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Pharmacy Compounding Standards: Sterile Preparations

Stay informed about the on-going updates to the standards for sterile compounding.

NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations

The NAPRA Model Standards for Pharmacy Compounding of Hazardous and Non-Hazardous Sterile Preparations provide pharmacists and pharmacy technicians with the minimum criteria to compound hazardous and non-hazardous sterile preparations.

As of January 1, 2022, pharmacies and pharmacy professionals in Manitoba providing sterile compounding services must fully comply with these standards.

If a pharmacy requires an exemption from compliance with these Model Standards, it must apply directly to CPhM Council for approval.

Please see the resources and information listed below for additional guidance on pharmacy compounding of sterile preparations.

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 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 compoundsRepackaging 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.

Sterile Compounding Exemption for Palliative Care Patients

An exemptions for the drawing-up of comfort care medications for palliative care patients in a setting that does not meet the NAPRA Model Standards for Sterile Compounding is in effect January 1, 2022 – January 1, 2023. CPhM Council will review the exemption prior to its expiry date.

It should be noted that the guidance below has been updated from what is currently in effect (set to expire December 31, 2021) and should be thoroughly reviewed prior to utilising this exemption.  Any pharmacy and/or pharmacist considering the implementation of this exemption must be compliant with the following requirements.

When deciding if the service should be provided:

  • The patient must be registered with the palliative care program.
  • The medications should be non-hazardous and the manipulation be low risk (as defined by NAPRA) and prepared from a commercially available sterile source only.
  • The preparation should be only a single manipulation (i.e. pre-filling a syringe).
  • All possibilities of training caregiver or family member to draw-up medication should be exhausted before pursuing this option.
  • The physician determines that this is the only viable method of effective treatment of the patient and the prescription indicates “For Emergency Use.”
  • The benefit vs. risk favours rapid access to the medication.

Once the decision has been made to provide the service:

  • The patient or agent must sign a waiver/release form to acknowledge the preparation is from a non-compliant facility “for emergency use only.”
  • The product should be monitored for signs of potential contamination at draw-up, and further education should be provided to the patient or patient’s agent to monitor before administration.
  • Preparation should take place in a designated compounding area following the standards for preparing immediate use preparations (see NAPRA Model Standards for Sterile Compounding).
  • The compounder must don minimum personal protective equipment (PPE) including but not limited to sterile gloves (or gloves that have been disinfected with sterile alcohol) and a medical grade mask.
  • The preparation must be performed by a pharmacist or pharmacy technician.
  • The preparation is limited to a 2-day supply that must be labelled with a maximum beyond use date of 48 hours from the point of preparation.
  • The non-compliant pharmacy is limited to supplying a maximum of six days (three occurrences under this exemption).
  • Supply of medications beyond the limits must occur from a NAPRA compliant facility. The pharmacy must refer the patient to a compliant facility or obtain medications prepared from a compliant facility.
  • The product must be stored appropriately at the pharmacy and education on home storage provided to the patient or patient’s agent.

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. 

Pharmacy Compounding Standards: Non-sterile Preparations

Stay informed about the standards for non-sterile compounding.

Learn more