NAPRA Model Standards for Compounding Non-Hazardous and Hazardous Sterile Preparations
The Standards for Compounding Sterile Non-Hazardous and Hazardous Preparations were created by the National Association of Pharmacy Regulatory Authorities (NAPRA), and approved by the Council of the Alberta College of Pharmacy (ACP) in 2016.
ACP Council determined that in Alberta, only a pharmacy technician or pharmacist may compound sterile preparations. This must not be delegated to a pharmacy assistant or another unregulated individual.
The implementation framework will give pharmacy professionals the requirements needed to adapt their facilities, policies, and procedures. The three phases spread the changes out over several years to ensure successful implementation.
The compliance deadlines for the Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations are as follows:
- The compliance deadline for Priority One is July 1, 2018.
- The compliance deadline for Priority Two is January 1, 2019.
- The compliance deadlines for Priority Three are
- July 1, 2020 for high risk sterile compounding; and
- July 1, 2021 for all remaining sterile compounding.
All the deadlines are the same for both Model Standards (hazardous and non-hazardous). Inspections for compliance with all three priorities will begin:
- in March 2019 for Priority Two;
- after July 1, 2020 for Priority Three for pharmacies that perform high-risk sterile compounding; and
- after July 1, 2021 for Priority Three for pharmacies that perform sterile compounding other than high-risk sterile compounding.
Pharmacy licensees will receive 30 days’ advance notice of the scheduled assessment. Thereafter, all pharmacies that perform high-risk sterile compounding will be inspected once every 18 months. All pharmacies that perform sterile compounding other than high risk will be inspected once every three years at minimum. Any re-inspections required will be determined by the pharmacy practice consultant and the sterile compounding assessor.
The following conditions must be met, if your pharmacy prepares sterile compounds, prior to July 1, 2018 to renew your pharmacy license for 2018/19:
- review NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-hazardous Sterile Preparations;
- identify the risk level (complexity, volume) of compounded sterile preparations;
- perform a gap analysis by comparing the Model Standards with current pharmacy sterile compounding procedures and facilities;
- prioritize the gap analysis and develop an action plan for compliance with the Model Standards; and
- initiate a quality assurance program, prioritizing
- verification of equipment, including Primary Engineering Control (PEC)*;
- verification of controlled areas (clean room and anteroom)*; and
- development of a written sampling plan for controlled areas according to specifications of a recognized standard, such as CETA applications guide CAG-002, CAG-003, or CAG-008.
*Under dynamic operating conditions, simulating the most complex of sterile compounds prepared in the facility
Verification of compliance with the above requirements will be through statutory declaration. Pharmacy licensees who have self-identified as preparing sterile products will receive an email from ACP with the statutory declaration and requesting current verification documents of PEC and controlled areas (within the last six months). Non-compliance may result in delays in the renewal of the pharmacy license. Pharmacy renewal packages will be mailed late April. You must complete, and submit the pharmacy licence renewal application in addition to meeting the Priority One requirements to renew your pharmacy licence.
As part of the inspection, 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).
- Pharmacies should meet or exceed core requirements for a sterile compounding service:
- All personnel, both compounding personnel and cleaning personnel, are aware and meet their roles and responsibilities.
- The pharmacy is in full compliance with compounding policies and procedures.
- Pharmacies should meet or exceed the production preparation requirements:
- compliance with beyond-use dating and dating methods, including consideration of the requirements surrounding sterility and endotoxin testing;
- compounded sterile preparation protocols;
- compounded sterile preparation log;
- complete patient file;
- conduct of personnel in areas reserved for the compounding of sterile preparations;
- aseptic compounding of non-hazardous sterile preparations – including, but not limited to, hand and forearm hygiene and garbing, cleaning, and disinfection;
- storage; and
- transport and delivery.
- Complete quality assurance program
- verification of equipment and facilities – certification, and written sampling plan;
- results and action levels;
- quality assurance of personnel involved in aseptic compounding – gloved fingertip sampling, media fill test;
- quality assurance of compounded sterile preparations; and
- documentation of quality control activities.
- Meet or exceed core requirements for a sterile compounding services
- Facilities and equipment.
The Model Standards for Compounding Hazardous Sterile Preparations were approved by ACP Council with the following amendments:
- An N95 or N100 NIOSH approved mask is not required when compounding hazardous products in a biological safety cabinet or compounding aseptic containment isolator.
- Pharmacy professionals compounding hazardous products, in compliance with these standards, are not required to wear clean room scrubs.