USP <795> / <797> vs USP <800>
The three compounding chapters — non-sterile, sterile, and hazardous drugs.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
Three USP chapters govern pharmacy compounding. <795> covers non-sterile compounding; <797> covers sterile compounding and its contamination controls and beyond-use dating; <800> covers the safe handling of hazardous drugs to protect personnel and the environment. They are complementary — a pharmacy compounding sterile hazardous drugs must satisfy all three — and acquire legal force through state adoption.
| ASPECT | USP <795> / <797> | USP <800> |
|---|---|---|
| Focus | <795> non-sterile quality · <797> sterility assurance | <800> worker & environmental protection from hazardous drugs |
| Primary risk addressed | Product quality and (in <797>) contamination of sterile preps | Occupational exposure to hazardous drugs |
| Key controls | Beyond-use dating, facilities, personnel competency, engineering controls | Containment engineering controls, PPE, spill control, deactivation |
| Applies when | Compounding non-sterile (<795>) or sterile (<797>) preparations | Handling any drug on the NIOSH hazardous-drug list |
| Overlap | A sterile hazardous compound triggers <797> + <800> | Layers on top of <795>/<797>, not instead of them |
| Legal force | Via state adoption by reference | Via state adoption by reference |
Apply <795> to non-sterile compounding and <797> to sterile compounding — the chapters that govern preparation quality, contamination control, and beyond-use dating.
Apply <800> whenever you handle hazardous drugs (per the NIOSH list) — it protects personnel and the environment through containment, PPE, and handling controls, and layers on top of <795>/<797>.
Think of them as stacking: <795> (non-sterile quality) and <797> (sterility assurance) govern the preparation, and <800> governs handling hazardous drugs regardless of sterility. A pharmacy compounding a sterile hazardous drug must satisfy <797> and <800> together. All three become enforceable through state adoption by reference — USP itself enforces nothing.
USP <795> / <797> vs USP <800>: frequently asked questions
Common questions on how USP <795> / <797> and USP <800> differ and when each applies.
What is the difference between USP <795>, <797>, and <800>?
<795> covers non-sterile compounding, <797> covers sterile compounding (contamination control and beyond-use dating), and <800> covers the safe handling of hazardous drugs to protect personnel and the environment. The first two are about product quality; <800> is about occupational and environmental safety.
Do the chapters overlap?
Yes — they stack rather than replace one another. A pharmacy compounding a sterile hazardous drug must meet <797> (sterility) and <800> (hazardous-drug handling) simultaneously, on top of general <795> quality principles for any non-sterile steps.
Are USP compounding chapters legally binding?
Not by themselves — USP is a standards body, not a regulator. The chapters acquire legal force where a state adopts them by reference (through its board of pharmacy or law), which most states do. Enforcement is by state boards and the FDA, not USP.
What triggers USP <800>?
Handling any drug identified as hazardous on the NIOSH hazardous-drug list. <800> then requires containment engineering controls, personal protective equipment, and handling/spill/deactivation procedures throughout receipt, storage, compounding, and disposal.