Pharmacy Temperature Excursion Response Log

Inspection log for documenting pharmacy refrigerator temperature excursions, affected product identification, pharmacist disposition, excursion duration, and corrective actions taken.

Inspection Details

• Date and time excursion was discovered
• Storage unit identification
  Record the refrigerator, freezer, or cold storage unit ID/location.
• Inspector or reporter name
• Temperature monitoring device verified
  Confirm the device or data logger used to identify the excursion was checked for accuracy and status.

Excursion Event Details

• Observed temperature at start of excursion
• Observed temperature at end of excursion
• Excursion duration
• Temperature range outside approved limits
  Document the acceptable storage range and the actual out-of-range condition.
• Excursion was contained and storage unit secured
  Confirm the affected unit was secured to prevent further product exposure.

Affected Product Identification

• Affected product names or NDCs
  List all potentially impacted medications, vaccines, or biologics.
• Lot numbers recorded
  Document lot numbers for each affected product when available.
• Expiration dates recorded
  Document expiration dates for affected products when available.
• Estimated quantity affected
• Products segregated pending disposition
  Confirm affected items were quarantined or otherwise segregated from usable stock.

Pharmacist Review and Disposition

• Pharmacist reviewed excursion
• Disposition decision
• Pharmacist rationale documented
  Summarize the basis for the disposition decision, including reference to product stability information or SOP if applicable.
• Notification completed to required parties
  Select all parties notified regarding the excursion.

Corrective Actions and Follow-Up

• Root cause identified
  Document the likely cause of the excursion, such as door left ajar, equipment failure, or power interruption.
• Corrective action taken
  Describe immediate corrective actions taken to restore compliant storage conditions and prevent recurrence.
• Preventive action assigned
  Document any follow-up action, maintenance request, staff retraining, or SOP update.
• Follow-up verification scheduled
  Record the date and time for post-incident verification or maintenance follow-up.

Inspector Attestation

• Inspector signature
• Inspection completed