Community Pharmacy Accreditation and Operation Practice Topic

It depends on the product’s classification at the federal level:

1. Natural Health Products (NHPs) containing pseudoephedrine and/or ephedrine (i.e., products assigned a NPN by Health Canada) are beyond the scope of the NAPRA National Drug Schedules (NDS) and therefore are not subject to the related NAPRA NDS conditions of sale.  However, pseudoephedrine and ephedrine are still defined as ‘drugs’ by Ontario regulations, which limits their sale to accredited pharmacies in Ontario.  In addition, Health Canada’s Ministerial Order sets out retail sale prohibitions for these NHPs across the country.

Designated Managers must ensure that these products are only available for sale while the pharmacy is in operation (i.e., when a pharmacist is physically present in the pharmacy, providing direct supervision to personnel).

Health Canada’s Order outlines the following conditions-of-sale restrictions:

• Non-combination (“single entity”) NHPs containing only pseudoephedrine and/or ephedrine as medicinal ingredient(s) cannot be accessible to the public for self-selection (e.g., must be kept behind the counter).
• Combination NHPs containing pseudoephedrine and/or ephedrine plus one or more other NHP ingredients (substances in Schedule 1 of the Natural Health Product Regulations) can be accessible to the public in the self-selection area of the pharmacy.

These restrictions also apply to remote dispensing locations (RDLs) and online sales. See related FAQ on “Who can sell products containing pseudoephedrine or ephedrine in the pharmacy.”

2. Health Canada’s Order does not apply to non-prescription drugs (NPDs) containing pseudoephedrine and/or ephedrine and other drugs (i.e., products assigned a DIN by Health Canada). Ontario regulations require pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules (NDS).

Therefore, if the NPD contains:

• Schedule II or III drug(s): The ingredient with the most stringent NAPRA schedule determines its conditions for sale (e.g., if the NPD contains Schedule II and III drugs, then Schedule II applies).
• Unscheduled (“Schedule U”) drug(s): They are not subject to the regulations and may be sold by any retail outlet.

In any case, the Designated Manager can choose to keep any NHP or NPD containing pseudoephedrine and/or ephedrine behind the counter if there are concerns about misuse or diversion.

It depends on the product’s classification at the federal level:

a) Natural Health Products (NHPs) containing pseudoephedrine and/or ephedrine (i.e., products assigned a NPN by Health Canada) are not included in the NAPRA National Drug Schedules (NDS) and therefore are not subject to the related NAPRA NDS conditions of sale. However, they are still defined as ‘drugs’ by Ontario regulations and Health Canada’s Ministerial Order sets out retail sale prohibitions for these products.

Designated Managers must ensure that these products are only available for sale while the pharmacy is in operation (i.e., when a pharmacist is physically present in the pharmacy, providing direct supervision to personnel).

Health Canada’s Order outlines the following conditions-of-sale restrictions:

• Non-combination (“single entity”) NHPs containing only pseudoephedrine and/or ephedrine as medicinal ingredient(s) can only be sold by a pharmacist or a person working under the supervision of a pharmacist.
• Combination NHPs containing pseudoephedrine and/or ephedrine plus one or more other NHP ingredients (substances in Schedule 1 of the Natural Health Product Regulations) can be sold only if a pharmacist is available to assist consumer prior to purchase if requested.

These restrictions also apply to remote dispensing locations (RDLs) and online sales. See related FAQ on “Can products containing pseudoephedrine or ephedrine only be sold in pharmacies?”

b) Health Canada’s Order does not apply to non-prescription drugs (NPDs) containing pseudoephedrine and/or ephedrine and other drugs (i.e., products assigned a DIN by Health Canada).

As Ontario regulations require pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules (NDS), if the NPD contains:

• Schedule II or III drugs
  • The ingredient with the most stringent NAPRA NDS conditions for sale determines whether pharmacist intervention is required; and
  • The Supplemental Standards of Practice for Schedule II and III Drugs apply.
• Unscheduled drug(s)
  • They are not subject to the regulations and may be sold by any retail outlet.

In any case, the Designated Manager can choose to implement procedures for a pharmacist to intervene in the sale of any NHP or NPD containing pseudoephedrine and/or ephedrine, if there are concerns about misuse or diversion.

The federal Precursor Control Regulations sets a maximum amount of pseudoephedrine and/or ephedrine that may be sold per package*, but not a limit on the total amount or quantity of pseudoephedrine and/or ephedrine that may be sold per transaction. Nevertheless, registrants have a professional and ethical obligation to prioritize the safety and best interests of the patient and the public.

If diverted to the illicit market, pseudoephedrine or ephedrine can be used to illegally produce D-methamphetamine (“meth”, “crystal meth”), which poses a significant risk to public health and safety. Given these risks, registrants must remain vigilant and exercise professional judgment when determining the quantity to sell, considering the patient and circumstances, to prevent potential substance misuse. For example, a registrant may restrict or limit the quantity sold to an individual if the request appears inappropriate based on their assessment.

*Based on maximum amount of pseudoephedrine and/or ephedrine base per package (e.g., maximum for pseudoephedrine base is 3 grams = 3.659 grams pseudoephedrine HCL). For conversion factors, refer to: https://www.deadiversion.usdoj.gov/quotas/conv_factor/index.html.

Providing a copy of the original with the transfer would be considered a best practice in the interest of patient safety. Unlike a refill, the logged prescription has never been dispensed and has not gone through the same complete checking process. This is the same reason registrants within their own practice site should be retrieving or viewing the original hardcopy before a logged prescription is dispensed.

The Code of Ethics also expects that when a patient moves from one healthcare provider to another, the relevant information is provided to the receiving healthcare provider, to ensure safe and effective transition of care

Refer to Sections 3 and 5 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.

Compounding is within the scope of practice and authorized acts for pharmacy professionals defined in the Pharmacy Act, and compounding non-sterile preparations according to recognized guidelines and standards is an entry-to-practice competency for both pharmacists and pharmacy technicians. Therefore, it is reasonable that the public and other health practitioners expect any pharmacy to provide some compounding services.

The requirements for “all levels of compounding” (Section 5), corresponding to Level A, should be attainable for all pharmacies already engaged in compounding. Moreover, the College‘s Code of Ethics expects that “registrants make every reasonable effort to provide quality cost-effective pharmacy care and services to patients and society.”

As explained in Section 3 of NAPRA’s Guidance Document, “given that pharmacists and pharmacy technicians are expected to maintain competency in basic compounding skills, they are also expected to provide compounded preparations within their level of expertise and within the limitations of available and appropriate facilities and equipment.”

As for all prescriptions, it is expected that a pharmacist will assess the prescription for a non-sterile preparation to determine whether it is the most appropriate therapy for the particular patient or if there is a suitable, safer alternative. If a compounded preparation is the best option, the Designated Manager/department head must ensure that the pharmacy has the resources necessary to safely and accurately prepare a quality preparation. If not, they have an ethical obligation to “assume responsibility for making reasonable efforts to ensure continuity of patient care when they are unable to provide requested pharmacy services.”

A Certificate of Accreditation may only be issued to a “bricks and mortar” pharmacy at a specific municipal address. There is no separate class of accreditation for online or internet pharmacies.

All pharmacies must meet the standards for accreditation and operation, as defined in the Drug and Pharmacies Regulation Act, 1990 and as established by the College. Please refer to Accreditation and Operation of a Pharmacy Guidance for more information and links to the relevant resources.

An accredited pharmacy may conduct business over the internet according to the College’s Operating Internet Sites Policy. This policy requires the pharmacy’s website to have its accreditation (“license”) number and the name of the Designated Manager so it can be verified by the pubic on the College’s public register.