A controlled drug product is a dosage form containing a controlled substance as an active pharmaceutical ingredient (API). Controlled substance is a chemical substance whose manufacture, possession, or use is regulated by a government, such as illicitly used drugs or prescription medications that are designated by law.
The Controlled Substances Act (CSA) in the U.S. is a federal regulation designed to prevent the diversion of certain potentially harmful substances for illegal use. To purchase controlled substances active pharmaceutical ingredient (API) for the production of a controlled substance pharmaceutical formulation, the purchaser must provide the supplier with its DEA certificate and certificate of procurement quota. The control applies for the manufacture, usage, handling, storage and distribution of controlled substance pharmaceutical formulations. It provides an efficient way to help medical professionals, lawmakers, and other officials across the country assess the benefits and dangers of various drugs and medications.
Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. However, as many controlled substances have continued medical use, access for patients in need is necessary. Controlled substances are classified into five different schedules. Each active pharmaceutical ingredient (API) is put into a specific schedule based on the following factors such as abuse potential, historical and current patterns of people abusing the drug, risk of users developing a dependence, etc.
Controlled substances are an important asset in the toolkit of a healthcare provider in any practice setting, chiefly because these medications act quickly and potently.The demand for controlled substance active pharmaceutical ingredients (APIs) has increased rapidly in recent years because these products have considerable potential to address unmet patient needs, particularly in therapeutic areas such as depression, PTSD, addiction and chronic pain management.
The development of existing controlled substance molecules in different dosages is boosting their demand in the prescription market.The market for the lawful use of controlled substances is in excess of $21 billion worldwide. Currently the U.S. is the largest segment, with an approximate 63% share of the global market for controlled drugs. Pharmaceutical companies that are interested in outsourcing DEA controlled substance manufacturing & development need a partner that is equipped to perform cGMP processes and several other levels of operational complexities.
There are a number of contract development and manufacturing organizations (CDMOs) that have in-depth understanding of the regulations, long-standing positive relationships with regulators, and a track record of successfully working with controlled substances that can accelerate early phase development and commercialization. Moreover, they may also offer integrated or stand alone services including pre-formulation services, analytical development services and formulation services for controlled substance formulations as well as controlled substance manufacturing & packaging, etc.