Restrictions on compounding and repackaging of narcotics and other controlled substances
April 17, 2019
The federal Narcotic Control Regulations prohibit the compounding and repackaging of narcotics, except in emergency situations (s45(1)(b)). The term “emergency situation” is not defined in the legislation; however, Health Canada’s Controlled Substances and Cannabis Branch has advised as follows:
"Scenarios are evaluated on a case-by-case basis. Generally speaking, emergency purposes could include an urgent public health need, a critical shortage of stock, or an order that could not be processed by a pharmacist that required immediate action. The sections of the regulations that allow for emergency sale or provision of controlled substances are not intended to be used for stock management purposes. Such sales or provisions are to be done on a prescription basis. Typically, the quantities involved would be limited to what is necessary to fill a single prescription.”
In that context, situations requiring emergency compounding or repackaging narcotics should be restricted to incidental events only and should not be a normalized practice. If there is a need to normalize the practice of compounding or repackaging narcotics, a compounding and repackaging pharmacy must hold a licensed dealer permit issued by Health Canada, as provided for under the Narcotic Control Regulations C.R.C. 1040 (Canada) and as required in s2.6 of the model agreement approved by Council.
The Benzodiazepine and Other Targeted Substances Regulations (BOTSR) permit the compounding and repackaging of benzodiazepines and other targeted substances pursuant to a prescription (s49); however, the BOTSR does not permit compounding and repackaging of these “in anticipation of a prescription.” That means that they must only be compounded and repackaged in response to individual prescriptions. There is no latitude for compounding or repackaging quantities that anticipate “the next” prescription.
Section G.03.014(b) of the Food and Drug Regulations - Part G (e.g., testosterone, phenobarbital) (FDR-G) allows a pharmacist, “upon receiving a written order for a controlled drug signed and dated by (b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes.” As with the BOTSR, drugs listed in FDR-G must only be compounded and repackaged in response to individual prescriptions and must not be compounded or repackaged “in anticipation of a prescription.”
Health Canada has established a working group with the National Association of Pharmacy Regulatory Authorities (NAPRA) to review patient needs in context with changing practice and distribution frameworks. Once better understanding the changing needs across Canada, the goal is to develop a modernized policy document that appropriately balances patient needs and the level of security and accountability that the regulations anticipate.
Interpretation and Administration of Compounding and Repackaging Agreements
The Pharmacy and Drug Act requires that an agreement approved by Council be entered between every pharmacy holding a compounding and repackaging license, and each community pharmacy that it provides compounded and repackaged drugs to. Council has approved two agreements: one for services that are provided to community pharmacies in Alberta, and one for services that are provided to pharmacies located in Saskatchewan, licensed by the Saskatchewan College of Pharmacy Professionals (SCPP).
Section 2.5 of the agreement addresses the compounding and repackaging of controlled substances. This must be read, interpreted, and applied consistent with the above limitations provided by the Controlled Substances and Cannabis Branch of Health Canada. If there is a need to repeatedly compound or repackage narcotics, a compounding and repackaging pharmacy must hold a licensed dealer permit issued by Health Canada, as provided for under the Narcotic Control Regulations C.R.C. 1040 (Canada); and as required in s2.6 of the model agreement approved by Council.