Allergen Immunotherapy Extract Mixing Log

Date/Time of Preparation: [Date and time of compounding]

Patient Name: [Patient full name]

DOB or MRN: [Date of birth or medical record number]

Ordering Clinician: [Clinician name and credentials]

Order/Prescription ID: [Order or prescription identifier]

Prescription Set ID: [Internal identifier for this compounded set]

Protocol Reference: [Protocol name and version] (Reference only; do not reproduce the dosing schedule in this log)

Prescription Set Summary

Intended Use: [New start / Refill / Re-mix after change / Transfer-in verification]

Total Number of Vials Produced: [Count]

Vial Size: [Volume per vial in mL]

Total Yield: [Total volume in mL]

Vial Details

(Repeat the following block for each vial in the prescription set.)

[Vial Number/Label Code]

Dilution: [Dilution ratio, e.g., 1:1 v/v, 1:10 v/v]

Final Volume (mL): [Final volume]

Beyond-Use Date (BUD): [Assigned BUD]

Storage Conditions: [Refrigerate per policy / Other]

Changes vs Prior Set: [Lot change, manufacturer change, concentration change, or other modifications] (Only include if applicable)

Component Table

(List every component used in compounding. Do not infer lot numbers, expiration dates, concentrations, or volumes—transcribe exactly as printed on source containers. Add rows as needed for all allergen extracts, diluents, and added substances.)

Component Type	Allergen/Component Name	Manufacturer	Source Concentration/Activity as Labeled	Lot Number	Manufacturer Expiration Date	Volume Added (mL)
[Allergen extract / Diluent / Added substance]	[Name; include genus/species if used]	[Manufacturer]	[Value and unit: BAU/mL, AU/mL, w/v, PNU]	[Lot number]	[Expiration date]	[Volume]
[Allergen extract / Diluent / Added substance]	[Name; include genus/species if used]	[Manufacturer]	[Value and unit: BAU/mL, AU/mL, w/v, PNU]	[Lot number]	[Expiration date]	[Volume]
[Allergen extract / Diluent / Added substance]	[Name; include genus/species if used]	[Manufacturer]	[Value and unit: BAU/mL, AU/mL, w/v, PNU]	[Lot number]	[Expiration date]	[Volume]

Beyond-Use Date Assignment

Mixing Date: [Date mixed]

Assigned BUD: [Assigned BUD]

BUD Basis: (Select all that apply)

• [ ] Earliest expiration among allergen components
• [ ] Earliest expiration among diluents
• [ ] Maximum allowable interval from mix date per policy (typically 1 year)
• [ ] Other: [Specify]

Quality Control and Release

• [ ] Visual inspection completed (clarity, particulates, container integrity, stopper/seal)
• [ ] Label applied and verified: patient identifier(s), vial number, dilution, BUD, storage instructions
• [ ] Refrigerated storage placement confirmed

Storage Location Identifier: [Location]

QC Outcome: [Approved for release / Not released—quarantined]

Deviation/Comments: [Document any QC failures, missing traceability data, or other issues requiring quarantine] (Only include if deviation present)

Attestation

Prepared by: [Name/Initials] Date/Time: [Date and time]

Verified by: [Name/Initials] Date/Time: [Date and time] (If verifier sign-off is pending, record "Verifier pending" and do not mark as released)

Supervising Clinician: [Name] Signature: ____ Date/Time: [Date and time]

On-site During Preparation: [Yes / No]

Supervising Clinician Attestation: "I attest that compounding occurred under my supervision and that the prepared prescription set matches the ordered formulation and labeling requirements."