Extending the Beyond-Use Dates for Sterile Preparations

GUIDELINE

Approved: June 2017

References:

Additional Resources:

College Contact: Pharmacy Practice


Introduction

The NAPRA Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations and Standards for Pharmacy Compounding of Hazardous Sterile Preparations were approved by the College Council in September 2016 for adoption and implementation in Ontario pharmacies by January 1, 2019. The College is providing pharmacies with tools to support implementation of the standards. This guidance is preliminary and will be updated as technology and practice evolves.

In all circumstances, patient safety is the primary concern. Every compounded preparation must be prepared using aseptic technique. Risks to patients are reduced when the established beyond-use dates (BUD) dates are applied according to a verified process.

BUDs are based on the risk that a preparation may be contaminated. An organization choosing to extend the BUD of a sterile preparation is expected to be able to provide the following:
  • Risk assessment;
  • Rationale and process;
  • Evidence to support the stability of the preparation in the final container and storage conditions;
  • Batch specific evidence to demonstrate sterility; and
  • Consultation and involvement of microbiology, and infection prevention and control.

Practitioners and/or organizations have a responsibility to ensure that any process used to prepare a sterile compounded preparation is verified and that there is no contamination of the preparation.

The following principles will assist practitioners to determine whether to extend the BUD of a compounded preparation.

Principles:

  1. The NAPRA standards are understood and met;
  2. Patient safety guides decision-making;
  3. A process of continuous quality improvement is applied to maintaining the environment, training staff and confirming competencies, and with respect to data gathering and analysis; and
  4. The anticipated urgency for access to a preparation is considered.