1 Chapter 1: Regulations and Standards of Non-Sterile Compounding
History of Non-Sterile Compounding in Canada
Non-sterile compounding has been a fundamental aspect of pharmacy practice in Canada, evolving alongside advancements in pharmaceutical manufacturing and regulation. Historically, pharmacists played a primary role in preparing customized medications before the rise of mass-produced pharmaceuticals in the 20th century. As commercial drug availability increased, compounding declined but remained essential for patient-specific needs. Here is a brief history:
Early Pharmacy Practice (Pre-20th Century – Mid-20th Century)
- Before the mass production of pharmaceuticals, pharmacists played a central role in preparing individualized medications for patients.
- Non-sterile compounding was a fundamental part of pharmacy practice, with pharmacists formulating pills, ointments, and solutions based on physicians’ prescriptions.
- With industrialization and the rise of commercial drug manufacturing, the role of compounding declined but remained necessary for patients requiring customized medications.
Regulatory Developments (Late 20th Century)
- The increasing availability of commercially prepared medications reduced the reliance on compounding.
- However, concerns about quality control and consistency led to growing regulatory oversight.
- Provincial pharmacy regulatory bodies began establishing guidelines, but regulations varied across Canada.
NAPRA Model Standards (2018)
- The National Association of Pharmacy Regulatory Authorities (NAPRA) recognized the need for national consistency and developed the Model Standards for Pharmacy Compounding of Non-sterile Preparations in 2018.
- These standards aimed to improve safety, ensuring proper risk assessment, personnel training, and facility requirements.
Current Landscape
- Provincial pharmacy regulatory bodies have adopted and enforced NAPRA’s standards, implementing them in phases to allow pharmacies time to comply.
- Modern non-sterile compounding now requires risk assessment, quality assurance measures, and proper facilities to minimize contamination and ensure patient safety.
- Ongoing advancements continue to refine best practices, integrating new technologies and safety protocols
Regulatory oversight strengthened in the late 20th century as concerns about quality and consistency grew. In 2018, the National Association of Pharmacy Regulatory Authorities (NAPRA) introduced the Model Standards for Pharmacy Compounding of Non-sterile Preparations, establishing national guidelines to enhance safety, risk management, and quality assurance. Provincial pharmacy regulators have since implemented these standards, modernizing compounding practices to ensure compliance, proper facility requirements, and patient safety.
Regulation of Pharmacy Practice in Canada
Pharmacy in Canada is a self-regulating profession, meaning that the federal and provincial/territorial governments delegate regulatory authority to external professional bodies. This allows pharmacy, like other self-regulated professions such as medicine and engineering, to establish and enforce its own performance, technical, ethical, and educational standards. Pharmacy regulatory authorities have the responsibility to license individuals and practice environments, ensuring that practitioners meet established requirements and taking disciplinary action when standards are not upheld. The primary mandate of this regulatory framework is public protection, ensuring safe and high-quality pharmacy care.
The National Association of Pharmacy Regulatory Authorities (NAPRA) serves as the national organization for pharmacy regulators in Canada. NAPRA supports its member organizations by developing model standards and guidelines that provinces and territories may adopt or adapt, helping harmonize pharmacy practice across jurisdictions. This facilitates the mobility of pharmacy professionals and promotes consistent patient care. Additionally, NAPRA engages in dialogue with government agencies and healthcare organizations, administers programs like the National Drug Schedules and Pharmacists’ Gateway Canada, and provides a platform for discussing national pharmacy practice issues.
Now that you have a bit of a history lesson of compounding in Canada, it is important to understand the roles of federal and provincial bodies play in compounding. Compounding non-sterile preparations in Canada requires adherence to a clear regulatory framework that ensures patient safety, product quality, and professional accountability. This framework is defined by both federal legislation and provincial/territorial pharmacy regulatory authority standards. Understanding the interplay between these levels of regulation is essential for pharmacy personnel to ensure compliance and uphold best practices in compounding
Federal Role in Non-Sterile Compounding
At the federal level, Health Canada oversees the Food and Drugs Act and associated regulations. Health Canada’s role primarily involves regulating:
- Manufactured health products (i.e., mass-produced, commercially available drugs).
- The distinction between compounding and manufacturing, as outlined in Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051).
- Enforcement of Good Manufacturing Practices (GMP) for manufacturers—not for pharmacy-based compounding.
Importantly, Health Canada does not regulate pharmacy compounding directly. Instead, it allows provinces and territories to regulate pharmacy practice, including compounding, provided compounding is carried out on a patient-specific basis and not for resale or mass distribution.
Provincial and Territorial Role in Non-Sterile Compounding
Regulation of non-sterile compounding in pharmacies is primarily the responsibility of provincial and territorial pharmacy regulatory authorities (PRAs). Each province or territory enforces standards through its own pharmacy legislation and bylaws. However, most PRAs have adopted or adapted national standards developed by NAPRA (National Association of Pharmacy Regulatory Authorities). It is very important to review and be current on the regulations put forth by your provincial regulatory authority.
NAPRA’s Role and the MSOP
In Canada, the National Association of Pharmacy Regulatory Authorities (NAPRA) has established the “Model Standards for Pharmacy Compounding of Non-sterile Preparations” to ensure the safety and quality of compounded non-sterile medications. These standards serve as a framework for pharmacy regulatory authorities across provinces and territories, guiding pharmacists and pharmacy technicians in evaluating their compounding practices, developing procedures, and implementing quality controls.
To assist with the implementation of these standards, NAPRA has also published the “Guidance Document for Pharmacy Compounding of Non-sterile Preparations.” This document provides detailed information on achieving the standards and offers direction on their application.
NAPRA has also published a list of expected Competencies for Pharmacists and Pharmacy Technicians.
It’s important to note that while NAPRA provides the national framework, the adoption and enforcement of these standards are under the authority of provincial and territorial pharmacy regulatory bodies. Each jurisdiction may have specific processes and timelines for implementation. Therefore, it’s neccessary to consult your local pharmacy regulatory authority for the most current and applicable regulations in your area.
Requirements for all levels of Non-Sterile Compounding Activities
Compounding Personnel Responsibilities:
All pharmacy staff involved in non-sterile compounding must understand and perform their duties according to the NAPRA Model Standards and their applicable provincial/territorial regulatory authority.
Key Roles:
- Pharmacy Manager or Department Head:
- Oversees the organization, development, and supervision of all non-sterile compounding activities.
- Non-Sterile Compounding Supervisor (Pharmacist or Pharmacy Technician):
- Manages and coordinates daily compounding operations.
- Verifies that personnel are trained and policies are understood.
- Ensures each preparation undergoes a proper risk assessment.
- Confirms that required facilities, equipment, and reference materials are available.
- Approves the creation and validation of Master Formulation Records (MFR) and determines appropriate Beyond-Use Dates (BUD) based on scientific evidence.
- Implements and monitors a quality assurance (QA) program.
- Maintains thorough records of all compounding decisions, activities, and verifications.
- Regulated Pharmacy Personnel (Pharmacists and Pharmacy Technicians):
- Compound non-sterile preparations following approved formulas and established policies.
- Complete and document all activities, verifications, and decisions.
- Ensure that all compounding and professional standards are upheld before dispensing or releasing products.
- Non-Regulated Personnel:
-
- May participate in compounding under direct supervision, following applicable provincial/territorial regulations.
-
Training and Competency Assessment:
- Training Programs:
- All staff involved in non-sterile compounding must complete a structured training program tailored to their responsibilities.
- Training must be documented.
- Skills Assessment:
- Competency evaluations must be performed regularly to ensure safe and accurate compounding practices.
- Documentation must be kept for assessments and any required corrective actions.
- Cleaning Personnel:
- Staff responsible for cleaning compounding areas must be properly trained to understand how effective cleaning prevents contamination and maintains preparation quality.
Policies and Procedures:
- Pharmacies must develop and maintain detailed policies and procedures for all compounding activities, including cleaning processes.
- These documents must:
- Be clear, comprehensive, and easily accessible.
- Be reviewed at least every three years, or sooner if regulations, standards, or practices change.
- Be updated promptly in response to changes affecting compounding activities
- If hazardous substances are compounded, additional policies must address specific handling requirements.
Facilities and Equipment for Non-Sterile Compounding
Facility Requirements:
- Compounding must occur in a dedicated, separate area large enough for personnel to work comfortably and safely.
- Storage must be orderly, secure, and off the floor to prevent contamination and allow proper cleaning.
- Compounding spaces must support easy cleaning and sanitation, with proper waste disposal systems in place.
- Adequate lighting must be installed to ensure visibility for all compounding tasks.
- Heating, ventilation, and air conditioning (HVAC) systems must be managed to protect ingredient stability and prevent contamination.
- Clean running water (hot and cold) must be available near or within the compounding area.
- Surfaces (furniture, walls, floors) must be constructed to allow frequent and thorough cleaning.
- Cleanliness and hygiene must be consistently maintained to protect the quality and integrity of compounded preparations.
Equipment Requirements:
- Equipment must be suitable for the intended compounding tasks and must not compromise product quality.
- All tools and instruments must be cleaned meticulously after each use to prevent cross-contamination and maintain preparation integrity.
- Records must be maintained for calibration and cleaning
To compound non-sterile preparations safely and legally in Canada, pharmacy technicians must understand both the national standards (NAPRA MSOP) and the provincial regulations that govern practice. Being informed about these requirements ensures that technicians can consistently apply best practices, conduct thorough assessments, and support safe patient care.
Media Attributions
- photot of NAPRA Non-Sterile Competencies
- photo of NAPRA guidance document
- photo of NAPRA MSOP document
