This policy is under review. This webpage will be updated once the policy has completed the review process and any relevant changes are made.
GUIDANCE
Published: August 2016
Legislative References:
Additional References:
- Opening a New Pharmacy Checklist
- Requirements for the Operation of a Remote Dispensing Location
- Standards of Operation
- Time-Delayed Safes Policy
Requirements for Accreditation & Operation
Expectations for the accreditation and operation of pharmacies in Ontario can be found in the Drug and Pharmacies Regulation Act (O. Reg. 264/16) The College provides further details regarding how a pharmacy can meet the requirements for accreditation and operation of a pharmacy in Ontario in this guidance document.
The guidance provided in this document should be read in conjunction with the relevant requirements as outlined in the Drug and Pharmacies Regulation Act (O. Reg. 264/16).
Information to Consider when Opening and Operating a Pharmacy
The College provides information on opening a pharmacy and operating a pharmacy.
Pharmacies in Ontario must meet and maintain the requirements outlined in the Opening a New Pharmacy Checklist and the additional requirements outlined in the Opening a Remote Dispensing Location Checklist if applicable.If a pharmacy does not meet the requirements for material size the Accreditation Committee may consider allowing the pharmacy to operate for a specified period of time if, despite all reasonable efforts, the pharmacy is unable to meet those requirements.
Information on required drug information resources and references to be provided for registrants can be found in Appendix A: Reference Guide for Ontario Pharmacies.
The College has published guidance on procurement and inventory management and provides information on the requirements for the dispensary and medication safety:
- Medication Procurement and Inventory Management
- Protecting the Cold Chain
- Practice Tool: Controlled Substances (Narcotics, Controlled Drugs and Targeted Substances) and Administering Injections
The OCP website also provides access to additional guidance materials related to requirements for delivering pharmacy services:
- Centralized Prescription Processing (Central Fill)
- Multi-Medication Compliance Aids
- Opioid Policy
- Standards for specialty non-sterile and sterile compounding
Requirements for Operating a Pharmacy
The entire premises on which a pharmacy operates must be appropriately maintained and kept will lit and ventilated. All furniture, equipment, appliances and fixtures must also be appropriately maintained and be kept clean and orderly. The pharmacy must be designed, constructed and maintained to ensure that the pharmacy can safely and appropriately store all drugs, and maintain the integrity of drugs at all times.
Every room where drugs are compounded, dispensed or stored must be kept in an orderly fashion and should not be used to store materials or equipment not regularly used for these purposes.
Requirements For Pharmacy Practice Management Systems
Computer systems used in pharmacies must meet national minimum requirements. National minimum requirements for the information systems used by pharmacists and pharmacy technicians have been developed in compliance with Canadian regulations and standards. The functional and administrative requirements for pharmacy management systems set out in the NAPRA document Pharmacy Practice Management Systems (PPMS) are designed to ensure the safety and efficacy of e-prescriptions and related electronic pharmacy records. The effective date for these requirements is January 1, 2016.
In addition, computer systems must have sufficient speed and capacity to enable efficient and effective practice by registrants, and ensure that there are deliberate and auditable procedures required before any information can be purged from the system.
Required Programs (i.e., Policies and Procedures) for all Pharmacies
Pharmacies must maintain the following written programs:
- The pharmacy must ensure regular cleaning of the premises the pharmacy is operated from including all furniture, equipment, appliances and automated pharmacy systems if applicable;
- The pharmacy must ensure regular maintenance of all equipment and appliances, including automated pharmacy systems if applicable;
- All staff performing dispensing or compounding activities must adhere to appropriate hygienic behaviour including:
- wearing of suitable attire and protective coverings, and
- using appropriate hand washing techniques.
Appendix A: Required Reference Guide for Ontario Pharmacies (Pharmacy Library)
Updated September 2018
Legislative Reference: Drug and Pharmacies Regulation Act, Ontario Regulation 264/16
Background
It is a standard of accreditation for a pharmacy to have available the references and resources that are required by registrants practicing in the pharmacy to meet the standards of practice of the profession and to support the pharmacy services the registrants provide.
The Board has approved the use of electronic and web-based library reference materials as an alternative to hard copy texts. Regardless of the format chosen, the Designated Manager/delegate must ensure sources of information are readily accessible.
Ontario College of Pharmacists and Regulatory Publications
Pharmacy professionals must have access to, and should be familiar with navigating, the OCP website.
Links to current legislation and OCP references are located under Rules and Standards of the Profession including, but not limited to:
- Federal Legislation (Government of Canada’s Justice Laws website)
- Provincial Legislation (Government of Ontario’s eLaws website)
- OCP Policies and Guidelines
- By-laws
- Code of Ethics
- Standards of Practice
- Additional resources such as:
Library Requirements
To enable registrants to meet the standards of practice, at a minimum, every pharmacy1 should have at least one reference in each of the following areas:
- A Canadian Drug Reference / Compendium
- A Drug Interaction Publication
- A Drug Therapy Publication
- A Patient Counselling Guide
- Additional references should be selected based on the pharmacy’s patient population to support the specific services provided. For example: natural health products, pediatrics, compounding, geriatrics, etc.
The College does not recommend a particular reference in any area. It is up to the Designated Manager/delegate to research and compare the different options available and to select the appropriate references for the pharmacy.
Procurement
As practice is constantly evolving, it is critical that any reference used is the current edition or latest version available. The selection of references should be reviewed and evaluated on a regular basis to ensure each remains relevant and suitable for its intended purpose. Textbooks may be procured from various sources, such as directly from the publisher, the bookstore of a local university, or various retail outlets including on-line booksellers. The College does not evaluate or endorse suppliers.
1Note that this section does not apply to remote dispensing locations (RDLs) where all drugs are dispensed from an automated pharmacy system as the accredited pharmacy operating the RDL must have the required resources to support pharmacy services for both the accredited
pharmacy and the RDL.
Revision History
| Version # | Date | Action |
|---|---|---|
| 1.00 | August 2016 | Guidance published |
| 1.10 | September 2025 | Existing Required Reference Guide added as Appendix A. |