Downloadable Documents for Compliance

Use these documents to aid in compliance with standards, whether State Boards of Pharmacy, USP or FDA.

The Gap Analysis for the current USP <795>, <797> and <800> are available now in Microsoft Word (.doc) or Excel (.xlsx) formats allowing easy modification to meet the requirements for your state.

The following documents are available:

USP <795> Pharmaceutical Compounding—Nonsterile Preparations
- Gap Analysis Survey - USP Format (MS Word .doc, 1,115 KB).
- Gap Analysis Survey - State Format (MS Word .doc 253 KB).

USP <797> Pharmaceutical Compounding—Sterile Preparations
- Gap Analysis Survey - USP Format (MS Word .doc, 1,600 KB).
- Gap Analysis Survey - State Format (MS Word .doc 608 KB).

USP <800> Hazardous Drugs—Handling in Healthcare Settings
- Preparation Checklist - Gap Analysis (MS Excel .xlsx, 1,445 KB).

- USP Chapter <800> Consensus Statement on Hazardous Drugs (Adobe .pdf, 1,716 KB) and Risk Assessment Templates (MS Excel, .xlsx, 125 KB)

- White Paper: Container-Closure System (Adobe .pdf, 31 KB).

- White Paper: Human-Use Sterilizing Filter Issue (Adobe .pdf, 1,258 KB).

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These documents may require Adobe Acrobat Reader.