USP Previews New Compounding Standards

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The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.


The US Pharmacopeial Convention (USP) has preposted its General Chapter <797> “Pharmaceutical Compounding-Sterile Preparations” for public comment. The chapter, which is to be published in the United States Pharmacopeia–National Formulary, has been under review by the Compounding Expert Committee since 2010 and has been revised to clarify requirements and incorporate feedback from stakeholders. 

Changes to the chapter include combining three previous compounding sterile preparations (CSP) contamination risk levels (low-, medium-, and high-risk) into two categories. The two categories, Category 1 and Category 2, are based on the conditions under which they are made and the time within which they will be used.  Category 1 CSPs have a shorter maximum beyond use date (BUD). Category 2 CSPs have a longer maximum BUD depending on factors such as sterility considerations. 

Chapter <797> includes expanded personnel qualification, such as more guidance on training, evaluation, and requalification of compounding personnel. Certain environmental monitoring requirements were increased, and the term “in-use time” was added. The term refers “to the time before which a manufactured product or CSP must be used after it has been opened or punctured.”


Also, information on the handling of hazardous drugs has been removed from Chapter <797> and move into Chapter <800> “Hazardous Drugs-Handling of Hazardous Drugs in Healthcare Settings,” which is currently under review.

“The proposed revision represents major changes in concepts and terminology, and therefore we believed it was important to give ample time for our stakeholders to comment on those changes,” said Jaap Venema, executive vice-president and chief science officer at USP, in a press release. “We are confident that the changes in Chapter <797> will help practitioners better understand and comply with the standards to prepare quality compounds.”

USP will hold an open microphone session on Oct. 21, 2015 where stakeholders can ask questions about the revision. The chapter can be found on USP’s website and will be officially posted on the Pharmacopeial Forum on Nov. 2, 2015.

Source: USP