Primary regulatory

USP General Chapter <797>: Pharmaceutical Compounding: Sterile Preparations

USP <797> establishes standards for sterile compounding including the use of bacteriostatic water for injection in multi-dose preparations, beyond-use dating, and storage requirements for reconstituted products.

United States Pharmacopeia (USP)Published 2023-11-01Accessed 2026-07-08

Open original source

Registry record

Source metadata

Publisher
United States Pharmacopeia (USP)
Source type
Primary regulatory
Registry ID
usp-797-sterile-compounding

Interpretation boundary

What this record can and cannot establish

Inclusion in the registry is not endorsement. The record supports only the claims that fit its design, population, date, and scope. Company, media, and community records can document that a claim was made without proving the claim itself.