On November 1, 2022, the USP published updates to their general chapters on compounding nonsterile and sterile preparations. USP Compounding <795> and <797> revisions include updates to beyond-use dates (BUDs), highlight advancements in science and clinical practice, clarify topics that may have caused confusion, and incorporate feedback from both stakeholder engagements and public comments received.
BUDs are the dates after which a compounded sterile preparation (CSP) or compounded nonsterile preparation (CNSP) should not be used, stored, or transported. The date is estimated using the date and time the preparation is made. The risk posed to patients is greatly reduced by using these dates. If the compounds are used after their expiration dates, there is a greater risk of chemical degradation, microbial contamination, and a change in the content’s integrity.
BUD Update for USP <795>: Nonsterile Preparations
Previously, the two distinguishing categories that determined a change in BUD were “nonaqueous” and “water-containing”; however, this caused confusion in the compounding space because there were scenarios when determining whether a substance contains water or whether a vehicle containing small amounts of water is considered aqueous were unclear. As a result, these classifications have been removed in favor of a new term: water activity. This new term is used to determine whether nonsterile preparations are susceptible to microbial contamination and hydrolysis degradation.
BUD Update for USP <797>: Sterile Preparations
Similarly, in this chapter, the characterization was changed from microbial contamination risk levels to categories 1 and 2 CSPs. These two categories are distinguished primarily by the conditions under which the preparations were created, the likelihood of microbial growth, and the time period in which they must be used. Additionally, category 3 CSPs were introduced with requirements based on the compounding procedure and storage condition of the preparations.
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