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NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations
- Phase one, two, three, and four for implementation are in effect.
For more information on the schedule and requirements for the various implementation phases, please see the Standards for Pharmacy Compounding of Non-Sterile Preparations Information Sheet.
Pharmacist’s Role and Responsibilities in Providing Non-sterile Compounding Services
In accordance with the Pharmacy Facilities Practice Direction, pharmacies must have space and equipment necessary to provide compounding as part of the practice of pharmacy.
Compounding personnel must maintain their competencies to provide non-sterile compounded drug products and services suitable to their level of competency, facilities, equipment, and training. A pharmacy must make appropriate accommodations to obtain a compounded product or refer the patient to another pharmacy with appropriate facilities or competencies when the treatment required by the patient is beyond the scope of the member’s professional practice or competence.
It is the expectation that any community or hospital pharmacy in Manitoba has the ability to dispense a simple compounded product, when appropriate, to a patient. A simple compounded product is defined as a Level A compound within the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations.
Non-Sterile Compounding Resources
- NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations
- NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations
- Where do I Start? Standards for Pharmacy Compounding of Non-sterile Preparations
- Guidelines for Pharmacists Regarding the Provision of Non-sterile Compounding Services
- Decision algorithm for risk assessment from the Model Standards for Pharmacy Compounding of Non-Sterile Preparations Guidance Document
- NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings
Non-Sterile Compounding Pharmacy Quality Assurance Self-Assessment
The Non-Sterile Compounding Pharmacy Quality Assurance (QA) Self-Assessment is a gap analysis tool created by the College to ease implementation of the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Do not submit this QA Self-Assessment to the College for approval or review.
Compounded Nasal and Sinus Preparations for Local Application
On Dec. 23, 2020 Council passed a motion that compounded nasal and sinus preparations (e.g. nasal sprays, nasal irrigation) that are intended for local application are distinct from compounded sterile preparations of nasal inhalation solutions that are intended for delivery to the lungs as included in the NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations. Where appropriate, compounded nasal and sinus preparations (e.g. nasal sprays, nasal irrigation) that are intended for local application can be prepared in a nonsterile environment, following the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations. Please note that when compounding these nasal preparations deemed as non-sterile, compliance with the NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations and Guidance Document is expected.
Included in this expectation, in part, is compliance with the following general guidance on whether to compound a preparation:
- Are the active ingredients already available in a manufactured product?
- Do you have a referenced formulation?
- Do you have the beyond-use date (BUD) and relevant stability data?
- Do you have a dedicated space for compounding that is clean and uncluttered?
- Do you have the appropriate equipment and ingredients to make the compounded preparation?
- Are your pharmacy personnel competent to perform compounding of the preparation?
- Can your pharmacy personnel compound the preparation without interruption?
- Should you refer this compounded preparation to another pharmacy with appropriate facilities, equipment and expertise?
Can I Dilute or Alter a Compound that I Received From Another Pharmacy?
No. Compounds that are prepared by a pharmacy cannot be further manipulated or used as an ingredient in a future preparation that will be compounded by another pharmacy. Health Canada’s Policy 0051 authorizes a pharmacy to compound a drug for a patient of another pharmacy only if it is pursuant to a prescription or if it is in anticipation of a prescription. There should be a reasonable expectation of receiving a valid prescription for a patient for that specific compounded preparation, which requires no adulteration.
For further information regarding the Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051), please see the following link.
NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations
- Phase one and two of implementation are now in effect.
- The phase three implementation deadline was extended by Council to January 1, 2022, including:
- Section 6.1 of the NAPRA Model Standards: Establish documented beyond-use dates and dating methods.
- Section 5.3 of the NAPRA Model Standards: Facilities and Equipment.
Facilities that will not be compliant with the original date of January 1, 2021, must submit plans to Chris Louizos (CLouizos@cphm.ca) outlining, in detail, how they will achieve compliance by the new deadline, January 1, 2022.
Sterile Compounding Resources
- NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations
- NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparation
Sterile Compounding Pharmacy Quality Assurance Self-Assessment
The Sterile Compounding Pharmacy Quality Assurance (QA) Self-Assessment is a gap analysis tool created by the College to ease implementation of the NAPRA Model Standards for Pharmacy Compounding of Sterile Preparations. Do not submit this QA Self-Assessment to the College for approval or review.
Pre-filling Insulin Syringes
The National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations highlight that greater attention must be paid to the environment in which compounded sterile preparations are prepared, the training of personnel and quality assurance procedures necessary in order to protect patients and pharmacy personnel.
A sterile environment is required for the production of compounded sterile products and the manipulation of sterile products. A sterile drug product that is transferred from vials or ampoules into sterile final containers with syringe and needle is classified as a sterile compound.
Pharmacies that are engaged in sterile compounding are required to meet the NAPRA Model Standards for Pharmacy Compounding of Hazardous and/or Non-Hazardous Sterile Preparations. Some of the requirements for sterile compounding facilities include an ISO 5 environment maintained in a primary engineering control (PEC) and maintenance of an ISO 7 or better clean room or segregated compounding area.
Pharmacists engaged in sterile compounding must ensure they have the appropriate facilities and competence when providing sterile compounds. Repackaging of sterile products, including the preparation of pre-filled syringes containing medications such as insulin is a sterile compounding activity.
Pharmacists who are asked to dispense pre-filled syringes and do not have the sterile compounding equipment and facilities to prepare in accordance with the NAPRA Standards must refer the patients to a pharmacy with the necessary resources to prepare them safely.
Amendments to the Model Standards for Pharmacy Compounding of Sterile Preparations
On March 25, 2019, Council approved the following amendment to the NAPRA Model Standards for Pharmacy Sterile Compounding:
- Personnel gloving procedure for sterile non-hazardous compounding may occur in the anteroom.
- Personnel gloving procedure for sterile hazardous compounding may occur as follows: Inner pair in the anteroom and outer pair in the cleanroom.
This amendment was extended by Council and remains in effect until January 1, 2022.
Sterile Compounding Exemption for Palliative Care Patients
College Council approved an exemption for pharmacies in the province to draw-up comfort care medications for palliative care patients in a setting that does not meet the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Sterile Compounding. The exemption is in place until January 1, 2022. This exemption will be reviewed by the College Compounding Task Force.
Council has approved the following guiding principles for this exemption to the NAPRA Model Standards for Hazardous and Non-Hazardous Sterile Compounding.
The guiding principles are below.
When deciding if the service should be provided:
- The medications should be non-hazardous and non-high-risk (i.e. not non-sterile ingredients)
- The products should be single manipulation
- There is no viable or closely equivalent commercial preparation available
- Risk vs. benefit favours rapid access to drawn-up product versus requiring product from a compliant sterile facility
- A patient must be registered with the palliative care program
- All possibilities of training caregiver or family member to draw up medication should be exhausted first before contemplating this option
- The physician determines that this is the only viable method of effective treatment of the patient
Once the decision has been made to provide the service:
- The patient or agent needs to sign a waiver/release form to acknowledge the risk associated with this option
- The product should be monitored for signs of potential contamination at draw-up, and further education should be provided to the patient’s agent to monitor before administration
- Preparation should take place in as sterile an area as possible to similar standards for preparing immediate use preparations (see NAPRA Model Standards for Sterile Compounding)
- The product must be stored appropriately at the pharmacy and education provided to the patient’s agent on storage at home
- Limits for the draws, if done outside NAPRA compliant areas, have a maximum expiry of three days
It is important that before a pharmacist pursues the above exemption, they should make every effort to seek the services of, or refer a patient to, a pharmacy that can provide sterile compounding that meets the NAPRA Model Standards fully. This is best practice and in the best interest of the patient and their safety.
Publicly List Your Pharmacy as a Sterile Compounding Pharmacy Care Provider
Currently, facilities performing Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparation are primarily occurring in hospitals and select (community) pharmacies within the Province of Manitoba. Although these services are available, there can be challenges identifying which pharmacies are engaging in this practice.
On May 7, 2021, in the interest of patient safety and access to care, College Council approved a new category in the Pharmacy Public Register to indicate those pharmacies with self-declared NAPRA compliant sterile compounding facilities. This new filter and listing will ensure that patients, pharmacists, and other healthcare practitioners have access to an up-to-date listing of pharmacies that provide sterile compounding services.
Pharmacies can now submit to the College a self-declaration of their provision of sterile compounding as a pharmacy care service. This declaration can occur at any time and will be included as part of the license application and renewal process moving forward. You can update this information on the Pharmacy Public Register with the following steps:
1) Log into your Pharmacy Portal.
2) Click Update Pharmacy Information – Add/Edit Employee Lists.
3) Read the self-declaration and click the check box to indicate both of the following:
- if you are currently providing any sterile compounding pharmacy care services at your pharmacy AND
- if you would like to have your pharmacy visible on the College website and the Public Register as one that has self-declared the provision of sterile compounding as a pharmacy care service (visible to other pharmacists and the public).
4) Click Save.
Once you have completed these steps, the Pharmacy Public Register will be updated, and the College will be notified of your self-declaration to provide sterile compounding services.