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4 References Used in Non-Sterile Compounding

In Canadian pharmacy practice, the safe and effective preparation of compounded medications relies heavily on the use of reputable, evidence-based references. Pharmacists and pharmacy technicians must be able to access and apply authoritative resources that guide decisions related to formulation, ingredient standards, stability, safety, and regulatory compliance. These references are essential to ensuring that compounding practices are aligned with national and provincial standards, minimize risk, and meet patient-specific therapeutic needs. This chapter outlines the core references used in pharmacy compounding and emphasizes their role in upholding professional responsibility and patient safety.

 

 Compounding pharmacy personnel use appropriate references and resources to:
  • Employ best practices and keep up-to-date with art, science and technology of compounding (continuous quality improvement, proper technique, use equipment and supplies appropriately)
  • Follow established regulations, standards and guidelines for compounding
  • Understand ingredient standards and excipient functionality, selection, and use
  • Develop Formulation and Compounding Records
  • Adapt recipe (active ingredient, excipients) and technique

 

Here are some key references commonly used:

 

Regulatory and Professional Guidelines

  • NAPRA (National Association of Pharmacy Regulatory Authorities)
    • Model Standards for Pharmacy Compounding of Non-Sterile Preparations
      • These standards outline the foundational requirements for non-sterile compounding practices across Canada.
    • Model Standards for Pharmacy Compounding of Sterile Preparations
      • This document provides detailed explanations and practical advice to help pharmacies implement the model standards effectively.
    • www.napra.ca

 

  • Saskatchewan College of Pharmacy Professionals (SCPP) (if practicing in Saskatchewan)
    • Provides specific provincial guidelines, templates, and risk assessment tools.
    • www.saskpharm.ca

 

 

  • Provincial Pharmacy Regulatory Authority Publications:
      • Many provincial bodies offer additional guidelines and resources tailored to their specific regulations.

 

Drug Information

 

Compounding Standards & Pharmacopeias

  • United States Pharmacopeia (USP)
    • USP <795> Pharmaceutical Compounding – Non-Sterile Preparations
    • USP <797> Pharmaceutical Compounding – Sterile Preparations
    • USP <800> Hazardous Drugs – Handling in Healthcare Settings
    • www.usp.org
  • Canadian Society of Hospital Pharmacists (CSHP)*
  • The British Pharmacopoeia (BP)

 

 

Existing Formulation Records 

 

Drug Formulation & Stability References

  • Trissel’s Stability of Compounded Formulations (Lawrence A. Trissel)
    • Essential for determining stability, compatibility, storage and beyond-use dating.
    • often found as part of Lexicomp
  • The Art, Science, and Technology of Pharmaceutical Compounding (Allen’s Compounding)
    • Provides detailed compounding techniques and formulations.
  • Remington: The Science and Practice of Pharmacy
    • A comprehensive reference on formulation, compounding, and pharmaceutical sciences.
  • Compendium of Pharmaceuticals and Specialties (CPS)
    • Published by the Canadian Pharmacists Association (CPhA), it includes monographs on commercially available drugs, but may also provide insights on compounding practices.
    • www.pharmacists.ca

 

Safety & Hazardous Drugs Handling

  • NIOSH List of Hazardous Drugs (U.S. National Institute for Occupational Safety and Health)
    • Guidelines for handling hazardous drugs safely.
    • Criteria and sources of information for determining whether a drug is hazardous, given its genotoxicity, carcinogenicity, reproductive and developmental effects, and organ toxicity.
    • www.cdc.gov/niosh
  • Workplace Hazardous Materials Information System (WHMIS)
    • The WHMIS is “a comprehensive system for providing health and safety information on hazardous products intended for use, handling, or storage in Canadian workplaces” – Canadian Centre for Occupational Health and Safety (CCOHS). WHMIS 2015 – hazard classes and categories. Hamilton, ON: CCOHS; 2015. [Last modified June 17, 2016.] Available from: Canadian Centre for Occupation Health and Safety
  • Safety Data Sheets (SDS) from Suppliers
    • Every ingredient used in compounding should have an SDS to ensure safe handling, storage, and disposal.

 

“Applied Pharmaceutics in Contemporary Compounding” current edition. Shrewsbury, Robert

    • This is a comprehensive textbook discussing the basics of compounding

* Indicates  membership is required

 

Things to Consider regarding references

Ensuring References Are Current and Accessible

Pharmacy personnel must verify that all references used in compounding are up-to-date and relevant to current standards of practice. This is especially important for pharmacopoeial monographs (e.g., USP chapters), stability data (e.g., Trissel’s), and national or provincial regulatory guidelines (e.g., NAPRA Model Standards, SCPP policies).

Best Practices Include:

  • Checking for the most recent editions or updates before relying on a reference.
  • Subscribing to regulatory body newsletters or alerts (e.g., Health Canada or NAPRA updates).
  • Using reputable online databases or institutional subscriptions to ensure access to current documents.
  • Keeping printed materials, such as compounding textbooks or pharmacopeias, in an accessible and regularly updated reference library in the compounding area.

 

Integration of References into Standard Operating Procedures (SOPs)

SOPs form the foundation of consistent, compliant, and safe pharmacy practice. They must include clear instructions on when and how to use references during the compounding process. These documents serve as both a training tool and a quality control measure.

Content to Include in SOPs:

  • A list of approved primary references (e.g., USP <795>, Trissel’s, Lexicomp, NAPRA guidance).
  • Procedures for verifying formulation records against reputable sources.
  • Instructions for handling new or unfamiliar formulations, including how to search for and validate a reliable recipe.
  • Documentation requirements that include citing the reference source used for each compounded preparation.

 

Digital and Print Reference Accessibility in the Compounding Area

To support safe and efficient workflow, pharmacies should ensure that reference materials—whether print or digital—are readily available to staff during compounding.

Practical Considerations:

  • Maintaining digital subscriptions to Lexicomp, RxVigilance, and other tools on designated workstations or tablets in the compounding lab.
  • Keeping printed copies of essential references such as Allen’s Compounding or the Handbook of Pharmaceutical Excipients near the compounding area.
  • Ensuring staff are trained on how to access and navigate both digital and physical resources quickly.
  • Establishing a backup plan for internet outages (e.g., keeping PDF versions of commonly used formulations or having a local database).

 

Access to high-quality compounding references is a cornerstone of responsible pharmacy practice in Canada. By consulting authoritative sources—from NAPRA standards to USP monographs, and from drug stability texts to safety data sheets—pharmacy personnel ensure that compounded preparations are not only tailored to individual patient needs but are also safe, legal, and professionally appropriate. Pharmacy professionals must remain familiar with these resources, know when and how to use them, and understand their role in continuous quality improvement and compliance with evolving standards of care.

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Pharmacy Non-Sterile Compounding in Canada Copyright © by Janet Hoda BSP, BSc is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, except where otherwise noted.

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