Section 56(1) Class Exemption for Pharmacists, Practitioners, Persons in Charge of a Hospital and Licensed Dealers for the Provision and Destruction of Unserviceable Stock and Post-consumer Returns

Pursuant to section 56(1) of the Controlled Drugs and Substances Act (CDSA) and subject to the terms and conditions herein, pharmacists, practitioners, persons in charge of a hospital, licensed dealers under the regulations to the CDSA, and individuals returning controlled substances that they believe on reasonable grounds were obtained under the CDSA or its regulations are hereby granted an exemption from the application of the provisions of the CDSA, the Narcotic Control Regulations (NCR), Part G of the Food and Drug Regulations  (Part G), and the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) listed below in the section entitled “Scope of the Exemption”.

Definitions

Except as defined below, the terms used in this exemption have the same meaning as they do in the CDSA and its regulations. For example, “targeted substance” as that term is used in this exemption, has the same meaning as the definition for the same term in s. 1 of the BOTSR, (i.e., it includes, but is not limited to all benzodiazepines listed in the schedules to the BOTSR):

Container

means a receptacle with a one way entry opening that prevents the removal of items once deposited.

Inspector

means a person employed by Health Canada, designated under an Act as an inspector, and is trained and certified to conduct inspections to verify compliance with an Act.

Licensed Dealer

means a licensed dealer under the NCR, Part G or the BOTSR.

Pharmacist

means a pharmacist as defined in any of, s. 2 of the NCR, s. G.01.001 of Part G and s. 1 of the BOTSR.

Pharmacy Intern

means a person who is enrolled at a provincially recognized pharmacy school as a pharmacy student, pharmacy intern, or an equivalent designation, and works in a pharmacy or dispensary in that province under the supervision of a pharmacist.

Pharmacy Technician

means a person who works in a pharmacy or dispensary and meets any applicable provincial or professional requirements in order to work as a pharmacy technician or equivalent designation.

Post-consumer returns

means unused or expired substance that is, or contains, a narcotic, targeted substance, or a controlled drug, that has been returned by an individual to a pharmacy for the purpose of destruction, but does not include any substance that has been returned to a hospital pharmacy from a patient ward.

Unserviceable stock

means a drug product containing a narcotic, targeted substance, or controlled drug that is expired or is unused and cannot be dispensed for some reason.

Purpose of this exemption

The purpose of this exemption is to facilitate the destruction of unserviceable stock and post-consumer returns. For that purpose, as set out in the remaining sections, this exemption:

1. authorizes a pharmacist, a practitioner or a person in charge of a hospital to sell, provide, transport or deliver unserviceable stock to a licensed dealer to destroy the unserviceable stock;
2. authorizes a pharmacist to receive post-consumer returns from individual consumers for the purpose of destruction and to sell, provide, transport or deliver them to a licensed dealer for the purpose of destruction;
3. authorizes a pharmacist, a practitioner or a person in charge of a hospital to undertake local destruction of their unserviceable stock;
4. authorizes a pharmacist, a practitioner or a person in charge of a hospital to utilize pharmacy interns or pharmacy technicians to serve as witnesses to the local destruction of targeted substances;
5. authorizes a licensed dealer who specializes in the destruction of narcotics, controlled drugs, or targeted substances to receive, sell, provide, transport, deliver, possess, and destroy post-consumer returns without keeping records with respect to the name and quantity of any narcotic, controlled drug, or targeted substance included in the post-consumer returns; and,
6. authorizes an individual to return controlled substances that the individual believes on reasonable grounds were obtained under the CDSA or its regulations to a pharmacy for the purpose of destruction.

Scope of the exemption

Pharmacists are exempt from the following provisions of the CDSA and its regulations:

1. Subsections 5(1) and 5(2) of the CDSA as they apply to the sale, provision, transportation or delivery of unserviceable stock or post-consumer returns to a licensed dealer for the purpose of destruction.
2. Subsections 8(1), 31(1), and 36(2) of the NCR as they apply to the sale, provision, transportation or delivery of unserviceable stock or post-consumer returns containing narcotics to a licensed dealer for the purpose of destruction.
3. Sections G.02.001, and G.03.002 of Part G as they apply to the sale, provision, transportation or delivery of unserviceable stock or post-consumer returns containing controlled drugs to a licensed dealer for the purpose of destruction.
4. Subsection 2(1) of the BOTSR as it applies to the witnessing of the local destruction of unserviceable stock or post-consumer returns containing targeted substances.
5. Paragraphs 2(2)(d) and (e) of the BOTSR as they apply to the destruction of  unserviceable stock or post-consumer returns containing targeted substances.
6. Subsection 51(2) of the BOTSR as it applies to the sale or provision of unserviceable stock containing targeted substances to licensed dealers for the purpose of destruction.

Practitioners are exempt from the following provisions of the CDSA and its regulations:

1. Subsections 5(1) and 5(2) of the CDSA as they apply to the sale, provision, transportation or delivery of unserviceable stock to a licensed dealer for the purpose of destruction.
2. Subsections 8(1) and 53(1) of the NCR as they apply to the sale, provision, transportation or delivery of unserviceable stock containing narcotics to a licensed dealer for the purpose of destruction.
3. Subsection 2(1) of the BOTSR as it applies to the witnessing of the local destruction of unserviceable stock containing targeted substances.
4. Section 58 of the BOTSR as it applies to the sale, provision, transportation or delivery of unserviceable stock containing targeted substances to a licensed dealer for the purpose of destruction.
5. Paragraphs 2(2)(d) and (e) of the BOTSR as they apply to the destruction of unserviceable stock containing targeted substances.
6. Section G.02.001 as it applies to the sale, provision, transportation or delivery of unserviceable stock to a licensed dealer for the purpose of destruction.

Persons in charge of a hospital are exempt from the following provisions of the CDSA and its regulations:

1. Subsections 5(1) and 5(2) of the CDSA as they apply to the sale, provision, transportation or delivery of unserviceable stock to a licensed dealer for the purpose of destruction.
2. Subsections 8(1) and 65(1) of the NCR as they apply to the sale, provision, transportation or delivery of unserviceable stock containing narcotics to a licensed dealer for the purpose of destruction.
3. Section G.02.001 and subsection G.05.003(1) of Part G as they apply to the sale, provision, transportation or delivery of unserviceable stock containing controlled drugs to a licensed dealer for the purpose of destruction.
4. Subsection 2(1) of the BOTSR as it applies to the witnessing of the local destruction of unserviceable stock targeted substances.
5. Paragraphs 2(2)(d) and (e) of the BOTSR as they apply to the destruction of unserviceable stock containing controlled substances.

Licensed Dealers who specialize in the destruction of narcotics, controlled drugs, and targeted substances are exempt from the following provisions of the CDSA and its regulations:

1. Subsection 4(1) of the CDSA as it applies to the possession of post-consumer returns received from a pharmacist.
2. Subsections 5(1) and 5(2) of the CDSA as they apply to the sale, provision, transportation or delivery of post-consumer returns.
3. Paragraphs 15(a) and (d) of the NCR as they apply to record keeping requirements for narcotics included in post-consumer returns received from a pharmacist.
4. Paragraphs G.02.014(1)(a) and (d) of Part G as they apply to record keeping requirements for controlled drugs included in post-consumer returns received from a pharmacist.
5. Paragraphs 35(a) and (c) of the BOTSR as they apply to the destruction of post-consumer returns received from a pharmacist that may contain a targeted substance.
6. Paragraph 33(1)(a) of the BOTSR as it applies to the destruction of post-consumer returns that may contain a targeted substance.

Individuals returning narcotics,  controlled drugs and targeted substances that they believe on reasonable grounds were obtained under paragraphs 3(1)(d) of the NCR, 4(2)(d) of the BOTSR, or G.01.002(1)(d) of Part G of the FDR:

1. Subsection 4(1) of the CDSA as it applies to the possession of post-consumer returns.
2. Subsections 5(1) and 5(2) of the CDSA as they apply to the sale, provision, transportation or delivery of post-consumer returns.
3. Subsections 8(1) and 65(1) of the NCR as they apply to the sale, provision, transportation or delivery of unserviceable stock containing narcotics to a retail pharmacy for the purpose of destruction.
4. Section G.02.001 and subsection G.05.003(1) of Part G as they apply to the sale, provision, transportation or delivery of unserviceable stock containing controlled drugs to a retail pharmacy for the purpose of destruction.

This exemption applies only to the extent necessary to facilitate the destruction of unserviceable stock and post-consumer returns.

Terms and Conditions

This exemption is applicable only if the following conditions are met:

General

1. Any receipt, sale, provision, transportation or delivery of a narcotic, controlled drug, or targeted substance under this exemption must be for the purpose of facilitating the destruction of that substance.     
2. Individuals who sell, provide, transport or deliver post-consumer returns to a retail pharmacy under the authority of this exemption must only do so by delivering it directly to a pharmacist, pharmacy intern, or a pharmacy technician who is present in a pharmacy at the time of delivery.
3. Unserviceable stock sold, provided, transported or delivered pursuant to this exemption may only be sold or provided, transported or delivered to a licensed dealer who is licensed and specializes in the destruction of the specific narcotic, targeted substance or controlled drug contained in the unserviceable stock.
4. Post-consumer returns that have been sold, provided, transported or delivered under this exemption may only be further sold, provided, transported or delivered to a licensed dealer who is licensed and specializes in the destruction of narcotics, targeted substances or controlled drugs.
5. Post-consumer returns that are sold, provided, transported or delivered to a licensed dealer for the purpose of destruction under this exemption must be packaged in a container.
6. Post-consumer returns must be stored in the dispensary of a retail pharmacy until they are destroyed or shipped to a licensed dealer.
7. Containers containing post-consumer returns that are sold, provided, transported or delivered to a licensed dealer must be marked in a manner that is sufficient to identify the package.
8. For greater certainty, unserviceable stock and post-consumer returns may be sold, provided, transported or delivered to a licensed dealer in a single shipment.
9. Containers containing post-consumer returns that are sold, provided, transported or delivered to a licensed dealer must not contain anything other than post-consumer returns or something that is facilitating the sale, provision, transportation or delivery of the post-consumer returns.

Orders and Record keeping - Unserviceable Stock

10. Sale, provision, transportation or delivery of unserviceable stock under this exemption may only occur after the pharmacist, practitioner or person in charge of a hospital initiating the sale or provision has obtained a written signed order from the licensed dealer to whom the stock will be sold, provided, transported or delivered for the purpose of destruction. The written order must specify the name, quantity and strength per unit of each narcotic, controlled drug, or targeted substance and must contain a written statement that the sole purpose of the order is destruction of the substances.
11. A pharmacist, practitioner or person in charge of a hospital must keep a record or cause a record to be kept of the:
    1. name, quantity and strength per unit of each drug substance or drug product included in any unserviceable stock sold or provided under this exemption,
    2. name and address of the licensed dealer to whom it was sold or provided, and
    3. date on which it was sold or provided.

Record keeping and Storage - Post Consumer Returns

12. A pharmacist selling or providing post-consumer returns to a licensed dealer for the purpose of destruction must keep a record or cause a record to be kept of the:
    1. number of containers containing post-consumer returns being sold or provided,
    2. date on which the container was sold or provided,
    3. identifying mark assigned to each container, and
    4. name and address of the licensed dealer to whom the container containing post-consumer returns was sold or provided.
13. Upon the receipt of post-consumer returns from a pharmacist, a licensed dealer must keep a record of:
    1. the number of containers containing post-consumer returns received,
    2. the date on which the container was received,
    3. any identifying mark assigned to a container, and
    4. the name and address of the pharmacist from whom the container containing post-consumer returns was received.

Destruction of Targeted Substances

14. For greater certainty, a pharmacist, practitioner or person in charge of a hospital destroying unserviceable stock containing targeted substances must comply with paragraphs 2(2)(a), (b) and (c) of the BOTSR. 
15. The destruction must be witnessed by the individual destroying the targeted substance and one other practitioner, pharmacy intern, pharmacy technician or inspector. Immediately following the destruction, the pharmacist, practitioner or person in charge of a hospital and the witness must comply with paragraph 2(2)(e) of the BOTSR with the necessary adaptations.  

Record Retention

16. Any record or written order required under this exemption must be retained for a period of two years and in a manner that permits an audit to be made of them. 

Suspension or Revocation

The exemption may be suspended without prior notice if the Minister considers that such suspension is necessary. 

The Minister may revoke the exemption if it is no longer necessary.

Unless it is suspended, this exemption will remain in effect until revoked.

Signed for and on behalf of the Minister of Health

Paul Loo
Director, Office of Controlled Substances
Controlled Substances Directorate
Opioid Response Team

Effective Date: February 23, 2018