All Changes to the Approved Pharmacy Diagram Require a Change in Layout Application Jun. 26, 2019

All Changes to the Approved Pharmacy Diagram Require a Change in Layout Application

During Pharmacy Practice Reviews, Compliance Officers continue to come across pharmacies with unreported changes to their layout. This is often due to confusion over the types of layout changes that need to be submitted to the College.

In a previous article, we discussed reporting changes to the layout of your pharmacy during renovations.

This article is intended to provide further clarification on what exactly constitutes a change in layout.

What is a Change in Layout?

A change in layout refers to any change made to the original pharmacy diagram, submitted to the College at the time of licensure.

During the licensure process, the pharmacy’s layout, as depicted in the pharmacy diagram submitted, is reviewed and verified prior to the pre-opening inspection. Once approved, the pharmacy is then licensed to operate with the layout depicted in the verified diagram.

Any changes made to the pharmacy that alter, affect or are in contrast to the submitted pharmacy diagram, must be reported to the College as a Change in Layout Application.

Examples of commonly reported layout changes include:

• 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 requirements (e.g. adding a physical barrier to prevent access to schedule 3 products (i.e. lock-and-leave), or removing part of the dispensing counter to put in a new metal safe for narcotics);
• Making changes to fixtures within a pharmacy (e.g. adding/removing a wall)

Additionally, spaces and/or fixtures that have been repurposed to complete activities different than those indicated in the original diagram, must also be reported to the College.

Repurposing Spaces

Spaces and/or fixtures that have been repurposed to complete activities different than what was originally indicated in the submitted pharmacy diagram, must also be reported to the College.

In these cases, although the physical elements of the space have not changed, and a renovation has not occurred, the purpose of the space is no longer consistent with that which is shown on the submitted pharmacy diagram. These types of changes can affect a pharmacy’s physical requirements such as security, minimum storage space, and minimum dispensing counter working space.

For example, dispensing activities should only be performed in the space indicated on the pharmacy diagram, to be the dispensing area. If a space on the diagram is specified for use as a separate and distinct storage area, dispensing activities must not be performed there.

Unreported Changes

If your pharmacy has undergone a renovation or change in layout 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.

Submitting a Change in Layout Application

A Change in Layout Application must be submitted to the College no later than 30 days before the change occurs and must include:

• PODSA Form 8G: Application for Change in Layout;
• Proposed pharmacy diagram for the renovation