Drugs

Drug Registration and Listing System (DRLS & eDRLS)

The Office of Compliance, Immediate Office oversees the electronic Drug Registration and Listing System (eDRLS), a key component of the Food and Drug Administration’s (FDA) ability to monitor drug safety.

Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S.  Additionally, foreign establishments must identify a U.S. agent and importers at the time of their registration. 

Registration information must be renewed annually. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual establishment registrations in the period from October 1st to December 31st of each calendar year. In addition, we remind you that at the time of annual registration, firms must list any drugs not previously listed. The FDA no longer accepts drug establishment registration and drug listing information in paper format unless a waiver is granted.  For information and instructions on filing registration and listing submissions, go to our the Electronic Drug Registration and Listing Instructions page.

Any additional updates to drug listing information must be submitted in June and December of each year. Drug establishment registration information allows FDA to identify all manufacturing facilities involved in producing drugs that are in commercial distribution in the United States, and drug listing information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drugs that are manufactured in establishments that are not properly registered and drugs that are not properly listed as required are misbranded and may be subject to regulatory action.

The FDA relies on registration and listing information for administering many key programs, including postmarketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.

New Information: Human Drug Compounding Registration And Product Reporting Procedures
Due to a continuing technical problem, the Food and Drug Administration (FDA) is not prepared to accept product reports from 503B outsourcing facilities for the December 2014 through May 2015 reporting period via Structured Product Labeling.  As a result, to satisfy the June 2015 product reporting requirement in section 503B(b)(2) of the Federal Food, Drug, and Cosmetic Act,  outsourcing facilities should submit reporting data to FDA in an Excel spreadsheet via an email attachment (see the draft guidance, Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act).  Reports must include drug products compounded during the six month period from December 1, 2014 through May 30, 2015. Product reports should be submitted to edrls@fda.hhs.gov.  Section 503B requires outsourcing facilities to submit product reports for this reporting period between June 1, 2015 and June 30, 2015 to satisfy their product reporting obligation.
 
For each drug identified in a product report, the outsourcing facility must provide the following information:
  • The National Drug Code (NDC) number of the final product, if assigned
  • The active ingredient and strength of active ingredient per unit;
  • The National Drug Code number of the source drug or bulk active ingredient, if available;
  • The source of the active ingredient;
  • The dosage form and route of administration;
  • The package description; and
  • The number of individual units produced;
 
Attached is an Excel template that you can use for your report.
FDA will review each product report upon receipt and contact you if we have any questions.

 

FDA has published guidances on registering and reporting product information for those entities that intend to register as outsourcing facilities per The Drug Quality and Security Act (DQSA). Further information can be found under Related Resources or on the Electronic Drug Registration and Listing Instructions page.
 
Related Resources 

 

Page Last Updated: 06/03/2015
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