15 Compounding Records
Compound Records
As was discussed previously, a formulation record serves as a standardized recipe for preparing a non-sterile compound. It ensures consistency, accuracy, and safety every time a particular compound is prepared, regardless of who performs the compounding. The formulation record is a master reference and is not updated with batch-specific data. It must be reviewed and validated periodically.
A compound record documents the actual preparation of a non-sterile compound. It includes batch-specific details and must be maintained for every prescription or batch prepared, regardless of whether it is a single-patient prescription or a batch for stock.
NAPRA-Required Elements of a Compound Record:
- Official or assigned name, strength, and dosage form
- Reference to the Master Formulation Record
- Names and quantities of all ingredients used
- Sources, lot numbers, and expiry dates of ingredients
- Total quantity compounded
- Assigned prescription number or batch number
- Date of preparation
- Assigned BUD
- Name of person(s) involved in:
- Preparing the compound
- Performing quality control checks
- Approving the final product
- Results of quality control (QC) procedures, such as:
- Weight range for filled capsules
- pH measurements
- Final volume/appearance checks
- Yield
- Any deviations from the Master Formulation Record
- Any observed problems, or adverse reactions reported
- Rationale for compounding, when applicable (e.g., patient allergy, commercial shortage, swallowing difficulties)
- Record of origin if the compound was made by another pharmacy (as permitted by provincial/territorial legislation)
Compound records can be paper-based or digital, using pharmacy software such as Kroll, and must be retained as required by the provincial/territorial pharmacy regulatory authority. For example, this may be 10 years or 2 years past the age of majority for pediatric patients.
Below is a sample paper compound record template. In most pharmacies, compound records are kept electronically in the software system, but must contain the same required information. An easy way to ensure this is to have a template that is copied into the electronic version every time, so nothing is missed.
Comparison Table: Formulation vs. Compound Record
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Recordkeeping for Compounded Preparations from Other Pharmacies
When dispensing a compound made by another pharmacy:
- The origin pharmacy must be documented.
- The dispensing pharmacy remains responsible for being able to track all preparations it dispenses.
- This supports traceability, quality assurance, and regulatory compliance.
Batch Records
- The compounding record for a batch, made in anticipation of a prescription (Rx)
- Usually filed by lot number
- Traceable to each patient
- Assign lot number based on date and compounder, e.g., DDMMYYYY-initial of compounder (04012025-JB)
- Keep records for batched compound in log book or computer software
Common Errors and how to avoid them:
| Common Error | Explanation | How to Avoid It |
|---|---|---|
| Incomplete or missing information | Omitting critical details such as lot numbers, expiry dates, or staff signatures. | Use a standardized checklist or digital template to ensure all fields are completed before final approval. Conduct a double-check process. |
| Illegible handwriting | Poor handwriting can lead to misinterpretation or failure to meet documentation standards. | Print clearly in black ink or use electronic records. Avoid cursive or unclear abbreviations. |
| Incorrect transcription from the Master Formulation Record | Copying wrong quantities, instructions, or ingredients from the MFR. | Always cross-check entries with the MFR before compounding. Have a second person verify transcription if possible. |
| Failure to document deviations | Changes in the process (e.g., ingredient substitution, equipment change) are not recorded. | Document all deviations with a clear explanation and rationale, including who approved the change. |
| Incorrect or missing BUD (Beyond-Use Date) | Assigning a BUD without following USP <795> or using outdated information. | Refer to the MFR or appropriate guidelines (e.g., USP <795>) and ensure the source for BUD determination is documented. |
| No reference to the Master Formulation Record | Failing to link the compound record to the source MFR used. | Ensure the exact title and/or unique ID of the MFR is recorded on the compound record. |
| Failure to track ingredient sources and lot numbers | Missing or incorrect documentation of ingredients used, compromising traceability. | Record each ingredient’s name, lot number, expiry date, and supplier immediately after weighing or measuring. |
| Lack of quality control results or missing QC documentation | Omitting test results (e.g., pH, weight checks), making it hard to verify product quality. | Perform and document all QC checks during compounding. Use predefined ranges and procedures from the MFR. |
| Unclear assignment of roles | It’s not documented who prepared, checked, or approved the compound. | Clearly identify each person’s role and require signatures or initials with date/time. This supports accountability. |
| Late or backdated entries | Documenting after-the-fact or altering dates to fit a timeline. | Record in real-time whenever possible. If corrections are needed, use strike-through with initials and explanation — never erase or backdate. |
| Poor storage of records | Records are lost, inaccessible, or not retained for the required period. | Follow your pharmacy’s and province’s retention policies (e.g., 10 years or 2 years past age of majority for pediatric records). Use secure, indexed storage — physical or electronic. |
Best Practice Tips:
- Practice using real templates in a simulated environment before working on live prescriptions.
- Double-check everything before signing off — another set of eyes is invaluable.
- Use initials with time and date for every documented step.
- Correct any errors with a strike-through with initials, date, and reason (audit-ready practices).
- Keep a “documentation mindset”: if it wasn’t recorded, it wasn’t done — especially in regulatory inspections.
Compound records are not just a formality — they are the backbone of professional, high-quality compounding practices. They document each compounding event in detail, from ingredient lot numbers and quality control checks to the identity of the staff involved. By completing accurate and complete compound records, you will ensure patient safety and dosage accuracy, support professional accountability, enable traceability in case of recalls or quality concerns, and stay compliant with provincial and national regulations.
