Implementing the New Model Standards for Pharmacy Compounding

The College has set out a four-year implementation plan for pharmacies and pharmacy professionals to adopt the new model standards for compounding of sterile preparations, recently released by the National Association of Pharmacy Regulatory Authorities (NAPRA).

The new standards include Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations, and Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations.

Allowing individual ingredients to be mixed together in personalized strengths and dosages based on a patient’s needs plays an important role in pharmacy practice. Standards are needed to ensure to ensure preparation quality and safety when compounding drugs for patients.

Evolving practice as well as the increased awareness of the risks of compounding sterile preparations on the health of both patients and compounding personnel led NAPRA to develop new model standards for pharmacy compounding.

The College recommends that those who compound sterile preparations follow the four-year implementation timeline to ensure they meet the all the requirements by May 2021, when the new bylaws are expected to come into effect.

A third and final Model Standards document for non-sterile preparations was released by NAPRA in March 2018. The College will be developing a proposed implementation plan for Board consideration, in due course.

Four Year Implementation Plan

Each phase in the implementation plan includes specific groupings of standards from the Model Standards. The College’s existing bylaws and policies will remain in place until May 2021 (i.e., after the four-year implementation period is complete) at which point they will be replaced by new bylaws that will be developed closer to May 2021. Once these new bylaws come into effect, all existing references to compounding standards will be repealed.

Phase 1

Phase 2

Phase 3

Phase 4

November 2017

May 2019

May 2020

May 2021

Define compounding risk level
Complete gap survey and prioritize a site plan

NAPRA standards:

6.3 (compounded sterile preparation log)
6.4 (patient file)
6.5 (personnel)
6.6 (aseptic compounding of sterile preparations)
6.7 (packaging)
6.8 (storage)
6.9 (transport and delivery of compounded sterile preparations)
6.10 (recall of sterile products of final compounded sterile preparations)

NAPRA standards:

5.1 (personnel)
5.2 (policies and procedures)
5.4 (maintenance log)
6.2 (compounded sterile preparation protocols)

NAPRA standards:

6.1 (beyond-use date)
6.11 (incident and accident management)
6.12 (waste management)
7.1 (program content)
7.2 (results and action levels)
7.3 (verification of equipment and facilities)
7.4 (quality assurance of personnel)
7.5 (quality assurance of compounded sterile preparation)
7.6 (documentation of quality control activities)

NAPRA standard:

5.3 (facilities and equipment)

Who We Heard From

To inform the approach to adopting and implementing the new Model Standards across BC, the College used a multi-step engagement process to seek input.

During the engagement on the implementation of the new Model Standards for pharmacy compounding of hazardous and non-hazardous sterile preparations, the College received significant engagement from pharmacy managers, pharmacists and pharmacy technicians involved in pharmacy compounding.

The College also conducted an environmental scan of all pharmacies (community and hospital) to determine how many are engaged in hazardous and non-hazardous sterile compounding, and non-sterile compounding.

Participation in the Pharmacy Compounding engagement:

261 completed responses through an online survey sent to pharmacy managers, pharmacists and pharmacy technicians involved in compounding sterile preparations (hazardous and non-hazardous)
Gap Analysis Survey sent to pharmacy managers, pharmacists and pharmacy technicians to determine gaps in existing practice in meeting the Model Standards
Workshop with pharmacy managers, pharmacists and pharmacy technicians that included a review of the Gap Analysis survey results and a series of questions to understand where potential barriers and challenges to meeting the Model Standards may exist.
Survey for each of the Model Standards

Gap Identification Tools

The College also developed two Gap Identification tools to help pharmacy professionals identify gaps in their compounding program and practices, and assist with developing plans to become compliant with the new compounding standards.