When opening a new pharmacy, the licensee applicant must ensure compliance with all standards and requirements prior to providing pharmacy services. There are several steps related to ensuring compliance that the licensee applicant and the proprietor’s representative must complete. These steps are outlined in detail on the New pharmacy: Letter of Intent (Step 1) and New pharmacy: Application for a pharmacy licence (Step 2) webpages.
Before starting the application process and at each step along the way, it is essential to carefully review the information and requirements, ensure compliance, and submit required information that is accurate and complete. Following are important steps to support preparedness:
- Before you start, think about the pharmacy services you intend to provide.
- Review and consider the pharmacy licence categories that apply to those services. Ensure you apply for the appropriate licence(s).
- Review the Foundational requirements: Guidance document for opening a licensed pharmacy and ensure all requirements are satisfied using the Foundational requirements: compliance checklist.
- Ensure compliance with all standards and requirements, as outlined in the Pharmacy inspection readiness form.
At each step throughout this process, the pharmacy practice consultant (PPC) relies on the applicant’s preparedness and the completeness and accuracy of the information provided.
Incomplete or inaccurate submissions lead to resubmissions and delays
When the applicant reaches Step 2, they submit their digital evidence, which includes licensee applicant documentation, proprietor documentation, and pharmacy-related documentation. If the PPC finds that any of the submitted information is incomplete or inaccurate, the licensee will be required to resubmit their digital evidence before an inspection is scheduled.
Incomplete or inaccurate digital evidence may lead to a delay for the onsite inspection, which may consequently impact the pharmacy’s opening date. As such, it is important to ensure all submitted information is accurate and comprehensive.
A lack of inspection preparedness leads to re-inspections and increased fees
Once digital evidence is reviewed and deemed satisfactory by the PPC, a pre-opening inspection will be scheduled, typically within three to four weeks of digital evidence acceptance. The licensee must ensure the pharmacy is fully functional prior to the pre-opening inspection.
If there are deficiencies identified during a pre-opening inspection requiring the PPC to complete another onsite inspection of the pharmacy, a re-inspection will be required to ensure that the pharmacy is fully compliant with all requirements. The re-inspection will incur a re-inspection fee. The re-inspection will be conducted based on when the deficiencies are corrected to the PPC’s satisfaction and based on the PPC’s availability. These delays may impact the pharmacy’s opening date.
Opening a pharmacy necessitates careful planning and preparation. Ensuring the pharmacy is prepared prior to the pre-opening inspection prevents delays as well as additional work and fees and helps keep the opening process on track. Ultimately, these processes help to ensure that, when a new pharmacy opens its doors, it is equipped to provide quality pharmacy care for Albertans.
