Subsection 56(1) class exemption for pharmacists administering controlled substances in Canada
Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), and subject to the terms and conditions herein, pharmacists practising outside of a hospital are hereby exempted from the following provisions of the CDSA when administering a controlled substance to a patient, provided the pharmacist is authorized to administer that controlled substance under the laws of the province or territory where the administration takes place:
- Subsections 5(1) and 5(2) of the CDSA
Definitions
Except as provided below, the terms used in this exemption have the same meaning as those provided in the CDSA and its regulations:
- Administer
- means the act of introducing a controlled substance into a human body.
- Controlled substance
- means any substance listed in Schedules I, II, III, or IV of the CDSA, except a restricted drug as defined in regulations made under the CDSA.
- Patient
- means an individual who is a client of a pharmacist and who holds a prescription for a controlled substance.
- Pharmacist
- means a person :
- who is entitled under the laws of a province or territory of Canada to practise as a pharmacist, and who is practising pharmacy in that province or territory; and
- whose scope of practice of pharmacy includes administration of controlled substances, in a manner consistent with any applicable provincial or territorial pharmacy legislation and any applicable policies of a provincial or territorial professional regulatory authority.
- Prescription
- means an authorization given by a practitioner that a stated amount of a controlled substance can be sold or provided to the individual named in it.
- Terms and Conditions
- This exemption is applicable if the following conditions are met:
- This exemption only applies to pharmacists who are not practising in a hospital pharmacy;
- Administration of a controlled substance cannot be delegated and may only be conducted by a pharmacist;
- Pharmacists must only administer a controlled substance to a patient who has a valid prescription for that substance;
- Pharmacists must only administer a controlled substance to a patient in accordance with any policies, guidelines, requirements (e.g. record-keeping requirements) and/or restrictions established by the relevant provincial or territorial government and by any relevant provincial or territorial professional regulatory authority;
- If record-keeping is not already required under Term 4, pharmacists must document the name and quantity of any controlled substances administered and the date of administration. These records must be retained for two (2) years from the date each record is created.
- Remaining quantities of controlled substances that cannot be administered must be destroyed.
- Suspension without notice
- This exemption may be suspended without prior notice if the Minister deems that such suspension is necessary to protect public health or safety.
- Revocation
- The Minister may revoke the exemption if they believe that it is no longer necessary or in the public interest.
- Effective date
- This exemption is effective as of April 1, 2026, and expires on the earliest of the following dates:
- The date on which it is replaced by another exemption; or
- The date on which it is revoked.
Signed for and on the behalf of the Minister of Health,
Carol Anne Chénard
A/Director General
Controlled Substances and Overdose Response Directorate
Health Canada