Standard Operating Procedures safety compliance

Pharmacy Sterile Compounding (USP 797)

USP 797 sterile compounding — garb, hand hygiene, hood prep, aseptic technique, BUD.

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Built for: Healthcare Pharmacy

What's inside this template

Steps

Pre-compound prep
Verify order, gather supplies, perform garbing in ante-area: hair cover, beard cover, mask, shoe covers, gown.
Hand hygiene + sterile gloves
Surgical hand wash 30 sec to elbows. Don sterile gloves in buffer area.
Hood preparation
Sterile 70% IPA wipe of hood interior. Allow 30 sec dry time. Confirm continuous airflow indicator.
Aseptic compounding
Maintain critical-zone air integrity. Disinfect every vial / port with sterile IPA wipe + 30 sec dry. Direct compound flow through first-air.
Verify + label + BUD
Pharmacist or qualified tech-check verifies. Label with patient, drug, dose, route, BUD per USP 797.
Document + remove
Compound log entry. Carry into transfer airlock. Record ambient air conditions if alerts triggered.

Common use cases

IV admixture compounding

TPN preparation

Chemo prep (combine with USP 800)

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Type: safety Category: Safety Compliance Difficulty: Advanced Time: 45 min Pharmacist Pharmacy Tech Sterile Compounding Pharmacy IV Room

1

Pre-compound prep
5 min

Verify order, gather supplies, perform garbing in ante-area: hair cover, beard cover, mask, shoe covers, gown.

Hair cover Mask Beard cover Shoe covers Sterile gown
2

Hand hygiene + sterile gloves
2 min

Surgical hand wash 30 sec to elbows. Don sterile gloves in buffer area.
Hood preparation verification
3 min

Sterile 70% IPA wipe of hood interior. Allow 30 sec dry time. Confirm continuous airflow indicator.
4

Aseptic compounding
25 min

Hand position blocking first-air to a critical zone is the most common technique error.

Maintain critical-zone air integrity. Disinfect every vial / port with sterile IPA wipe + 30 sec dry. Direct compound flow through first-air.
Verify + label + BUD verification
5 min

Pharmacist or qualified tech-check verifies. Label with patient, drug, dose, route, BUD per USP 797.
6

Document + remove
5 min

Compound log entry. Carry into transfer airlock. Record ambient air conditions if alerts triggered.

Outcome: CSP labeled, dispensed, log entry complete.