on the road to compliance with USP Chapter 797 include determining the risk level of the compounding done in your facility, performing a practice gap analysis of your compounding activities, and developing an action plan for compliance. You will likely find that some of elements of the action plan (for example, improved gowning, gloving, and hand washing procedures) are relatively easy and inexpensive to implement. For more information, see the ASHP Discussion Guide on USP Chapter 797.
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8. What can I do if I have questions about USP Chapter 797 that aren't answered in the ASHP Compounding Resource Center?
Be sure to read the Question and Answer on USP Chapter 797 with Clyde Buchanan. If you still have unanswered questions, you can contact USP. If you have questions or comments about the ASHP Compounding Resource Center, you can email the ASHP Practice Standards and Quality Division at quality@ashp.org.
ASHP Disclaimer
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.