Compounding Records and Worksheets in BC

Compounding or manufacturing

• Compounding happens inside a client and healthcare professional relationship, for a therapeutic need or a product shortage. The pharmacist must be able to show that relationship.
• A pharmacy may prepare very limited quantities ahead of a prescription under a standardized batch procedure.
• Preparing products to sell to third parties outside that relationship is manufacturing. Manufacturing needs a Health Canada establishment licence, a Drug Identification Number, and a Notice of Compliance.

Sources: Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada) (read 2026-09-24)

What BC checks

• PODSA Bylaws section 19(2) bars dispensing a quantity of drug that will not be fully used before the manufacturer's expiry date.
• HPOA Bylaws Schedule E.1 requires the client record to include the generic name, strength, and dosage form of the drug, including compound formulations.
• PODSA Bylaws section 23.7 adopts the NAPRA model standards for sterile compounding. The CPBC practice review checks POL-0051, the expiry rule, and the client record for non-sterile work.

Sources: PODSA Bylaws (CPBC) (read 2026-09-24) · HPOA Bylaws, Schedule E.1 Community Pharmacy Services (CPBC) (read 2026-09-24) · Practice Review Program pharmacy review form (CPBC) (read 2026-09-24)

The Master Formulation Record

The NAPRA guidance puts the Master Formulation Record at the centre of a preparation. It holds everything needed to compound the product the same way every time.

• Name, strength, and dosage form of the preparation, with the expected yield.
• Each ingredient with its quantity, source, and lot number.
• Calculations for ingredient quantities and active ingredient doses.
• Compatibility and stability data with references.
• Equipment, special precautions, and personal protective equipment.
• Mixing instructions, a sample label with the assigned BUD, and the container and storage requirements.

Sources: Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)

The compounding record

The pharmacy keeps a compounding record for each individual prescription and for each batch. When a marketed drug exists, the reason for compounding goes in the client's file.

• Reference to the Master Formulation Record and the assigned batch or prescription number.
• Names, quantities, sources, lot numbers, and expiry dates of all ingredients.
• Date of preparation and total quantity compounded.
• Names of the people who prepared, quality-checked, and approved the preparation.
• The assigned beyond-use date and the results of quality control checks.

Sources: Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)

Beyond-use dates

A beyond-use date (BUD) is the date after which a compounded preparation should not be used. Without stability data for the specific preparation, the NAPRA guidance sets maximum BUDs by formulation type.

• Non-aqueous formulations: the earlier of the earliest ingredient expiry date or 6 months.
• Water-containing oral formulations: not later than 14 days, stored at a controlled cold temperature.
• Water-containing topical, dermal, mucosal, liquid, and semi-solid formulations: not later than 30 days.
• The BUD never exceeds the expiry date of any component.
• POL-0051 expects the expiry to rest on known stability data. Without it, the date should be short, usually limited to the duration of the prescription or use.

Sources: Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada) (read 2026-09-24) · Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)

How PharmFlow writes the worksheet

A PharmFlow compound worksheet stores the preparation name, instructions, and an ingredient list with drug name, DIN, quantity, unit, and concentration. Validation requires at least one ingredient with a name, a positive quantity, and a unit.

The aqueous flag suggests a default BUD: 14 days for an aqueous preparation and 180 days otherwise. The pharmacist assigns the real date against stability data and the formulation type.

Frequently asked questions

Does every compound need a compounding record?

Yes. The NAPRA guidance requires a compounding record for each individual prescription and for each batch preparation.

Sources: Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)

What beyond-use date fits a water-containing oral?

Not later than 14 days at a controlled cold temperature, where there is no stability data for the specific preparation.

Sources: Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)

Can a pharmacy compound stock for another pharmacy to sell?

Not outside the client and healthcare professional relationship. POL-0051 treats that as manufacturing, which needs a federal establishment licence. A pharmacy without a compounding service may contract another pharmacist who provides it.

Sources: Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada) (read 2026-09-24)

Does the PharmFlow default BUD replace the standard?

No. The worksheet suggests a date. The pharmacist assigns the BUD conservatively against stability data and the formulation type.

Sources: Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)

Sources

• Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada) (read 2026-09-24)
• Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA) (read 2026-09-24)
• PODSA Bylaws (CPBC) (read 2026-09-24)
• HPOA Bylaws, Schedule E.1 Community Pharmacy Services (CPBC) (read 2026-09-24)
• Practice Review Program pharmacy review form (CPBC) (read 2026-09-24)