US Drug Registration and Listing

Our US compliance experts help to register your drug establishment and list each drug that is manufactured  with the FDA.  Our team can also provide assistance with submitting the required drug listing information to the FDA for all homeopathic medicines.

US Drug Registration and Listing System (DRLS & eDRLS)

Any person engaged in drug manufacturing, preparing, propagating, compounding, or processing in the US or that are offered for import into the US must register their establishments with the Food and Drug Administration (FDA) as well as list each drug manufactured at their establishment for commercial distribution. They must also submit updated information about their drug listing to the FDA twice each year – in June and in December. The purpose is to notify the FDA of any changes in information.

All drugs registered with the FDA must be listed in its database and maintained through periodic renewal. Only after the labeler’s code is issued will the drug listing be added to the FDA’s database (takes approximately two business days).  The FDA NDC database will confirm the drug listing and its status will be indicated. Drug listings have to be updated annually to ensure their status is active.

Information Required from Outsourcing Facility

According to the FDA, accurate, complete, and updated information related to establishment registration and drug listing is required to promote patient safety. For each drug identified, the establishment must provide the following information:

  • NDC number of the final product if issued
  • Strength of active ingredient per unit
  • The source of the active ingredient
  • The NDC number of the source drug if available
  • The dosage form and route of administration
  • The package description and the number of individual units produced
  • The NDC number of bulk active ingredients if available
US Drug Listing

Why QSS for US Drug Listing (DRLS)

Why You Should Choose QSS for your FDA Drug Establishment Registration and Drug Listings.

There are many reasons to choose us for your FDA Drug Establishment Registration and Drug Listings:

  • We can register your establishment quickly and with no delays
  • We provide assistance in listing each drug manufactured with the FDA 
  • We have solutions for registration renewal within the timeframe set by the FDA
  • We file listing updates at any time in the calendar year
  • We independently audit your products and collect and submit information
  • We enable you to stay in compliance with FDA requirements

Frequently Asked Questions

There are many reasons to choose us for filing your US Drug Listings:

  • Help in registering your establishment
  • Assistance in listing each drug with the FDA
  • Solutions for registration renewal within the timeframe set by FDA
  • Listing updates at any time in the calendar year
  • Independently audit your products and collect and submit information
  • Enable you to stay in compliance with FDA requirements.

According to the FDA, accurate, complete, and updated information related to establishment registration and drug listing is required to promote patient safety. For each drug identified, the establishment must provide the following information:

  • NDC number of the final product if issued
  • Strength of active ingredient per unit
  • The source of the active ingredient
  • The NDC number of the source drug if available
  • The dosage form and route of administration
  • The package description and the number of individual units produced
  • The NDC number of bulk active ingredients if available

Any person engaged in drug manufacturing, preparing, propagating, compounding or processing in US or that are offered for import into US must register their establishments with the Food and Drug Administration (FDA) as well as list each drug manufactured at their establishment for commercial distribution. They must also submit updated information about their drug listing to FDA twice each year – June and December. The purpose is to notify FDA if there is any change in information.

All drugs registered with FDA must be listed in its database and maintained through period renewal. Only after the labeler’s code is issued, the drug listing will be added to the FDA’s database in around two business days.  FDA NDC database will confirm the drug listing and its status will be indicated. Drug listings must be updated annually to ensure their status is active.

Yes, there is no cost for listing drugs with the FDA.

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