The scope of this policy framework includes medicines for human and veterinary use. This directive applies to all drugs under the Food and Drugs Act (z.B. Schedule C (radiopharmaceuticals), Schedule D (Biologics), Schedule F (Prescription Drugs) and Schedule G (controlled substances), as well as over the Counter drugs. However, note that this directive does not apply to natural health products (NHP) that are governed by the rules applicable to natural health products. A separate document is made available by the Natural Health Products Directorate for the compounding of NHP. All health care professionals who make medicines for mixed products must also comply with all relevant sections of the Food and Drugs Act, including Sections 3 – Prohibited Advertising; 8 – Prohibited sale of drugs; 9 – drug deception; and 11 – Manufacturing unhygienic medicines. Chart 1.0 – Manufacturing and Compounding Process – Flow chart showing the distribution between pharmaceutical companies, manufacturing and the federal government, as well as health professionals, compounding activities and provincial/territorial bodies. Production activities are regulated by the federal government and their requirements must be met, including a drug identification number, establishment licence and compliance notification. Compounding activities are regulated by provincial and territorial regulators and their standards and requirements must be met. Discussions are taking place between the federal government and national territorial regulators. The general guidelines for compounding and manufacturing activities are summarized in Schedule I.
Under this directive, health professionals are those who are accredited by their respective provincial/territorial supervisory authorities. Compounding is therefore an authorized or authorized act that falls within the practice of professions such as pharmacy and medicine/dentistry/veterinary or other health professionals. Health care professionals involved in compounding must comply with existing provincial/territorial/federal rules and their standards for these services. Responsibility for the risk resulting from compounding activities is assumed by licensed healthcare professionals in the treatment and care of their patients/clients. In essence, when a person is unable to clearly determine whether a particular activity is considered a production or compounding, he or she can contact either the health products and food industry supervisory authority or the Provincial/Territorial Authority (see Section 7.0 Associate Documents/Links – Contact List). On that date, discussions can be held between the two jurisdictions to determine definitively whether an activity is considered a compilation or production. In February 1997, a multidisciplinary workshop on drug compounding and manufacturing was held in Canada. The need to clarify roles and jurisdictions, as well as concerns about certain products, processes and service providers, were among the many issues highlighted. In July 2000, the strategy paper Manufacturing and Compounding Drug Products in Canada was released by Health Canada, following consultation with the National Association of Regulatory Drug Control Authorities (NAPRA) and the Canadian Hospital Drug Society (CSHP).