For Your Information – NAPRA Seeks Input on Compounding Consultation Document
The National Association of Pharmacy Regulatory Authorities (NAPRA) has released a consultation entitled “Model Document for Pharmacy Regulatory Authority Use – Non-sterile Compounding Standards” and “Model Document for Pharmacy Regulatory Authority Use – Sterile Compounding Standards”. The Document is intended to guide provincial pharmacy regulators in shaping pharmacy compounding practice across Canada. Such NAPRA documents presently exist for sterile and non-sterile compounding and establish a standard of practice when adopted by a pharmacy provincial regulatory authority (PRA). The intent is to replace those documents with the current consultation Document. You will find the NAPRA document in the link below:
CONSULTATION DOCUMENT “Model Documents for PRA Use Compounding Standards” January 2026
Patient safety is a shared professional priority. However, certain proposed changes, if adopted, could have adverse impact upon veterinary clinics and, by extension, upon the patients we collectively serve.
Why this matters to your clinic
1. Potential loss of access to compounded medications for office use
Restricting or eliminating office use compounds will likely result in:
- Treatment delays
- No “on hand” compounded drugs and therefore, reduced timely patient access to drugs not commercially available but needed for emergency use
- Increased cost (ultimately) to patients
It has always been the right of Canadian practitioners to obtain drugs they deem necessary for their office practice (“office use” drugs). This has been recognized at the Canadian federal and provincial levels.
LINK Food and Drug Regulations section C.01.043
The revised document for consultation is noticeably absent the term “office use” but instead, uses “patient-specific.” As such, it can be argued that “office use” will cease in any Canadian jurisdiction where the revised consultation Document is adopted, since there is no provision in it for such procurement by practitioners for use within their practices – even if permitted by practitioners’ licensing authorities/practice standards. Pharmacies would not be permitted to compound “for office use” but only where a “patient-specific” prescription is issued by the practitioner, given the content of these proposed standards.
Below are examples of how the concept of “office use” is permitted across Canada within various professions.
(Current document, @p4, “3. Regulatory Framework” para #2: “In the absence of a patient-specific prescription, and with a prescriber’s order for office use, compounders may prepare a compounded product at an appropriate scale, time or frequency to ensure it is being used within a patient–healthcare professional relationship. Compounders may also prepare batches of compounded product in limited quantities in anticipation of future prescriptions.”)
https://www.cvo.org/standards/guide-use-of-compounded-drugs-in-veterinary-medicine
(see “In-Office Use”)
https://ocpinfo.com/ocp-resources/six-important-tips-for-using-the-narcotics-monitoring-system/
(Point #3)
https://oralhealthbc.ca/wp-content/uploads/2022/08/03.02.021-prescribing-and-dispensing-drugs.pdf
(see pages 6 & 7)
https://www.ontario.ca/files/moh-odp-reference-manual-en.pdf
(p346, “Office Use Prescriptions”)
2. Reduced maximum beyond-use dates (BUDs) for compounded preparations
The proposed standards introduce more restrictive approaches to assigning beyond-use dates for both sterile and non-sterile compounded medications. If implemented, these changes could substantially shorten BUDs for necessary compounds, particularly sterile preparations. Shorter BUDs may make compounding impractical by increasing costs, increasing medication wastage and therefore limiting a clinic’s ability to stock essential drugs. If a compounder has stability data supporting longer BUDs, there is no scientific evidence that these proposed limitations are “rooted in objective replicable science and provide clear patient benefit.” (March 17th, 2022 Alliance for Pharmacy Compounding letter to USP Compounding Expert Committee)
Suggested Action
NAPRA has explicitly requested feedback through these consultation surveys. Veterinary voices are critically important, as these standards are written primarily through a human-health lens and do not fully reflect the unique realities of everyday veterinary compounding practice. It is essential that NAPRA hears directly from veterinary professionals about how these proposed changes could affect patient outcomes, clinic operations, and access to care.
We respectfully encourage you to:
- Complete the NAPRA survey sections relevant to compounding, particularly those addressing Office-use compounding and Beyond-use dates.
- Provide written comments via respective survey input areas, describing how these changes would impact your clinic and your patients.
- Contact NAPRA directly to share your perspective as a veterinary healthcare provider. (info@napra.ca).
The consultation is open until March 15, 2026 (11:59 p.m. ET).
Thank you for taking the time to ensure the veterinary profession’s patient care needs are considered and included in these changes to national compounding standards.
Jennifer Yonda, RPh, Designated Manager, Summit Veterinary Pharmacy Ltd.
Dean Adams, President, Summit Veterinary Pharmacy Ltd.