In Alberta, as of January 1, 2020, all licensed pharmacies must be compliant with the first two priorities towards compliance with ACP’s Standards for Pharmacy Compounding of Non-Sterile Preparations.
What does this mean? Regardless of the risk level of your compounded non-sterile preparations, you must have:
Assessed your compounding risks and gaps;
Completed a risk assessment for the non-sterile compounds that you make or plan to make in your pharmacy;
Ensured that your compounding and cleaning staff is appropriately trained and assessed;
Developed policies and procedures to meet the ACP’s Standards for Pharmacy Compounding of Non-Sterile Preparations;
Developed a quality assurance program for both your facility and your personnel; and
Identified infrastructure changes required in your pharmacy.
Your Priority One and Two gaps must be closed whether you plan on mixing two creams together or compounding with hazardous ingredients. You do not want to be deficient in these areas of compounding practice. If you have procrastinated, you have procrastinated long enough – these compounding standards are not going away and they will be enforced across the country. If you can’t safely compound in your pharmacy, sign an agreement with a pharmacy that can compound for you. I always recommend visiting the pharmacy with which you enter into a compounding agreement so you can assess how and where the compounds for your patients are made.
Don’t forget – pharmacies that require infrastructure changes must have those completed by July 1, 2020. The next six months will go very quickly, so do not delay!