4 Chapter 4: References Used in Non-Sterile Compounding
In Canada, pharmacists and pharmacy technicians must use reputable references to ensure accuracy, safety, and compliance in compounding practices.
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
- Model Standards for Pharmacy Compounding of Non-Sterile Preparations
- Saskatchewan College of Pharmacy Professionals (SCPP) (if practicing in Saskatchewan)
- Provides specific provincial guidelines, templates, and risk assessment tools.
- www.saskpharm.ca
- Health Canada
- Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)
- The purpose of this document is to provide background information on the compounding and manufacturing of drugs in Canada and to provide a policy framework to assist in distinguishing between compounding and manufacturing activities of drug products in Canada.
- www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/policy-manufacturing-compounding-drug-products.html
- Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)
- Provincial Pharmacy Regulatory Authority Publications:
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- Many provincial bodies offer additional guidelines and resources tailored to their specific regulations.
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Drug Information
- Lexi-Comp*
- Lexi Drugs
- Martindale: The Complete Drug Reference
- Stat-Rx
- www.wolterskluwer.com/en/solutions/uptodate/enterprise/lexidrug
- Handbook of Pharmaceutical Excipients
- Health Canada’s Drug Product Database (DPD)
- good for checking if a product is commercially available
- www.health-products.canada.ca/dpd-bdpp/
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)*
- Compounding: guidelines for pharmacies. Ottawa, ON: CSHP; 2014.
- www.cshp.ca/Site/Site/Content/Home.aspx
- The British Pharmacopoeia (BP)
- Provides official monographs and standards for pharmaceuticals.
- www.pharmacopoeia.com/
Existing Formulation Records – there are many places you can find existing formulation records
- Children’s Hospital of Eastern Ontario
- IWK Health Drug Information Resource
- free resource
- www.dir.iwk.nshealth.ca/Home/CompoundingFormulas
- RX Vigilance*
- subscription service
- www.vigilance.ca/drug-compounding-formulas-rxvigilance
- PCCA (Professional Compounding Centers of America)* – Membership-based and includes validated formulation records.
- Sick Kids Pharmacy Compounding recipes
- free access but read disclaimer
- www.sickkids.ca/en/care-services/for-health-care-providers/compounding-service/
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: http://www.ccohs.ca/oshanswers/chemicals/whmis_ghs/hazard_classes.html
- 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
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- This is a comprehensive textbook discussing the basics of compounding
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