There are two regulatory pathways for OTC drugs in the United States: development under the OTC monograph process; or through the New Drug Application (NDA) process. Products that do not meeting the conditions of the OTC drug monograph must seek approval through the NDA process.
Over-the-counter (OTC), also known as non-prescription drugs, are products that have been evaluated to be safe and appropriate for consumption without the supervision of a health care professional.
There are two regulatory pathways for OTC drugs: development under the OTC monograph process; or through the New Drug Application (NDA) process. The OTC monograph route outlines the classification of ingredients that can be used to treat a specific disease or conditions without a prescription, and the appropriate dose and direction of use. If a product meets the requirements of the monograph, it can enter the USA market without FDA pre-approval. Products which do not meet the conditions of the monograph must seek approval through the NDA process.
NHP Consulting has an in-depth understanding of these regulations and can determine the appropriate drug classification (monograph vs NDA) as well as help prepare compliant labels to meet the safety, effectiveness, and labeling requirements as per the OTC drug monograph. (At this time, NHP Consulting is only assisting with OTC drug submissions, and not NDA submissions.)