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Non-Sterile Compounding Under USP : Beyond-Use Dating Errors That Trigger Recalls

  • 78 minutes
  • 41 slides
What we'll cover
  • 0:00 Why BUD Errors Escalate
  • 8:00 USP Dating Logic
  • 18:00 Recall Trigger Mistakes
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What you'll take away

Practical shifts you can apply this week

  • Identify Recall-Prone BUD Errors

    Spot the dating decisions regulators question first in recalled non-sterile compounds.

  • Compare Defensible Dating Rationale

    See how sound support differs from copied dates, loose assumptions, and inherited defaults.

  • Diagnose Hidden Support Gaps

    Find where formulation, packaging, storage, and records quietly weaken an assigned BUD.

  • Apply A Pre-Release Review

    Use a practical method to challenge high-risk BUDs before product release and patient use.

  • Design A Corrective Action Plan

    Turn findings into SOP, training, and workflow fixes that reduce repeat BUD errors.

Agenda

What we'll cover

  1. 0:00

    Why BUD Errors Escalate

    Why dating mistakes lead to recalls, what patient risk looks like, and what this session covers.

  2. 8:00

    USP Dating Logic

    How dosage form, ingredients, water, packaging, storage, and evidence shape a defensible BUD.

  3. 18:00

    Recall Trigger Mistakes

    Copied BUDs, longest-ingredient shortcuts, water assumptions, and package-storage mismatches.

  4. 29:00

    Evidence That Actually Supports

    What counts as traceable support, where literature helps, and where it starts to wobble.

  5. 39:00

    High-Risk Product Scenarios

    Oral liquids, multi-ingredient creams, converted dosage forms, and frequently opened containers.

  6. 47:00

    Inspection And Complaint Signals

    The clues inspectors and complainants notice before anyone argues the science in detail.

  7. 54:00

    Build A Stronger Review

    A practical checklist, escalation points, recap, and next-step challenge review for your team.

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