Due to the COVID-19 pandemic, world-wide demand has soared for hand sanitizer and anti-viral products. Below, we outline five basic steps for domestic and foreign manufacturers or domestic distributors who want to get their drug product into the US market but never dealt with the FDA’s electronic drug registration and listing. The scope of products includes: Rx (Prescription Drugs) and OTC (Over the counter) – ex. Hand Sanitizer, API’s (active pharmaceutical ingredients) and homeopathic, herbal and dietary supplements.

Who is responsible to for Drug registration and Drug listing?  The manufacturer is primarily responsible; however, the Drug importer and/or distributor also has the responsibility for Drug registration.

The five process steps for Drug registration and Drug listing :

1. Does your firm have a Duns & Bradstreet (DnB) number (or DUNS number)? If no- go to www.dnb.com where you can initiate the registration  for free if located in the US and not time restricted.  Obtaining a DUNS number for a foreign firm may take time.
2. Next step, register with FDA for a Labeler code for your product. FDA assigns the first five digit of an NDC code. This is a two-step process: 1) – first request labeler code from FDA, 2) and second register the file with FDA, but is a near similar process and takes 24 hours to populate into databases. The NDC code requires both a Product code, or the next 3 digits and the last two digits at end is the package code which are both assigned by the manufacturer.

Example: NDC 12345-123-01 {Labeler Code-Product Code-Package Code}

• After the Labeling and NDC code is prepared, next your firm must register its Manufacturing Facility (Establishment Registration). It is important to note, that the information provided must match Duns and Bradstreet which includes the DUNS #, address, point of contact, etc.
• Register your Drug Product through an SPL submission, which contains the Content of Labeling and Drug Facts, the label images (text-selectable pdf) as well as the metadata of the drug listing data elements. Further information and the current registry can be found in the FDA NDC directory (https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm and Drug listing information through DailyMed: (https://dailymed.nlm.nih.gov/dailymed/).
• Each year you must remember to re-certify or delist the listing if no longer in use.

If you require further regulatory consultation or assistance, please reach out to us at info@accuratefdaconsulting.com with your needs and requirements and we will respond to you with a free quote as quickly as possible.