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Glossary

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Contract Manufacturing Organization (CMO)

What is a Contract Manufacturing Organization (CMO)? A Contract Manufacturing Organization (CMO) is a third-party company that provides drug manufacturing services under contract to pharmaceutical firms. CMOs may produce APIs, intermediates, or finished dosage forms, and must operate in compliance with current Good Manufacturing Practices (cGMPs). According to the FDA, CMOs must be registered establishments, inspected regularly, and subject to the same regulatory […]

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Controlled Substance

What Is a Controlled Substance? A controlled substance is a drug, chemical, or precursor regulated by law due to potential for abuse, addiction, or public health threat. These are classified into schedules based on medical utility, abuse risk, and safety, reflecting stringent national and international control frameworks. Why Is Regulation of Controlled Substances Crucial? Strict governance ensures:

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Controlled Substances Act (CSA)

What is Controlled Substances Act (CSA)? CSA, short for the Controlled Substances Act, is a cornerstone U.S. federal statute—enacted in 1970 and signed into law by President Richard Nixon—that regulates the manufacturing, importation, distribution, and use of certain drugs and chemicals. It establishes five drug schedules based on accepted medical use, abuse potential, and dependence liability. Why Does the Controlled Substances Act (CSA)

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