Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
Bureau of drug surveillance therapeutic products programme - Amended July 1999 (original version February 1985)
99-020701
Therapeutic Products Programme
Holland Cross, Tower "B"
2 nd Floor, 1600 Scott Street
Address Locator # 3102D1
Ottawa, Ontario
K1A 1B6
September 1 st , 1999
To: Associations
Subject : Draft Directive on Physical Security Requirements for Controlled Substances
This is further to my correspondence of July 27, 1999, inviting you to comment on a draft Directive on Physical Security Requirements for Controlled Substances, including benzodiazepines and other targeted substances. My letter indicated that this draft document could be found on the TPP's website. Unfortunately, technical problems prevented us from making this document available on our website. Please note that this document can now be found on the website at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index-emg.php. Furthermore, a hard copy was forwarded to you early August, 1999. Should you have not received a copy and cannot access the website, you may want to contact us at (613) 954-6540. Arrangements for delivery will be made promptly.
Due to these unexpected circumstances, the comment period is extended until September 24, 1999. Any comment relating to the proposed Directive on Physical Security Requirements for Controlled Substances should be forwarded to Ms. Andrée Bernard, Bureau of Drug Surveillance, Therapeutic Products Programme, Finance Building, Address Locator: 0201D4, Ottawa, Ontario, K1A 1B9.
Please accept my apologies for any inconvenience this situation may have caused you.
Original signed by
Dann M. Michols
Director General
99-020701
Therapeutic Products Programme
Holland Cross, Tower "B"
2 nd Floor, 1600 Scott Street
Address Locator # 3102D1
OTTAWA, Ontario
K1A 1B6
July 28, 1999
To: Associations
Subject : Draft Directive on Physical Security Requirements for Controlled Substances.
Security Guidelines were developed in 1985 to establish minimum security standards for the storage of controlled substances. These requirements continue to apply to all licensed dealers of controlled substances as well as to research scientists and analysis laboratories. They are also intended to assist them in their own risk assessment and help them establish the security level that will meet their needs.
On March 27, 1999, the proposed Regulations on Benzodiazepines and Other Targeted Substances were published in the Canada Gazette, Part I. In order to enable licensed dealers, research scientists and analysis laboratories, to provide adequate security measures for these substances, the document on physical security requirements was reviewed and amended to include them. The Directive on Physical Security Requirements for Controlled Substances will apply to these drugs and substances once the new Regulations come into force.
The proposed additions in the Directive represent only the first step to an overall review of this document. In the next phase, new security technologies and other issues will be addressed.
Comments relating to the proposed Directive on Physical Security Requirements for Controlled Substances should be forwarded by August 20, 1999 to Andrée Bernard, Bureau of Drug Surveillance, Therapeutic Products Programme, Finance Building, Address Locator 0201D3, Tunney's Pasture, Ottawa,Ontario, K1A 1B9.
This document is available in electronic format on the Therapeutic Products Programme Website at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/indexeng.php.
Original Signed By
Dann M. Michols
Director General
The following guidelines are intended to establish realistic minimum security standards, for the storage of controlled substances which are flexible enough to take into consideration advances in technology, changes in the drug scene, local problems, construction materials and construction expertise. They are also intended to assist licensed dealers in their own risk assessment when designing security which best meets their needs.
A variety of different secure structures will be accepted. Diversity, from a security point of view, is ideal as a thief with a knowledge of one company's security system will not be able to utilize this knowledge when trying to steal drugs from another company. These security requirements have been designed in such a way that a company can upgrade their security, should this be required, without going to a great deal of expense provided they have a good basic security system. This upgrading may be occasionally necessary due to the increased quantity of drugs being stored or the increased desirability of a drug by the illicit market.
This guideline has been written for all licensed dealers, manufacturing or distributing controlled substances as well as for research scientists and analysis laboratories.
Licensed dealers' security, including manufacturers, distributors, analysis laboratories and research scientists, will be reviewed against these guidelines.
In a risk assessment there are two major factors which must be considered, the consequence of the event and the probability of the events occurring.
After completing a risk assessment, a security system can be designed which is commensurate with the value of the drugs being protected and the anticipated threat to the drugs.
By incorporating these security controls into the planning stages of the building a major reduction in both capital and operating costs can be realized and it will avoid costly upgrading at a later date should there be a need to increase the level of security.
It is unlikely that any large building can incorporate maximum operating efficiency and maximum security because these two requirements are sometimes, by their very nature, at variance with each other. At the same time it should also be remembered that human nature will render uncontrollable any unrealistic security restrictions. Thus one of the most important reasons for integrating security at the planning stage is a need to reduce the operational restrictions imposed by security requirements and eliminate those security requirements which may be considered by employees to be unrealistic. Careful planning can point out which operational procedures will be certain to generate major security hazards and will also show how a security system might cause major obstructions in the operational plan. How well these problems are identified and how they are resolved will determine the ultimate effectiveness of the security system. Thus the controls and requirements of the security system must be logical and not overly restrictive, if they are to be used by employees.
There are several security concepts which have been developed over the years. Each has its advantages and disadvantages when used in the context of licensed dealers who handle items which are generally small, easily portable and have a high illicit market value. As some of the advantages of these concepts can be beneficially incorporated into a company's overall security they are outlined below:
Any location within a 100 km radius of the centre of any city experiencing, according to Bureau records, a large number of break and entry, armed robbery, pilferage, loss in transit and unexplained losses where the losses included controlled substances.
Areas which meet this criteria are as follows:
Cities such as Hamilton, Kitchener, and Victoria fall within the Region I because they are within 100 km of a city mentioned in Region I.
Any location within a 50 km radius of the centre of a city experiencing according to Bureau records, significant numbers of break and entry, armed robbery, pilferage, loss in transit and unexplained losses where these losses included controlled substances.
The areas in this Region are:
Any location in Canada not in Region I or II.
Note: These prices are calculated using a combination of the illicit market price for a finished product as well as for the raw material.
Table 1 - prices to be utilized in determining the illicit value of Controlled substances
Any drug which is not listed above and is not a derivative of any drug listed in A to I above, will be valued at its commercial price or the price of drugs having similar pharmacological properties. The price to be used will be the higher one.
All controlled substances not listed in A to I above will be priced at the usual price of the most commonly sold size. If the drug is being held as "raw material" the price used will be the usual commercial price of the material.
Category A | Region "I" Security Level |
Region "II" Security Level |
Region "III" Security Level |
---|---|---|---|
Licencee Holdings $150,000,001 and up |
11 | 11 | 10 |
Licencee Holdings $31,250,001 to $150,000,000 |
10 | 10 | 9 |
Licencee Holdings $6,250,001 to $31,250,000 |
9 | 9 | 8 |
Licencee Holdings $1,250,001 to $6,250,000 |
8 | 8 | 7 |
Licencee Holdings $250,001 to $1,250,000 |
7 | 7 | 6 |
Licencee Holdings $50,001 to $250,000 |
6 | 5 | 5 |
Licencee Holdings $10,001 to $50,000 |
5 | 4 | 4 |
Licencee Holdings $0.00 to $10,000 |
4 | 3 | 3 |
*Category B | Region "I" Security Level |
Region "II" Security Level |
Region "III" Security Level |
---|---|---|---|
* When the licencee's holdings exceed the maximum ($10,000), the security requirements of category "A" will apply. |
|||
Licencee Holdings $2,501 to $10,000 |
3 | 3 | 3 |
Licencee Holdings $501. to $2,500 |
2 | 2 | 2 |
Licencee Holdings $0.00 to $500. |
1 | 1 | 1 |
The value of a licencee's holdings is calculated using the prices shown in this appendix, (table 1) multiplied by the maximum inventory of controlled substances on the premises at any time. Only drugs and drug formulations requiring storage in a vault or safe (see Appendix D) need to be used in the calculation.
Category b is limited only to licensed researchers and analytical firms where no drug distribution is involved.
The following pages offer a description of the security levels 1 through 11 which are presented as the Bureau's minimum requirements for the different security levels. Appendix "D" identifies the types of drugs which will be allowed storage inside a steel caged area and also provides a description of the cage requirements. The Bureau will allow alternate methods of construction provided the penetration resistance is at least equal to the standard.
Laminates which are materials such as cement blocks, plywood, steel mesh, polycarbonates, etc., sandwiched together can be used effectively to offer a level of attack resistance which is at least equal to that of the traditional poured cement or cement block type vault. However, companies wishing to use laminates rather than the traditional cement vault, (due to weight problems, economic considerations, convenience, etc.) should consider discussing the proposed security with the Bureau Inspector in their region before commencing construction in order to ensure that the force resistance is at least equivalent to the Bureau's minimum requirements.
1.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 1 security. The required level is determined by the location of the researcher and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1).
1.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
1.2.1 . Cupboard, refrigerator, a drawer in a steel cabinet, or an equivalent may be used for this level of security provided it is located in a locked room and fastened to the room's floor or wall. The device used to store the researcher's inventory is to be secured with an approved padlock (see Appendix E) or its equivalent.
1.2.2 . The approved security device, in 1.2.1., must be located in an area to which the public does not have access.
1.2.3 . Records of the issuing of combinations and keys, under the authorization of an officer in the institution, shall be maintained and be available to Therapeutic Products Programme (TPP) inspectors.
2.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 2 security. The required level is determined by the location of the researcher and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1).
2.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
2.1.3 . An alarm system is required. It must at least activate a local electric horn or bell when an unauthorized access is attempted.
2.2.1 . Steel cabinet, refrigerator or equivalent is acceptable provided it is located in a locked room and fastened to a wall or floor in such a manner that it is not moveable. The cabinet or refrigerator must be locked with an approved padlock (see Appendix E) .
2.2.2 . The approved security device, in 2.2.1., must be located in an area to which the public does not have access.
2.2.3 . Records of the issuing of combinations and keys, under the authorization of an officer in the institution, shall be maintained and be available to TPP inspectors.
3.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 3 security. The required level is determined by the location of the licensed dealer or researcher and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1).
3.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
3.1.3 . An alarm system is required. It must at least activate a local electric horn or bell when an unauthorized access is attempted.
3.2.1 . Wall/Floor/Ceiling
3.2.2 . Door
3.2.3 . Records of the issuing of combinations and keys, under the authorization of an officer in the institution, shall be maintained and be available to TPP inspectors.
3.3.1 . A records safe may be used for this security level providing it is not rated lower than U.L.C. (Underwriters Laboratories of Canada) type "D" (350 - 1 new rating). The safe must be anchored to the floor.
3.3.2 . The safe must be located in a locked cupboard or room. No window should be located within 4.5 metres (15') from the grade level or roof deck unless it is locked. There are no size restrictions on the windows. Windows are not permitted within 1 metre (3') of the door. Windows fixed or openable with a lock must have a grill or screen of 3.5 mm (10 gauge) expanded metal mesh or equivalent installed in a manner that it is removable from the inside only. An acceptable alternative to the window requirements stated above is if the windows are polycarbonate glazed and mounted in a heavy duty frame.
3.3.3 . If the safe is located in a metal cage, in lieu of a locked room or cupboard then the cage must conform to the description of a cage given in Appendix D.
4.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 4 security. This level is determined by the location of the licensed dealer or researcher and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1).
4.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
4.1.3 . Minimum Electrical Detection Requirements:
4.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code.
4.1.5 . The secure environs, if they include a vault, safe or caged area, must be located at least 1 metre (3') from any outside wall if it is located on either a ground floor or if it is accessible from a roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement, applies regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
4.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
4.2.1 . Walls
4.2.2 . Door
4.3.1 . A records safe (fire resistant safe) may be used for this level of security providing it has a U.L.C. (Underwriters Laboratories of Canada) rating of class A, B, or C (New Ratings 350-4, 350-2, 350-1 respectively).
4.3.2 . It should be noted that the class "C" safe offers the same force resistance as the class "A" and "B" safes. Class "A" and "B" safes are constructed with more insulating material which results in increased fire protection for the contents.
4.3.3 . The safe can be installed in a room which is normally under a lock and key system. (See 4.3.6. below). The room must be equipped with a detector which will indicate when there is an unauthorized attempt to open the door. The room and door must meet the requirements of 3.2.2 and 3.3.2.
4.3.4 . Records of the issuing of combinations and keys, under the authorization of an officer in the institution, shall be maintained and be available to TPP inspectors.
4.3.5 . If the safe is located in a metal caged area, in lieu of the locked room, the cage must meet the requirements outlined in Appendix D.
4.3.6 . Safe must be anchored to the floor in such a manner that it cannot be removed without first opening the door.
4.4.1 . Certain controlled substances may be held in a caged area. Appendix D identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
5.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 5 security. This level is determined by the location of the licensed dealer and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1).
5.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
5.1.3 Minimum Electrical Detection Requirements:
5.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangement of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm (1 1/2") diameter.
5.1.5 . The secure environs if they include a vault, safe or caged area, must be located at least 1 metre (3') from any outside wall if located on a ground floor or an accessible roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
5.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
5.2.1 . Walls
5.2.2 . Door
5.3.1 . A records safe (fire resistant safe) may be used for this level of security providing it has a U.L.C. (Underwriters Laboratories of Canada) rating of class A, B, or C (New Ratings 350-4, 350-2, 350-1 respectively).
5.3.2 . It should be noted that the class "C" safe offers the same force resistance as the class "A" and "B" safes. Class "A" and "B" safes are constructed with more insulating material which results in increased fire protection for the contents.
5.3.3 . The safe can be installed in a room which is normally under a lock and key system. (See 5.3.6. below). The room must be equipped with a detector which will indicate when there is an unauthorized attempt to open the door. The room and door must meet the requirements of 3.2.2 and 3.3.2.
5.3.4 . Records of the issuing of combinations and keys, under the authorization of an officer in the institution, shall be maintained and be available to TPP inspectors.
5.3.5 . If the safe is located in a metal caged area, in lieu of the locked room, the cage must meet the requirements outlined in Appendix D.
5.3.6 . Safe must be anchored to the floor in such a manner that it cannot be removed without first opening the door.
5.4.1 . Certain controlled substances may be held in a caged area. Appendix D identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
6.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 6 security. This level is determined by the location of the licensed dealer and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1) .
6.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
6.1.3 . Minimum Electrical Detection Requirements:
6.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangement of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm (1 1/2") diameter.
6.1.5 . The secure environs if they include a vault, safe or caged area, are to be located at least 1 metre (3') from any outside wall if located on a ground floor or an accessible roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
6.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
6.2.1 . Walls
6.2.2 . Door
6.3.1 . If a safe is to be used for level 6 security instead of a vault, it is to be a burglar resistant safe which is Underwriter Laboratories of Canada (ULC) rated at a level ULC-TL-15.
6.3.2 . The safe can be installed in a room which is normally under a lock and key system. (See 6.3.5. below). The room must be equipped with a detector which will indicate when there is an unauthorized attempt to open the door. The room and door must meet the requirements of 3.2.2 and 3.3.2.
6.3.3 . Records of the issuing of combinations and keys, under the authorization of an officer in the institution, shall be maintained and be available to TPP inspectors.
6.3.4 . Safe must be anchored to the floor in such a manner that it cannot be removed without first opening the door.
6.3.5 . If the safe is located in a metal cage, in lieu of a locked room, the cage must meet the requirements outlined in Appendix D.
6.4.1 . Certain controlled substances may be held in a caged area. Appendix D identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
7.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 7 security. This level is determined by the location of the licensed dealer and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1) .
7.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
7.1.3 . Minimum Electrical Detection Requirements:
7.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangement of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm (1 1/2") diameter.
7.1.5 . The secure environs if they include a vault, safe or caged area, are to be located at least 1 metre (3') from any outside wall if located on a ground floor or an accessible roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
7.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
7.2.1 . Walls
7.2.2 . Door
7.3.1 . If a safe is to be used for level 7 security instead of a vault, it is to be a burglar resistant safe which is Underwriters Laboratories of Canada (ULC) rated at a level ULC-TL-30.
7.3.2 . The safe is to be located in a caged area which meets the requirements described in Appendix D.
7.3.3 . The caged area described in 7.3.2 should be located in a locked room.
7.3.4 . Safe must be anchored to the floor in such a manner that it cannot be removed without first opening the safe door.
7.3.5 . If the safe is equipped with a combination lock, the lock combination must be stored in a secure location and changed yearly, or whenever a person knowing the combination no longer requires it.
7.4.1 . Certain controlled substances may be held in a caged area. Appendix D identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
8.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 8 security. This level is determined by the location of the licensed dealer and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1) .
8.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
8.1.3 . Minimum Electrical Detection Requirements:
8.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangement of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm (1 1/2") diameter.
8.1.5 . The secure environs if they include a vault, safe or caged area, are to be located at least 1 metre (3') from any outside wall if located on a ground floor or an accessible roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
8.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
8.1.7 . A clear area of 0.6 metres (2') around vault to be used for inspection and detection purposes shall be maintained around all safes and vaults in this category.
8.2.1 . Walls
8.2.2 . Door
8.3.1 . If a safe is to be used for level 8 security instead of a vault, it is to be a burglar resistant safe which is Underwriters Laboratories of Canada (ULC) rated at a level TRTL-30.
8.3.2 . The safe is located in a caged area which meets the requirements described in Appendix D.
8.3.3 . The caged area described in 8.3.2 should be located in a locked room.
8.3.4 . The safe is to be anchored to the floor in such a manner that it cannot be removed without first opening the door.
8.3.5 . If the safe is equipped with a combination lock, the lock combination must be stored in a secure location and changed yearly, or whenever a person knowing the combination no longer requires it.
8.4.1 . Certain controlled substances may be held in a caged area. Appendix "D" identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
9.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 9 security. This level is determined by the location of the licensed dealer and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1) .
9.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
9.1.3 . Minimum Electrical Detection Requirements:
9.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangement of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm(1 1/2") diameter.
9.1.5 . The secure environs if they include a vault, safe or caged area, are to be located at least 1 metre (3') from any outside wall if located on a ground floor or an accessible roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
9.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
9.1.7 . A clear area of 0.6 metres (2') around vault to be used for inspection and detection purposes shall be maintained around all safes and vaults in this category.
9.2.1 . Walls
9.2.2 . Door
9.3.1 . If a safe is to be used for level 9 security instead of a vault, it is to be a burglar resistant safe which is Underwriters Laboratories of Canada (ULC) rated at a level TRTL-30 x 6.
9.3.2 . The safe is to be located in a caged area which meets the requirements described in Appendix D.
9.3.3 . The caged area described in 9.3.2 should be located in a locked room.
9.3.4 . The safe is to be anchored to the floor in such a manner that it cannot be removed without first opening the door.
9.3.5 . If the safe is equipped with a combination lock, the lock combination must bestored in a secure location and changed yearly, or whenever a person knowing the combination no longer requires it.
9.4.1 . Certain controlled substances may be held in a caged area. Appendix "D" identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
10.1.1 . The following are examples of the minimum requirements which the Bureau will accept for level 10 security. This level is determined by the location of the licensed dealer and the maximum inventory. The monetary value of the inventory is calculated using the illicit value of the drug. (See Appendix B, Table 1) .
10.1.2 . The Bureau will consider alternate forms of secure environs, such as laminates, providing they are equal in force resistance to the examples given below.
10.1.3 . Minimum Electrical Detection Requirements:
10.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangement of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm(1 1/2") diameter.
10.1.5 . The secure environs if they include a vault, safe or caged area, are to be located at least 1 metre (3') from any outside wall if located on a ground floor or an accessible roof. The Bureau may consider certain conditions to be equivalent to the 1 metre (3') requirements. These conditions may be in the form of another building in close proximity to the secure environs, ditches, cement pylons, etc. The 1 metre (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
10.1.6 . Ventilation - Openings in the vault for ventilation or air conditioning are not allowed if the overall security of the vault is lowered. In instances where either a circulation of air or air conditioning is necessary for the drug stability, one of the following conditions must be met:
10.1.7. A clear area of 0.6 metres (2') around vault to be used for the inspec tion and detection purposes shall be maintained around all safes and vaults in this category.
10.2.1 . Walls/Ceiling/Floor (Floor on grade)
Note: The above is an indication of the minimum security required for this level. A laminate type of vault using steel and poured concrete/cement blocks may be considered by the Bureau to be equivalent to the above vault.
Note: A cage is to be used in conjunction with this vault and will extend completely around the vault with a 0.6 mm (2') standoff.
(see 10.1.3. (i) and 10.1.7. above) . This clear area is not to be used for the storage of controlled drug preparations or oral prescription narcotics as outlined in Appendix D.
10.2.2 . Door
10.3.1 . If a safe is to be used for level 10 security it is to be a burglar resistant type which has been U.L.C. (Underwriters Laboratories of Canada) rated at a level TXTL-60X6.
10.3.2 . This class of safe may not be easily acquired but can be purchased on a special order. The Bureau may consider a combination of two or more safes to be equivalent to level 10 security requirement depending on U.L.C. ratings of the safes being used.
10.3.3 . The safe is to be located in a caged area which meets the requirements described in Appendix D.
10.3.4 . The caged area described in 10.3.3 should be located in a locked room.
10.3.5 . If the safe is equipped with a combination lock, the lock combination must be stored in a secure location and changed yearly, or whenever a person knowing the combination no longer requires it.
10.3.6 . The safe is to be anchored to the floor in such a manner that it cannot be removed without first opening the door.
10.4.1 . Certain controlled substances may be held in a caged area. Appendix D identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
11.1.1 . Licensed Dealers who require level 11 security are to submit their proposals to this Bureau for evaluation. Due to the extremely high illicit value of the inventory to be maintained at this level, the Bureau judges each proposal on its own merits. However, the security must exceed the level 10 requirements.
11.1.2 . It may aid the review process if a diagram of the building is supplied indicating the location of doors, windows, vault, and intrusion detectors as well as the location of the proposed vault. The security proposal is to cover the following topics:
11.1.3 . Minimum Electrical Dectection Requirements
11.1.4 . All electrical conduit for the alarm system, security equipment, lighting, telephone, etc. shall be in accordance with any applicable electrical code. All conduit entering the walls, ceiling, or floor shall have at least one offset within the vault structure. Arrangements of bends shall be so that drainage is to the exterior. Conduit shall not exceed 3.8 cm (1 1/2") diameter.
11.1.5 . The secure environs are to be located at least 1 metre (3') from any outside wall if located on a ground floor or accessible from a roof. The 1 meter (3') requirement applies, regardless of the distance from the ground or accessible roof, if construction is to be against a wall which is common to another company.
11.1.6 . Ventilation - Describe any opening in the vault to be used for ventilation or air conditioning, and explain how the opening will be protected.
11.1.7 . A clear fenced area of at least 0.6 meters (2') to be used for inspection and detection purposes shall be maintained completely around all vaults in this category. (See Appendix D for the requirements of fence (cage) construction).
This clear area is not to be used for the storage of controlled drug preparations or oral prescription narcotics as outlined in Appendix D.
11.2.1 . Walls/Ceiling/Floor (Floor on Grade)
11.2.2 . Door
11.3.1 . Certain controlled substances may be held in a caged area. Appendix "D" identifies the drugs which can be stored in this manner as well as the requirements for both the cage's construction and its electrical detection equipment.
All controlled substances must be stored in a vault, safe etc. (see Appendix B) . However, the Office will consider exempting from this requirement those categories of drugs and formulations which have demonstrated through a long history, that they have a low potential for diversion. These exemptions will be withdrawn should the potential for diversion increase. Currently, the following drugs and formulations as finished products in their final packaging may be stored in a "caged" area:
12.1.1 . The caged area is to be located at least 1 metre (3') from an outside wall if located on a ground floor or accessible from a roof. The Bureau considers a common wall shared with another firm to be an outside wall, therefore, a 1 metre (3') free area is required. The Bureau may consider equivalents to the 1 metre (3') free area (see examples 4.1.5) .
12.1.2 . The caged area should preferably be located in a locked room.
12.1.3 . Sufficient electrical detection to detect unauthorized movement within the caged area.
12.1.4 . Cage door or gate to be secured with an approved padlock (see Appendix E) or its equivalent.
12.2.1 . Walls/Ceiling
The walls and ceiling of a caged area will be constructed of 3.5 mm (10 gauge) rolled and flattened metal mesh which has 2.5 cm x 5 cm (1" x 2") diamond shaped openings securely fastened together. If the existing floor and ceiling are to be used then the walls are to extend from structural floor to structural ceiling. The gate or door will provide force resistance equivalent to that of the walls and ceiling and be equipped with electrical door contacts.
Manufacturer | Model | Shackle diameter (mm) | Shackle clearance (mm) |
---|---|---|---|
ABLOY | 3071 | 11 | 25 |
AMERICAN | 570 (with dead locking) |
10 | 28 |
BEST | 27B462 (with security sheath) |
12 | 32 |
MASTER | 15 | 11 | 25 |
MEDECO | 50-600 | 10 | 25 |
PAPAIZ | CR60 | 10 | 35 |
VIRO | 304/60 MM | 10 | 35 |
Andrée Bernard
andree_bernard@hc-sc.gc.ca
TEL: (613) 954-1541
FAX: (613) 941-4760