For any pharmacy engaged in compounding — whether non-sterile preparations, sterile injectables, or hazardous drugs — understanding the United States Pharmacopeia (USP) general chapters that govern your practice is not optional. These standards directly determine the quality requirements for every Active Pharmaceutical Ingredient (API) you source and every preparation you produce.
Overview: The Three Core USP Compounding Chapters
There are three primary USP general chapters that apply to most compounding pharmacies in the United States:
- USP <795> — Pharmaceutical Compounding: Nonsterile Preparations
- USP <797> — Pharmaceutical Compounding: Sterile Preparations
- USP <800> — Hazardous Drugs: Handling in Healthcare Settings
USP Chapter <795>: Nonsterile Compounding
USP <795> governs the preparation of compounded medications that are not intended to be sterile — including creams, ointments, oral solutions, troches, suppositories, and capsules. The 2023 revision (effective November 2023) significantly updated requirements around:
- Beyond-Use Dating (BUD) — the period after compounding during which a preparation may be used, now more conservatively defined based on water activity and storage conditions
- Quality control — written procedures for ingredient verification, equipment calibration, and finished preparation testing
- Master Formulation Records — detailed documentation requirements for every compounded formulation
- Compounding Supervision — the licensed pharmacist’s direct oversight requirements
API Quality Requirements Under USP 795
Under USP <795>, APIs must be obtained from suppliers that can provide appropriate documentation, typically including a CoA confirming the substance meets USP monograph standards (where a monograph exists) or otherwise demonstrates suitable pharmaceutical-grade quality. Using a non-pharmaceutical-grade ingredient when a pharmaceutical-grade alternative exists is a direct violation.
USP Chapter <797>: Sterile Compounding
USP <797> governs preparations that must be sterile — including injections, ophthalmic preparations, and any preparation administered directly into the body where contamination could be life-threatening. The 2023 revision introduced major changes including:
- New contamination risk categories — replacing the old Category 1/2/3 system with a simpler Category 1 (no sterility testing required, shorter BUDs) and Category 2 (sterility testing required, longer BUDs)
- Environmental monitoring requirements — more rigorous airborne particle and viable organism testing in cleanrooms
- Personnel training and competency — annual gloved fingertip sampling, media fill testing, and garbing competency evaluations
- Facility design standards — ISO classification requirements for cleanrooms and ante-areas
API Quality for Sterile Compounding
For sterile preparations, the API quality bar is even higher than for non-sterile. APIs must meet endotoxin/pyrogen specifications, and suppliers should provide endotoxin test results (LAL test) as part of their documentation package. This is a requirement that many lower-quality API suppliers cannot meet.
USP Chapter <800>: Hazardous Drug Handling
USP <800> applies to any healthcare setting that handles drugs classified as hazardous — including many oncology drugs, antiviral compounds, and certain hormone therapies commonly used in compounding. Key requirements include:
- Designated negative pressure rooms for hazardous drug compounding
- Personal protective equipment (PPE) protocols
- Closed system drug transfer devices (CSTDs)
- Staff training on hazardous drug exposure risks
- Medical surveillance programs for exposed personnel
State Enforcement: Know Your Jurisdiction
While USP sets the federal guidance framework, actual enforcement is primarily conducted by State Boards of Pharmacy. As of 2024, most states have formally adopted USP <795> and <797> as enforceable standards, though the timeline varies. A few states have enacted even stricter local requirements.
The FDA enforces cGMP requirements for 503B outsourcing facilities, which go significantly beyond USP requirements and include full manufacturing-level controls.
How API Sourcing Connects to Your USP Compliance
Your compliance with USP <795> and <797> starts before any compounding takes place — it starts with your API supplier. A supplier who cannot provide batch-specific CoA documentation, cannot demonstrate third-party testing, or sources from unverified manufacturers puts your entire compliance program at risk.
MedConnectRx maintains supplier qualification records for every API source we use, and we can provide documentation packages that align with your internal USP compliance program. Contact us to discuss your specific documentation needs.