
Over-the-counter (OTC) drugs are products that can be obtained without a prescription. These drugs can be found in the aisles of a pharmacy, grocery store, or gas station. In order to legally market an OTC, one must either market in compliance with an OTC drug monograph, or market under the authority of an approved product through a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA).