Mandatory Listing: Drug listing is compulsory for all establishments engaged in manufacturing, repacking, relabeling, or salvaging drug products for commercial distribution in the U.S. This includes prescription drugs, over-the-counter (OTC) drugs, and biologic drug products.

Submission of Information: Drug establishments must submit detailed information about each drug product they market, including the product’s proprietary and established names, active ingredients, dosage forms, strengths, route of administration, and packaging information.

Electronic Submission: Drug listing information must be submitted electronically to the FDA. The Electronic Drug Registration and Listing System (eDRLS) is the primary platform for submitting drug listing information, though other FDA-approved electronic submission systems may also be used.

Timely Submission: Drug listing information must be submitted to the FDA in a timely manner. This includes upon initial registration with the FDA, upon the introduction of a new drug product to the market, and when there are changes to existing drug products or manufacturing facilities.

Updates and Amendments: Drug establishments are responsible for updating their drug listing information as needed to reflect any changes, such as new products, discontinued products, formulation changes, or changes in manufacturing facilities. Updates must be submitted to the FDA promptly.

Accuracy and Completeness: Drug establishments must ensure that the information provided in their drug listing submissions is accurate, complete, and up-to-date. This helps maintain the integrity of the FDA’s drug listing database and ensures the availability of accurate information for regulatory purposes.

Compliance and Enforcement: Compliance with drug listing requirements is essential to meet FDA regulations and avoid regulatory actions. Failure to comply with listing requirements may result in enforcement actions by the FDA, including warning letters, fines, or product recalls.