Drugs

Electronic Registration and Listing Compliance Program

Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL). Establishment registrations and drug listing data provide the agency with a list of all drug manufacturers currently manufacturing drugs for U.S. commercial distribution and a current inventory of all drugs in the U.S. commercial distribution. Part of this data is published online in the FDA National Drug Code Directory, FDA Label Repository, FDA Drug Establishment Current Registration Site and NIH’s DailyMed for public, health care professionals, and healthcare industry access.

Requirements for establishment registration and drug listing are outlined in section 510 of the Federal Food, Drug, and Cosmetic Act and part 207 of Title 21 of the Code of Federal Regulations (CFR), which was revised in 2016 and went into effect on November 29 of the same year.

Accuracy and integrity of establishment registration and drug listing data are essential to the FDA’s mission to minimize the exposure of the public to unsafe and ineffective drugs. Several key programs inside and outside the agency such as inspections and reimbursement rely upon registration and listing information. Although FDA has several automated validation rules in place to stop the submission of inaccurate and incomplete data at its entry point, many steps within the process cannot be automated.

Our compliance program focuses on ways to find inaccuracies in the data after it has been submitted to the agency. We subsequently take action to have firms correct those data inaccuracies and ultimately remove them from the public sites if corrections are not made as required. Certain violations of the FD&C Act can result in further actions such as a warning letter. To date, FDA has issued the following warning letters:

If you have any questions about our registration and listing compliance program, or if you believe our published registration or listing data includes any error, please contact us at eDRLS@fda.hhs.gov.

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Page Last Updated: 06/19/2017
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