Pharmacy Sterile Compounding (USP 797) Checklist [FREE PDF]

Pharmacists and pharmacy technicians use this checklist per USP General Chapter 797 pharmaceutical compounding sterile preparations and state board of pharmacy sterile compounding requirements.

  • Industry: Healthcare / Pharmacy
  • Frequency: Per Shift
  • Estimated Time: 10-15 minutes
  • Role: Compounding Pharmacist
  • Total Items: 8
  • Compliance: USP 797 (2023), State Board of Pharmacy

Cleanroom & Environmental Monitoring

Verify cleanroom conditions and environmental monitoring.

  • Is the ISO 7 buffer room maintaining positive pressure differential per USP 797?
  • Are viable and non-viable environmental monitoring results within action levels?
  • Has the cleanroom been cleaned and disinfected per the SOPs and schedule?
  • Cleanroom monitoring notes

Compounding Practices & Garbing

Verify aseptic technique and garbing compliance.

  • Are compounding personnel garbed properly (shoe covers, gown, gloves, mask, cap)?
  • Is aseptic technique maintained during compounding in the PEC (hood/isolator)?
  • Are beyond-use dates assigned per USP 797 based on risk level and storage conditions?
  • Compounding practices notes

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Why Use This Pharmacy Sterile Compounding (USP 797) Checklist [FREE PDF]?

This pharmacy sterile compounding (usp 797) checklist [free pdf] helps healthcare / pharmacy teams maintain compliance and operational excellence. Designed for compounding pharmacist professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: per shift.

Ensures compliance with USP 797 (2023), State Board of Pharmacy. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Pharmacy Sterile Compounding (USP 797) Checklist [FREE PDF] cover?

This checklist covers 8 inspection items across 2 sections: Cleanroom & Environmental Monitoring, Compounding Practices & Garbing. It is designed for healthcare / pharmacy operations and compliance.

How often should this checklist be completed?

This checklist should be completed per shift. Each completion takes approximately 10-15 minutes.

Who should use this Pharmacy Sterile Compounding (USP 797) Checklist [FREE PDF]?

This checklist is designed for Compounding Pharmacist professionals in the healthcare / pharmacy industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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