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Pharmacy Compounding Standards: Non-sterile Preparations

Stay informed about the standards for non-sterile compounding.

NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations

The NAPRA Model Standards for Pharmacy Compounding (NMSPC) of Non-sterile Preparations and the Guidance Document for Pharmacy Compounding of Non-sterile Preparations provide pharmacists and pharmacy technicians with the minimum required criteria to compound non-sterile preparations. College Council approved the NMSPC of Non-sterile Preparations in 2018 and pharmacies and pharmacy professionals providing non-sterile compounding services must fully comply with these standards as of April 1, 2021.

Please see the resources and information listed below for additional guidance on pharmacy compounding of non-sterile preparations.

Pharmacist’s Role and Responsibilities in Providing Non-sterile Compounding Services

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.

Compounded Nasal and Sinus Preparations for Local Application

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?

Can I Dilute or Alter a Compound that I Received From Another Pharmacy?

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.  

Pharmacy Compounding Standards: Sterile Preparations

Stay informed about the on-going updates to the standards for sterile compounding.

Learn more