What OCP assessors check in non-sterile compounding

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 Ontario College of Pharmacists publishes the checklist it assesses non-sterile compounding against: the Non-Sterile Preparations Assessment Criteria, updated in February 2026. This guide summarizes it section by section and ends with a list of documents to have ready.

How the criteria are organized

The criteria follow the sections of the Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Each line is a standard statement, with a pointer to the section of the guidance document that explains how to meet it. The College suggests using the document to understand expectations and to carry out a gap analysis. All Ontario pharmacies that compound have had to meet the standards in full since January 1, 2022. Some lines in the criteria are requirements, worded “must”. Others come from the guidance document and are worded “should”; the College says those may be met by other means that have been proven equivalent or superior.

Sections 2 and 3: should you be compounding this?

  • The pharmacist or pharmacy technician uses professional judgment to decide whether compounding is appropriate.
  • A patient and healthcare professional relationship exists before compounding.
  • Staff have reviewed the questions that separate compounding from manufacturing.
  • For a prescriber’s office-use order, there is a process to confirm the relationship and to keep the scale, timing and frequency appropriate.

Section 4: risk assessment

  • A risk assessment is performed to identify the level of requirements, considering complexity, the need for verification, frequency, cross-contamination, physical characteristics, quantities, facilities, equipment, the type of hazardous drug, exposure of personnel and the risk of microbial contamination.
  • It is reviewed at least every 12 months, or sooner if practice or standards change.
  • The decision algorithm is used to determine the level.
  • Safety data sheets and references are consulted, and the procedures for safe compounding are documented on the master formulation record.

How to complete the College risk assessment template

Section 5: requirements for all levels

People. The Designated Manager is responsible for compounding activities. A non-sterile compounding supervisor, a pharmacist or pharmacy technician, is designated and meets the responsibilities in the guidance document. The supervisor has completed the College’s Non-Sterile Compounding Supervisor Training Course. All compounding personnel have the expertise required and follow the procedures, and cleaning personnel are trained.

Procedures and training. Policies and procedures exist for all compounding activities, including cleaning, and are readily retrievable. They are reviewed at least every 3 years. A training and skills assessment program is established, administered and documented. There is a verification process for each critical step, with an independent check where possible: calculations, ingredient selection and measurement, mixing technique and the final product.

Space and equipment. Compounding takes place in a separate, designated space away from heavy traffic, large enough to work safely and avoid cross-contamination. The area is clean, orderly and in good repair. Components, equipment and containers are stored off the floor, and cardboard packaging stays out of the compounding area. Ventilation is controlled, with no air vents directly over work areas. Surfaces are smooth, impervious and non-porous. Hot and cold running water is available in or close to the area. Equipment suits the preparations, is cleaned after each use, and is inspected and calibrated as the manufacturer recommends or at least once a year, with records.

Section 6: product and preparation requirements

  • Beyond-use dates are assigned conservatively from evidence and literature. The manufacturer’s expiry date is not used as the beyond-use date.
  • A master formulation record exists for each compound, with rationale, references and the developer of the formula, and is readily accessible. What goes in the record
  • Ingredients come from recognized, reliable sources and are stored to preserve quality. Ingredients needing special precautions are identified. Safety data sheets are up to date and available.
  • A complete compounding record is kept for each prescription and batch.
  • Personnel follow hygiene and conduct rules: protective equipment, no jewellery, food or drink.
  • Each stage of the process and the final product are verified.
  • Labels identify all active ingredients and their concentration and show the beyond-use date and any storage or handling information. Packaging and transport suit the preparation.
  • There is a recall procedure that can identify and notify the patients or pharmacies that received a preparation.

Section 7: quality assurance

A quality assurance program is in place that periodically verifies and documents that compounding activities are carried out according to the standards.

Section 8: levels of requirements

  • Level A: only simple or moderate preparations are compounded in the Level A space. Materials classified as health hazards are used there only in occasional small quantities, assessed as low risk to personnel, with safety precautions and controls in place.
  • Level B: a dedicated room separate from the rest of the pharmacy. For certain powders, aromatic and hazardous products, the room is ventilated and entirely closed, or has a ventilated containment device. The containment device is externally vented, which is preferred, or has redundant HEPA filters in series, is maintained as the manufacturer recommends, and is certified at least every 6 months.
  • Level C: a physically separated room, externally ventilated through HEPA filtration, with appropriate air exchange and negative pressure, and an appropriate containment device.

Level A, B and C explained

Section 9: hazardous preparations

This is the longest section. For pharmacies that compound hazardous preparations, the criteria cover:

  • A sink with hot and cold water, an eyewash station, and water sources and drains at least 1 metre from the containment device
  • For a Level C room: external venting through HEPA filtration, physical separation, at least 12 air changes per hour and negative pressure of 2.5 Pa, with pressure measured continuously and an alarm
  • Smooth, impermeable, non-shedding surfaces, and no windows or doors opening directly outside
  • Procedures for receiving, unpacking and storing hazardous products, with ventilated, signed storage
  • Deactivation, decontamination and cleaning of the room, the containment device and reusable equipment, by trained personnel, with safety data sheets for the cleaning products on site
  • Protective equipment approved for hazardous compounding
  • Procedures and training for accidental exposure and spills, with stocked spill kits
  • Hazardous waste procedures and containers
  • Certification of the room and containment device at installation and at least every 6 months, surface contamination measured at least every 6 months, room temperature documented daily, and all the records retained

The supervisor training course

Since February 5, 2026, any pharmacist or pharmacy technician newly assigned as a non-sterile compounding supervisor must complete the College’s training course within three months of starting, and preferably before. Current supervisors of pharmacies found not to be meeting the standards have one month to complete it, a period the College’s operations advisors may extend. The course is free. It has seven modules, covering the supervisor’s role, policies and procedures, risk levels, training and skills assessment, facilities and equipment, product and preparation requirements, and quality assurance, plus a practice module with two risk assessment scenarios, and it ends with a final exam. Supervisors receive a certificate, which should be kept, and new supervisors declare completion in the OCP portal.

Documents to have ready

  • A risk assessment for each preparation, reviewed within the last 12 months, with the review dated and signed
  • A master formulation record for each preparation
  • Compounding records for prescriptions and batches
  • Policies and procedures, with review dates within the last 3 years
  • Training and skills assessment records for everyone who compounds, verifies or cleans
  • Cleaning logs, temperature logs, and equipment maintenance and calibration records
  • Current safety data sheets
  • Quality assurance program records
  • The supervisor’s course certificate, where it applies
  • For hazardous compounding: containment device and room certification reports, contamination monitoring results, spill kit checks and the hazardous waste procedure

Paper is only part of an assessment. The room, the equipment and what staff actually do are looked at too.

Sources

Missing some of these documents?

We write risk assessments, master formulation records and procedures for Ontario pharmacies from their own information. How we work with Ontario pharmacies

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