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Compounding and repackaging agreements amended

May 18, 2022
New versions of the agreements are available on the ACP website.

Council has amended the compounding and repackaging agreements that are required between compounding and repackaging (C&R) pharmacies and community or institution pharmacies that they provide services to. The revised versions come into effect immediately; therefore C&R pharmacies and those receiving services from them should rescind former agreements and enter into new agreements using the revised versions.

Separate agreements have been approved for community pharmacies and institution pharmacies as defined in section 4 of the Pharmacy and Drug Act. For instances where a pharmacy that would otherwise be considered an institution pharmacy holds a community pharmacy licence, the community pharmacy C&R agreement must be used. Should the community licence be discontinued for any reason or should the institution pharmacy not have a community licence, then an agreement using the institution form must be entered into.

What’s new?

The agreements do not reflect substantive policy change. A new definition for repackaging, derived from Health Canada’s policy on compounding, has been included. Most other changes are to make the agreements consistent with current legislation, and to make each agreement as equivalent as possible.

Significant professional considerations

Regulated members are reminded that compounding and repackaging agreements authorize the compounding of drugs pursuant to a prescription for a patient, or in anticipation of a prescription for a patient. Compounding must only occur in small quantities in anticipation of prescriptions within short periods. Refer for our Link article from January 12, 2022, for more information.

This is especially true for narcotics and controlled substances. Special attention must be provided to section 2.5 and 2.6 of the agreement approved by Council which restricts the compounding of these drugs by C&R pharmacies strictly for emergency purposes as defined by Health Canada, and as further defined in the Standards of Practice for Pharmacists and Pharmacy Technicians (SPPPT).

Signing the agreement

Section 19 of the Pharmacy and Drug Regulation requires that C&R pharmacies enter into a contract with all pharmacies to which they provide C&R services. The purpose of these contracts is to provide clarity about roles and responsibilities between the pharmacies, as responsibility for the quality of products and the safety of patients is shared. Therefore, licensees of community pharmacies and directors of institution pharmacies should exercise diligence before entering into an agreement with a C&R pharmacy to ensure confidence in the quality assurance processes that are in place.

C&R contracts must be entered into by the licensee, not the proprietor’s agent. The agreements are tools to support the responsibilities of the licensees in each instance; they are not meant to be business contracts. Should a pharmacy owner, proprietor, or proprietor’s agent enter a business contract with a C&R pharmacy, that contract must not usurp the intent, or any aspect of the C&R agreement approved by Council.