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Revisions and Impact

The United States Pharmacopeia (USP) is a scientific non-profit organisation that sets standards used worldwide for the identity, quality, purity and strength of medicines, as well as food ingredients and dietary supplements.

The organisation’s mission is to improve global health through public standards and related programs that help ensure that quality, safety, and benefit of medicines and foods. With the advancement of technologies and medicine, new standards are created to ensure the health and wellbeing of the public.

The previous standard classified compounded sterile preparations (CSPs) as low, medium, or high-risk CSPs based on the sterility of the starting components and the number and types of compounding manipulations. The published revision, however, eliminates this system of classifications and instead classifies sterile preparations as either a category 1 or category 2 CSP based on the conditions under which the product was prepared.

The published revision changes the system for assigning beyond-use dates to CSPs. Instead of assigning a maximum allowable beyond-use date (BUD) based on the risk level of the preparation, the published revision follows a new system for assigning BUDs based on several different factors related to achieving and maintaining sterility.



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