Controlled substances: fewer CMOs, more regulations
As a result of increased scrutiny and required internal controls, the efforts and costs to maintain production facilities that are capable of producing and storing controlled substances, especially for molecules such as oxycodone and fentanyl, have also increased.
Specifically, more monitoring requirements by CMOs during the manufacturing and handling of controlled drugs are now required.
“For example, it varies by material, but, in general, the movement, surveillance, secure storage (safes) and reconciliation (material balances) are all managed extensively to ensure there is no loss or diversion,” David Mayers, President, WellSpring, told Outsourcing-Pharma.com.
As he explained, in most countries, CMO personnel must be registered with the government and hold credentials in order to appropriately oversee controlled substance operations. Often, a background check is also required and in some cases, such as in Japan, certification by a physician.
“Each employee is trained accordingly to our SOPs to comply with the heightened requirements associated with handling controlled substances,” added Mayers.
Crossing boarders
The regulations for CMOs, importers/exporters, and manufacturers are all governed by regulatory bodies, such as the US Drug Enforcement Administration (DEA) in the US, or the Office of Controlled Substances in Canada.
According to Mayers, there is a misconception that controlled substances aren’t allowed to cross the Canadian border, therefore preventing some products from being produced by Canadian contract manufacturing facilities.
“There are many ways to manufacture controlled substances in Canada, provided the products are in compliance with import/export regulations in their home nation,” explained Mayers. “Even if the substance is banned in Canada, Canadian regulators permit such commerce to proceed with minimal bureaucracy and legal red tape.”
Mayers said that while Canada is generally considered to be an open market, the US is a comparatively closed market. “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,” he added.
Handling materials
To maintain security and accountability in order to prevent diversion and protect material, CMOs are required to handle, store, transport, and destroy material in a regulated manner. Materials, even raw materials, must be for “for an approved purpose and the quantities imported are defined and registered,” explained Mayers.
Ultimately, according to Mayers, while the controlled drugs market has been increasing, the overall number of CMOs manufacturing has decreased as regulations and costs have increased – “even with increased capacity as a result of mergers and available facilities,” he added. “In addition, many of the major pharmaceutical companies in the industry have wanted to maintain internal control to ensure security of their supply chain.”
