HQ Cortex
All compliance regimes

USP <797> & <800> — Sterile and Hazardous Compounding

Pharmacy compounding standards for sterile preparations and hazardous drugs (only applies to compounding-pharmacy customers).

Supported
0(0%)
In progress
2(25%)
Not yet planned
6(75%)
Tracked8

Why this matters: USP <797> and <800> apply to pharmacies and 503B outsourcing facilities that compound sterile or hazardous-drug preparations. They are state-board enforceable and inspections frequently cite documentation gaps. HQ Cortex does not yet ship a compounding-pharmacy mode — this page tracks what we would need to add for that customer segment.

This regime applies to specific customer types. Listed here for transparency; deeper support requires an opt-in module.

Status legend

  • SupportedWe can do this today.
  • In progressPartially in place or actively in development.
  • Not yet plannedNot yet started or not in scope.

Sterile Compounding (<797>)

  • Master Formulation Records (MFR) per CSP

    In progress

    Locked, versioned MFRs per Compounded Sterile Preparation: ingredients, quantities, equipment, BUD, sterility/stability evidence.

    In HQ Cortex: Versioned formulation records map cleanly to MFRs. Compounding-specific fields (sterility classification, USP category) are not yet exposed.

    USP <797> §11

  • Beyond-Use Date (BUD) calculator

    Not yet planned

    USP <797> Category 1/2/3 logic (room temp / refrigerated / frozen); pull from <797> tables.

    In HQ Cortex: Not yet implemented.

    USP <797> §13

  • Personnel competency (gloved-fingertip, media-fill)

    Not yet planned

    Track gloved-fingertip sampling, media-fill testing, garbing competency; block scheduling if expired.

    In HQ Cortex: Not yet implemented.

    USP <797> §3

  • Environmental monitoring (EM)

    Not yet planned

    Temperature/humidity, viable air & surface sampling, action-level alarms with investigation workflow.

    In HQ Cortex: Not yet implemented.

    USP <797> §6

  • Sterility & endotoxin test capture

    In progress

    Attach lab results, link to batch, block release until passing.

    In HQ Cortex: QC test results can capture these; compounding-pharmacy-specific release gating is not yet wired.

    USP <797> §17

Hazardous Drugs (<800>)

  • NIOSH Hazardous Drug list sync

    Not yet planned

    Pull/sync the NIOSH HD list; flag products containing HDs; enforce HD-specific workflow.

    In HQ Cortex: Not yet implemented.

    USP <800> §3

  • HD Assessment of Risk (AoR)

    Not yet planned

    Per-HD/dosage-form AoR with alternative containment strategies recorded and reviewed annually.

    In HQ Cortex: Not yet implemented.

    USP <800> §3

  • Spill & exposure incident log

    Not yet planned

    Capture spill events, exposed personnel, medical surveillance follow-up.

    In HQ Cortex: Not yet implemented.

    USP <800> §15

References

Last reviewed: May 2026.