Pharmacy Compounding Standards: Sterile Preparations

• NAPRA Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations
  • Sterile Non-Hazardous Compounding Implementation Schedule

• NAPRA Model Standards for Pharmacy Compounding of Hazardous Sterile Preparation
  • Sterile Hazardous Compounding Implementation Schedule

• NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

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.

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 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.

CPhM Council has again approved an extension of the exemption 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.  Council will review the exemption again prior to the new expiry date of January 1, 2026.  Any pharmacy or pharmacist that is considering utilization of this exemption must be knowledgeable and fully complaint 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 a 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, 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:

• A process for obtaining informed consent must be implemented and followed. This must include a meaningful discussion with the patient/caregiver/decision-maker on associated risks and alternatives of the provided pharmacy service.  
• 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 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 6 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 must be provided to the patient’s agent on storage at home.  

Prior to consideration of using the above exemption, it is imperative that pharmacists make every effort to seek the services of, or refer a patient to, a pharmacy that can provide sterile compounding that fully meets the NAPRA Model Standards for Sterile Compounding. This is considered ideal, best practice, and in the best interest of patient safety. The exemption is intended to provide timely access to necessary medications in order to offer the pharmacist and patient/caregiver time to source out fully compliant sources of the drug product.