Seeking Feedback on Non-Sterile Compounding Standards

Feedback deadline was: Nov. 17, 2016

Summary

The Ontario College of Pharmacists (OCP) is currently seeking feedback on the Model Standards for Pharmacy Compounding of Non-Sterile Preparations developed by the National Association of Pharmacy Regulatory Authorities (NAPRA).

The College is inviting all pharmacists and pharmacy technicians who engage in non-sterile compounding to review these standards and provide feedback. While general comments are welcome, it would be appreciated if submissions could specify the section and/or page number of the item being addressed, along with a rationale or reference supporting the comment, if any.

These draft standards have been developed to provide those who compound non-sterile preparations with the standards necessary to evaluate practice, develop procedures, and implement quality control measures, thereby improving quality and safety for both staff and patients. Along with other provincial pharmacy regulators, OCP will consider comments received and submit feedback to NAPRA.

An Ontario Working Group comprised of pharmacy professionals currently working within the area of non-sterile compounding will assist in the preparation of the submission.

Read the Model Standards for Pharmacy Compounding of Non-Sterile Preparations


Background

NAPRA based these standards on those that are already in place in Quebec, which are in turn based on General Chapter <795> of the United States Pharmacopeia – National Formulary (USP – NF).

It is the intention of OCP that, wherever possible, national standards will be adopted. Most recently, Council approved the implementation by January 2019 of the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.


Common Questions

Will these standards apply only to pharmacists and pharmacy technicians?
OCP is accountable only for pharmacies and registered pharmacy professionals; however, it is recommended that all health professionals engaged in non-sterile compounding review and meet these standards once approved.

What is OCP's role in ensuring the standards are met?
The role of OCP is to evaluate the operation of pharmacies and the practice of pharmacy professionals, including the adoption and implementation of standards. College Practice Advisors will evaluate the adoption of these standards, and others, in the course of their contact with pharmacy professionals during pharmacy practice assessments.

When will these standards take effect?
NAPRA will review the submissions of pharmacy regulators across the country and determine what changes to make to these draft standards, if any. Once NAPRA finalizes the standards, OCP council will consider the timing of their implementation.


Read the Feedback

View the feedback received to date.