There is a massive shift from prescription to over-the-counter (OTC) drugs in the US. The FDA can legally approve the manufacture of prescription drugs as OTC. Legal expert Heidi Gertner says this broader shift depends on pharmaceutical companies getting involved. Pharmacists have a key role in implementing change. The FDA regulates OTC drugs through monographs that establish conditions for safety and efficacy in 36 therapeutic categories. Some drugs may be switched from prescription to OTC after assessing consumers' ability to use them safely. Ninety-five percent of OTC drugs approved through an NDA or ANDA were previously available by prescription for the same indication.