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Priority Two deadline approaching for compounding non-hazardous and hazardous sterile preparations

December 12, 2018
Sterile compounding facilities must be compliant by January 1, 2019.

The second compliance deadline for the NAPRA Model Standards for Compounding Non-Hazardous and Hazardous Sterile Preparations is January 1, 2019. If your pharmacy prepares sterile compounds, the requirements of Priority Two must be met by that date.

The complete standards for both hazardous and non-hazardous sterile preparations can be found on the Standards of Practice page on the ACP website.

The requirements of Priority Two are listed on the sterile compounding page on the ACP website.

As a reminder, the major elements of Priority Two are the following:

  • Pharmacies must meet or exceed core requirements for a sterile compounding service.
  • Pharmacies must meet or exceed the production preparation requirements.
  • Pharmacies must develop and finalize their own quality assurance program.

Priority Two focuses largely on quality assurance and represents the bulk of your team’s efforts towards compliance with the NAPRA Sterile Compounding Standards. Be proactive! There are many tools within the NAPRA Sterile Compounding Standards to support compliance. It is not sufficient to show only evidence of policies and procedures; your team must be able to demonstrate compliance with policies and procedures.

Compliance with Priority Two will be assessed through an ACP in-person assessment. These assessments will begin in March 2019. You will be required to show evidence of each of the required elements whether it be direct observation by the assessor (e.g., hand hygiene and garbing, aseptic technique) or review of documentation (e.g., cleaning logs, preparation logs, policies and procedures).  Pharmacy licensees will receive 30 days’ advance notice of the scheduled assessment.

Inspections for compliance with all three priorities indicated in the NAPRA standards will begin after July 2020 for pharmacies that perform high-risk sterile compounding. For pharmacies that perform sterile compounding other than high-risk sterile compounding, inspections will begin after July 2021.

Thereafter, all pharmacies that perform sterile compounding will be inspected once every three years at minimum. Those pharmacies that perform high-risk sterile compounding will be inspected once every 18 months. Any re-inspections required will be determined by the professional practice consultant and the sterile compounding assessor.

In addition, please keep in mind that compliance with Priority One must be ongoing. All gaps identified in the required verification of PEC(s) and controlled areas must be addressed as of January 1, 2019.

Verification of your equipment and environment must continue at a minimum of every six months. If there are gaps identified between NAPRA assigned beyond-use dating and risk level of the sterile products that your team is preparing, these gaps must be closed. If beyond-use dates are extended, this must be supported through batch-specific sterility and endotoxin testing (if applicable).