Non-Sterile Compounding, Sterile Compounding

3 Guiding Principles of the New Drug Preparation Premises Framework

Light bulb with rays shine from colorful geometric shapes on green wooden background
Share this:

The College has developed a framework outlining three guiding principles that drug preparation premises and registrants should adhere to in order to ensure an environment and culture that promotes patient, compounding personnel and healthcare provider safety.

Drug Preparation Premises

A Drug Preparation Premises (DPP) is any place where a pharmacist or pharmacy technician engages in drug preparation activities, or where drug preparation activities take place that a pharmacist or pharmacy technician supervises. DPPs do not include:

  • A pharmacy with a valid certificate of accreditation issued under the Drug and Pharmacies Regulation Act
  • A premises with a valid establishment license issued under the Food and Drugs Act (Canada), or
  • A hospital or a health or custodial institution approved or licensed under any general or special Act

DPPs engage in non-sterile compounding and/or sterile compounding activities that may include non-hazardous and/or hazardous drug preparations. They provide preparations to a variety of facilities such as hospitals, prescriber offices, ambulatory care clinics, veterinarians and community pharmacies.

Guiding Principles

The DPP framework provides three guiding principles that DPPs and registrants should adhere to:

Patient centered icon

1. Patient-centered outcomes
DPPs play an important role in enabling patient’s access to quality specialty compounded preparations. While DPPs do not have direct contact with the patient who receives the compounded preparations, they must be mindful that a patient ultimately receives their compounded preparation. The ultimate goal of the DPP preparations is to have the patient achieve the desired outcomes from their medications.

To enable compounding personnel to provide the delivery of safe and effective patient-centered outcomes, a DPP must meet the College’s inspection criteria which includes compounding preparations according to evidence-based practices, having a quality risk management program, and having a safe and effective workflow design, among other requirements.

Safety centered icon

2. Safety-centered care
To ensure safe and quality preparations, it is critical that DPPs have the necessary infrastructure, facilities, policies and procedures, a quality assurance program and employee adherence to processes.

As the registrant will be held accountable for the integrity of the preparation, registrants who decide to outsource preparations from a DPP must perform their own due diligence in selecting a DPP. Inappropriate compounding practices can put employees and patients at risk for harmful outcomes.

To provide safety-centered compounding, DPPs must have compounding personnel able to consult a variety of up-to-date references to safely compound preparations, a comprehensive quality assurance program, a complete risk assessments for non-sterile and sterile preparations, and written policies and procedures governing how a Beyond-Use Date (BUD) is determined for all compounded preparations, among other requirements.

Professional accountability icon

3. Professional accountability
As registrants of the College, pharmacists and pharmacy technicians have professional accountabilities and responsibilities to uphold, including adhering to all federal and provincial legislation, College policies, guidance and the Code of Ethics.

Registrants may be employed at a DPP, supervising a DPP or involved in the purchase of preparations from a DPP. Registrants of the College are responsible for the compounding of DPP preparations and further manipulations of such performed by pharmacy professionals.

Registrants responsible for purchasing from a DPP must perform their due diligence in selecting a DPP. It is recommended to form a working group or committee with expertise in materials management, risk management and pharmaceutical compounding to make this decision. Senior management and legal should also be part of this group or committee.

Ongoing communication between the registrant and the DPP is important to ensure the DPP is able to meet the explicit pharmaceutical service requirements of the customer, are aware of the intended purpose of the compounded preparation and for the registrant to understand how the DPP is preparing the compounded preparation.


Share this: