On November 1, 2023, the updated United States Pharmacopoeia (USP) chapters <795> and <797> compounding standards will become effective.  How well do you know what’s in the new standards and what this means for your pharmacy?  Let’s take a deep dive into this important topic for any pharmacy that engages in sterile or non-sterile compounding. 

We are currently a little over halfway through the one-year implementation timeline since the revised USP <795> and <797> standards were published on November 1, 2022.  The updated guidelines reflect advancements in the science and practice of compounding, along with stakeholder feedback, and are intended to improve the quality and safety of compounded drugs.  On November 1, 2023, the revised chapters will become effective, and many state pharmacy boards have added new guidelines to their respective pharmacy regulations. This article will provide a detailed overview of the new guidelines to help pharmacies comply with adoption of these updated requirements.

Many of the updated guidelines center around Beyond-Use Date (BUD) calculations for compounded sterile and non-sterile preparations.  Beyond-Use Dates are the time limits after which a compounded preparation must not be used or kept.  After the BUD arrives, the compounded preparation may be at increased risk of microbial contamination, degradation, or loss of container closure system integrity.   The BUD is calculated based on the date and time the compound is prepared.  Assigning and complying with clinically appropriate BUDs is necessary to ensure patient safety.   

USP <795> – Non-Sterile Compounding 

Non-sterile compounding is more than just coal tar ointments and magic mouthwash – USP <795> also covers commercially available compounding kits (ex. erythromycin/benzoyl peroxide gel) and flavoring agents like FlavoRx.  However, non-sterile compounding does not include tablet splitting, or reconstituting antibiotic suspensions. Read more >