Pharmacy Compounding Standards: Non-sterile Preparations
Stay informed about the standards for non-sterile compounding.
Learn moreStay informed about the on-going updates to the standards for sterile compounding.
The NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations provide pharmacists and pharmacy technicians with the minimum criteria to compound hazardous and non-hazardous sterile preparations.
As of January 1, 2022, pharmacies and pharmacy professionals in Manitoba providing sterile compounding services must fully comply with these standards.
If a pharmacy requires an exemption from compliance with these Model Standards, it must apply directly to CPhM Council for approval.
Please see the resources and information listed below for additional guidance on pharmacy compounding of sterile preparations.
The Sterile Compounding Pharmacy Quality Assurance (QA) Self-Assessment is a gap analysis tool created by the College to ease implementation of the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations. Do not submit this QA Self-Assessment to the College for approval or review.
The NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations highlight that greater attention must be paid to the environment in which compounded sterile preparations are prepared, the training of personnel and quality assurance procedures necessary in order to protect patients and pharmacy personnel.
A sterile environment is required for the production of compounded sterile products and the manipulation of sterile products. A sterile drug product that is transferred from vials or ampoules into sterile final containers with syringe and needle is classified as a sterile compound.
Pharmacies that are engaged in sterile compounding are required to meet the NAPRA Model Standards for Pharmacy Compounding of Hazardous and/or Non-Hazardous Sterile Preparations. Some of the requirements for sterile compounding facilities include an ISO 5 environment maintained in a primary engineering control (PEC) and maintenance of an ISO 7 or better clean room or segregated compounding area.
Pharmacists engaged in sterile compounding must ensure they have the appropriate facilities and competence when providing sterile compounds. Repackaging of sterile products, including the preparation of pre-filled syringes containing medications such as insulin is a sterile compounding activity.
Pharmacists who are asked to dispense pre-filled syringes and do not have the sterile compounding equipment and facilities to prepare in accordance with the NAPRA Standards must refer the patients to a pharmacy with the necessary resources to prepare them safely.
CPhM Council has again approved an extension of the exemption for the drawing-up of comfort care medications for Palliative Care patients in a setting that does not meet the NAPRA Model Standards for Sterile Compounding. Council will review the exemption again prior to the new expiry date of January 1, 2024. Any pharmacy or pharmacist that is considering utilization of this exemption must be knowledgeable and fully complaint with the following requirements:
When deciding if the service should be provided:
Once the decision has been made to provide the service:
Prior to consideration of using the above exemption, it is imperative that pharmacists make every effort to seek the services of, or refer a patient to, a pharmacy that can provide sterile compounding that fully meets the NAPRA Model Standards for Sterile Compounding. This is considered ideal, best practice, and in the best interest of patient safety. The exemption is intended to provide timely access to necessary medications in order to offer the pharmacist and patient/caregiver time to source out fully compliant sources of the drug product.
In the interest of patient safety and access to care, CPhM asks that pharmacy managers self-declare, and make public where appropriate, the sterile hazardous and sterile non-hazardous compounding services 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 hazardous and/or non-hazardous sterile compounding as a pharmacy care service.
For more information on the compounding standards for sterile preparations in effect in Manitoba, please click the following links:
Pharmacy managers can update this information on the Pharmacy Public Register with the following steps:
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 non-sterile Level C compounding services is also provided on your Pharmacy Portal if needed.
Stay informed about the standards for non-sterile compounding.
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