USP <797> & <800> software with live BUD, EM and containment strategy for every CSP.
The 2023 revision of USP <797> made beyond-use dating, environmental monitoring, gowning competencies and master formulation records enforceable requirements — and USP <800> added a NIOSH-list-driven assessment of risk, containment primary engineering controls and medical surveillance for hazardous drugs. V5 replaces the compounding logbook plus the EM spreadsheet plus the HD binder with one compounding-facility file the Board of Pharmacy inspector can navigate in an hour.
You're shopping because the last Board of Pharmacy inspection cited an outdated BUD table and a missed viable-air sampling round.
BUDs are assigned from a printed table that hasn't been updated since the 2023 revision took effect
Environmental monitoring — viable air, viable surface, non-viable particle counts — lives in three separate spreadsheets
Gowning and media-fill competencies are a training binder, not a workflow that gates hood access
The NIOSH HD list update lands and nobody re-runs the Assessment of Risk
Master formulation records and compounding records live as Word files, versioned by filename
Medical surveillance for HD-handling personnel is a paper attestation with no re-review clock
USP <797> / <800> compounding, run as one file.
BUD engine (Category 1 / 2 / 3)
Beyond-use date assigned from the 2023 <797> tables — Category 1 (≤12h controlled / 24h refrigerated), Category 2 (sterility-testing and storage tables), Category 3 (sterility-tested with extended dating) — from the CSP's composition, storage temperature and PET/sterility evidence, not a wall chart.
Environmental monitoring (viable + non-viable)
Sampling plan per ISO class — non-viable particle counts (ISO 5 / 7 / 8), viable air (active air per shift/day depending on category), viable surface at every risk-based location, personnel glove-fingertip and gowning — with action-level trending and investigation workflow when a limit is exceeded.
Gowning, garbing & media-fill competency
Initial and every-6-month (Cat 1/2) or every-12-month (Cat 3) competency — hand hygiene and garbing observation, gloved-fingertip sampling after garbing and after media fill, and media-fill test — with hood access gated on current competency status, no exception.
USP <800> Assessment of Risk
Every NIOSH-listed drug on the formulary carries either the default containment strategy (C-PEC in a C-SEC with negative pressure, closed-system transfer, PPE per activity) or a documented Assessment of Risk with alternative controls, re-evaluated on every NIOSH list update and at least every 12 months.
Master formulation & compounding records
Master Formulation Record per §14 with ingredients, calculations, equipment, procedure, QC and BUD — instantiated per prep as a Compounding Record capturing lot, expiry, weight/volume verified, personnel and in-process checks, electronically signed and retained per state Board rules.
PEC / C-PEC certification & medical surveillance
Every ISO 5 primary engineering control (LAFW, BSC, CACI, CAI) and USP <800> C-PEC certified every 6 months per CETA CAG-003 — cert on file, next-due clock live. HD-handling personnel medical surveillance baseline plus periodic per ASHP/USP guidance.
What changes the day this goes live.
- BUDs match the 2023 <797> tables for every CSP — no wall chart, no stale rules
- Missed EM samples surface the day they're missed, not at the annual inspection
- Gowning and media-fill status gates hood access — no untrained tech at the BSC
- A NIOSH HD list update triggers Assessment-of-Risk re-review inside a week
- The Board of Pharmacy inspector gets one compounding-facility file, not five binders
The frameworks a designated person owns.
USP <797> (Nov 2023)
Pharmaceutical Compounding — Sterile Preparations. Category 1/2/3 CSP framework, BUD tables, personnel training and competency, facility and engineering controls, environmental monitoring, cleaning/disinfection, sterilisation and sterility testing.
USP <800>
Hazardous Drugs — Handling in Healthcare Settings. Applies to receipt, storage, compounding, dispensing, administration and disposal of any drug on the NIOSH hazardous drug list — containment strategy, PPE, medical surveillance, spill response.
NIOSH HD List + State Board of Pharmacy
The current NIOSH list of antineoplastic and other hazardous drugs (2024 update) plus state-specific Board of Pharmacy compounding rules that adopt or supplement <797>/<800> for the licensee.
USP <797> / <800> software, answered.
How does V5 assign a BUD?
V5 evaluates the CSP against the 2023 <797> decision tree: Category 1 (compounded in a segregated compounding area, ≤12h controlled room temperature or 24h refrigerated), Category 2 (compounded in a cleanroom, dating from Table 11/12 based on sterility testing and storage), or Category 3 (sterility-tested with extended dating and endotoxin testing). The BUD is derived, signed and printed on the label — not chosen from a wall chart.
What environmental monitoring frequency does V5 enforce?
Non-viable particle counts every 6 months (or on facility change) per ISO 14644, viable air sampling per shift for Cat 2/3 (or per day of compounding), viable surface sampling monthly (Cat 2) or per shift (Cat 3), gloved-fingertip sampling after each garbing and after media fill. V5 schedules each sample, tracks receipt from the contract lab, trends against action levels and opens investigation when exceeded.
How does the USP <800> Assessment of Risk work?
For any NIOSH-listed drug on the formulary the default is full <800> containment. If the pharmacy elects an Assessment of Risk (typically for final dosage forms that don't require manipulation), V5 captures the drug, dosage form, activity, alternative containment strategy and PPE — signed by the designated person and re-reviewed at least every 12 months and on every NIOSH list update.
Does V5 handle non-sterile compounding under <795> too?
Yes. USP <795> for non-sterile compounding is supported by the same MFR/CR engine with the <795> BUD framework (aqueous / non-aqueous / solid, water-activity-based). The environmental and containment requirements diverge — <795> doesn't require ISO-classified space, but <800> containment still applies when the compound is on the NIOSH list.
Run USP <797> / <800> on one live compounding file.
Free trial. Real BUD engine, real EM, real gowning gates, real HD containment.