NAPRA's Model Standards ask a pharmacy to assign every non-sterile preparation to Level A, Level B, or Level C based on the hazards and complexity involved. The level then drives the facilities, engineering controls, and personal protective equipment (PPE) the preparation calls for. This guide explains what each level means and how a documented risk assessment arrives at one.
Educational overview only — not regulatory or professional advice. The licensed pharmacist who signs an assessment retains professional responsibility for classifying and documenting each preparation under NAPRA's Model Standards and their provincial regulator's requirements.
What are NAPRA's risk levels for non-sterile compounding?
NAPRA — the National Association of Pharmacy Regulatory Authorities — publishes the Model Standards for Pharmacy Compounding of Non-sterile Preparations that provincial regulators across Canada adopt. Those standards ask each pharmacy to assess its non-sterile preparations and sort them into three ascending risk levels so that the controls in place match the hazard:
- Level A — simple, lower-risk preparations.
- Level B — preparations that call for additional containment.
- Level C — the highest-hazard preparations, requiring the most stringent containment and controls.
Assigning a level is a documented, repeatable judgment. CompoundCheck describes its assessments as NAPRA-aligned and informed by USP <795> and <800> — an accurate description of how the software works, not a certification. Whether a given preparation meets NAPRA's Model Standards is a determination the pharmacy and its regulator make and document.
Level A, B and C at a glance
A quick comparison. Treat every cell as a typical pattern, not a rule — the level and the specific controls come from the documented assessment for each preparation.
| Level | Typical hazard / complexity | Facility & ventilation | Recommended PPE (for pharmacist review) |
|---|---|---|---|
| A | Non-hazardous, routine preparations; no NIOSH-listed drug and no escalating GHS/WHMIS hazard. | General non-sterile compounding area (informed by USP <795>). | Standard (non-chemotherapy) gloves and a designated lab coat, with any item-specific protection the assessment adds. |
| B | A confirmed hazard that is not a NIOSH-listed antineoplastic, or a hazard handled in a higher-exposure form such as a powder. | Additional containment or ventilation, informed by USP <795> and <800>. | Chemical-resistant gloves, a protective gown, eye protection, and respiratory protection where indicated. |
| C | The highest-hazard preparations, including those involving NIOSH-listed hazardous drugs. | Dedicated containment and engineering controls, informed by USP <800>. | Chemotherapy-rated gloves and gown, respiratory and eye protection, and containment appropriate to the drug. |
What is Level A compounding?
Level A is the lowest-risk tier: simple, non-hazardous non-sterile preparations where standard procedures and everyday PPE are generally sufficient. In practice this is routine compounding of ingredients that do not appear on the NIOSH List of Hazardous Drugs and do not carry an escalating GHS/WHMIS hazard classification.
Typical characteristics, facility and PPE at Level A
Level A work is generally performed in a pharmacy's ordinary non-sterile compounding area (informed by USP <795>), with standard (non-chemotherapy) gloves and a designated lab coat. An important nuance: the risk level and the specific PPE are decided separately. A preparation can stay Level A while the assessment still recommends eye protection or a mask for a particular ingredient — added protection does not, by itself, push the level up.
A typical Level A example
For a straightforward, non-hazardous topical ointment prepared from recognized non-hazardous ingredients, a typical assessment might conclude Level A, with standard PPE and procedures — while still noting any handling precaution a specific ingredient warrants.
What is Level B compounding?
Level B covers moderate-hazard non-sterile preparations that call for additional containment beyond routine practice. It typically applies when an ingredient carries a confirmed health hazard — but is not a NIOSH-listed antineoplastic (those point toward Level C) — or when the physical form of the preparation raises exposure.
Typical characteristics, facility and PPE at Level B
What commonly pushes a preparation from A to B is a confirmed hazard classification (for example a carcinogen, mutagen, reproductive toxicant, acute toxin, respiratory sensitizer, or corrosive) or a hazardous substance handled as an airborne powder. Level B work generally calls for additional containment or ventilation, chemical-resistant gloves and a gown, and eye and respiratory protection where indicated — informed by USP <795> and <800>.
A typical Level B example
For a preparation compounded from a bulk powder that carries a confirmed health-hazard classification but is not a NIOSH-listed antineoplastic, a typical assessment might conclude Level B, with added containment and PPE for the pharmacist to review and confirm.
What is Level C compounding?
Level C is the highest-hazard tier — the preparations that demand the most stringent containment, dedicated engineering controls, and specialized handling. In non-sterile compounding this centres on hazardous drugs, particularly those on the NIOSH List of Hazardous Drugs. (Sterile preparations are governed by additional standards that are outside the scope of this non-sterile guide.)
Typical characteristics, facility and PPE at Level C
Level C generally calls for dedicated containment and engineering controls, chemotherapy-rated gloves and gown, and respiratory and eye protection — informed by USP <800>, the chapter that addresses handling hazardous drugs in healthcare settings. These are drawn from the sources the requirements rely on (the NIOSH 2024 list and USP), not claims CompoundCheck certifies on a pharmacy's behalf.
A typical Level C example
For a non-sterile preparation involving a drug on the NIOSH list, a typical assessment might conclude Level C, with full containment and chemotherapy-rated PPE. Hazardous status is one input the assessment weighs — the pharmacist assigns and signs the final level.
How is a preparation assigned to a risk level?
The level comes from a documented risk assessment, not a single attribute. The assessment weighs several factors together, and the pharmacist makes and signs the call.
The factors a NAPRA risk assessment weighs
- Hazardous-drug status (whether an ingredient appears on the NIOSH list).
- The GHS/WHMIS hazard classification of each ingredient.
- Dosage form and physical state — a powder can raise exposure where a cream would not.
- Route and potential for exposure during preparation.
- Quantities, frequency, and overall process complexity.
A guiding principle is escalate-only, most-conservative-wins: the preparation takes the highest level any single ingredient demands, and a non-hazardous excipient never lowers a hazardous active's level.
Where hazardous drugs fit — NIOSH 2024 and USP <800>
Drugs on the NIOSH List of Hazardous Drugs in Healthcare Settings (2024) drive the containment expectations that USP <800> describes. CompoundCheck treats any NIOSH-listed drug in a non-sterile preparation conservatively — routing it toward the most protective handling rather than assuming a lower level — while leaving the final determination to the signing pharmacist.
When uncertainty escalates to the more protective level
A dependable assessment is fail-safe: when an ingredient can't be verified or its hazard data can't be confirmed, the safe default is the more protective level with the uncertainty flagged — never a confident guess. "We don't know" is never treated as "safe."
How do NAPRA levels relate to USP <795> and <800>?
NAPRA's Model Standards are the Canadian framework that provincial colleges enforce. USP <795> (non-sterile compounding) and USP <800> (handling hazardous drugs) are United States Pharmacopeia chapters whose guidance NAPRA's requirements draw on. That is why CompoundCheck describes its assessments as "informed by" USP <795> and <800>, not as meeting a US standard — the operative standard in Canada is the NAPRA Model Standard your regulator has adopted.
How often should a NAPRA risk assessment be reviewed?
Keep the risk assessment current: re-review it whenever the formula, ingredients, process, or underlying hazard data change, and periodically under your pharmacy's standard operating procedures and your provincial regulator's requirements — many pharmacies re-review at least annually. Recording the dataset versions and rationale keeps the assessment part of a record you can hand to an inspector.
Common questions about NAPRA risk levels
What is the difference between Level A and Level B compounding?
Level A covers simple, non-hazardous non-sterile preparations where standard procedures and everyday PPE are generally sufficient. A preparation moves up to Level B when it involves an ingredient or process that calls for additional containment — for example a confirmed hazardous substance that is not a NIOSH-listed antineoplastic, or a hazard handled as an airborne powder. The signing pharmacist assigns and documents the level for each preparation.
Does every non-sterile compound need a documented risk assessment?
NAPRA's Model Standards ask a pharmacy to assess and document the risk level of its non-sterile compounds. The point of the assessment is to match facilities, engineering controls and PPE to the hazards and complexity involved, and to keep a record a provincial inspector can review.
Is a hazardous drug like estradiol automatically Level C?
Hazardous-drug status is one important input, not an automatic verdict. A drug on the NIOSH List of Hazardous Drugs raises containment considerations, but the level a pharmacy assigns depends on the full documented assessment — the substance, its physical form, the process, and the exposure potential. CompoundCheck takes a deliberately conservative stance on NIOSH-listed drugs, but the licensed pharmacist makes and signs the final decision.
Who assigns the risk level — the pharmacist or the software?
The licensed pharmacist. Software such as CompoundCheck does the cross-referencing against published hazard data and pre-populates a draft, but NAPRA places professional responsibility with the pharmacist, who reviews the evidence, documents any overrides with a rationale, and signs the final assessment.
How often should a NAPRA risk assessment be reviewed?
Keep it current: re-review whenever the formula, ingredients, process, or underlying hazard data change, and periodically under your pharmacy's standard operating procedures and your provincial regulator's requirements — many pharmacies re-review at least annually. A current review is part of an audit-ready record.
How CompoundCheck assigns NAPRA risk levels
CompoundCheck turns a compounding formula PDF into a NAPRA-aligned risk assessment, Master Formulation Record, and audit trail in minutes. The classification is produced by a deterministic rules engine working from published hazard data — generative AI reads the document and drafts narrative text for pharmacist review, and never assigns a risk level, PPE requirement, or engineering control. Every hazard claim traces to an authoritative source:
- NIOSH List of Hazardous Drugs in Healthcare Settings (2024)
- PubChem GHS classifications
- Health Canada's Drug Product Database
- EPA CompTox Chemicals Dashboard
When a source can't verify something, the assessment says so and escalates to the more protective level instead of guessing. Every rule the engine fired — with its trigger and cited evidence — is recorded, so the licensed pharmacist can review the reasoning, document any overrides, and sign. The pharmacist keeps professional responsibility for the final decision; CompoundCheck does the cross-referencing and the paperwork.
CompoundCheck is in a closed pilot with a Canadian compounding pharmacy; application data is hosted in Canada (AWS Canada Central, Montréal) and the product is built for PIPEDA. Join the pilot waitlist →
About this guide
This guide is published by CompoundCheck as general education for Canadian compounding pharmacy teams. It is not regulatory or professional advice, and it does not assign a binding risk level to any specific drug or preparation — that determination belongs to the licensed pharmacist who signs the assessment. Last reviewed July 5, 2026.
Sources: NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations; NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 (DHHS (NIOSH) Publication No. 2025-103). See also our Terms of Service and Privacy Policy.