GUIDANCEDOCUMENT FOR PHARMACISTS, AND DEALERS LICENSED TO DESTROY NARCOTICS, CONTROLLED DRUGS, TARGETED SUBSTANCES OR PRECURSORS:
Handling and Destruction of Post-Consumer Returns Containing Narcotics, Controlled Drugs, Targeted Substances
Date AdoptedEffective Date
Controlled Substances Directorate
Healthy Environments and Consumer Safety Branch
1
FORWARD
Guidance documents are meant to provide assistance to regulated parties on how to comply with governing statutes and regulations. Guidance documents also provide assistance to departmental staff involved in administering legislation, regulations and/or policies do so in a manner that is fair and consistent.
Guidance documents are administrative instruments that do not have the force of law and are thus not intended to substitute for, supersede or limit the requirements set out under prevailing legislation.In the case of any discrepancy between this document and the actual text of prevailing legislation, the legislative text will prevail.
It is equally important to note that Health Canadareserves the right to request information or material, or define conditions notspecifically described in this document in order to allow the Department to verifycompliance with relevant regulations and/or adequately mitigate the risk of diversion ofcontrolled substances to the illicit market.
Any questions of interpretation concerning this guidance document should be directed to the Compliance Division within the Controlled Substances Directorate (CSD) at .
TABLE OF CONTENTS
1.0INTRODUCTION
1.1Context
1.2Objectives
1.3Scope and Application
2.0Roles and Responsibilities
2.1Pharmacists working in a retail or community pharmacy
2.2Licensed Dealers including those Licensed to Destroy
3.0Post-Consumer Returns
3.1Personnel Involved
3.2Record Keeping
3.3Storage
3.4Destruction
4.0Procedure for Destruction
4.1Local Destruction of Post-Consumer Returns
4.2Sending to a Dealer Licensed to Destroy
4.2.1Order Requirements
4.2.2Record Keeping
4.3Sending to a Third Party Post-Consumer Return Collection Service
4.3.1Record-Keeping
5.0Loss or Theft of Post-Consumer Returns
1.0INTRODUCTION
The Controlled Drugs and Substances Act (CDSA) provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused.Except as authorized under its related regulations or via an exemption issued under section 56 of the Act, most activities involving substances regulated under the Act, e.g., possession, import, export, trafficking,possession for the purposes of trafficking, production, etc., are prohibited.
The substances regulated under the CDSA are grouped into Schedules I to VI to the Act.Schedules I to V list controlled substances while Schedule VI lists precursors, the chemicals commonly used to make controlled substances.
At the present time, there are several sets of regulations made under the CDSA that set out the circumstances under which activities with controlled substances or precursors are permitted.These regulations are administered by the Controlled Substances Directorate (CSD) within the Healthy Environments and Consumer Safety Branch of Health Canada.Four regulations are relevant to this Guidance Document:
- Benzodiazepines and Other Targeted Substances Regulations(BOTSR)
- Narcotic Control Regulations(NCR)
- Precursor Control Regulations (PCR)
- Part G of the Food and Drug Regulations(FDR-Part G)
1.1Context
This guidance document is being issued to clarify the recommended procedures for the collection, handling, and destruction of post-consumer returns.
A class exemption is also being issued to allow for the handling and destruction of post-consumer returns. This guidance should be read in conjunction with the 2016 class exemption.
1.2Objectives
This guidance will:
- set out procedures for pharmacists involved in the collection, handling and destruction of unused or expired drug products containing a narcotic, controlled drug,targeted substance, or precursor that are returned by an individual consumer (post-consumer returns);
- clarify that dealers licensed to destroy a narcotic, controlled drug,targeted substance, or precursor can accept post-consumer returns as well as unserviceable stock; and,
- set out record-keeping requirements for licensed dealers receiving, handling and destroying post-consumer returns.
1.3Scope and Application
This document applies to:
- pharmacists, as referenced in the NCR, FDR-Part G, BOTSR, PCR;and
- licensed dealers including those licensed to possess narcotics, controlled drugs or targeted substances for the purposes of destruction.
2.0Roles and Responsibilities
2.1Pharmacists working in a retail or community pharmacy
Pharmacists are responsible for taking custody of the post-consumer returns, and securing them until they are destroyed locally or are sent off-site for destruction purposes.
2.2Licensed Dealers including those Licensed to Destroy
Licensed dealers,including those licensed to destroy,mustmeet record-keeping requirements and carry out any destruction of post-consumer returns in accordance with all applicable federal, provincial and municipal legislation.
3.0Post-Consumer Returns
Post-consumer returns areunused or expired drug substances or drug products that may contain a narcotic, targeted substance, controlled drug or precursorthat are returned by an individual consumer.Post-consumer returns do not include drug products returned to a hospital pharmacy from patient wards.
3.1Personnel Involved
It is recommended that post-consumer returns be received by a pharmacist or regulated pharmacy technician, and that they be deposited in a secure container that is located within the dispensaryarea of the pharmacy immediately after receipt.
3.2Record Keeping
Pharmacists may want to suggest to consumers returning unused or expired medications that they remove personal information from pill bottles and packages.
As a matter of policy, Health Canada has been recommending that pharmacists record the name of the drug products, strength and quantity for post-consumer returns.Effective x-date Health Canada no longer requires this information to be recorded for post-consumer returns.Consequently, there is no requirement to separate the controlled substances from other prescription or non-prescription medications.
For record keeping requirements for destruction, please consult section 4 of this document.
3.3Storage
Post-consumer returns should be stored in collection containers that have a one way entry opening so that items cannot be removed once deposited.
It is recommended that collection containers be kept in the pharmacy dispensary when in active use, and that access is limited to staff who require access.Visitors should not be left unattended around collection containers in active use.
Collection containers should also contain an inner liner that is opaque, tear-resistant, has a unique identifier for tracking purposes and can be sealed as soon as it is full.Procedures should also be put in place to monitor the security of full linersbefore disposition.A list of companies from whom inner liners meeting these specifications can be purchased is included in Annex A.
If the pharmacist chooses to place the collection container outside the dispensary, it is recommended that the container be secured to the floor.
Pharmacists are also encouraged to use other means to enhance security in and around the dispensary area, e.g., the installation of security cameras.
Licensed dealers are not required to store post-consumer returns with their inventory containing narcotics, controlled drugs, or other targeted substances, however, these products should be stored in a manner that prevents their diversion.Post-consumer returns will not contribute to the value permitted based on a licensed dealer’s physical security directive level.
3.4Destruction
Pharmacists have three choices with respect to the destruction of post-consumer returns:
- they can destroy the returns locally, in a manner similar to that used for the local destruction of unserviceable stock (see Guidance Document For Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable stock Containing Narcotics, Controlled Drugs, Targeted Substances);
- they can sendpost-consumer returns*directly to a dealer licensed to destroy narcotics, controlled drugs, targeted substances, or precursors (see section 4.2);or
- they can use the services of a third party post-consumer return collection service who is a dealer licensed to destroy narcotics, controlled drugs, targeted substances, or precursors (see section 4.3)[1].
Pharmacists should treat all post-consumer returns as controlled substances.
*Note that post-consumer returns can be shipped with unserviceable stock being sent to a dealer licensed to destroy narcotics, controlled drugs, or targeted substances, but they are not to be co-mingled in order to ensure the proper record-keeping.
4.0Procedure for Destruction
4.1Local Destruction of Post-Consumer Returns
Pharmacists carrying out local destruction of post-consumer returns should record the date of the destruction took place, the unique identifier of the liner, and the number of liners destroyed.
If post-consumer returns are to be destroyed at the same time as unserviceable stock, the pharmacist carrying out the local destruction should add the information of post-consumer returns (i.e.,unique identifier of the liner) to the record of unserviceable stock local destruction.
The generated record must be signed by the pharmacist, practitioner or person in charge of the hospital who carried out the destruction process and the witness present.Both persons must sign and print their names on a joint statement indicating that they witnessed the destruction and that the substance was altered or denatured to such an extent that its consumption was rendered impossible or improbable.
This informationmust be recorded in a register similar to that required to be kept for orders involving narcotics, controlled drugs, and targeted substances, and mustbe retained for a period of two years, in a manner that permits an audit to be made[2].
4.2Sending to a Dealer Licensed to Destroy
As authorized in the 2016 class exemption, only a practitioner, pharmacist or person in charge of a hospital can arrange for a narcotic, controlled drug, or targeted substanceto be sold or provided to a dealer who is licensed to destroy them, and this responsibility cannot be delegated or discharged to another employee.
4.2.1Order Requirements
There is no order requirement for the sale or provision of post-consumer returns to a dealer licensed to destroy narcotics, controlled drugs, or targeted substances. If post-consumer returns are being included in a shipment of unserviceable stock, the record generated in relation to the unserviceable stock mustnote their inclusionby recordingthe number of liner(s) collected, the date the liner(s)are collected, the unique identifier/tracking number assigned to each liner, and the name and address of the licensed dealer to whom the shipment was sold or provided.
4.2.2RecordKeeping
If a shipment of unserviceable stock being sold or provided to a dealer licensed to destroy them contains only post-consumer returns or post-consumer returns combined with unserviceable stock, a pharmacist mustnote the post-consumer returns by recordingthe number of inner liner(s)collected, the date the inner liner(s) are collected, the unique identifier/tracking number assigned to each inner liner, and the name and address of the licensed dealer to whom the shipment was sold or provided.
Similarly, if a shipment being sold or provided to a dealer licensed for destruction contains only post-consumer returns or post-consumer returns combined with unserviceable stock, the licensed dealer must note the post-consumer returns by recording: the number of inner liner(s) being received; the date the inner liner(s) are being received; the unique identifier/tracking number assigned to each inner liner ; and, the name and address of the pharmacist from whom the shipment was received.
These records must be retained for a period of two years, in a manner that permits an audit to be made in accordance with the 2016 Section 56 Class Exemption for Pharmacists, for the Sale or Provision of Post-Consumer Returns to Dealers Licensed to Destroy Them.
4.3Sending to a Third Party Post-Consumer Return Collection Service
Pharmacists are responsible for arranging for the collection of post-consumer returns via a third party post-consumer return collection service, and this responsibility cannot be delegated or discharged to another employee. Third party post-consumer return collection services should be dealers licensed to destroy narcotics, controlled drugs, targeted substances, or precursors.
4.3.1Record-Keeping
Pharmacists should record the following information prior to the collection of post-consumer returns by a third party post-consumer return collection service:
- the number of liner(s)being collected;
- the date the liner(s) are being collected, and
- the unique identifier/tracking number assigned to each liner.
This information should be recorded in a register similar to that required to be kept for orders involving narcotics, controlled drugs, and targeted substances, and should be retained for a period of two years, in a manner that permits an audit to be conducted.[3]
5.0Loss or Theft of Post-Consumer Returns
Any loss or theft of post-consumer returns should be reported to law enforcement and Health Canada. Please refer to the Guidance Document Reporting of Loss or Theft of Controlled Substances and Precursors.
Annex A: Companies Who Sell Inner-Liners Meeting Health Canada Specifications
Infekta International Packaging
Lake Forest IL, USA
1-866-847-4413
Upward Packaging Inc.
Vancouver, BC
(604) 215-1545
ESBE Scientific
Markham, ON
1-800-268-3477
Note that some inner liners may not be available with a unique identifier. As such, pharmacists may need to purchase labels which include a unique identifier and attach them to the inner liners for record-keeping and tracking purposes.
Annex B: Definitions
The following definitions are provided for reference:
“controlled drug”: / means a drug set out in the Schedule to Part G of the FDR and includes a preparation[4];“destruction”: / means to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable;
“licensed dealer”: / means the holder of a dealer’s licence issued under the NCR, the FDR – Part G, the BOTSR or the PCR;
“local destruction”: / means on-site destruction;
“narcotic”: / means any substance set out in the Schedule to the NCR or anything that contains any substance set out in that Schedule[5];
“practitioner”: / means a person who is registered and entitled under the laws of a province to practise in that province the profession of medicine, dentistry or veterinary medicine, and includes any other person or class of persons prescribed as a practitioner[6];
“precursor”: / means a substance included in Schedule VI to the CDSA;
“post-consumer return”: / means unused or expired drug substance or drug products containing a narcotic, targeted substance, controlled drug or precursor that are returned by an individual consumer to a retail pharmacy for destruction purposes but do not include drug products returned to a hospital pharmacy from patient wards;
“regulated technician”: / means a person who is registered, regulated and entitled under the laws of a province to practise in that province (e.g., pharmacy technician or veterinary technician);
“targeted substance”: / means a controlled substance that is included in Schedule 1 to the BOTSR or a product or compound that contains a controlled substance that is included in Schedule 1 to the BOTSR;
“third-party post-consumer return collection service”:
“unserviceable stock”: / means a service which collects post-consumer returns from retailpharmacies and ensures their proper disposal and destruction;
means drug product containing a narcotic, targeted substance, or controlled drug that is unused, expired and/or that cannot be dispensed for some reason.
1
[1]In some provinces, the provincial Ministry of the Environment may have a standing arrangement in place with a single third party post-consumer return collection service.
[2]See section 31(1) of the Controlled Drugs and Substances Act.
[3]See section 31(1) of the Controlled Drugs and Substances Act.
[4]See G.01.001(1) of Part G-FDR.
[5]See Interpretation section of the NCR.
[6]See Section 2.(1) of the CDSA.