Non-sterile compounding documentation for Alberta pharmacies

What ACP requires

ACP introduced its standards in three priorities: a risk assessment for each non-sterile compound the pharmacy prepares; a quality assurance program and documented procedures, including compounding, cleaning and personnel training; and facilities and equipment. The final deadline for existing pharmacies, extended during the pandemic, was July 1, 2021. New, relocated and renovated pharmacies must comply from the start.

ACP has stated that compounding should only occur within a facility’s capabilities and the risk assessments completed for the compounds it prepares, and that where the level of risk is uncertain the higher standard must be followed.

How Alberta projects work

Everything is done remotely. You send your list of preparations and the documents you already have. For procedures we add a questionnaire and a video walk-through of the compounding area. Documents are written against ACP’s standards and guidance document, not another province’s, and delivered as Word files for your compounding supervisor to review and sign.

Common questions

Are Alberta’s standards different from Ontario’s?

Both are based on the same national model, so the structure is the same: risk assessments, Levels A to C, master formulation records, procedures and quality assurance. ACP publishes its own adapted version, and that is the text we write to for Alberta pharmacies.

We compound only a few simple preparations. Do we still need all this?

The standards apply to every pharmacy that compounds non-sterile preparations. The amount of paperwork follows what you compound: a handful of preparations means a handful of assessments and records, and the procedures for a Level A area are the shortest set.

Read ACP’s Standards for Pharmacy Compounding of Non-Sterile Preparations