Securing Schedule 3 products

The National Association of Pharmacy Regulatory Authorities (NAPRA)’s National Drug Schedules model includes three schedules, including Schedule 1 drugs, Schedule 2 drugs, and Schedule 3 drugs.

Schedule 1 and 2 drugs must be retained within the dispensary of the pharmacy where there is no public access. Patients are not able to access these drugs without the assistance of a regulated member. Schedule 3 drugs, however, are available without a prescription and may be sold from the self-selection area of the pharmacy.

Schedule 3 drugs may present risks to certain populations. Therefore, there are requirements in place to ensure patients have access to the necessary information and support before purchasing Schedule 3 drugs:

• Schedule 3 drugs must be stored within view of regulated members working in the dispensary¹;
• the pharmacist must be available, accessible, and approachable to assist² a patient to make an appropriate self-medication selection; and 
• the self-selection area of the pharmacy where Schedule 3 drugs are sold is defined as the “patient services area;”
  • note that the prescription department includes the dispensary and the patient services area.

If the prescription department does not occupy all of the premises and shares the premises with another health professional or business, or is part of a larger business enterprise (e.g., a pharmacy located in a grocery or department store), the pharmacy must operate as a lock and leave pharmacy.³ 

The licensee of a lock and leave pharmacy must ensure that when the pharmacy is closed

• the dispensary and all drugs (including Schedule 3 drugs) are locked up to prevent unauthorized access; and
• no drugs are dispensed, provided for sale, or sold from the pharmacy.

A pharmacy operating as a lock and leave must have

• a secure lockable barrier that effectively prevents access to the dispensary, scheduled drugs (including Schedule 3 drugs), and patient records when the pharmacy is closed,
  • unauthorized personnel should not easily be able to access the dispensary either over, under, or through the secure lockable barrier;
• adequate key-control policies; and
• its own security system.

Licensees must ensure Schedule 3 drugs are appropriately secured. When the pharmacy is located where it does not occupy all of the premises, even if both businesses intend to operate for the same hours, the licensee must have appropriate lock and leave measures in place and must notify ACP.

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1. Requirements defined in standard 5.6 of the Standard for the Operation of Licenced Pharmacies.
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2. Requirements defined in standard 9 of the Standards of Practice for Pharmacists and Pharmacy Technicians. ↩︎
3. Requirements defined in requirements 4 and 7 of the Foundational requirements: Guidance document for opening a licensed pharmacy. ↩︎