
Monograph Categories
There are several monograph categories for OTC Drugs in Canada, such as Labeling Standard, TPD Category IV, and NSAIDs. Meeting their requirements is difficult.
Regulatory Pathways
To market OTC drugs in USA, you need to go through two Regulatory Pathways, OTC Drug Monograph Application Process and the OTC New Drug Application (NDA) process.
Good Manufacturing Practices
Any firm (domestic or foreign) manufacturing, distributing, or importing OTD drugs require to show evidence that they are following GMP.
Establishment License
To manufacture, sell, or import non-prescription drugs, businesses must obtain an establishment license.