Implementation of Non-Sterile Compounding Standards: Tips from the College’s Operations Advisors

To support pharmacies in their implementation of the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations, Pharmacy Connection asked the College operations advisors to each name one piece of advice they would give to registrants.

Read the standards and resources
Read both the Model Standards and the companion guidance document for Pharmacy Compounding of Non-Sterile Preparations, in their entirety.
Review the Pharmacy Connection articles addressing requirements, common questions and additional resources to support implementation.
Resources
- Model Standards for Pharmacy Compounding of Non-Sterile Preparations
- Guidance Document for Pharmacy Compounding of Non-Sterile Preparations
- Non-Sterile Compounding articles in Pharmacy Connection

Look at your practice as a whole, not just individual compounded preparations
Apply the risk-based approach to your entire compounding practice: identify risks, assess them and mitigate them through safety measures and administrative controls. Consider the cumulative risk associated with all preparations being compounded by the pharmacy.
Resources
- Frequently Asked Questions
- Non-Sterile Preparations Assessment Criteria to assess gaps between current practices and requirements of the standards
- November 4 Webinar Slides Part Two – Risk Assessments and Requirements

Safety first
The standards are designed first and foremost to keep patients and pharmacy personnel safe. How can you reduce the risk of errors during preparation of the prescription? How can you create a safe work environment and protect those performing the compounding from potential hazards?
Resources
- November 4 Webinar Slides Part One – Rationale for Standards
- Frequently Asked Questions
- Implementing the Non-Sterile Compounding Standards: A Closer Look at Personal Protective Equipment (Article)

Focus on the patient: assess the prescription and evaluate the need for compounding
Ask yourself, is the compounded preparation the most appropriate for the patient? Is there a suitable manufactured product commercially available? Can it be safely compounded in your pharmacy? Remember to document and defend any decision you make.
Resources
- November 4 Webinar Slides Part Three – Patient Assessment

Review all of the compounds you are making and ensure appropriate documentation is available
Ensure you have the appropriate record for each compound that the pharmacy prepares. Do you have up-to-date Master Formulation Records, which include all necessary information to compound the preparation, for every specific non-sterile preparation?
Resources

Keep progressing and take it one step at a time
Break down the required tasks into smaller chunks and set timelines for completion. What can you plan for this month, next month and the month after that to move your pharmacy forward?