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Undergoing Pharmacy Renovations? Don’t Forget to Report Layout Changes to the College
During Pharmacy Practice Reviews, Compliance Officers have come across a number of pharmacies that have not reported changes to the layout of their pharmacies after undergoing renovation. The College requires that the current layout of a pharmacy be consistent with the pharmacy diagram that the College has on record.
Minimum physical requirements are in place in order to ensure that registrants have sufficient room to prepare products. This helps to reduce the number of interruptions experienced by registrants, thus mitigating and preventing potential errors.
Reporting changes to the layout of a pharmacy is not a new requirement. Pursuant to section 4.1(3) of the Pharmacy Operations and Drug Scheduling Act, the direct owner must give the Registrar 30 days’ written notice of any changes respecting the layout of the pharmacy.
Before opening a new pharmacy, the authorized representative of the direct owner will have to submit the floorplan/diagram of the pharmacy as part of the application process. This pharmacy diagram is used to assess whether the proposed layout meets the basic physical requirements laid out in the bylaws (e.g. size of the dispensary).
As part of the pre-opening process, once the new pharmacy is built, the authorized representative must provide digital evidence (i.e. photos/video) to the College’s Licensure Department that all physical requirements have been met. Digital evidence will be reviewed by College staff to ensure that the layout of the pharmacy is consistent with the previously submitted diagram. When the pharmacy licence is issued, the pharmacy diagram becomes a record of the pharmacy’s layout, and is used by Compliance Officers or Investigators during future inspections. As such, the College requires that the diagram on record is up-to-date and reflective of the current layout of the pharmacy.
Change in Layout
A change in layout refers to changes fromthe original pharmacy diagram submitted to the College. These changes may include, but are not limited to:
- Changing the location of a physical requirement (e.g. moving the double stainless steel sink from the left side of the dispensary to the right);
- Changing the measurements/size/area of physical requirements in the pharmacy diagram (e.g. expanding the size of the dispensary);
- Adding or removing a physical requirement (e.g. adding a physical barrier to prevent access to schedule 3 products (i.e. lock-and-leave), adding a new consultation room, or removing part of the dispensing counter to pu in a new metal safe for narcotics);
- Making changes to the fixtures of a pharmacy (e.g. removing/adding a wall).
Refer to the pharmacy diagram checklist (community/telepharmacy or hospital) for the physical requirements in a pharmacy diagram.
Note that changes that do not impact the pharmacy diagram are not considered changes in layout for licensure purposes. Some examples include: changing the colour scheme of the pharmacy (e.g. wall/counter top), changing the “Medication Information” sign without changing the location, or changing the location of your microwave.
Reporting a Change in Layout
If you are planning to change the layout of your pharmacy, you must submit the Change in Layout application form and the proposed new pharmacy diagram no later than 30 days before the change occurs. Once the new pharmacy diagram is approved, follow the instructions in the confirmation letter to complete the rest of the process.
It is advised that you wait for College approval before making the actual changes to your pharmacy, in case the proposed changes do not meet the legislated physical requirements.
Unreported Renovations
If your pharmacy has undergone a renovation without reporting it to the College, you must submit the Change in Layout application form, the amended pharmacy diagram, and the pharmacy pre-opening report (with digital evidence) as soon as possible.
If your current layout does not meet the requirements, you will be asked to rectify the areas of non-compliance.
For a more detailed outline of the Change in Layout application process, visit:
bcpharmacists.org/change-layout or contact the College’s Licensure Department at [email protected].
- PRP Insights