Ontario College of Pharmacists
Regulation - LGIC
Bill or Act:
Drug and Pharmacies Regulation Act
Summary of Decision:
The regulations were filed with the Registrar of Regulations as O. Reg. 58/11 under the Drug and Pharmacies Regulation Act and O. Reg. 59/11 under the Pharmacy Act, 1991 on March 10, 2011. Both regulations will be published in the Ontario Gazette on March 26, 2011.
Regulation 551 (General), Regulation 545 (Child Resistant Packages) and Ontario Regulation 297/96 (General) made under the Drug and Pharmacies Regulation Act (DPRA) were revoked and a new regulation was made under the DPRA, including complementary amendments to Part VII.2 of Ontario Regulation 202/94 under the Pharmacy Act, 1991 were made to update the language in those sections to align them with the DPRA regulation. Key highlights of the decision included the following:
- Approved new definitions and language to reflect current pharmacy practice
- Approved new record-keeping requirements
- Approved that pseudoephedrine and ephedrine are classified as drugs in Ontario. This would ensure that these substances are sold in a manner which protects against diversion and illicit use
- Approved requirements relating to the issuance and renewal of Certificates of Accreditation
- Approved updated standards for owning and operating pharmacies to promote transparency and accountability
- Approved new proprietary misconduct provisions that would enable the College to hold all owners and/or operators of pharmacies in Ontario equally responsible, whether or not they are members of the College
- Approved the regulatory framework that would authorize Ontario pharmacies to dispense certain drugs through remote dispensing locations
June 21, 2010
Summary of Proposal:
In Ontario, the regulation of health professions is based on a self-governance model. There are 21 health regulatory colleges governing 23 health professions under the Regulated Health Professions Act, 1991 (“RHPA”) and their respective health profession Acts.
Health regulatory colleges operate at arm’s length from the provincial government and independently administer their own internal processes. While regulatory amendments (e.g., accreditation requirements, proprietary misconduct, etc) require the review of the Minister of Health and Long-Term Care and approval by the Lieutenant Governor in Council, health regulatory colleges are given the authority in legislation to make regulations on a variety of subject matters.
The Ontario College of Pharmacists (“College”) is the registering and regulating body for pharmacy practice in Ontario. All persons within Ontario who wish to dispense prescriptions and sell products defined as drugs to the public must first have met the professional qualifications set by the College, and be registered as a pharmacist. Likewise, all pharmacies must meet certain standards for operations and be accredited by the College. In addition to setting initial standards, the College ensures ongoing adherence to the professional and operational standards. The Drug and Pharmacies Regulation Act (“DPRA”) governs the accreditation, ownership and operation of pharmacies.
Summary of Proposal
The College is proposing to consolidate and amend Ontario Regulation 297/96, Regulation 545 and Regulation 551 made under the DPRA. Some of the key proposed amendments include the following:
• Introduce new definitions and clarify language in the draft regulation to reflect current pharmacy practice
• Introduce amendments for electronic records and new record-keeping requirement
• Clarify that pseudoephedrine and ephedrine are classified as drugs in Ontario. The proposed amendment would ensure that these substances are sold in a manner which protects against diversion and illicit use
• Clarify requirements relating to the issuance and renewal of Certificates of Accreditation
• Update the standards for owning and operating pharmacies to promote transparency and accountability
• Introduce new proprietary misconduct provisions that would enable the College to hold all owners and/or operators of pharmacies in Ontario equally responsible, whether or not they are members of the College
• Introduce the regulatory framework that would authorize Ontario pharmacies to dispense certain drugs through remote dispensing locations
The College is currently circulating the proposed regulation amendments made under the DPRA to its members and other stakeholders for feedback.
483 Huron Street, Toronto, ON M5R 2R4
March 14, 2011