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Pharmacy Compounding Standards

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

1. NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations

  • Phase one, two, and three for implementation are in effect.
  • The phase four deadline for implementation is April 1, 2021.

For more information on the schedule and requirements for the various implementation phases, please see the Standards for Pharmacy Compounding of Non-Sterile Preparations Information Sheet.

Resources

Non-Sterile Compounding Pharmacy Quality Assurance Self-Assessment

The Non-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 Non-Sterile Preparations. Do not submit this QA Self-Assessment to the College for approval or review.

2. NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations

  • Phase one and two of implementation are now in effect.
  • The phase three implementation deadline was extended by Council to January 1, 2022, including:
    • Section 6.1 of the NAPRA Model Standards: Establish documented beyond-use dates and dating methods.
    • Section 5.3 of the NAPRA Model Standards: Facilities and Equipment.

Facilities that will not be compliant with the original date of January 1, 2021, must submit plans to Chris Louizos (CLouizos@cphm.ca) outlining, in detail, how they will achieve compliance by the new deadline, January 1, 2022.

Resources

 

Sterile Compounding Pharmacy Quality Assurance Self-Assessment

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.

Amendments to the Model Standards for Pharmacy Compounding of Sterile Preparations

On March 25, 2019, Council approved the following amendment to the 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 was extended by Council and remains in effect until January 1, 2022.