# Compounding Records and Worksheets in BC Health Canada and NAPRA rules for non-sterile compounding: the compounding and manufacturing line, the Master Formulation Record, the compounding record, and beyond-use dates. Last updated September 24, 2026. Canonical HTML version: https://pharmflow.io/guides/compounding-worksheets Compounding means combining two or more ingredients, at least one a drug or active component, to make a final product ready for dosing. Health Canada policy POL-0051 draws the line between compounding and manufacturing. This guide lists the records a non-sterile compounding service keeps and the beyond-use date limits in the NAPRA guidance document. - Source: [Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada)](https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html) (read 2026-09-24) - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (read 2026-09-24) ## 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. - Source: [Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada)](https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html) (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. - Source: [PODSA Bylaws (CPBC)](https://library.bcpharmacists.org/6_Resources/6-1_Provincial_Legislation/5082-PODSA_Bylaws.pdf) (read 2026-09-24) - Source: [HPOA Bylaws, Schedule E.1 Community Pharmacy Services (CPBC)](https://library.bcpharmacists.org/6_Resources/6-1_Provincial_Legislation/5322-HPOA_Bylaws.pdf) (read 2026-09-24) - Source: [Practice Review Program pharmacy review form (CPBC)](https://library.bcpharmacists.org/5_Programs/5-2_PRP/5164-PRP_PharmReview_Form.pdf) (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. - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (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. - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (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. - Source: [Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada)](https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html) (read 2026-09-24) - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (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. - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (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. - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (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. - Source: [Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada)](https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html) (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. - Source: [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (read 2026-09-24) ## Sources - [Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051 (Health Canada)](https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html) (read 2026-09-24) - [Guidance Document for Pharmacy Compounding of Non-sterile Preparations (NAPRA)](https://www.napra.ca/publication/guidance-document-for-pharmacy-compounding-of-non-sterile-preparations/) (read 2026-09-24) - [PODSA Bylaws (CPBC)](https://library.bcpharmacists.org/6_Resources/6-1_Provincial_Legislation/5082-PODSA_Bylaws.pdf) (read 2026-09-24) - [HPOA Bylaws, Schedule E.1 Community Pharmacy Services (CPBC)](https://library.bcpharmacists.org/6_Resources/6-1_Provincial_Legislation/5322-HPOA_Bylaws.pdf) (read 2026-09-24) - [Practice Review Program pharmacy review form (CPBC)](https://library.bcpharmacists.org/5_Programs/5-2_PRP/5164-PRP_PharmReview_Form.pdf) (read 2026-09-24)