Beyond-Use Date Documentation and USP 797: Supporting Complete MFR Records

Understanding BUD Requirements Under USP 797

Beyond-use dates (BUDs) are included in most Master Formulation Records (MFRs), but a BUD alone may not meet current USP 797 expectations. The 2023 revision of USP 797 introduced a two-category BUD framework and requires that each BUD entry also include the storage conditions and documented basis for the assignment. Ensuring complete BUD documentation can help pharmacies identify potential gaps before an inspection.

Common Documentation Gaps

Many MFRs created before the November 2023 revision still reflect the prior risk-level framework (low, medium, or high risk) instead of Category 1 or Category 2 designations. More commonly, MFRs list only the BUD timeframe, with storage conditions and rationale documented elsewhere or not at all.

When these elements are missing or separated, a BUD entry may be considered incomplete during an inspection, even if the timeframe itself is accurate.

Introducing Focal Pointe’s MFR Library

Focal Pointe’s MFR Library provides structured fields for each component of BUD documentation. By keeping the timeframe, storage condition, rationale, and supporting references together, pharmacies can maintain consistency and simplify review processes.

What Complete BUD Documentation Should Include

Note: Requirements reflect USP General Chapter <797> (2023 revision) as adopted by applicable state boards of pharmacy. Pharmacies should also verify alignment with state-specific and accrediting-body requirements.

• BUD timeframe: The assigned date or duration in days, hours, or minutes.
• Storage condition: The applicable storage method (refrigerated, controlled room temperature, or frozen) documented in the same section as the BUD.
• Documented basis for the assignment:
  • Category 1: Reflects compliance with environmental monitoring requirements.
  • Category 2: References specific sterility testing and stability data.
  The rationale should be clear and retrievable during an inspection.
• Supporting references: Compounding journals, compendial guidelines (USP chapters), published stability data, manufacturer stability information, and validated internal stability studies, including access dates where applicable.

Reviewing Your Current BUD Documentation

If your MFRs were created before the 2023 revision or migrated from a legacy system, reviewing BUD documentation is a practical starting point:

• Prioritize high-risk or frequently compounded sterile preparations.
• Verify that each record includes all four components: timeframe, storage condition, documented basis, and supporting references.
• Update records that still use prior risk-level terminology to reflect Category 1 or Category 2 designations.

How Structured MFR Systems Support Compliance

Structured MFR systems can help maintain complete BUD documentation by:

• Keeping components together: Dedicated fields prevent documentation from being scattered across sections.
• Supporting category designation: Structured fields prompt documentation of Category 1 or 2 rationale.
• Linking supporting references: Upload stability studies and library references with access dates for easy retrieval.
• Standardizing records: Consistent formatting across MFRs simplifies internal reviews and inspection readiness.

Note: While structured systems support documentation consistent with USP 797, pharmacies remain responsible for ensuring accuracy and compliance with all applicable regulatory requirements.

See How Focal Pointe’s MFR Library Can Help

Request a demo to explore how Focal Pointe’s MFR Library helps maintain complete, consistent BUD documentation. See firsthand how to:

• Review BUD entries across the MFR library
• Document category designation and rationale in structured fields
• Link supporting references with access date logging
• Ensure every BUD entry includes all required components

Request a Demo →