The FD&C Act defines drugs, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”.FDA requires manufacturers, re-packers, and re-labelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent. The Office of Compliance, Immediate Office oversees the Drug Registration and Listing System (DRLS) and the electronic Drug Registration and Listing System (eDRLS), key components of the Food and Drug Administration’s (FDA) ability to monitor drug safety.Drugs, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA, or comply with the appropriate monograph for an OTC drug.An NDA is the vehicle through which drug sponsors formally propose that FDA approve a pharmaceutical for sale and marketing in the United States. FDA only approves an NDA after determining, for example, that the data is adequate to show the drug’s safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients and for new indications entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system, and their “switch” to OTC status is then approved, also through the NDA system.Registrants are required to submit initial listing information of all OTC drugs in commercial distribution at the time of FDA establishment registration. The listing information should submit in SPL format and should upload the product image also. If a private label distributor (PLD) is listing the OTC drug with US FDA, the PLD may request their own NDC Labeler code, but PLD does not require FDA establishment registration. By submitting the drug listing information the PLD assumes the full responsibility for compliance with US FDA drug listing requirements.
JK Consulting Services:
Drug Establishment Registration
OTC drug Products
Drug Master Files
Abbreviated New Drug Application (ANDA)
Homeopathic Drug Listing
Active Pharmaceutical Ingredient (API) Listing and etc.