Beyond use dating for compounded pharmaceuticals

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Therefore, USP 797 and USP 795 are considered enforceable, while USP 1075 and USP 1160 are simply considered guidelines for best practices.

USP 795 - USP Chapter 795, Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals.

extemporaneous compounding - Extemporaneous compounding can be defined as the preparation, mixing, assembling, packaging, and labeling of a drug product based on a prescription from a licensed practitioner for the individual patient in a form that the drug is not readily available in (extemporaneous = impromptu, compounding = the act of combining things).Most expiration dates are given in years for commercial products.Beyond use dates are used for compounded preparations and are generally in days or months.The Joint Commission follows guidance from CMS on this issue, and surveyors from both agencies have cited organizations for not following the explicit directions in the manufacturer’s package insert when it comes to drug storage, stability, and beyond use dating.Only following the manufacturer’s directions for injectable medications has proven difficult and wasteful in some situations for two primary reasons: 1) complete information on storage, stability, compatibility, and beyond use dating is often not provided in the official prescribing information, and 2) newer, evidence-based information on these matters can sometimes be found in peer reviewed journals and compendia fully endorsed by national pharmacy organizations.

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