Non-Sterile Compounding

Up to Standard: Tips on Meeting Non-Sterile Compounding Standards

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While pharmacy professionals continue to prepare their pharmacy for full implementation of NAPRA’s Model Standards for Pharmacy Compounding of Non-Sterile Preparations by January 1, 2022, College operations advisors are engaging registrants during pharmacy assessments to offer support and guidance, ensuring pharmacy professionals are aware of the obligations under the standards.

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. Phase 3—the final implementation phase of the non-sterile compounding standards—is focused on ensuring the facility and equipment required for the preparation of all non-sterile compounds are in compliance with the standards. Refer to section 5.4 of the Guidance Document for Pharmacy Compounding of Non-Sterile Preparations for more information.

Pharmacy Connection asked College operations advisors to offer a piece of advice they would give to registrants to support implementation of the standards and contribute to health and safety at the pharmacy for both patients and pharmacy professionals. Here’s what they had to say.

Access Resources and Engage Peers

Reflect on Your Current Practice & Activities

  • Reflect on your practice using a critical eye and consider what improvements should be made to continue to compound preparations with the policies and processes in place to ensure quality, consistency and safety.
  • If your pharmacy is using a space that has been converted to support compounding activities (i.e., office or storage space), special attention is needed to ensure the facility requirements (Section 5.4.1) are met and the health and safety of pharmacy staff and patients is maintained
  • Become familiar with your equipment (e.g., C-PEC or “hoods”, Section 5.4.2), including understanding how they function, how – and how often – they need to be maintained and certified to determine if they meet the standards.
  • When in doubt, defer to higher standard – safe, quality patient care should always be your top priority.

Plan for the Future

  • Plan now for the equipment and supplies your pharmacy will need in 2022 as there could be significant backorders due to supply chain pressures.
  • To ensure continuity of care, have an emergency plan in place to transition patients if your pharmacy is unable to safely provide certain compounding services.

Test Your Knowledge

Use the below educational tool to anonymously test your knowledge of the non-sterile compounding standards.

Opening a window provides
adequate ventilation

Compounding drugs that pose health hazards on the counter in a Level A area is not appropriate 

Level C rooms must be certified

Additional Resources

Exploring the Foundations of Pharmacy Renovations

(NAPRA) Model Standards for Pharmacy Compounding of Non-sterile Preparations

Guidance Document for Pharmacy Compounding of Non-sterile Preparations

Table 3: Examples of policies & procedures
Table 6: Example of components of a quality assurance program

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