Drug Preparation Premises

On May 15, 2013 the Ministry of Health and Long-term Care announced a regulation authorizing the College to inspect drug preparation premises where pharmacists and pharmacy technicians engage in or supervise drug preparation activities.

Pharmacists and pharmacy technicians must notify the College if employed in a drug preparation premises. The status and/or outcome of drug preparation premises inspections are publicly posted on Find a Pharmacy or Pharmacy Professional.

The College has developed a framework outlining three guiding principles that drug preparation premises and registrants should adhere to in order to ensure an environment and culture that promotes patient, compounding personnel and healthcare provider safety.

Background

These regulations were initially drafted in an effort to address a gap in regulatory oversight that was identified as a result of the March 2013 allegations of under-dosing of chemotherapy drugs to Ontario patients. The medications were supplied by an independent company to four hospitals in Ontario and one in New Brunswick. For more information read the Ministry of Health and Long-Term Care’s press release.

Drug Preparation Activities: means reconstituting, diluting or otherwise preparing a drug or combining, admixing or mixing together two or more substances, at least one of which is a drug, to create a final product for the purposes of the sale or provision to another person, other than pursuant to or in anticipation of a prescription.

Drug Preparation Premises: means any place where a pharmacist or pharmacy technician engages in drug preparation activities, or where drug preparation activities take place that a pharmacist or pharmacy technician supervises, but does not include:

  1. A pharmacy in respect of which a valid certificate of accreditation has been issued under the Drug and Pharmacies Regulation Act
  2. A premises in respect of which a valid establishment license has been issued under the Food and Drugs Act (Canada), or
  3. A hospital or a health or custodial institution approved or licensed under any general or special Act