Non-Sterile Compounding Standards
In December 2017, College Council adopted the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Non-Sterile Preparations. The standards are accompanied by a Guidance Document for Pharmacy Compounding of Non-Sterile Preparations.
The standards apply to ALL pharmacies that perform any type of non-sterile compounding in any quantity (whether once in a while or every day).
The College is currently working towards establishing an appropriate implementation timeline. However, pharmacies are expected to begin implementation of the standards now.
Updates on implementation of the standard will be provided on this page. It is the responsibility of the Designated Manager and pharmacy professionals to ensure they stay up to date by reviewing this page and College communications regularly.
About the Standards
These standards are an important way of protecting patients and increasing patient safety.
The aim of the standards is to provide pharmacists and pharmacy technicians who compound non-sterile preparations with the information necessary to evaluate their practice, develop service-related procedures and implement appropriate quality controls for both patients and compounding personnel.
Model standards represent the minimum requirements that must be met regardless of practice site and against which performance can be measured. The College gave pharmacy professionals the opportunity to comment on the draft standards through a consultation in late 2016. NAPRA also incorporated input from pharmacy regulatory bodies and practicing pharmacists and pharmacy technicians across the country. It is the intention of the College that, whenever possible, national standards will be adopted.
These standards effectively replace the College’s 2006 Guideline for Compounding Preparations and NAPRA’s Guidelines for Pharmacy Compounding (2006).
It is the expectation of the College that implementation of the standards should begin now; there is no need to wait until the implementation timeline is announced.
Pharmacy professionals should be proactive:
- Review and become familiar with the standards and guidance.
- Conduct an assessment to identify gaps between the standards required in the pharmacy and your current practice, processes and compounding environment. The guidance document can be used to provide more details on how the standards can be achieved.
- Undertake a risk assessment to identify the appropriate level of requirements to minimize contamination of each compounding product and to provide adequate protection for personnel. Use Diagram 1: Decision algorithm for risk assessment found in the guidance document.
- Start work to close those gaps. For example, pharmacies can begin by reviewing current policies and procedures, master formulations and Safety Data Sheets. Additionally, pharmacies could inventory all compounds that are prepared in the pharmacy and decide whether they will continue to produce them and, if so, what category the compound would fall into.
- Look for resources (e.g. education) that are relevant to any gaps in knowledge or processes