ACP inspections: digital evidence submission
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ACP inspections: digital evidence submission template Objectives This document will provide guidance and a template to licensees who are submitting digital evidence as part of a pharmacy inspection process. Unless otherwise indicated, this
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01
ACP inspections: digital evidence submission template<br>
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Objectives This document will provide guidance and a template to licensees who are submitting digital evidence as part of a pharmacy inspection process.
Unless otherwise indicated, this template should only be submitted to ACP once all required images have been added to the document. Any required digital evidence that is not to be added into the template (as outlined in Appendix A) must be submitted separately as independent documents.
Once digital evidence is submitted, your pharmacy practice consultant (PPC) will follow up with additional instructions, which may include clarification of the evidence submitted or scheduling of an inspection.<br>
Unless otherwise indicated, this template should only be submitted to ACP once all required images have been added to the document. Any required digital evidence that is not to be added into the template (as outlined in Appendix A) must be submitted separately as independent documents.
Once digital evidence is submitted, your pharmacy practice consultant (PPC) will follow up with additional instructions, which may include clarification of the evidence submitted or scheduling of an inspection.<br>
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Tips to avoid delays Ensure that you have read and understand the requirement(s) as outlined in the:
Foundational Requirements: Guidance Document for Opening a Licensed Pharmacy, and
Foundational Requirements – Compliance Checklist.
The digital evidence submitted in this template for each item must demonstrate that the item meets the foundational requirements.
The digital evidence submitted must be an actual real-time depiction of your pharmacy. Photos from other pharmacies or stock photos are not acceptable.
The digital evidence must be of sufficient quality and provide sufficient context for the College to assess whether the requirements are met.
Please ONLY insert images in the appropriate boxes on each slide.
If no slide is present for a particular foundational requirement, this indicates the required compliance evidence will be assessed elsewhere.<br>
Foundational Requirements: Guidance Document for Opening a Licensed Pharmacy, and
Foundational Requirements – Compliance Checklist.
The digital evidence submitted in this template for each item must demonstrate that the item meets the foundational requirements.
The digital evidence submitted must be an actual real-time depiction of your pharmacy. Photos from other pharmacies or stock photos are not acceptable.
The digital evidence must be of sufficient quality and provide sufficient context for the College to assess whether the requirements are met.
Please ONLY insert images in the appropriate boxes on each slide.
If no slide is present for a particular foundational requirement, this indicates the required compliance evidence will be assessed elsewhere.<br>
04
Foundational requirement #1 Digital evidence required of the external premises includes:
Multiple photos showing the external view of the pharmacy premises, including a panorama of surrounding and adjacent businesses.
Close-up photos of the external-facing signage, including the operational hours. These photos must clearly identify the location(s) where the signage is posted.
If the pharmacy is a lock-and-leave pharmacy, an additional photo displaying the operational hours of the store.
Digital evidence required of the internal premises includes:
Photo(s) of the prescription department taken from the internal front entry space of the premises.
Close-up (5-10 feet away, facing the dispensary) photo(s) of the signage used to differentiate the prescription department from the public area.
Photo(s) documenting any and all physical variations within the premises, including but not limited to flooring, decor, and fixtures.
Photo(s) of the thermostat displaying the temperature within the premises.
Photo(s) of the pharmacy and consultation room with 360o views demonstrating sufficient lighting. At least 2 photos should be submitted from the dispensary itself.<br>
Multiple photos showing the external view of the pharmacy premises, including a panorama of surrounding and adjacent businesses.
Close-up photos of the external-facing signage, including the operational hours. These photos must clearly identify the location(s) where the signage is posted.
If the pharmacy is a lock-and-leave pharmacy, an additional photo displaying the operational hours of the store.
Digital evidence required of the internal premises includes:
Photo(s) of the prescription department taken from the internal front entry space of the premises.
Close-up (5-10 feet away, facing the dispensary) photo(s) of the signage used to differentiate the prescription department from the public area.
Photo(s) documenting any and all physical variations within the premises, including but not limited to flooring, decor, and fixtures.
Photo(s) of the thermostat displaying the temperature within the premises.
Photo(s) of the pharmacy and consultation room with 360o views demonstrating sufficient lighting. At least 2 photos should be submitted from the dispensary itself.<br>
05
Foundational requirement #1 (Digital Evidence of the external premises – photos of the pharmacy and surrounding businesses)<br>
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Foundational requirement #1 (Digital Evidence of the external premises – photos of the pharmacy and surrounding businesses (2))<br>
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Foundational requirement #1 (Digital Evidence of the external premises – photos of the external signage for the pharmacy)<br>
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Foundational requirement #1 (Digital Evidence of the external premises – photos of the signage for the operational hours of the pharmacy)<br>
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Foundational requirement #1 (Digital Evidence of the internal premises – photos of the pharmacy and prescription department from entry to premises)<br>
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Foundational requirement #1 (Digital Evidence of the internal premises – photos of the pharmacy and prescription department from entry to premises (2))<br>
11
Foundational requirement #1 (Digital Evidence of the internal premises – photos of the pharmacy and prescription department from entry to premises (3))<br>
12
Foundational requirement #1 (Digital Evidence of the internal premises – thermostat and lighting)<br>
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Foundational requirement #1 (Digital Evidence of the internal premises – additional photos demonstrating sufficient lighting)<br>
14
Foundational requirement #2 Digital evidence required of the security system includes:
Photo(s) of all installed alarm panel(s) taken no further than 10 feet from the device.
Photo(s) of any and all cameras, motion sensors, and door sensors installed in the pharmacy.
If one panoramic photo can demonstrate the installation and location of these items, that will be sufficient.
Photo(s) of the viewing panel or monitor that displays the footage from the security cameras.
Photo(s) of any and all security gates, bars, or window grills installed in the pharmacy.
NOTE: A test to determine if the alarm system is operative will be conducted at the time of the inspection.<br>
Photo(s) of all installed alarm panel(s) taken no further than 10 feet from the device.
Photo(s) of any and all cameras, motion sensors, and door sensors installed in the pharmacy.
If one panoramic photo can demonstrate the installation and location of these items, that will be sufficient.
Photo(s) of the viewing panel or monitor that displays the footage from the security cameras.
Photo(s) of any and all security gates, bars, or window grills installed in the pharmacy.
NOTE: A test to determine if the alarm system is operative will be conducted at the time of the inspection.<br>
15
Foundational requirement #2 (Digital Evidence of the security system – alarm panel(s))<br>
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Foundational requirement #2 (Digital Evidence of the security system – cameras, motion sensors, door sensors)<br>
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Foundational requirement #2 (Digital Evidence of the security system – cameras, motion sensors, door sensors (2))<br>
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Foundational requirement #2 (Digital Evidence of the security system – viewing panel/screen for monitor that displays camera footage)<br>
19
Foundational requirement #2 (Digital Evidence of the security system – security gates, grills, or bars installed in the pharmacy)<br>
20
Foundational Requirement # 3 Digital evidence required for drug storage locations includes:
Photos of where Schedule 1 drug products will be stored in the dispensary.
Photos of where Schedule 2 drug products will be stored in the dispensary. Photos of where Schedule 3 drug products will be stored in the patient services area.
Photos of where homeopathic products will be stored in the patient services area.
Submit multiple photos from different angles to clearly demonstrate the locations of the storage areas.
Photos of shelf labels and/or signs for homeopathic products.<br>
Photos of where Schedule 1 drug products will be stored in the dispensary.
Photos of where Schedule 2 drug products will be stored in the dispensary. Photos of where Schedule 3 drug products will be stored in the patient services area.
Photos of where homeopathic products will be stored in the patient services area.
Submit multiple photos from different angles to clearly demonstrate the locations of the storage areas.
Photos of shelf labels and/or signs for homeopathic products.<br>
21
Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 1 Drugs from multiple angles)<br>
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Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 1 Drugs from multiple angles (2))<br>
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Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 1 Drugs from multiple angles (3))<br>
24
Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 2 Drugs from multiple angles)<br>
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Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 2 Drugs from multiple angles (2))<br>
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Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 2 Drugs from multiple angles (3))<br>
27
Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 3 Drugs from multiple angles)<br>
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Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 3 Drugs from multiple angles (2))<br>
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Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for Schedule 3 Drugs from multiple angles (3))<br>
30
Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for homeopathic products from multiple angles)<br>
31
Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying storage locations for homeopathic products from multiple angles (2))<br>
32
Foundational requirement #3 (Digital evidence required for the drug storage and location – photos identifying shelf labels and/or signage for homeopathic products)<br>
33
Foundational requirement #5 Digital evidence for physical specifications of the dispensary includes:
Photo(s) of the prescription drop-off and pick-up areas that clearly show their locations within the prescription department.
Photos should be taken from a distance to show the placement of these areas as well as any signage identifying their locations.
Additional photos (from the dispensary and public perspective) should be taken 5-10 feet from these areas to demonstrate the barriers in place to meet privacy requirements.
Photo(s) of any and all dispensing counters within the dispensary. Photo(s) should be submitted from multiple angles/ends of the counters.
Photos of any and all aisle spaces within the dispensary, including those between medication storage shelving. Photo(s) should be submitted from both ends of the aisle.
NOTE: A pharmacy with ONLY a compounding and repackaging licence, that does not have a community licence, does not require drop-off and pick-up areas.<br>
Photo(s) of the prescription drop-off and pick-up areas that clearly show their locations within the prescription department.
Photos should be taken from a distance to show the placement of these areas as well as any signage identifying their locations.
Additional photos (from the dispensary and public perspective) should be taken 5-10 feet from these areas to demonstrate the barriers in place to meet privacy requirements.
Photo(s) of any and all dispensing counters within the dispensary. Photo(s) should be submitted from multiple angles/ends of the counters.
Photos of any and all aisle spaces within the dispensary, including those between medication storage shelving. Photo(s) should be submitted from both ends of the aisle.
NOTE: A pharmacy with ONLY a compounding and repackaging licence, that does not have a community licence, does not require drop-off and pick-up areas.<br>
34
Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the drop-off at a suitable distance from patient waiting and high traffic areas with suitable sound and visual barriers)<br>
35
Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the drop off a suitable distance from patient waiting and high traffic areas with suitable sound and visual barriers viewed from the dispensary)<br>
36
Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the pick-up area a suitable distance from patient waiting and high traffic areas with suitable sound and visual barriers)<br>
37
Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the pick-up area a suitable distance from patient waiting and high traffic areas with suitable sound and visual barriers viewed from the dispensary)<br>
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Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the counter-space within the dispensary from multiple angles)<br>
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Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the counter-space within the dispensary from multiple angles (2))<br>
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Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the counter-space within the dispensary from multiple angles (3))<br>
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Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the aisle spaces within the dispensary from multiple angles)<br>
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Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the aisle spaces within the dispensary from multiple angles (2))<br>
43
Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the entryways within the dispensary from multiple angles)<br>
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Foundational requirement #5 (Digital Evidence for the dispensary – photos identifying the entryways within the dispensary from multiple angles (2))<br>
45
Foundational requirement #6 Digital evidence for physical barriers includes:
Photos of the physical material (walls, doors, gates) used to separate the dispensary from the patient services area.
Photos should be submitted from the perspective of the dispensary as well as the public area (at least one each) and should provide a panoramic view of the space.
Photos of all access points from the patient services area into the dispensary.
Photos should be submitted that clearly show the location of the access gates/doors as well as the specific features of the access points (locking features of gate or door).<br>
Photos of the physical material (walls, doors, gates) used to separate the dispensary from the patient services area.
Photos should be submitted from the perspective of the dispensary as well as the public area (at least one each) and should provide a panoramic view of the space.
Photos of all access points from the patient services area into the dispensary.
Photos should be submitted that clearly show the location of the access gates/doors as well as the specific features of the access points (locking features of gate or door).<br>
46
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying barriers to entering the dispensary (internal view from dispensary)<br>
47
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying barriers to entering the dispensary (internal view from dispensary (2))<br>
48
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying barriers to entering the dispensary (external view from patient services area)<br>
49
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying barriers to entering the dispensary (external view from patient services area (2))<br>
50
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying gates/doors for entering the dispensary (internal view from dispensary)<br>
51
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying gates/doors for entering the dispensary (internal view from dispensary (2))<br>
52
Foundational requirement #6 (Digital Evidence for the physical barriers – photos identifying gates/doors for entering the dispensary (external view from patient services area)<br>
53
Foundational requirement #7 Digital evidence for the time-delayed metal safe includes:
Photos of the time-delayed safe clearly indicating its location within the dispensary.
The photo must also clearly demonstrate the lockable functionality of the time-delayed safe.
Photos of time-delayed signage in the dispensary and at all external entrances to the pharmacy.<br>
Photos of the time-delayed safe clearly indicating its location within the dispensary.
The photo must also clearly demonstrate the lockable functionality of the time-delayed safe.
Photos of time-delayed signage in the dispensary and at all external entrances to the pharmacy.<br>
54
Foundational requirement #7 (Digital Evidence for time-delayed metal safe – photos identifying the time-delayed safe within the dispensary)<br>
55
Foundational requirement #7 (Digital Evidence for time-delayed metal safe – photos identifying the time-delayed safe within the dispensary (2))<br>
56
Foundational requirement #7 (Digital Evidence for time-delayed metal safe – photos of the time-delayed safe signage in the dispensary)<br>
57
Foundational requirement #7 (Digital Evidence for time-delayed metal safe – photos of the time-delayed safe signage at external entrance(s))<br>
58
Foundational requirement #8 Digital evidence for additional requirements of the dispensary includes:
Photo(s) of all cabinets or shelves where drugs or health care products will be stored in the dispensary.
Photo(s) of all cabinets or shelves where drugs or health care products will be stored in the patient services area.
Photos of all laboratory grade or full-size domestic refrigerator(s) intended to store drug product, that clearly identify the location of the refrigerator(s) within the dispensary.
The photos must display the inside of the refrigerator to ensure the device is not a ‘bar’ style.
Photos of the installed temperature monitoring device that show the current, minimum, and maximum temperature on the display, as well as its actual location on/in the refrigerator.
Photos of all sinks clearly indicating their locations.
A separate photo must be submitted for each sink installed within the pharmacy.
Photos of all telephones that clearly indicates their locations.<br>
Photo(s) of all cabinets or shelves where drugs or health care products will be stored in the dispensary.
Photo(s) of all cabinets or shelves where drugs or health care products will be stored in the patient services area.
Photos of all laboratory grade or full-size domestic refrigerator(s) intended to store drug product, that clearly identify the location of the refrigerator(s) within the dispensary.
The photos must display the inside of the refrigerator to ensure the device is not a ‘bar’ style.
Photos of the installed temperature monitoring device that show the current, minimum, and maximum temperature on the display, as well as its actual location on/in the refrigerator.
Photos of all sinks clearly indicating their locations.
A separate photo must be submitted for each sink installed within the pharmacy.
Photos of all telephones that clearly indicates their locations.<br>
59
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – general photos demonstrating cabinets and shelving for drugs and health product) NOTE: Photos submitted to demonstrate compliance with foundational requirement #3 may also be representative of the required digital evidence for foundational requirement #8<br>
60
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – general photos demonstrating cabinets and shelving for drugs and health product (2)) NOTE: Photos submitted to demonstrate compliance with foundational requirement #3 may also be representative of the required digital evidence for foundational requirement #8<br>
61
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – photos identifying the refrigerator(s) installed in the dispensary) NOTE: Digital evidence must be submitted for all refrigerators used for medication or vaccine storage.<br>
62
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – photos identifying the internal view of the refrigerator(s) installed in the dispensary) NOTE: Digital evidence must be submitted for all refrigerators used for medication or vaccine storage.<br>
63
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – photos identifying the temperature monitoring device for the refrigerator(s)) NOTE: Digital evidence must be submitted for all refrigerators used for medication or vaccine storage.<br>
64
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – photos identifying the sink(s) within the dispensary)<br>
65
Foundational requirement #8 (Digital evidence for additional requirements of the dispensary – photos identifying telephones installed in the pharmacy)<br>
66
Foundational requirement #9 Digital evidence for identifying the storage of pharmacy records include:
Photos of your patient record storage areas or rooms that demonstrate where these areas are located within the pharmacy.
If a separate room outside of the dispensary (but on the pharmacy premises) will be used for patient record storage, provide additional photos demonstrating how the records are secured from unauthorized access.
If your pharmacy will be storing records electronically, provide photos of the device(s) used to create these records (i.e., scanners).
Digital evidence for electronic infrastructure includes:
Photos of all computer terminals installed in the dispensary, including any terminals within private counselling room(s).
Photos must clearly show where these devices are located within the dispensary.
Photos of the operating system used for creating records (e.g., Kroll).
Photos of the health information transmission system (e.g., fax machine) that clearly indicates its location within the dispensary.
NOTE: A pharmacy with ONLY a compounding and repackaging licence, that does not have a community licence, does not require access to the Alberta Netcare Electronic Health Record<br>
Photos of your patient record storage areas or rooms that demonstrate where these areas are located within the pharmacy.
If a separate room outside of the dispensary (but on the pharmacy premises) will be used for patient record storage, provide additional photos demonstrating how the records are secured from unauthorized access.
If your pharmacy will be storing records electronically, provide photos of the device(s) used to create these records (i.e., scanners).
Digital evidence for electronic infrastructure includes:
Photos of all computer terminals installed in the dispensary, including any terminals within private counselling room(s).
Photos must clearly show where these devices are located within the dispensary.
Photos of the operating system used for creating records (e.g., Kroll).
Photos of the health information transmission system (e.g., fax machine) that clearly indicates its location within the dispensary.
NOTE: A pharmacy with ONLY a compounding and repackaging licence, that does not have a community licence, does not require access to the Alberta Netcare Electronic Health Record<br>
67
Foundational requirement #9 (Digital Evidence for record-keeping requirements – photos identifying the location of record-storing shelves or rooms within the dispensary)<br>
68
Foundational requirement #9 (Digital Evidence for record-keeping requirements – photos identifying the location and security features of record-storing shelves or rooms outside the dispensary) If this is not applicable to your pharmacy (i.e. records will all be stored in the dispensary), move to the next item<br>
69
Foundational requirement #9 (Digital Evidence for record-keeping requirements – photos identifying the equipment used for creating electronic records (i.e., scanner(s)) If this is not applicable to your pharmacy, move to the next item<br>
70
Foundational requirement #9 (Digital Evidence for record-keeping requirements – photos identifying the operating system used for creating records (e.g., Kroll, etc.) If this is not applicable to your pharmacy, move to the next item<br>
71
Foundational requirement #9 (Digital evidence for electronic infrastructure – photos identifying computer terminals installed in the pharmacy)<br>
72
Foundational requirement #9 (Digital evidence for electronic infrastructure – photos identifying computer terminals installed in the pharmacy (2))<br>
73
Foundational requirement #9 (Digital evidence for electronic infrastructure – photos identifying the fax machine or system installed in the pharmacy)<br>
74
Foundational requirement #10 Digital evidence for compounding services
If a designated Level A compounding area is present in the pharmacy, provide photos of the entire counter from both ends.
If a designated Level B or C compounding room is present in the pharmacy, provide photos of the entrance to the compounding room that clearly shows its location within the dispensary and how staff will access this area. Additionally, submit photos of the following, as applicable, within the compounding room:
Ceiling, floor and all walls
Intake and return air vents
Sink(s)
Containment ventilated enclosure(s) (CVE or ‘hood’)
Any and all counters used for compounding or staging
Any and all shelving or cabinetry to be used for equipment or material storage
Temperature, humidity, and pressure monitors
NOTE: If your pharmacy will not directly compound preparations onsite, move to foundational requirement #11.<br>
If a designated Level A compounding area is present in the pharmacy, provide photos of the entire counter from both ends.
If a designated Level B or C compounding room is present in the pharmacy, provide photos of the entrance to the compounding room that clearly shows its location within the dispensary and how staff will access this area. Additionally, submit photos of the following, as applicable, within the compounding room:
Ceiling, floor and all walls
Intake and return air vents
Sink(s)
Containment ventilated enclosure(s) (CVE or ‘hood’)
Any and all counters used for compounding or staging
Any and all shelving or cabinetry to be used for equipment or material storage
Temperature, humidity, and pressure monitors
NOTE: If your pharmacy will not directly compound preparations onsite, move to foundational requirement #11.<br>
75
Foundational requirement #10 cont. Digital evidence for compounding services (all levels)
Photo(s) demonstrating that your pharmacy possesses
a prescription balance and calibration weights,
measuring equipment,
compounding equipment,
personal protective equipment, and
an eyewash station.<br>
Photo(s) demonstrating that your pharmacy possesses
a prescription balance and calibration weights,
measuring equipment,
compounding equipment,
personal protective equipment, and
an eyewash station.<br>
76
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the Level A compounding area within the dispensary from multiple angles) If your pharmacy contains a Level B or C compounding room, proceed to the next slide; otherwise, proceed to Foundational requirement #11.<br>
77
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the entrance to the Level B or C compounding room within the dispensary) If your pharmacy contains a Level A compounding area, return to the previous slide.<br>
78
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the ceiling, floor and all walls of the Level B or C compounding room) If your pharmacy contains a Level A compounding area, return to slide 76.<br>
79
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the ceiling, floor and all walls of the Level B or C compounding room (2)) If your pharmacy contains a Level A compounding area, return to slide 76.<br>
80
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the intake and return air vents within the Level B or C compounding room) If your pharmacy contains a Level A compounding area, return to slide 76.<br>
81
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the sink within the Level B or C compounding room If your pharmacy contains a Level A compounding area, return to slide 76.<br>
82
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the counters and shelving within the Level B or C compounding room from multiple angles If your pharmacy contains a Level A compounding area, return to slide 76.<br>
83
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the counters and shelving within the Level B or C compounding room from multiple angles (2)) If your pharmacy contains a Level A compounding area, return to slide 76.<br>
84
Foundational requirement #10 (Digital evidence for compounding services – photos identifying the containment ventilated enclosure (CVE) (i.e. hood) within the Level B or C compounding room If your pharmacy contains a Level A compounding area, return to slide 76.<br>
85
Foundational requirement #10 (Digital evidence for compounding services – photos identifying temperature, humidity, and pressure monitors. If your pharmacy contains a Level A compounding area, return to slide 76.<br>
86
Foundational requirement #10 (Digital evidence for compounding services – photos identifying presence of prescription balance and calibration weights)<br>
87
Foundational requirement #10 (Digital evidence for compounding services – photos identifying measuring equipment)<br>
88
Foundational requirement #10 (Digital evidence for compounding services – photos identifying compounding equipment)<br>
89
Foundational requirement #10 (Digital evidence for compounding services – photos identifying compounding equipment (2))<br>
90
Foundational requirement #10 (Digital Evidence for compounding services – photos of Personal Protective Equipment (PPE) for compounding)<br>
91
Foundational requirement #10 (Digital evidence for compounding services – photos of the location of the eyewash station)<br>
92
Foundational requirement #11 Digital evidence for private consultation area(s) includes:
Private Consultation Area:
Photos demonstrating the location of any private counselling room(s) from multiple angles. Photos should be taken from the patient perspective (approximately 10 feet outside the private room facing toward it) as well as the dispensary perspective (to illustrate how pharmacy personnel will access the room).
Photos of the inside of the private counselling room should identify the amount of workspace available in the room.
Submit one photo from the entry to the counselling room looking in, and another photo from the opposite end of the counselling room looking out.
NOTE: A pharmacy with ONLY a compounding and repacking (C&R) licence, that does not have a community licence, does not require a private consultation area<br>
Private Consultation Area:
Photos demonstrating the location of any private counselling room(s) from multiple angles. Photos should be taken from the patient perspective (approximately 10 feet outside the private room facing toward it) as well as the dispensary perspective (to illustrate how pharmacy personnel will access the room).
Photos of the inside of the private counselling room should identify the amount of workspace available in the room.
Submit one photo from the entry to the counselling room looking in, and another photo from the opposite end of the counselling room looking out.
NOTE: A pharmacy with ONLY a compounding and repacking (C&R) licence, that does not have a community licence, does not require a private consultation area<br>
93
Foundational requirement #11 (Digital evidence for private consultation area– photos identifying the location of the private consult room)<br>
94
Foundational requirement #11 (Digital evidence for private consultation area– photos identifying the location of the private consult room from the dispensary perspective)<br>
95
Foundational requirement #11 (Digital evidence for private consultation area– photos identifying the location of the private consult room from the patient perspective)<br>
96
Foundational requirement #11 (Digital evidence for private consultation area– photos documenting the inside of the private consult room from the entry door(s))<br>
97
Foundational requirement #11 (Digital evidence for private consultation area– photos documenting the inside of the private consult room from the entry door(s) (2))<br>
98
Foundational requirement #11 (Digital evidence for private consultation area– photos documenting the inside of the private consult room from within the room)<br>
99
Foundational requirement #11 (Digital evidence for private consultation area– photos documenting the furnishings inside the private consult room)<br>
100
Foundational requirement #12 Digital evidence for signage includes:
Photo(s) of all required signs posted within the pharmacy. Either multiple photos or one photo displaying all items may be sufficient, however the photo(s) must clearly show where the signage is posted and how this signage is visible to patients in the pharmacy.
Empty frames or alternative temporary posters taped to the location where these signs will be posted are sufficient for this requirement.<br>
Photo(s) of all required signs posted within the pharmacy. Either multiple photos or one photo displaying all items may be sufficient, however the photo(s) must clearly show where the signage is posted and how this signage is visible to patients in the pharmacy.
Empty frames or alternative temporary posters taped to the location where these signs will be posted are sufficient for this requirement.<br>
101
Foundational requirement #12 (Digital Evidence for signage in pharmacy – photos identifying signage locations for license, concerns, and Code of Ethics) Hours of Operation signage to be submitted in slides for Requirement #1 and time-delayed safe signage to be submitted in slides for Requirement #7.<br>
102
Foundational requirement #12 (Digital Evidence for signage in pharmacy – photos identifying signage locations for license, concerns, and Code of Ethics (2)) Hours of Operation signage to be submitted in slides for Requirement #1 and time-delayed safe signage to be submitted in slides for Requirement #7.<br>
103
Foundational requirement #12 (Digital Evidence for signage in pharmacy – photos identifying placeholder locations for license, concerns, and Code of Ethics) Hours of Operation signage to be submitted in slides for Requirement #1 and time-delayed safe signage to be submitted in slides for Requirement #7.<br>
104
Foundational requirement #13 Digital evidence for references includes:
Photos of either hard copy references or that demonstrate electronic access to all required references.
If submitting proof of electronic access, the screenshots or photos must demonstrate unique access credentials for your pharmacy and show access into the reference. NOTE: Each pharmacy must have their own references – no sharing between pharmacy sites.<br>
Photos of either hard copy references or that demonstrate electronic access to all required references.
If submitting proof of electronic access, the screenshots or photos must demonstrate unique access credentials for your pharmacy and show access into the reference. NOTE: Each pharmacy must have their own references – no sharing between pharmacy sites.<br>
105
Foundational requirement #13 (Digital Evidence for required dispensary references – photos identifying access to Canadian compendium, drug interaction reference, therapeutic reference, and OTC reference)<br>
106
Foundational requirement #13 (Digital Evidence for required dispensary references – photos identifying access to natural health products reference and foreign drug reference)<br>
107
Foundational requirement #13 (Digital Evidence for required dispensary references – photos identifying access to the medical dictionary)<br>
108
Foundational requirement #13 (Digital Evidence for required dispensary references – photos identifying access to the veterinary medicine reference)<br>
109
Foundational requirement #16 Digital evidence for the Continuous Quality Improvement program (CQI+) includes:
Photos that demonstrate a subscription to a practice incident management platform.
A confirmation email from the practice incident management platform vendor to confirm pending enrolment in the chosen software.
Photos demonstrating access to a safety self-assessment tool.
A confirmation email from the safety self-assessment platform provider to confirm pending enrolment in the chosen software.
Photos that demonstrate that a Data Sharing Agreement (DSA) has been established with the Institute for Safe Medication Practices Canada (ISMP)
A confirmation email from ISMP to confirm pending enrolment for DSA.
NOTE: Documentation for policies and procedures to support CQI+ program is outlined in Appendix A.
NOTE: Requirement for CQI+ must be in place by February 1, 2026.<br>
Photos that demonstrate a subscription to a practice incident management platform.
A confirmation email from the practice incident management platform vendor to confirm pending enrolment in the chosen software.
Photos demonstrating access to a safety self-assessment tool.
A confirmation email from the safety self-assessment platform provider to confirm pending enrolment in the chosen software.
Photos that demonstrate that a Data Sharing Agreement (DSA) has been established with the Institute for Safe Medication Practices Canada (ISMP)
A confirmation email from ISMP to confirm pending enrolment for DSA.
NOTE: Documentation for policies and procedures to support CQI+ program is outlined in Appendix A.
NOTE: Requirement for CQI+ must be in place by February 1, 2026.<br>
110
Foundational requirement #16 (Digital Evidence for required CQI+ program – photos identifying access to a practice incident management platform OR a confirmation email from the practice incident management platform vendor to confirm pending enrolment in the chosen software)<br>
111
Foundational requirement #16 (Digital Evidence for required CQI+ program – photos demonstrating access to a safety self-assessment tool OR a confirmation email from the safety self-assessment platform provider to confirm pending enrolment in the chosen software)<br>
112
Foundational requirement #16 (Digital Evidence for required CQI+ program – photos of a Data Sharing Agreement (DSA) with the Institute for Safe Medication Practices Canada (ISMP) OR a confirmation email from ISMP to confirm pending enrolment for DSA)<br>
113
Foundational requirement #17 Digital evidence for identifying all staff working in the pharmacy includes:
Photo(s) of name tags required for all staff working at the pharmacy.
Photos should demonstrate, at minimum, the name and role of the individual.
Licensees must identify their role as the pharmacy licensee or pharmacy manager.
NOTE: If unregulated individuals have already been hired by the pharmacy, completed criminal record checks must be available upon request during the onsite inspection.<br>
Photo(s) of name tags required for all staff working at the pharmacy.
Photos should demonstrate, at minimum, the name and role of the individual.
Licensees must identify their role as the pharmacy licensee or pharmacy manager.
NOTE: If unregulated individuals have already been hired by the pharmacy, completed criminal record checks must be available upon request during the onsite inspection.<br>
114
Foundational requirement #17 (Digital Evidence for employee identification – photos documenting nametags for employees and regulated members at the pharmacy)<br>
115
Foundational requirement #18 Digital evidence for the public area includes:
Photo(s) documenting any and all physical variations within the premises, including but not limited to flooring, decor, and fixtures.
Close-up (5-10 feet away, facing the dispensary) photo(s) of the signage used to differentiate the prescription department from the public area.<br>
Photo(s) documenting any and all physical variations within the premises, including but not limited to flooring, decor, and fixtures.
Close-up (5-10 feet away, facing the dispensary) photo(s) of the signage used to differentiate the prescription department from the public area.<br>
116
Foundational requirement #18 (Digital Evidence for public area – photos of the physical separation of the prescription department from the public area, including but not limited to décor, flooring, or fixtures; or physical separation and signage) NOTE: Photos submitted to demonstrate compliance with foundational requirement #1 may also be representative of the required digital evidence for foundational requirement #18<br>
117
Foundational requirement #18 (Digital Evidence for public area – photos of the physical separation of the prescription department from the public area, including but not limited to décor, flooring, or fixtures; or physical separation and signage (2)) NOTE: Photos submitted to demonstrate compliance with foundational requirement #1 may also be representative of the required digital evidence for foundational requirement #18<br>
118
Foundational requirement #19 Digital evidence for shared premises includes:
Photo(s) of signs differentiating the pharmacy from other business.
Photo(s) of walls or physical space separating the pharmacy from other business.
Photos should be submitted from the perspective of the other business to the dispensary and vice versa.
NOTE: If this is not applicable to your pharmacy, (i.e., does not share premises with other business) move to foundational requirement #20.<br>
Photo(s) of signs differentiating the pharmacy from other business.
Photo(s) of walls or physical space separating the pharmacy from other business.
Photos should be submitted from the perspective of the other business to the dispensary and vice versa.
NOTE: If this is not applicable to your pharmacy, (i.e., does not share premises with other business) move to foundational requirement #20.<br>
119
Foundational requirement #19 (Digital evidence for shared premises – photos of the signage differentiating the pharmacy and the other business)<br>
120
Foundational requirement #19 (Digital evidence for shared premises – photos identifying physical barriers or space separating the pharmacy from the other business (view from dispensary to other business))<br>
121
Foundational requirement #19 (Digital evidence for shared premises – photos identifying physical barriers or space separating the pharmacy from the other business (view from other business to dispensary))<br>
122
Foundational requirement #20 Digital evidence required for a lock and leave pharmacy includes:
Photo(s) of the independent alarm panel taken no further than 10 feet from the device and clearly demonstrating the placement of the panel within the dispensary.
Photo(s) of any and all security gates and doors that are used to close off the dispensary outside of pharmacy operational hours.
Photo(s) of any and all lock and leave panels installed in the public area to restrict access to Schedule 3 products outside of pharmacy operational hours.
NOTE: If this is not applicable to your pharmacy, (i.e., not a lock and leave pharmacy) move to the next item.<br>
Photo(s) of the independent alarm panel taken no further than 10 feet from the device and clearly demonstrating the placement of the panel within the dispensary.
Photo(s) of any and all security gates and doors that are used to close off the dispensary outside of pharmacy operational hours.
Photo(s) of any and all lock and leave panels installed in the public area to restrict access to Schedule 3 products outside of pharmacy operational hours.
NOTE: If this is not applicable to your pharmacy, (i.e., not a lock and leave pharmacy) move to the next item.<br>
123
Foundational requirement #20 (Digital Evidence for lock and leave pharmacies – independent alarm panel(s) for the dispensary)<br>
124
Foundational requirement #20 (Digital Evidence for lock and leave pharmacies – security gates/doors to close off dispensary outside pharmacy hours)<br>
125
Foundational requirement #20 (Digital Evidence for lock and leave pharmacies – installed lock and leave panels for schedule 3 products)<br>
126
Appendix A Additional supporting documentation required Confirmation of submission of the expedited Privacy Impact Assessment (PIA) requirements to the Office of the Information and Privacy Commissioner (OIPC) including:
the policies and procedures that support Sections B and E of the OIPC PIA requirements, and
the OIPC cover letter.
Policies and Procedures Manual (must be comprehensive and specific to the proposed operations and patient services of the pharmacy, including section(s) on the pharmacy closure plan, disaster recovery plan, and continuous quality improvement program).
Policies and procedures for compounding, if applicable
If the pharmacy will directly compound preparations on site, submit documentation of sample risk assessments and master formulation records, compounding records, the personnel training and assessment program, and CVE (i.e., hood) and compounding room certification reports, if applicable.
Policies and procedures for mail order pharmacy services, if applicable.
Policies and procedures for the satellite pharmacy, if applicable.<br>
the policies and procedures that support Sections B and E of the OIPC PIA requirements, and
the OIPC cover letter.
Policies and Procedures Manual (must be comprehensive and specific to the proposed operations and patient services of the pharmacy, including section(s) on the pharmacy closure plan, disaster recovery plan, and continuous quality improvement program).
Policies and procedures for compounding, if applicable
If the pharmacy will directly compound preparations on site, submit documentation of sample risk assessments and master formulation records, compounding records, the personnel training and assessment program, and CVE (i.e., hood) and compounding room certification reports, if applicable.
Policies and procedures for mail order pharmacy services, if applicable.
Policies and procedures for the satellite pharmacy, if applicable.<br>