Direct comparison
USP 797 vs. 795 Compounding Compared
USP 797 (sterile) vs. USP 795 (nonsterile) compounding compared: environment, CSP categories, personnel testing, documentation, and beyond-use dating.
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How do USP 797, USP 795 compare side by side?
The table below compares USP 797, USP 795 across 8 procurement-relevant dimensions, from what it governs through typical settings.
Side-by-side comparison
| Dimension | USP 797 | USP 795 |
|---|---|---|
| What it governs | Compounding a preparation that must be sterile at administration (IV admixtures, TPN, injectables, ophthalmic, intrathecal) | Compounding a preparation that is not required to be sterile (most oral liquids, capsules, tablets, topical creams/ointments, suppositories) |
| Current official version | Published USP-NF 2023 Issue 1 (Nov 1, 2022); official since November 1, 2023 | Published USP-NF 2023 Issue 1 (Nov 1, 2022); official since November 1, 2023 — first major revision since 2014 |
| Compounding environment | Category 1: unclassified Segregated Compounding Area (SCA) with ISO Class 5 primary engineering control. Category 2: classified cleanroom suite (ISO Class 7 buffer room + ISO Class 8 or better anteroom). Category 3: full Category 2 facility plus additional testing. | A designated, suitably clean and organized compounding area with equipment appropriate to the preparations compounded — no ISO-classified cleanroom or sterile primary engineering control required. |
| Personnel competency testing | Garbing/hand-hygiene observation, gloved fingertip sampling, and media-fill testing, at intervals that vary by CSP category (verify exact interval against the current chapter) | Hand hygiene, garbing appropriate to nonsterile work, and technique-specific competency evaluation — no gloved fingertip sampling or media-fill testing, since there is no sterility claim to verify |
| Key documentation | Master formulation record, compounding record, CSP category assignment, environmental monitoring records, PEC/room certification records | Master formulation record and compounding record; documentation of any stability data relied on for beyond-use dating |
| Beyond-use date (BUD) basis | Primarily the CSP Category (reflecting the verified level of environmental control), plus storage condition, dosage form, and any sterility/stability testing or applicable stability data — see the current chapter's BUD tables for exact allowable periods. | Primarily whether the formulation is aqueous or nonaqueous, the dosage form/packaging, storage condition, and whether supporting stability data exists — the chapter provides conservative default BUDs where no stability data is available. |
| Interaction with USP 800 | If the drug is a NIOSH-listed hazardous drug and must be compounded sterile, 797 and 800 both apply — 800 layers additional containment engineering controls on top of 797's sterile-compounding requirements. | If the drug is a NIOSH-listed hazardous drug and is compounded nonsterile, 795 and 800 both apply — 800 layers additional containment requirements on top of 795's nonsterile compounding requirements. |
| Typical settings | Hospital IV/TPN rooms, outpatient infusion pharmacies, 503A/503B sterile compounding facilities, investigational drug services | Community and hospital outpatient pharmacies compounding oral/topical preparations, veterinary compounding, 503A nonsterile compounding facilities |
Common questions
Common questions about USP 797 vs USP 795
How do I know if a preparation falls under USP 797 or USP 795?
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The determining factor is whether the finished preparation must be sterile at the point of administration, not how complicated the compounding process is. An injectable, IV admixture, or ophthalmic/intrathecal preparation falls under 797 regardless of how simple the compounding steps are; an oral, topical, or other route that does not require sterility falls under 795, even if the formulation itself is complex.
Can a single pharmacy be subject to both chapters?
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Yes. Many hospital and community pharmacies compound both sterile and nonsterile preparations and have to satisfy 797's requirements for the sterile work and 795's requirements for the nonsterile work as separate, parallel compliance obligations — they are not alternatives to choose between.
Are USP 797 and 795 federally mandatory?
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Neither chapter is a self-executing federal statute. Both become enforceable mainly through state board of pharmacy regulations that incorporate the current USP-NF, and through accreditation surveys that reference it. Adoption language and enforcement timing vary by state, so confirm the specific rules of each state a pharmacy is licensed under.
Does USP 800 replace 797 or 795?
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No. USP 800 governs facility engineering controls for hazardous drugs specifically, and applies alongside whichever of 797 or 795 fits the preparation's sterility requirement — it adds containment requirements rather than substituting for either chapter.
