Pharmacy Compounding Standards

Model Standards for Compounding of Sterile Preparations

Non-Hazardous and Hazardous Sterile Preparations

The practices outlined in the Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations and Hazardous Sterile Preparations are mandatory for pharmacies engaged in this compounding.

New Model Standards for Pharmacy Compounding will come into effect soon. Phase one and two are currently in effect, with phase three becoming mandatory January 1, 2021.

For more information on the schedule, see the documents provided from NAPRA.

Amendments to the Model Standards for Pharmacy Compounding of Sterile Preparations

On March 25, 2019, Council approved the following amendment to the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Sterile Compounding:

• Personnel gloving procedure for sterile non-hazardous compounding may occur in the anteroom.
• Personnel gloving procedure for sterile hazardous compounding may occur as follows: Inner pair in the anteroom and outer pair in the cleanroom.

This amendment remains in effect until January 1, 2021.

Reference:

NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations Section 6.6.2.1 page 45

NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations – Section 6.6.2.1 page 49

Model Standards for Compounding of Non-Sterile Preparations

The deadline for the implementation of Phase one of the Model Standards for Compounding of Non-Sterile Preparations is postponed until October 1, 2020.

For more information on the schedule, see our implementation chart.

Based on questions the College received in preparation for phase one of implementation of the model standards, we developed “Where do I start? Standards for Pharmacy Compounding of Non-sterile Preparations” for pharmacy professionals in Manitoba.

Quality Assurance Self-Assessment

To ease the implementation of these model standards, the College created a Pharmacy Quality Assurance Self-Assessment tool.

Note: The Pharmacy Quality Assurance Self-Assessment is a tool for gap analysis. You should not submit it to the College for approval or review.