FDA OTC Drug Compliance Requirements
If your product's manufacturing facility has been listed in FDA and has FEI number, start with no. 3
1) Obtain a DUNS number & Designate a US FDA Agent
A valid DUNS number (Dun and Bradstreet Data Universal Numbering System number) must be included in your establishment registration SPL submission. The FDA uses it to identify your facility in the eDRLS system.
Your US Agent is your official FDA contact, receives inspection notices and regulatory correspondence, and must be physically located in the United States. Foreign facilities only. All foreign cosmetic facilities must designate a US FDA Agent before facility registration can be completed. Domestic facilities do not require a US Agent.
2) Register Your Drug Establishment and obtain an FEI Number
Drug establishment registration is submitted through the FDA Electronic Drug Registration and Listing System (eDRLS) in SPL format. Asla Partners handles the entire submission for foreign and domestic establishments. Registration must be renewed annually between October 1 and December 31. There is no government fee for basic drug establishment registration.
A Facility Establishment Identifier (FEI) number is the FDA's unique identifier for your facility and is required for MoCRA facility registration through the Cosmetics Direct portal. The FEI number is assigned by the FDA. If your facility does not yet have one, or if you need to locate an existing FEI number before beginning registration, Asla Partners can assist with FEI number requests for both foreign and domestic cosmetic facilities.
3) Submit Drug Product Listings in SPL Format with NDC
NDC Labeler Code is required before you can list any drug product with the FDA or place an NDC number on a drug label. The Labeler Code is assigned by the FDA and is specific to your company. Asla Partners assists with Labeler Code applications for both foreign and domestic companies.
Every drug product commercially distributed in the United States must be listed with the FDA in Structured Product Labeling (SPL) format. Listings must include the NDC number, product name, dosage form, active ingredients, and labeling. Asla Partners handles SPL submission for each product for foreign and domestic establishments.
4) Review Labels for OTC Drugs Compliance
All drug labels must comply with FDA labeling requirements, including ingredient declaration in descending order of predominance, required label elements, and permissible claims. Asla Partners offers cosmetic label compliance review for foreign and domestic companies.
5) Certify Drug Listings Annually
All active drug product listings must be certified or updated each year between October 1 and December 31, the same window as establishment registration renewal. Failing to certify removes your products from the FDA NDC directory. Asla Partners handles annual certification as part of our renewal service.