The first compliance deadline for the Model Standards for Compounding Non-Hazardous and Hazardous Sterile Preparations is less than three months away. The first deadline is July 1, 2018 for Priority One. The requirements in Priority One must be complied with, if your pharmacy prepares sterile compounds, prior to July 1/18 to renew your pharmacy license for 2018/19.
A new webpage on the Alberta College of Pharmacists’ website will be the source for information on the Model Standards (both non-hazardous and hazardous), and the deadlines for the three priorities.
The standards were created by the National Association of Pharmacy Regulatory Authorities (NAPRA), and approved by the Council of the Alberta College of Pharmacists (ACP) in June 2016. The Model Standards are the minimum requirements, it is possible to exceed them.
The three phases spread the changes out over several years to ensure successful implementation.
The compounding webpage will have details on each phase, the deadline for all the conditions to be met and how compliance will be verified. The first deadline is for “Priority One” on July 1, 2018. The deadline to comply with Priority Two requirements is January 1, 2019. And compliance with Priority Three requirements is due July 1, 2021.
Pharmacy licensees who have self-identified as preparing sterile products will receive an email from ACP with the statutory declaration and requesting current verification documents of Primary Engineering Control and controlled areas within the last six months. If you do not receive this email and your pharmacy prepares sterile compounds, please contact Jennifer Mosher at Jennifer.firstname.lastname@example.org .
The compounding webpage consolidates all relevant information in this one location on the ACP website.