risk assessments for non-sterile compounding
A written risk assessment for every preparation you compound, with the hazards identified, the quantity and frequency weighed, and a reasoned Level A, B or C. Prepared by a pharmacist from your formulas and safety data sheets, ready for your supervisor to review and sign.
What the standards ask for
Under the national model standards, a risk assessment must be done for each preparation, taking every ingredient into account, and reviewed at least every 12 months. It has to look at risk to the preparation and risk to the people making it, consider the pharmacy’s cumulative compounding, and end in a level of requirements: A, B or C. The reasoning must be written down with references. That reasoning is what an assessor reads.
What each assessment covers
- Every ingredient with its physical form, supplier, DIN or CAS number and the references consulted
- NIOSH 2024 list status (Table 1 or Table 2) and WHMIS health hazards from section 2 of the safety data sheet
- Ventilation needs, reproductive risk and other risks to the compounder
- Risks to the preparation: microbial contamination, cross-contamination and interrupted workflow
- Quantity made, frequency, and whether it counts as an occasional small quantity once cumulative risk is considered
- Complexity: simple, moderate or complex, with the reason
- Facilities, equipment, training and personal protective equipment required
- How each identified risk is mitigated in your pharmacy
- The assigned level, the rationale, and the sign-off and review dates
For Ontario pharmacies we can deliver assessments in the layout of the template the College published in February 2026, or in our own layout covering the same points. The College states that use of its template is optional.
Why the level is not a lookup
There is no official list of Level A, B and C preparations. The same drug can land on different levels in different pharmacies, because quantity, frequency, dosage form and the pharmacy’s total hazardous workload all count. The Ontario College’s own worked examples show the range: hydrocortisone powder in clotrimazole cream, 30 g made every two months, is assessed at Level A, while progesterone 400 mg suppositories made weekly in batches of 60 are assessed at Level C. We document the reasoning for your volumes, not someone else’s. Level A, B and C explained
Cumulative risk
Small, occasional quantities cannot be judged one preparation at a time. The standards require the supervisor to consider everything the pharmacy compounds, even on different days. Our assessments record quantity and frequency for each preparation and state how the pharmacy’s combined compounding was taken into account.
How it works
- Send your list of preparations with ingredients, strengths, the usual quantity made and how often.
- Tell us your suppliers and send the safety data sheets you have on file.
- We send a fixed quote, then draft each assessment.
- You review the drafts. One round of revisions is included if requested within 14 days of delivery.
- Your supervisor signs and dates each assessment, and reviews it at least every 12 months.
Common questions
Do different strengths need separate assessments?
Yes. The Ontario College’s companion guide gives hydrocortisone 1% and 2% in clotrimazole cream as an example of two preparations that each need their own assessment.
Who decides the level?
Your non-sterile compounding supervisor does. We prepare the assessment and the reasoning; the supervisor checks it against what actually happens in the pharmacy and signs it. Where the level is uncertain, regulators expect the higher standard to be applied.
What happens at the 12-month review?
Each assessment is checked against current practice, volumes, safety data sheets and standards, then dated and signed again. We offer the review as a separate service.
Our assessment points to Level B or C, but our space is Level A. What then?
Then the preparation should not be made there as things stand. The options are to add controls and document why they are sufficient, to upgrade the space, or to refer the preparation to a pharmacy with the right facilities. We will tell you plainly when an assessment points that way.
Where can I read more?
The OCP risk assessment template, question by question and NIOSH 2024, WHMIS and “occasional small quantity”.