What is USP <795>?
United States Pharmacopeia chapter for nonsterile compounding. Covers quality standards, master formulation records, compounding procedures, and beyond-use dating for non-sterile preparations.
The 2023 revision of USP <795> tightened beyond-use dating around water activity: nonpreserved aqueous preparations are limited to 14 days refrigerated, preserved aqueous to 35 days, nonaqueous oral liquids to 90 days, and other nonaqueous forms to 180 days — always capped by the shortest ingredient expiry.
The chapter also expects designated persons, documented training and competency, master formulation and compounding records, and defined cleaning and facility standards for nonsterile compounding areas.
See how CompliRx handles this in practice:
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