How Are You Preparing For the New Standards For Non-Sterile Compounding?

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 are involved in any type of non-sterile compounding in any quantity (whether once in a while or every day).

The College, in collaboration with other pharmacy regulators across the country, is currently working towards establishing an appropriate implementation timeline.

Proactive preparation for the standards could include:

• Reviewing and becoming familiar with the standards and guidance.
• Conducting 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.
• Undertaking a risk assessment to identify the appropriate level of precautions required 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.
• Starting 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.
• Looking for resources (e.g. education) that are relevant to any gaps in knowledge or processes.

The standards are an important part of protecting patients. It is the responsibility of the Designated Manager, pharmacy manager and pharmacy professionals to ensure that they are up-to-date on these new standards and are moving towards achieving implementation.

To learn more and stay up-to-date, visit the Non-Sterile Compounding Key Initiative on the College’s website.