File No: 00-102830-878
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Healthy Environments and Consumer Safety Branch
Address Locator: #3503D
August 29, 2000
To: Provincial Licencing Authorities of Pharmacists and Pharmacists
Subject: Benzodiazepines and Other Targeted Substances Regulations
The Benzodiazepines and Other Targeted Substances Regulations have been published in Canada Gazette, Part II, on June 21, 2000. They will come into force on September 1, 2000. These regulations are available on the Therapeutic Products Programme website at the following location: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index-eng.php.
The following information is provided to explain to pharmacists regulatory requirements that will come with the promulgation of these Regulations. For pharmacists practicing in hospitals, please refer to the guidance document prepared for these establishments. Attached is a list of targeted substances to whose the Regulations will apply.
A pharmacist receiving a targeted substance from a licensed dealer, another pharmacist or a hospital must keep a record of the following information:
The new regulations do not introduce any change to current practice with regard to prescription requirement. A targeted substance can only be sold or provided to an individual or for the benefit of an animal upon receipt of a prescription issued by a practitioner either in writing or verbally.
If the prescription is transmitted verbally, the following information must be recorded by the pharmacist before filling it:
The pharmacist must also keep a hard copy or create a written record of the verbal prescription.
A prescription for a targeted substance can be refilled if the practitioner specified on the prescription the number of refills. Conditions applicable to refills are described in the Regulations.
When a pharmacist fills or refills a prescription for a targeted substance, the following information must be recorded:
For refills, copies of the original prescription are not required as long as the above mentioned information is recorded.
Prescriptions for targeted substances do not have to be filed in the special prescription files used for narcotics and controlled substances.
A pharmacist can transfer a prescription for a targeted substance to another pharmacist, except if that prescription has already been transferred.
Before selling or providing a targeted substance under a prescription that has been transferred, a pharmacist must:
The transferring pharmacist must record the date of the transfer, the name of the pharmacist to whom the prescription is transferred, the name and address of the pharmacy where the prescription is being transferred and, if applicable, the number of refills that are being transferred.
A pharmacist may sell, provide, send, deliver, transport a targeted substance without a prescription to one of the following persons upon receipt of an order from that person specifying the name and quantity of the targeted substance:
For transactions with a licensed dealer, the Minister or an individual to whom an exemption has been granted, the order must be written.
Transactions with another pharmacist are authorized only if the targeted substance is required by that other pharmacist because of a delay or shortfall in an order for the targeted substance placed with a licensed dealer.
Details pertaining to information that must be recorded upon receipt of a verbal order are described in the Regulations.
A pharmacist may only store a targeted substance in an place that is used for the purpose of conducting their business or professional practice and in an area in that place where only authorized employees have access. The pharmacist must take any reasonable steps to ensure the security of the targeted substances and to prevent their loss or theft.
A pharmacist must report to the Minister any loss or theft of a targeted substance within 10 days of its discovery. Loss and Theft Report forms are available at the Office of Controlled Substances.
A pharmacist who closes the premises in which a targeted substance is stored must inform the Minister of the date of the closure, the location to which the targeted substance was moved and the quantity of the targeted substance that has moved. The pharmacist has 10 days after the closure to provide to the Minister with the required information.
A pharmacist may destroy a targeted substance if the following conditions are met:
There will be no authorization or approval document issued by the Office of Controlled Substances with respect to this activity.
As for narcotics and controlled drugs, the Minister will issue a notice to licensed dealers and other pharmacists to inform them that they must not sell or provide targeted substance to the pharmacist named in the notice whenever the circumstances for issuing such a notice exist.
Those circumstances are:
Other circumstances under which the Minister may issue a notice are:
This notice will be issued to:
Since this document is only intended to summarize the main points of the content of the new Benzodiazepines and Other Targeted Substances Regulations, please refer to the Regulations in their entirety.
Should you have any question on this document or on the Regulations, please do not hesitate to contact us at (613) 954-1541.
Carole Bouchard, B. Pharm, M.A.P.
Office of Controlled Substances
Healthy Environments and Consumer Safety Branch