Usp 797 low risk beyond use dating

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While the safety of compounded sterile preparations (CSPs) has been an important topic in the practice of pharmacy for decades, the recent tragic deaths related to fungal contamination of preservative-free methylprednisolone injection have once again put the topic on the national stage.

IPA used to sanitize gloves, surfaces, and critical sites shall remain at least 30 seconds before such materials are contacted to prepare CSPs.

The next official will appear either in an annual USP revision, e.g., USP 29 in 2006, or in one of the two semiannual supplements to each annual USP revision.

The earliest possibility, but an unlikely probability, would be Supplement 2 to USP 28 in late 2005.

It has since been adopted by some pharmacy regulatory and accrediting bodies, especially some U. state boards of pharmacy, and the Joint Commission on Accreditation of Health Care Organizations, JCAHO. The process to create or revise USP content, which includes opportunity for public involvement, is described in the front pages of each bimonthly issue of USP’s official journal, Pharmacopeial Forum, PF.

The SCC met October 13-14, 2004, during and within five weeks following which it approved the proposed revisions to that are summarized here.

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