Draft national compounding standards: where things stand
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.
Read this first. This page describes proposed documents that are not final. NAPRA has said the drafts are still subject to change, that the final documents will likely be different, and that they may not be implemented the same way in every province or territory. NAPRA has also asked pharmacy professionals to wait to hear directly from their own provincial or territorial regulator. Nothing here changes what your pharmacy must do today.
The short version
- NAPRA began reviewing its compounding model standards in 2024.
- From January 13 to March 15, 2026 it consulted publicly on two drafts, one for non-sterile and one for sterile compounding.
- On June 3, 2026 NAPRA said the drafts remain subject to change and asked that education on them wait until they are final.
- As of October 1, 2026, NAPRA has not announced final versions.
- Your pharmacy’s requirements are still the ones your regulator has in force now.
What was consulted on
The non-sterile draft is titled Model Document for Pharmacy Regulatory Authority Use: Non-sterile Compounding Standards. It is intended to update the 2018 Model Standards for Pharmacy Compounding of Non-Sterile Preparations and its guidance document. NAPRA described the aims of the review as aligning the documents with the outcomes-based approach of its other model documents, updating them against current references, addressing concerns with the existing documents, and making sure they reflect current and anticipated future pharmacy practice. A separate consultation on how regulators will approach compounding competence closed on the same date.
NAPRA’s model documents are exactly that: models. Each provincial or territorial regulator decides whether and how to use them, so requirements may differ between provinces even after a final version exists.
What the consultation draft proposed
The points below come from the January 2026 consultation document. They show the direction of the draft only. Any of them may change.
- Structure. Nine sections, each with an overarching principle, standards of practice and indicators: training and assessment of personnel, assessing risk, environment and equipment, components, policies and procedures, master formulation records and beyond-use dates, the compounding process, quality of final preparations, and quality assurance and improvement.
- Levels. Level A, B and C were kept as the names for the compounding environments.
- Risk assessment in two tiers. A facility risk assessment covering all preparations, completed at least every 12 months, and a risk assessment for each preparation, reviewed at least every 3 years.
- Review cycles. Master formulation records and policies and procedures reviewed at least every 3 years.
- Beyond-use dates. A new default table that sorts preparations into aqueous and non-aqueous by water activity: 14 days refrigerated for non-preserved aqueous preparations, 35 days for preserved aqueous preparations, 90 days for non-aqueous oral liquids and 180 days for other non-aqueous preparations, with conditions for extending them.
- Competency. Competency assessment annually for personnel who compound hazardous preparations.
- Environment. An eyewash station close to the compounding area at Level A, and for Level C at least 12 air changes per hour and negative pressure of at least 2.5 Pa.
- Uncertainty. Where the risk is uncertain, defer to the most stringent requirements.
What NAPRA has said since
In its June 3, 2026 notice on education sessions, NAPRA said that:
- the draft documents are still subject to change, and the final documents will likely be different;
- education on the drafts should be postponed until the documents are final, and NAPRA requires anything that does go ahead to carry a clear disclaimer that it concerns proposed documents that are subject to change and may not be implemented the same way in every province or territory;
- the final documents will be models for regulators, who set and implement their own requirements;
- pharmacy professionals should wait to hear directly from their own regulator;
- there will be many steps and ample time between the final NAPRA documents and each regulator’s own implementation.
What to do now
- Keep meeting the requirements in force. In Ontario and the other provinces that adopted the 2018 model standards, and in Alberta under the College’s adapted version, those remain the requirement. Under the model standards, risk assessments are reviewed at least every 12 months and procedures at least every 3 years.
- Do not rebuild your documents around a draft. Numbers such as the proposed beyond-use dates are not in force and may change.
- Keep your documents easy to update. Risk assessments, master formulation records and procedures that are dated, versioned and referenced can be revised quickly when your regulator announces a change.
- Watch your regulator, not the rumour mill. The announcement that matters will come from your provincial or territorial college, with its own timeline.
We will update this page when NAPRA publishes final documents or a regulator announces how it will use them.
Sources
- Consultation: Model Documents for PRA Use – Non-sterile and Sterile Compounding Standards (NAPRA, January 13, 2026; closed March 15, 2026)
- Education Sessions Related to Draft NAPRA Documents (NAPRA, June 3, 2026)
- Model Standards for Pharmacy Compounding of Non-Sterile Preparations (NAPRA, 2018), the model document several regulators have adopted or adapted