USP <795> and <797> Updates: What Compounders and Practices Need to Know

The United States Pharmacopeia (USP) updated its compounding standards in 2023, with revised versions of USP <795> (Non-Sterile Preparations) and USP <797> (Sterile Preparations) taking effect. These updates have significant implications for compounding pharmacies and, by extension, for the medical practices that source from them.

This post covers the key changes and what they mean for your practice.

USP <795> and <797> are official standards published by the United States Pharmacopeia that govern pharmaceutical compounding. They are incorporated by reference into state pharmacy regulations in most states, making them legally binding for compounding pharmacies.

USP <795> covers non-sterile compounding — oral preparations, topicals, suppositories, and other preparations that do not need to be sterile.

USP <797> covers sterile compounding — injectable preparations, ophthalmic preparations, and other preparations that must be sterile.

The most significant change in the revised USP <795> is the restructuring of BUD date categories. The previous version had three categories (aqueous, non-aqueous, solid). The revised version has a more nuanced framework:

Category 1 BUDs (no stability data required):

• Aqueous preparations: 14 days refrigerated
• Non-aqueous preparations: 90 days at controlled room temperature or 180 days refrigerated
• Solid preparations: 180 days at controlled room temperature or refrigerated

Category 2 BUDs (stability data required):

• Longer BUD dates are permitted if the compounder has stability data supporting them
• The stability data must be from appropriate testing (not just literature references in all cases)

Implication for practices: Compounders assigning BUD dates longer than the Category 1 defaults must have stability data to support them. Ask your supplier which category their products fall into and whether they have the supporting data.

The revised USP <795> includes updated requirements for:

• Facility design and environmental controls
• Equipment calibration and maintenance
• Personnel training and competency assessment

More explicit requirements for:

• Master formulation records
• Compounding records
• Complaint handling
• Deviation management

The revised USP <797> significantly restructured BUD dates for sterile preparations:

Category 1 BUDs (no sterility testing required):

• Preparations compounded in ISO 5 environment
• BUDs: 12 hours at controlled room temperature, 24 hours refrigerated

Category 2 BUDs (sterility testing required):

• Preparations with longer BUDs require sterility testing
• BUDs up to 45 days at controlled room temperature or 90 days refrigerated (with testing)
• Longer BUDs require additional stability and sterility data

Implication for practices: Sterile compounded preparations with BUD dates longer than Category 1 limits must have sterility testing documentation. This is particularly relevant for injectable GLP-1 preparations.

The revised USP <797> includes updated requirements for:

• ISO classification of compounding areas
• Environmental monitoring programs
• Garbing and hand hygiene procedures
• Personnel competency assessment

More detailed requirements for master formulation records, including:

• Stability information
• BUD assignment rationale
• Quality control specifications

Your compounding supplier should be operating under the revised USP standards. Ask:

• "Are you operating under the revised USP <795> and <797> standards?"
• "What category are your BUD dates — Category 1 or Category 2?"
• "If Category 2, can you provide the stability data supporting your BUD dates?"
• "For sterile preparations, can you provide sterility testing documentation?"

Under the revised standards, COAs for sterile preparations should include sterility testing results. Verify that your supplier's COAs include all required testing.

The revised USP standards had a compliance deadline. Compounders that have not updated their practices to comply with the revised standards are operating out of compliance. This is a red flag.

Our pharmacy network operates under the revised USP <795> and <797> standards. We can provide documentation of our compliance posture and the stability data supporting our BUD date assignments.

Contact us with quality questions →

This content is for informational purposes only and does not constitute legal advice. USP standards are updated periodically. Consult current USP standards and qualified legal counsel for specific compliance guidance.