OTC Drug

There are many FDA regulations that apply to drugs; these regulations are substantially different from the ones that regulate food and cosmetics. Under the Federal Food Drug and Cosmetic Act (FDCA), “drugs” are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”. Drugs are also described as “articles intended to affect the structure or any function of the body of man or other animals.” 

Diaz Trade Consulting can assist with the FDA drug establishment registration and drug listing requirements.