What You Need To Know About Manufacturing OTC Products

By Julia Huang, Regulatory Affairs Associate, Bora Pharmaceuticals

In the most general terms, an over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the world for use without medical supervision.

As more medications move to OTC status, people are interested in playing a more active role in managing their health and controlling their healthcare choices. As a result, OTC products are generally accepted as an important part of healthcare. However, self-medication comes with risks. The understanding of what constitutes an OTC drug and the mode of dispensing can differ widely between regions and countries.