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”. Additionally, FDA regulations define “drugs” as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
The Center for Drug Evaluation and Research (CDER) has different regulatory requirements for new prescription drugs, generic drugs and over-the-counter (OTC) drugs. FDA Solutions Group’s services are focused on the needs of the OTC drug sector.
FDA Solutions Group offers assistance with the following registration and compliance requirements:
Drug Establishment Registration
Domestic and foreign drug establishments that manufacture, prepare, propagate, compound, or process drugs must register their drug establishment with the FDA. Click here to get started.
OTC Drug Listings
Registered drug facilities must submit drug product listing information for all OTC drugs offered for import or intended for commercial distribution within the U.S., prior to entering the new drug product into the stream of commerce. The listing information must be submitted to FDA electronically in SPL format, in order to finalize the process and record the NDC on the FDA’s database. Click here to learn more.