Pharmacy Compounding Standards: Non-sterile Preparations

In accordance with the Pharmacy Facilities Practice Direction, pharmacies must have space and equipment necessary to provide compounding as part of the practice of pharmacy.

Compounding personnel must maintain their competencies to provide non-sterile compounded drug products and services suitable to their level of competency, facilities, equipment, and training. A pharmacy must make appropriate accommodations to obtain a compounded product or refer the patient to another pharmacy with appropriate facilities or competencies when the treatment required by the patient is beyond the scope of the member’s professional practice or competence.

It is the expectation that any community or hospital pharmacy in Manitoba has the ability to dispense a simple compounded product, when appropriate, to a patient. A simple compounded product is defined as a Level A compound within the NAPRA Model Standards  for Pharmacy Compounding of Non-Sterile Preparations.

• NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations
• NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations
• Where do I Start? Standards for Pharmacy Compounding of Non-sterile Preparations
• Guidelines for Pharmacists Regarding the Provision of Non-sterile Compounding Services 
• Decision algorithm for risk assessment from the Model Standards for Pharmacy Compounding of Non-Sterile Preparations Guidance Document
• NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

On Dec. 23, 2020 Council passed a motion that compounded nasal and sinus preparations (e.g. nasal sprays, nasal irrigation) that are intended for local application are distinct from compounded sterile preparations of nasal inhalation solutions that are intended for delivery to the lungs as included in the NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations. Where appropriate, compounded nasal and sinus preparations (e.g. nasal sprays, nasal irrigation) that are intended for local application can be prepared in a nonsterile environment, following the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Please note that when compounding these nasal preparations deemed as non-sterile, compliance with the NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations and Guidance Document is expected. 

Included in this expectation, in part, is compliance with the following general guidance on whether to compound a preparation:

• Are the active ingredients already available in a manufactured product?
• Do you have a referenced formulation?
• Do you have the beyond-use date (BUD) and relevant stability data?
• Do you have a dedicated space for compounding that is clean and uncluttered?
• Do you have the appropriate equipment and ingredients to make the compounded preparation? 
• Are your pharmacy personnel competent to perform compounding of the preparation? 
• Can your pharmacy personnel compound the preparation without interruption?
• Should you refer this compounded preparation to another pharmacy with appropriate facilities, equipment and expertise?

No. Compounds that are prepared by a pharmacy cannot be further manipulated or used as an ingredient in a future preparation that will be compounded by another pharmacy. Health Canada’s Policy 0051 authorizes a pharmacy to compound a drug for a patient of another pharmacy only if it is pursuant to a prescription or if it is in anticipation of a prescription. There should be a reasonable expectation of receiving a valid prescription for a patient for that specific compounded preparation, which requires no adulteration. 

For further information regarding the Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051), please see the following link.  

In the interest of patient safety and access to care, CPhM asks that pharmacy managers self-declare, and make public, the non-sterile Level C compounding their pharmacies provide.

Although these services are available, there are challenges identifying which pharmacies are engaging in this practice. Patients, prescribers, and pharmacists will now be able to use the Pharmacy Public Register to find appropriate compounding facilities using drop-down filters.

Pharmacies can now submit a self-declaration to CPhM of their provision of non-sterile Level C compounding as a pharmacy care service. For more information on the compounding standards for non-sterile preparations in effect in Manitoba, please click the following link:

NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations

Pharmacy managers can update this information on the Pharmacy Public Register with the following steps:

1. Log into your Pharmacy Portal.
2. Click “Update Pharmacy Information – Add/Edit Employee Lists or Compounding Declarations.”
3. Read the self-declaration and use the selections provided to indicate what NAPRA compliant compounding services your pharmacy provides and which services you want publicized.
4. Click Save.

Once you have completed these steps, the Pharmacy Public Register will be automatically updated, and CPhM will be notified of your compounding self-declarations.

Note: A declaration for the provision of sterile hazardous and non-hazardous compounding services is also provided on your Pharmacy Portal if needed.