Non-Sterile Compounding Phase 2: How to Meet the July 1, 2021 Deadline


It is the College’s expectation that pharmacies and pharmacy professionals continue to be engaged in preparing their pharmacy for full implementation of the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Use the fillable checklist to guide activities for each phase of implementation.


COLLEGE OPERATIONS ADVISORS LOOKING FOR COMPLETION OF RISK AND GAP ASSESSMENTS

In Phase 1, which had a deadline of January 1, 2020, pharmacies performing non-sterile compounding were focussed on assessing their risks and gaps, including reviewing the NAPRA standards and guidance documents, completing risk assessments, determining the level of requirements the pharmacy must meet (i.e. A, B or C) and performing a gap analysis between current practice and the level.

As the January 1, 2020 deadline has now passed, College operations advisors will be looking for completion of Phase 1 activities when performing pharmacy assessments (see section 4).


FOCUS ON PHASE 2: TRAINING AND QUALITY ASSURANCE

In Phase 2, the priorities are training and assessment of all personnel engaged in non-sterile compounding, developing and implementing policies and procedures, and creating a quality assurance program. In order to meet the upcoming deadline, pharmacies can:

  • Create Master Formulation Records for each preparation, including all necessary information to compound the preparation and the assignment of a beyond-use date (BUD) for each preparation. See Section 6 of the Guidance document.
  • Develop policies and procedures for all aspects of non-sterile compounding. Note that hazardous preparations require additional policies and procedures. See Section 5.3 of the Guidance document and Section 9.3, 9.4 and 9.5 related to hazardous.
  • Complete a skills assessment for existing non-sterile compounding/cleaning personnel. See Section 5.2 of the Guidance document.
  • Develop a training program for non-sterile compounding personnel and ensure there is training on policies and procedures as they are developed. See Section 5.2 of the Guidance document.
  • Develop a quality assurance program for personnel to verify ongoing effectiveness of, and compliance with, policies and procedures. See Section 7.3 and 7.4 of the Guidance document.
  • To support the upcoming Phase 3, with a deadline of January 1, 2022, begin developing other components of the pharmacy’s quality assurance program. See Section 7 of the Guidance document.

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