Accreditation and Operation of a Pharmacy

GUIDANCE

Published: August 1, 2016

Legislative References:

  • DPRA O. Reg. 264/16

Additional References:

College Contact: Pharmacy Practice


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 and operating a pharmacy on the Opening and Operating a Pharmacy webpage.

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 members can be found on the College’s website at: 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:

The OCP website also provides access to additional guidance materials related to requirements for delivering pharmacy services:


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 members, 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.