ACP’s Priority Three Deadline is Fast Approaching

Just a reminder that the Alberta College of Pharmacy’s deadline for Priority Three Non-Sterile Compounding Compliance is July 1, 2021.  The rollout for compliance was as follows:

  • The compliance deadline for Priority One: Assessing risks and gaps was January 1, 2020.
  • The compliance deadline for Priority Two: Compounding and cleaning, personnel training, and quality assurance was January 1, 2020.
  • The compliance deadline for Priority Three: Facilities and equipment is July 1, 2021.

It is time to ensure that your compounding facility does not require any structural changes.  That is, based on the risk level of compounded preparations, do you meet the facility requirements for Level, A, B and/or C containment?  Some questions to ask yourself are:

  • for Level A, do you have a dedicated space reserved for use for compounding?  Is it sufficiently sized?  Is it out of the way of dispensary traffic?
  • for Level B, do you have a closed off compounding room, with a door? Is there a sink with hot and cold running water? Are the walls, floors, other surfaces impermeable?  Are they cleanable?  Has your primary engineering control been certified?
  • for Level C (in addition to level B requirements) do you need a safety shower? Do you have evidence of temperature, humidity, and pressure monitoring?

It is very important that you ensure compliance with the other two priorities, and that you haven’t gotten complacent and let things slide.  If you have had your compounding practice previously assessed by the ACP, ensure that you have corrected all previously identified deficiencies.  Review your master formulation records and risk assessments to ensure that they are current.  Don’t forget to document this review.  Ensure your compounding and cleaning personnel have been appropriately trained and assessed.  You must document these assessments.  Are  your SOPs up to date?  Does your staff know where to find the SOPs if they are unsure of the required procedure?

Remember, all this effort has one goal in mind: safety,  Your safety, your staff’s safety, and your patients’ safety.