Over-The-Counter (OTC) Drugs come with their own unique set of requirements, and dicentra’s expertise is by no means confined to dietary supplements, cosmetics and foods. We also assist companies in obtaining licenses to sell their OTC drug products. There are over 300,000 OTC drug products marketed in the United States, due to this large number the FDA conducts a regulatory review based on the active pharmaceutical ingredient and labeling by therapeutic class (e.g. antacids), rather than by assessing individual drug formulations. For each category, an OTC drug monograph is developed and published in the Federal Register under 21 CFR parts 331-358.
There are two regulatory pathways for an OTC drug:
Companies producing OTCs are also required to ensure that their product meets the standards for safety and efficacy, is compliant with GMPs and meets the labeling requirements as set out in 21 CFR part 201.66. Let dicentra ensure your OTC application is completed accurately and efficiently.