Drugs

Drug Registration and Listing System (DRLS & eDRLS)

Notice To All 503B Outsourcing Facilities
Product Reporting Technical Problem

Due to a technical problem with the product reporting system, outsourcing facilities are currently unable to send Source NDC data in the HUMAN COMPOUNDED DRUG LABEL document type when submitting 503B product reports using FDA’s drug registration and listing system. Therefore, at this time, outsourcing facilities do not need to provide the Source NDC for active ingredients when submitting product reports for the June 2014 - November 2014 reporting period.  

Outsourcing facilities that use CDER Direct to complete their product reports should choose/use “Active Ingredient, Ingredient is the Basis of Strength” as the ingredient type for their active ingredients when completing the product report.  The Source NDC field will not appear, and outsourcing facilities should fill out the rest of the ingredient information as appropriate.

Outsourcing facilities that use alternate methods to generate and submit Structured Product Labeling (SPL) product reports should make whatever changes are necessary to identify all active ingredients, but need not provide the Source NDC for active ingredients when submitting product reports for the June 2014 - November 2014 reporting period.

For additional information, please refer to FDA’s guidance documents concerning 503B registration and product reporting.


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

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: 12/24/2014
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