Our article Out of Danger: Controlled Drug Manufacture, was featured in samedanltd.com in the spring of 2015. It’s focus is on the manufacturing, handling and distribution of controlled substances and drugs.
A controlled substance is a drug or chemical whose manufacture, possession or distribution is highly regulated by the government and subject to legislative control.
Controlled drugs include the following: illegal drugs, prescription medications, and chemicals considered precursors to the production of illegal drugs. These are all deemed to cause harm to an individual, if they are not properly used.
Controlled drug manufacture and distribution is closely monitored by the United Nations (UN) on a global basis. The construction of an international legal framework for controlled drugs has gone through several stages of development since the 1920 prohibition of alcohol in the US.
In 1961, the UN Single Convention on Narcotic Drugs was established as a universal system to limit the cultivation, production, distribution, trade use and possession of narcotic substances strictly to medical and scientific purposes, with special attention to substances produced from plants.
A decade later, in 1971, the Convention introduced prescription requirements for controlled drugs, as well as a regulatory framework to include the inspection of manufacturers (exporters, importers, wholesale and retail distributers, and medical/ scientific institutions). In a groundbreaking move, the Convention also created four schedules for controlled psychotropic substances, mainly evaluated based on the risk of creating drug dependency.
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As well as controlled drug manufacture we provide complete drug development and manufacturing services
With over 35 years’ experience of processing potent and non-potent drug products, PCI provides a true partnership and consultative approach from pre-clinical formulation development and API characterization through to full commercial launch.