The non-sterile compounding SOP list: 33 topics

By Dumitru Musteata, RPh, Pharmacy Compounding Compliance. Last reviewed October 1, 2026.

This guide is independent commentary. It has not been reviewed, approved or endorsed by NAPRA or by any pharmacy regulatory authority, and the interpretations in it are the author’s own, not NAPRA’s. Your provincial or territorial regulator sets the requirements that apply to your pharmacy. They may or may not be based on NAPRA’s model documents and can differ between provinces, so always check your regulator’s current documents.

The non-sterile compounding standards require written policies and procedures for all compounding activities. The guidance document turns that into a concrete list: Table 3, in section 5.3.1, names 33 topics. This guide sets out the list, shows which topics apply to which pharmacies, and describes how each procedure should be built.

What the standards and guidance say about procedures

  • Policies and procedures must be established for all activities related to compounding. They must be clear and describe the activities in detail, including cleaning.
  • They must be reviewed at least every 3 years, or sooner if practice or standards change, and updated promptly when a change affects practice. The review should be documented.
  • Additional procedures are required if staff handle hazardous products.
  • The non-sterile compounding supervisor must make sure the procedures are applied and followed.

The guidance document describes Table 3 as a list of potential policies and procedures. It is a starting point, not a rule that every pharmacy must hold all 33.

A. Personnel and facilities (12 topics)

  • A.1.1 Attire and dress code: personal clothing, jewellery, hairstyles
  • A.1.2 Health conditions: reasons for temporary withdrawal from compounding
  • A.1.3 Expected behaviour in compounding areas: no eating or drinking, following procedures, avoiding unnecessary conversation
  • A.2.1 Initial training and assessment program
  • A.2.2 Program to assess maintenance of competency
  • A.2.3 Training and assessment of cleaning and disinfecting personnel
  • A.2.4 Additional training for handling and compounding complex or hazardous products
  • A.3.1 Delegation of technical activities to people other than pharmacists or pharmacy technicians
  • A.4.1 Access to the controlled area or room
  • A.4.2 Necessary facilities and equipment
  • A.4.3 Maintenance of facilities and equipment: certification, calibration, filters, pressure verification
  • A.4.4 Cleaning of facilities and equipment

B. Compounded non-sterile preparations (17 topics)

  • B.1 Beyond-use dates of products used in a preparation
  • B.2 Beyond-use dates of final preparations
  • B.3 Hand hygiene
  • B.4 Personal protective equipment in compounding areas and for compounding
  • B.5 Bringing equipment and products into the room
  • B.6 Deactivation, decontamination and cleaning of the containment device
  • B.7 Receipt, unpacking and storage of hazardous products
  • B.8 Verification of the compounding process, including validation of calculations by a pharmacist, and of final preparations
  • B.9 Labelling of final preparations
  • B.10 Packaging of final preparations
  • B.11 Storage of products used and of final preparations
  • B.12 Transport and delivery of final preparations
  • B.13 Recording of preparations in the patient file
  • B.14 Hazardous waste management
  • B.15 Accidental exposure of personnel to hazardous products
  • B.16 Spills and spill management
  • B.17 Recall of products, ingredients or compounded preparations

C. Quality assurance program (4 topics)

  • C.1 Verification and maintenance of equipment, and verification of appropriate storage of ingredients
  • C.2 Environmental control of facilities and the primary engineering control
  • C.3 Environmental monitoring of chemical contamination for hazardous products
  • C.4 Quality assurance of compounded preparations: a protocol, compliance with the prescription, documentation in logs

Which topics apply to your pharmacy

Most of the list applies to any pharmacy that compounds: personnel, training, cleaning, beyond-use dates, hand hygiene, verification, labelling, packaging, storage, delivery, records, recalls and quality assurance. Some topics depend on what you handle:

  • Hazardous products: B.7, B.14, B.15 and B.16, plus the hazardous part of A.2.4. If your risk assessments show that you handle hazardous drugs or materials, even occasionally, additional procedures are required.
  • A containment device or controlled room: B.6, A.4.1, the certification and pressure parts of A.4.3, C.2 and C.3.
  • Non-regulated staff who compound: A.3.1.

The honest way to decide is a gap analysis: go down the list, note what you do today, and mark each topic as covered, partly covered, missing or not applicable, with the reason. Your risk assessments settle the hazardous questions. Level A, B and C explained

How each procedure should be built

The guidance document provides a procedure template (section 5.3.2). Its parts are:

  • Pharmacy name, procedure number, effective date, and who approved it and when
  • Title, aim and objective
  • Target personnel, with the responsibilities of each group: supervisor, pharmacist, pharmacy technician, non-regulated personnel, cleaning personnel
  • Required facilities, equipment and materials, including protective equipment and the logs to be used
  • The procedure itself, step by step, for each person involved, with examples of labels and logs
  • The logs and competency assessments the procedure requires
  • References, with publication dates and editions
  • Procedure history: who drafted it, who revised it, and what changed

What makes a procedure usable

  • It describes your pharmacy. It names your room, your equipment, your cleaning products and who does what. A procedure that could belong to any pharmacy tells staff nothing.
  • It matches what happens. If the procedure says the balance is verified daily and the log shows weekly, one of them has to change.
  • It points to its records. Each procedure should name the log or form that shows it was followed. The quality assurance program then has something to check.
  • It is dated and signed. The approval signature and the 3-year review date are what make it a current policy of the pharmacy.

How procedures connect to the rest of the file

Procedures are one of the main sets of documents the standards expect, alongside a risk assessment and a master formulation record for each preparation and a quality assurance program. The standards also require compounding records, training records and logs. The example quality assurance program in the guidance document checks that policies and procedures are in place and updated every 3 years, that compounding records and logs are reviewed quarterly, and that references and safety data sheets are checked yearly.

Sources

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