Bordering on Myth: Controlled Substances and the Canadian Border

Posted by Wellspring Pharma Services


There is a common misconception that controlled substances won’t be allowed to cross the Canadian border, thus preventing some pharmaceutical products from being produced by Canadian contract manufacturing facilities. We need to move past this fallacy. There are many proven ways to manufacture controlled substances in Canada, provided the products are in compliance with import/export regulations in their home nation. Even if the substance is banned in Canada, Canadian regulators permit such commerce to proceed with minimal bureaucracy and legal red tape.

Canada is generally considered to be an open market, allowing companies to import raw

materials into the country with relative ease. In contrast, the United States is a comparatively closed market; the U.S. Drug Enforcement Administration (DEA) is relatively strict and its regulatory bodies look at pharmaceuticals much differently than Canada. Canadian regulatory enforcement is very specific, enabling relatively open borders without compromising safety, because Canadian regulators make a distinction between natural health and over-the-counter products versus pharmaceutical products.

Because of this differentiation, drug manufacturing is often easier in Canada than in other countries. Countries often classify drugs perceived as a societal threat, such as narcotics, as either “controlled” or “scheduled” substances. Controlled substances may or may not be able to transit the country without being sourced directly from within that country. In the U.K., for example, regulators do not allow certain raw materials to enter the country, creating a closed system that restricts specific substances that are not manufactured inside the country.

While these regulations are primarily designed to protect people, they also serve a political objective to protect domestic markets. Canada’s regulators are more open-minded about international commerce and trade, including the processing and production of controlled substances, thereby fostering an environment that supports Canada’s pharmacopeia and encourages manufacturing in Canada for foreign entities.

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Topics: production, CMO Partner, exports, open market, imports

WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.

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