The OCP risk assessment template, question by question

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.

In February 2026 the Ontario College of Pharmacists published a risk assessment template for non-sterile compounding, a companion guide and two worked examples. This guide walks through the template’s five sections and 17 questions and explains what to write in each.

What is required and what is optional

  • Required: a risk assessment for each compounded preparation, taking every ingredient into account, with the rationale documented and references consulted.
  • Required: a review at least every 12 months, or sooner if practice or standards change.
  • Required: consideration of cumulative risk across everything the pharmacy compounds.
  • Optional: the College’s template itself. The College states that use of the template is optional and that how a pharmacy documents its risk assessments is at the discretion of the non-sterile compounding supervisor.

One assessment covers one preparation. A different strength is a different preparation: the companion guide gives hydrocortisone 1% and 2% in clotrimazole cream as an example of two assessments.

Before you start, gather the formula, the safety data sheet for each active ingredient and chemical, the product monograph for any commercial product used, the NIOSH 2024 list, and your real numbers: how much you make and how often.

Section A: identify the risks (questions 1 to 6)

1. Preparation name

Use one naming format for every assessment so they can be filed and found. The companion guide suggests each active ingredient with its strength, followed by the dosage form, for example “Salicylic acid 5% Coal tar 10% topical solution”. A sample label or a pseudo-identification number (PIN) can be added.

2. Ingredients

List every ingredient with its manufacturer, its DIN (commercial products) or CAS number (active ingredients and chemicals), its physical characteristics and the references you consulted. The physical form matters because it drives exposure and contamination risk: a powder behaves differently from a cream. Note the date of each safety data sheet and make sure it is the supplier’s current version.

3. NIOSH list

Check each ingredient against the NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, and record whether it is in Table 1 or Table 2. The companion guide adds a caution: a drug can still be hazardous even if it is not on the list. How the 2024 list is organized

4. WHMIS health hazards

Look at section 2 (hazard identification) of each safety data sheet and record any health hazard classification. Commercial drug products with a DIN do not have safety data sheets. For those, consult the safety data sheet of the active ingredient and the product monograph.

5. Risks to the compounder

Three sub-questions: does any ingredient (a) require ventilation for preparation, (b) present a reproductive risk, or (c) present any other risk to the person compounding? Sections 8 and 11 of the safety data sheet and the warnings in the product monograph are the places to look. If you answer “No / not applicable”, say how you verified it.

6. Risks to the preparation

Tick each risk that applies: microbial contamination, cross-contamination with other products, interruption to workflow, or another risk you specify. The companion guide notes that the answer may well be “yes” here. Liquids, creams and ointments are susceptible to microbial contamination, shared equipment and tight space invite cross-contamination, and a busy dispensary interrupts. Every risk ticked here needs a matching measure in question 15.

Section B: assess the risks (questions 7 to 12)

7 and 8. Quantity and frequency

Record the average quantity made at a time and how often the preparation is made: daily, weekly, monthly or otherwise. Use what actually happens, not what looks best.

9. Is it an “occasional small quantity”?

The standards give no number for this. The companion guide asks you to weigh the concentration and amount of active ingredient, the average quantity, the frequency, and the cumulative risk: the combined risk of all the preparations the pharmacy compounds, even if each one seems occasional and small. Write your rationale, and include the cumulative picture in it. A periodic report of the hazardous ingredients used across all preparations is a practical way to support the answer.

10 and 11. Facilities, equipment and training

State the facilities and equipment needed to make the preparation, and whether additional training is required.

12. Complexity

Choose simple, moderate or complex and give your reasons. The definitions come from an earlier edition of USP General Chapter <795> and are reproduced in the guidance document:

  • Simple: the preparation has a USP compounding monograph, or appears in a peer-reviewed journal article with specific quantities, procedure, equipment and stability data with a beyond-use date.
  • Moderate: it requires special calculations or procedures, or stability data for that specific formulation are not available.
  • Complex: it requires special training, environment, facilities, equipment and procedures. Examples include transdermal dosage forms, modified-release preparations and some inserts and suppositories for systemic effects.

Many everyday preparations are moderate for the second reason. In the College’s first worked example the preparation is classed as moderate because it has no USP compounding monograph.

Section C: mitigate the risks (questions 13 to 15)

13. Personal protective equipment

For each item, answer yes or no and name the specific type: eye protection, mask or respirator, face protection, gloves, gown or lab coat, and anything else such as hair or shoe covers. The template carries a reminder that surgical masks do not provide respiratory protection against drug exposure.

14. Risks to the compounder

Explain how each risk identified in question 5 is handled: (a) how the required ventilation is achieved, (b) how the reproductive risk is mitigated, and (c) how other risks are mitigated.

15. Risks to the preparation

For each risk ticked in question 6, describe the measure you use: cleaning procedures, dedicated or disposable equipment, compounding at a quiet time or in a separate room, and so on.

The companion guide points supervisors to the hierarchy of controls and notes that personal protective equipment, while important, is the least effective control because there are many ways it can fail.

Section D: the result (questions 16 and 17)

Question 16 is the level: A, B or C. Question 17 is the rationale, and it is the part that gets read. Summarize what led to the level and describe the requirements that must be in place. A useful test from the companion guide is to ask whether the preparation needs any of the following: specialized equipment or facilities, special education or competencies, uninterrupted workflow, or additional measures such as extra verification steps or protective equipment. If it does, the guide says the rationale should identify whether a higher level of requirements than your pharmacy’s is needed and, where moving to a higher level is not possible, should outline the additional mitigation measures and the evidence that they will be effective. If you are unsure which level applies, the College’s direction is to go with the higher standard. What each level requires

Section E: sign-off

Record the date completed, the date last reviewed, who completed the assessment, and the name and signature of the non-sterile compounding supervisor. At each review, at least every 12 months, the supervisor should date and sign the assessment again.

What the two worked examples show

Example 1: hydrocortisone 1% powder in clotrimazole 1% cream. Thirty grams, made once every two months. Neither ingredient is on the NIOSH list, but the safety data sheets show WHMIS health hazards. It is treated as an occasional small quantity, classed as moderate, and assigned Level A, with eye protection, a fit-tested N95 mask, nitrile gloves and a designated lab coat, and with compounding done after the pharmacy closes to avoid interruptions.

Example 2: progesterone 400 mg suppositories. Sixty suppositories, made weekly. Progesterone is in NIOSH Table 2, and its safety data sheet lists reproductive toxicity and carcinogenicity. It is not treated as an occasional small quantity, it is classed as complex, and it is assigned Level C: a dedicated room with external venting through HEPA filtration and negative pressure, an externally vented containment device, dedicated equipment and hazardous-drug protective equipment.

The examples are illustrations, not rulings. The same progesterone made rarely and in small amounts could be assessed differently, and the College says assessments of similar formulations can come out differently in different pharmacies. Your assessment has to reflect your quantities, your frequency and your space.

Five checks before the supervisor signs

  1. Every “No / not applicable” in question 5 says how it was verified.
  2. Question 9 addresses cumulative risk, not only this preparation.
  3. Every risk ticked in question 6 has a matching measure in question 15.
  4. The level in question 16 matches the room and equipment described in question 10.
  5. The safety data sheets are current, and the review date is within the last 12 months.

Sources

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